Systems and methods for diabetes management

Abstract

Systems, devices, and methods are provided for incorporating a drug delivery device into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose monitor, a connected insulin pen, and software. An integrated management system may generate a plurality of reports, which may include data related to analyte levels (e.g., glucose levels) and delivered drugs (e.g., delivered insulin). The drug delivery device may also provide feedback to the user.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 392,753, filed on July 27, 2022, the entire contents of which are expressly incorporated herein by reference for all purposes. This application is also related to U.S. Provisional Application No. 63 / 177,706, filed on April 21, 2021, and U.S. Provisional Application No. 63 / 236,910, filed on August 25, 2021, the entire contents of which are expressly incorporated herein by reference for all purposes. Technical Field

[0003] The subject matter described herein generally relates to systems, devices, and methods related to an integrated system for diabetes management, such as, for example, an integrated platform that connects insulin pens with a common viewing platform so that data can be shared among multiple parties. Background Art

[0004] Detection and / or monitoring of analyte levels (e.g., glucose, ketones, lactate, oxygen, hemoglobin A1C, etc.) can be extremely important to the health of individuals with diabetes. Diabetic patients may experience complications, including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients often need to monitor their glucose levels to ensure that they remain within a clinically safe range, and can also use this information to determine whether and / or when insulin is needed to lower the glucose level in their body or when additional glucose is needed to raise the glucose level in their body.

[0005] Growing clinical data demonstrates a strong correlation between glucose monitoring frequency and glycemic control. Despite this correlation, many individuals diagnosed with diabetes do not monitor their glucose levels as frequently as they should due to a combination of factors including inconvenience, test judgment, pain associated with glucose testing, and cost.

[0006] For patients who rely on the administration of medications (e.g., insulin) to treat or manage diabetes, it is desirable to have a system, device, or method that can integrate glucose data with insulin dosage data and provide more actionable insights to both patients, caregivers, and HCPs. Manual recording of insulin dosages is not only a huge time investment, but also often results in inaccurate dosage records. In addition, sharing these manual records with HCPs is cumbersome for patients and fraught with workflow issues.

[0007] Therapeutic management of diabetes often requires the use of multiple medications with different delivery frequencies (i.e., daily, weekly) and routes of administration (oral or injectable). The combination of medication type, delivery frequency, and route of administration can be difficult to manage, placing a significant cognitive burden on the user, which often translates into poor consistency in dosing regimens. Studies have shown that in insulin-dependent people with type 1 diabetes, up to 24% of mealtime rapid-acting insulin boluses and 36% of once-daily long-acting basal doses are missed, leading to poor glucose control and diabetes management. Existing dose logs are only useful when the user wants to record them. Their effectiveness is directly related to the user's willingness to record doses and refer to past records. The dawn of connected dosing technology, such as insulin pens, has enabled doses to be automatically recorded into a companion mobile phone application as they are delivered without user action. While useful in daily management, this approach has two significant disadvantages: (1) it cannot be directly correlated with blood glucose results; and (2) insulin doses are typically presented in a table format that is difficult to read and interpret over a large time window.

[0008] For these and other reasons, there is a need for improved systems, methods, and apparatus relating to integrated systems for diabetes management. Summary of the invention

[0009] Provided herein is an exemplary embodiment of a system, device and method related to diabetes management, including an integrated management system, which includes an analyte monitoring device, a drug delivery device, a reader device, monitoring software and reporting software. In many embodiments, an analyte monitoring device (e.g., continuous or transient (flash) glucose monitor) and a drug delivery device (e.g., an insulin pen) are coupled to the reader device communication ground, so that analyte data, dosage record and other information can be easily transmitted to a computing device including monitoring and / or reporting software. The integrated system can include a GUI display, which indicates and helps a user to connect the drug delivery device to the monitoring software on, for example, a reader device, so that dosage records and other information can be transmitted from the drug delivery device. The integrated system also includes reporting software, which can produce multiple reports, and these reports are combined with data about analyte levels and measurement and drug dosage and measurement.

[0010] The method addresses both of these issues by utilizing glucose data as an indicator of poor dosage consistency and presenting the data in a manner that allows a trained health care professional to quickly identify situations where poor drug dosage consistency leads to poor glycemic control. In some embodiments, glucose data may be the sole indicator of poor dosage consistency.

[0011] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or will become apparent to one skilled in the art upon examination of the following drawings and detailed description. All such additional systems, devices, methods, features, and advantages are intended to be included within this specification, within the scope of the subject matter described herein, and protected by the appended claims. In the absence of explicit recitation of features of the exemplary embodiments in the claims, those features should in no way be construed as limiting the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The details of the subject matter described herein regarding its structure and operation may be apparent by studying the accompanying drawings, in which like reference numerals refer to like parts. The components in the drawings are not necessarily to scale, but emphasis is placed on illustrating the principles of the subject matter. In addition, all illustrations are used to convey concepts, in which relative sizes, shapes and other detailed attributes may be shown schematically rather than literally or precisely.

[0013] Figure 1A and 1B is a block diagram of an example embodiment of an integrated management system.

[0014] Figure 2A is a schematic diagram depicting an example embodiment of a sensor control device.

[0015] Figure 2B is a block diagram depicting an example embodiment of a sensor control device.

[0016] Figure 3A is a schematic diagram depicting an exemplary embodiment of a drug delivery device.

[0017] Figure 3B is a block diagram depicting an example embodiment of a drug delivery device.

[0018] Figure 3C is a schematic diagram depicting an example embodiment of a drug delivery device having a smart button.

[0019] Figure 4A is a schematic diagram depicting an exemplary embodiment of a display device.

[0020] Figure 4B is a block diagram depicting an exemplary embodiment of a display device.

[0021] Figure 5 is a block diagram depicting an example embodiment of a user interface device.

[0022] Figure 6 is a flow diagram of a user experience of an example embodiment of an integrated management system.

[0023] Figure 7is a flow chart of the user experience of adding a drug delivery device to an integrated management system.

[0024] Fig. 8A is a block diagram depicting an example embodiment of a snapshot report.

[0025] Figures 8B-8C is an example embodiment of a snapshot report.

[0026] Fig. 9A is a block diagram depicting an example embodiment of a weekly summary report.

[0027] Figure 9B-9G is an example embodiment of a weekly summary report.

[0028] Fig. 10A is a block diagram depicting an example embodiment of a daily log report.

[0029] Figures 10B-10C is an example embodiment of a daily log report.

[0030] Fig.11A is a block diagram depicting an example embodiment of a daily pattern report.

[0031] Figures 11B-11C is an example embodiment of a daily pattern report.

[0032] Figures 11D-11E is an exemplary embodiment of a daily pattern report GUI that may be displayed on a display device.

[0033] Fig. 12A is a block diagram depicting an example embodiment of a mealtime pattern report.

[0034] Figures 12B-12C is an example embodiment of a meal time pattern report.

[0035] Fig.13A is a block diagram depicting an example embodiment of a device detail report.

[0036] Fig. 13B is an example embodiment of a device detail report.

[0037] Fig.14 is a block diagram depicting an example embodiment of an AGP report.

[0038] Fig.15A is a block diagram depicting an example embodiment of a GUI from a patient dashboard.

[0039] Fig. 15B is an example embodiment of a GUI from a patient dashboard.

[0040] Fig.16Ais a block diagram depicting an example embodiment of a GUI associated with a data source Modal having a connected pen.

[0041] Fig. 16B is an example embodiment of a GUI associated with a data source Modal having a connected pen.

[0042] Fig.17A is a block diagram depicting an example embodiment of an alert associated with a connected insulin pen.

[0043] Fig. 17B is an example embodiment of an alert associated with a connected insulin pen.

[0044] Figures 18A-18B is a block diagram depicting an example embodiment of comparing AGP reports.

[0045] Fig.18C is an exemplary AGP showing all data.

[0046] Fig.18D is an exemplary AGP showing data excluding missed doses.

[0047] Fig.19 is an example embodiment of a comparison report.

[0048] Figures 20A-20D is an example embodiment of a GUI for connecting a medical delivery device with a monitoring application.

[0049] Figures 20E-20F is an example embodiment of a GUI for managing a user's connected medication delivery devices.

[0050] Figures 21A-21B is an example embodiment of a GUI for downloading and viewing medication records. Fig. 21C is an example embodiment of a GUI for editing medication dosage annotations.

[0051] Fig.21D is an example embodiment of a GUI for prompting a user to learn to connect a drug delivery device.

[0052] Fig. 22 is an example embodiment of a GUI for customizing the name of a drug delivery device. Figures 23A-23C is an example embodiment of a GUI for errors involving transmitted data. Figures 24A-24C is an example embodiment of an insulin summary report GUI.

[0053] Fig.25 is an exemplary method for displaying a missed meal dose alert or message.

[0054] Fig.26is an exemplary method for displaying a correction dose alarm or message.

[0055] Fig. 27 is an exemplary method for displaying a congratulatory reminder or message.

[0056] Fig.28A -E is an exemplary embodiment of a daily view report GUI.

[0057] Fig.29A -D is an exemplary method for displaying analyte profiles based on filtered data. Fig. 30A -C is an exemplary method for displaying analyte metrics based on filtered data. Fig.31A -B is an exemplary method for providing feedback on a drug delivery device. Fig.32A are exemplary methods for providing tactile feedback on a drug delivery device. Fig.32B is an exemplary method for providing a safety measure against administering a higher than recommended dose.

[0058] Fig.32C An exemplary method of adjusting alarm parameters in response to a medication dose is provided.

[0059] Figures 32D-32G is an exemplary method for providing protection against late dosing.

[0060] Fig.32H is an exemplary method of providing a safety measure when a zero dose is recommended.

[0061] Fig.32I is an exemplary method of how the action of a drug delivery device affects the display of a reader device.

[0062] Fig.32J is an exemplary method of providing a quick way of delivering a dose to a drug delivery device.

[0063] Fig.33A is a side view of the attached pen.

[0064] Fig.33B yes Fig.33A End view of the pen connected in.

[0065] Figures 34A-34D Medication pen and smart button are depicted.

[0066] Fig.35 is a diagram of an exemplary drug pump. DETAILED DESCRIPTION

[0067] Before describing the present subject matter in detail, it should be understood that the present disclosure is not limited to the specific embodiments described herein, as these may of course vary. It should also be understood that the terminology used herein is only for the purpose of describing specific embodiments and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0068] In general, embodiments of the present disclosure include systems, devices, and methods related to integrated diabetes management. An integrated diabetes management system may include an intelligent delivery system, such as a connected smart insulin pen, a glucose sensor, software for receiving and processing data from the glucose sensor and the intelligent delivery system, and a viewing platform capable of determining and visualizing dosage analysis. An integrated management system (IMS) may also include reports that include an understanding of the effects of various insulin doses and treatment recommendations, including medication recommendations.

[0069] Integrated diabetes management can be implemented as software and / or firmware instructions stored in the memory of a computing device for execution by at least one processor or its processing circuit. The computing device can be owned by a user or a health care professional (HCP), and the user or HCP can interface with the computing device through a user interface. According to some embodiments, the computing device can be a server or a trusted computer system accessible via a network, and the integrated management software can be presented to the user in the form of an interactive web page through a browser executed on a local display device (with a user interface), and the local display device communicates with the server or trusted computer system through a network. In this and other embodiments, the integrated management software can be executed across multiple devices, or partially executed on the processing circuit of the local display device and partially executed on the processing circuit of the server or trusted computer system. It will be understood by those skilled in the art that when the IMS is described as performing an action, such an action is performed according to instructions stored in a computer memory (including instructions hard-coded in a read-only memory), which, when executed by at least one processor of at least one computing device, causes the IMS to perform the described action. In all cases, in contrast to being performed by instructions stored in a memory, the action can be performed by hardware (e.g., a dedicated circuit) that is hardwired to implement the action instead.

[0070] In addition, as used herein, the system on which IMS is implemented can be referred to as an integrated management system. The integrated management system can be configured to provide the sole purpose of integrated management, or can be a multifunctional system in which integrated management is only one aspect. For example, in some embodiments, the integrated management system can also monitor the analyte level of the user. In some embodiments, the integrated management system can also deliver drugs to the user, for example, using injection or infusion equipment. In some embodiments, the integrated management system can monitor both analytes and delivered drugs.

[0071] These embodiments and other embodiments described herein represent improvements in the field of computer-based dosage determination, analyte monitoring, and drug delivery systems.Specific features and potential advantages of the disclosed embodiments are discussed further below.

[0072] Before describing the integrated management embodiments in detail, it is first desirable to describe an example of an integrated management system upon or through which an integrated management application may be implemented.

[0073] Example Embodiments of Integrated Systems

[0074] Figure 1A is a block diagram depicting an example embodiment of an integrated system 100. In this embodiment, the integrated management system 100 is capable of delivering one or more medications, recording medication dosages, monitoring one or more analytes, determining and viewing analyses, and providing treatment recommendations. This multi-functional example serves to illustrate the high degree of interconnectivity and performance available with the system 100.

[0075] Here, the system 100 includes a sensor control device (SCD) 102 configured to collect analyte level information from a user, a drug delivery device (MDD) 152 configured to deliver a drug to a user, and a display device 120 configured to present information to a user and receive input or information from a user. The structure and function of each device will be described in detail herein. The system 100 is configured for highly interconnected and highly flexible communications between devices. Each of the three devices 102, 120 and 152 can communicate directly with each other (without passing through an intermediate electronic device) or indirectly with each other (such as through a cloud network 190, or through another device and then through the network 190). In Figure 1A The bidirectional communication capability between devices and between each device and network 190 is shown by bidirectional arrows. However, those skilled in the art will appreciate that any of one or more devices (e.g., SCDs) may be capable of unidirectional communication, such as broadcast, multicast, or advertising communication. In each case, whether bidirectional or unidirectional, the communication may be wired or wireless. The protocols governing the communication on each path may be the same or different and may be proprietary or standardized. For example, the Bluetooth (include Wireless communications between devices 102, 120, and 152 may be performed using a wireless (Low Energy) standard, a Near Field Communication (NFC) standard, a Wi-Fi (802.11x) standard, a mobile phone standard, or other standards. All communications on each path may be encrypted, and Figure 1A Each device may be configured to encrypt and decrypt those communications that are sent and received. In each case, Figure 1A The communication path can be direct (e.g., Bluetooth or NFC) or indirectly (e.g., Wi-Fi, mobile phone, or other Internet protocols). Embodiments of system 100 do not require Figure 1A The ability to communicate across all paths indicated in .

[0076] In addition, although Figure 1A A single display device 120, a single SCD 102, and a single MDD 152 are depicted, but those skilled in the art will appreciate that the system 100 may include a plurality of any of the above devices. By way of example only, the system 100 may include a single SCD 102 that communicates with a plurality (e.g., two, three, four, etc.) of display devices 120 and / or a plurality of MDDs 152. Alternatively, the system 100 may include a plurality of SCDs 102 that communicate with a single display device 120 and / or a single MDD 152. Furthermore, each of the plurality of devices may be the same or a different device type. For example, the system 100 may include a plurality of display devices 120, including a smart phone, a handheld receiver, and / or a smart watch, each of which may communicate with the SCD 102 and / or the MDD 152, as well as with each other.

[0077] Analyte data can be transmitted between each device within the system 100 in an autonomous manner (e.g., automatically sent according to a schedule) or in response to a request for analyte data (e.g., a request for analyte data is sent from a first device to a second device, followed by the analyte data being sent from the second device to the first device). Other techniques for transmitting data can also be employed to accommodate more complex systems like the cloud network 190.

[0078] Figure 1B1 is a block diagram depicting another example embodiment of an integrated management system 100. Here, the system 100 includes an SCD 102, an MDD 152, a first display device 120-1, a second display device 120-2, a local computer system 170, and a trusted computer system 180 accessible by a cloud network 190. The SCD 102 and the MDD 152 are capable of communicating with each other and with the display device 120-1, which can act as a communication hub for aggregating information from the SCD 102 and the MDD 152, processing the information and displaying the information where desired, and transmitting some or all of the information to the cloud network 190 and / or the computer system 170. Conversely, the display device 120-1 can receive information from the cloud network 190 and / or the computer system 170, and transmit some or all of the received information to the SCD 102, the MDD 152, or both. The computer system 170 can be a personal computer, a server terminal, a laptop computer, a tablet computer, or other suitable data processing device. Computer system 170 may include or provide software for data management and analysis and for communicating with components in system 100. Computer system 170 may be used by a user or medical professional to display and / or analyze analyte data measured by SCD 102. Figure 1B A single SCD 102, a single MDD 152, and two display devices 120-1 and 120-2 are depicted, but those skilled in the art will appreciate that system 100 may include a plurality of any of the foregoing devices, wherein each of the plurality of devices may include the same or different types of devices.

[0079] Still reference Figure 1BAccording to some embodiments, the trusted computer system 180 may be physically or virtually owned by a manufacturer or distributor of components of the system 100 through a secure connection, and may be used to perform authentication of devices (e.g., devices 102, 120-n, 152) of the system 100, to securely store a user's data, and / or as a server serving a data analysis program (e.g., accessible via a web browser) to perform analysis on the user's measured analyte data and medication history. The trusted computer system 180 may also act as a data hub for routing and exchanging data between all devices that communicate with the system 180 through the cloud network 190. In other words, all devices of the system 100 that are capable of communicating with the cloud network 190 (e.g., directly connected to the Internet or indirectly via another device) are also capable of communicating with all other devices of the system 100 that are capable of communicating directly or indirectly with the cloud network 190. Display device 120-2 is depicted as communicating with the cloud network 190. In this example, device 120-2 may be owned by another user who is authorized to access the analyte and medication data of the person wearing SCD 102. For example, the person who owns display device 120-2 may be a parent of a child wearing SCD 102 as one example, or a caregiver of an elderly patient wearing SCD 102 as another example. System 100 may be configured to communicate analyte and medication data about the wearer to another user who has authorized access to the data over cloud network 190 (e.g., via trusted computer system 180).

[0080] Exemplary Embodiments of Analyte Monitoring Devices The analyte monitoring functionality of the integrated management system 100 may be implemented by including one or more devices capable of collecting, processing, and displaying analyte data for a user. Exemplary embodiments of such devices and methods of using them are described in International Publication No. WO2018 / 152241 and U.S. Patent Publication No. 2011 / 0213225, the entire contents of which are incorporated herein by reference for all purposes.

[0081] Analyte monitoring can be performed in a variety of different ways. For example, a "continuous analyte monitoring" device (e.g., a "continuous glucose monitoring" device) can automatically and continuously or repeatedly send data from a sensor control device to a display device, such as according to a schedule, with or without a prompt. As another example, a "transient analyte monitoring" device (e.g., a "transient glucose monitoring" device or simply referred to as a "transient" device) can be transmitted from a sensor control device in response to a request for data initiated by a user through a display device (such as using a near field communication (NFC) or radio frequency identification (RFID) protocol) (e.g., scanning). An analyte monitoring device using a sensor configured to be partially or entirely placed in the user's body can be referred to as an in vivo analyte monitoring device. For example, an in vivo sensor can be placed in the user's body so that at least a portion of the sensor is in contact with a body fluid (e.g., interstitial (ISF) fluid, such as dermal fluid in the dermis or subcutaneous fluid under the dermis, blood or other), and the analyte concentration in the body fluid can be measured. In vivo sensors can use various types of sensing techniques (e.g., chemical, electrochemical or optical). Some systems using in vivo analyte sensors can also operate without the need for finger puncture calibration.

[0082] "In vitro" devices are those in which the sensor is brought into contact with a biological sample outside the body (or more precisely "ex vivo"). These devices typically include a port for receiving an analyte test strip carrying a user's bodily fluid that can be analyzed to determine the user's blood glucose level. Other in vitro devices have been proposed that attempt to non-invasively measure a user's in vivo analyte levels, such as by using optical techniques that can measure in vivo analyte levels without mechanically penetrating the user's body or skin. In vivo and ex vivo devices typically include in vitro capabilities (e.g., an in vivo display device that also includes a test strip port).

[0083] The present subject matter will be described with respect to sensors capable of measuring glucose concentration, but detection and measurement of concentrations of other analytes are within the scope of the present disclosure. These other analytes may include, for example, ketones, lactate, oxygen, hemoglobin A1C, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormone, hormones, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, troponin, etc. The concentration of drugs may also be monitored, such as antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin. The sensor may be configured to measure two or more different analytes at the same or different times. In some embodiments, a sensor control device may be coupled to two or more sensors, one of which is configured to measure a first analyte (e.g., glucose), and the other one or more sensors are configured to measure one or more different analytes (e.g., any of those described herein). In other embodiments, a user may wear two or more sensor control devices, each capable of measuring a different analyte.

[0084] The embodiments described herein may be used with all types of in vivo, in vitro, and ex vivo devices capable of monitoring the analytes described above and other analytes.

[0085] In many embodiments, the sensor operation can be controlled by SCD 102. The sensor can be mechanically and communicatively coupled to SCD 102, or can be communicatively coupled to SCD 102 using only wireless communication technology. SCD 102 can include electronic devices and power sources that enable and control the analyte sensing performed by the sensor. In some embodiments, the sensor or SCD 102 can be self-powered, so that no battery is required. SCD 102 can also include a communication circuit for communicating with another device (e.g., a display device) that may or may not be local to the user's body. SCD 102 can reside on the user's body (e.g., attached to or otherwise placed on the user's skin, or carried in the user's clothing, etc.). SCD 102 can also be implanted in the user's body with the sensor. The functions of SCD 102 can be divided between a first component implanted in the body (e.g., a component that controls the sensor) and a second component residing on or outside the body (e.g., a relay component that communicates with the first component and also communicates with an external device such as a computer or smart phone). In other embodiments, the SCD 102 may be external to the body and configured to non-invasively measure the user's analyte level. Depending on the actual implementation or embodiment, the sensor control device may also be referred to as a "sensor control unit", "on-body electronics" device or unit, "on-body" device or unit, "in-vivo electronics" device or unit, "in-vivo" device or unit, or "sensor data communication" device or unit, to name a few examples. In some embodiments, the SCD 102 may include a user interface (or user interface) (e.g., a touch screen) and is capable of processing analyte data and displaying the resulting calculated analyte level to the user. In this case, the integrated management embodiments described herein may be implemented in whole or in part directly by the SCD 102. In many embodiments, the physical form factor of the SCD 102 is minimized (e.g., to minimize appearance on the user's body) or the sensor control device may be inaccessible to the user (e.g., if fully implanted), or other factors may make it desirable to have a display device that can be used by the user to read the analyte level and interface with the sensor control device.

[0086] Figure 2A 1 is a side view of an example embodiment of an SCD 102. The SCD 102 may include a housing or base 103 for sensor electronics ( Figure 2B), which can be electrically coupled to the analyte sensor 101, which is configured here as an electrochemical sensor. According to some embodiments, the sensor 101 can be configured to reside partially within the user's body (e.g., through the outermost surface of the skin), where it can be in fluid contact with the user's bodily fluids and used together with the sensor electronics to measure the user's analyte-related data. A structure for attachment 105, such as an adhesive patch, can be used to secure the housing 103 to the user's skin. The sensor 101 can extend through the attachment structure 105 and protrude from the housing 103. Those skilled in the art will understand that other forms of attachment to the body and / or housing 103 can be used in addition to or in place of an adhesive and are fully within the scope of the present disclosure.

[0087] The SCD 102 can be applied to the body in any desired manner. For example, an insertion device (not shown), sometimes referred to as an applicator, can be used to position all or part of the analyte sensor 101 through the outer surface of the user's skin and contact it with the user's body fluids. In doing so, the insertion device can also position the SCD 102 on the skin. In other embodiments, the insertion device can first position the sensor 101, and then the accompanying electronic device (e.g., wireless transmission circuit and / or data processing circuit, etc.) can be coupled to the sensor 101 manually or with the aid of a mechanical device (e.g., inserted into a mounting member). Examples of insertion devices are described in U.S. Patent Publications 2008 / 0009692, 2011 / 0319729, 2015 / 0018639, 2015 / 0025345 and 2015 / 0173661, 2018 / 0235520, all of which are incorporated herein by reference as a whole for all purposes.

[0088] Figure 2B is a block diagram depicting an example embodiment of an SCD 102 having an analyte sensor 101 and sensor electronics 104. The sensor electronics 104 may be implemented in one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), a processor or controller, a memory, a programmable gate array, etc.). Figure 1BIn an embodiment of the present invention, the sensor electronics 104 includes high-level functional units, including an analog front end (AFE) 110 configured to interface with the sensor 101 in an analog manner and convert analog signals to digital form and / or convert analog signals from digital form (e.g., using an A / D converter), a power supply 111 configured to power components of the SCD 102, processing circuits 112, memory 114, timing circuits 115 (e.g., such as oscillators and phase-locked loops for providing clocks or other timing to components of the SCD 102), and communication circuits 116 configured to communicate with one or more devices external to the SCD 102 (such as the display device 120 and / or the MDD 152) in a wired and / or wireless manner. The SCD 102 can be implemented in a highly interconnected manner, wherein the power supply 111 is connected to the SCD 102. Figure 2B Each of the components shown in the drawings is coupled, and those components that transmit or receive data, information, or commands (e.g., AFE 110, processing circuitry 112, memory 114, timing circuitry 115, and communication circuitry 116) may be communicatively coupled to each other such component via, for example, one or more communication connections or buses 118.

[0089] Processing circuitry 112 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or distributed among multiple different chips (and portions thereof). Processing circuitry 112 may include on-board memory. Processing circuitry 112 may interface with communication circuitry 116 and perform analog-to-digital conversion, encoding and decoding, digital signal processing, and other functions that facilitate converting data signals into a format suitable for wireless or wired transmission (e.g., in-phase and quadrature). Processing circuitry 112 may also interface with communication circuitry 116 to perform the reverse functions necessary to receive wireless transmissions and convert them into digital data or information.

[0090] The processing circuit 112 can execute instructions stored in the memory 114. These instructions can cause the processing circuit 112 to process the raw analyte data (or pre-processed analyte data) and arrive at the final calculated analyte level. In some embodiments, the instructions stored in the memory 114, when executed, can cause the processing circuit 112 to process the raw analyte data to determine whether one or more of the following: the calculated analyte level, the average calculated analyte level within a predetermined time window, the calculated rate of change of the analyte level within the predetermined time window, and / or the calculated analyte metric exceeds a predetermined threshold condition. These instructions can also cause the processing circuit 112 to read the received transmission and operate on it to adjust the timing of the timing circuit 115, process data or information received from other devices (e.g., calibration information, encryption or authentication information received from the display device 120, etc.), perform tasks to establish and maintain communication with the display device 120, interpret voice commands from the user, and cause the communication circuit 116 to send, etc. In embodiments where SCD 102 includes a user interface, the instructions may cause processing circuitry 112 to control the user interface, read user input from the user interface, cause information to be displayed on the user interface, format data for display, etc. The functionality encoded in the instructions described herein may alternatively be implemented by SCD 102 using hardware or firmware designs that do not rely on executing stored software instructions to implement the functionality.

[0091] Memory 114 may be shared by one or more of the various functional units present within SCD 102, or may be distributed between two or more of them (e.g., as separate memories present within different chips). Memory 114 may also be its own separate chip. Memory 114 is non-transitory and may be volatile (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.). Communication circuitry 116 may be implemented as one or more components (e.g., transmitters, receivers, transceivers, passive circuits, encoders, decoders, and / or other communication circuits) that perform functions for communicating on corresponding communication paths or links. Communication circuitry 116 may include or be coupled to one or more antennas for wireless communication.

[0092] The power supply 111 may include one or more batteries, which may be rechargeable or single-use disposable batteries. A power management circuit may also be included to regulate battery charging and monitor the use of the power supply 111, boost power, perform DC conversion, etc.

[0093] Additionally, on-skin or sensor temperature readings or measurements may be collected by an optional temperature sensor (not shown). These readings or measurements may be transmitted (either individually or as aggregated measurements over time) from SCD 102 to another device (e.g., display device 120). However, instead of or in addition to actually outputting the temperature measurements to the user, the temperature readings or measurements may be used in conjunction with a software routine executed by SCD 102 or display device 120 to correct or compensate the analyte measurements output to the user.

[0094] The exemplary embodiment insulin delivery system of drug delivery device can be classified according to whether delivery is carried out in an automatic or manual manner. At one end of the scope, the fully automatic insulin delivery system such as full closed-loop insulin delivery system is based on the information mainly from the glucose monitoring module such as CGM system, determines the insulin dosage and delivers the insulin dosage via insulin pump at any time. At the other end of the scope, the fully manual insulin delivery system relies on the user to determine appropriate dosage based on known information (for example, their health status, dietary consumption and CGM system) and insulin dosage calculation method. Then, the user can start insulin delivery on insulin delivery module or device, and the insulin delivery module or device are for example traditional insulin syringe, insulin pen, intelligent insulin pen or insulin pump. Somewhere in the middle is a decision support system (DSS), which can mainly receive information from glucose monitoring module (for example CGM system) and determine the insulin dosage suggestion, but requires the user to approve / deliver the dosage via corresponding insulin delivery module or equipment (MDD 152) (for example traditional insulin syringe, insulin pen, intelligent insulin pen or insulin pump). The system for determining dosage recommendation guidance is described in U.S. Patent Publication No. 2021 / 0050085 and U.S. Application Serial No. 17 / 591,229, which are expressly incorporated herein by reference in their entirety for all purposes. The drug delivery function of the integrated management system 100 can be implemented by including one or more drug delivery devices (MDD) 152. MDD 152 can be any device configured to deliver a specific dose of medicine. MDD 152 can also include a device that sends data about the dose to IMS, such as a pen cap, even if the device itself may not deliver the drug. MDD 152 can be configured as a portable injection device (PID), which can deliver a single dose, such as a pill, at each injection. PID can be a basic manually operated syringe, in which the drug is preloaded in the syringe or must be drawn into the syringe from a reservoir before injection. However, in most embodiments, the PID includes an electronic device for interacting with the user and performing drug delivery. PID is commonly referred to as a medicine pen, although a pen-like appearance is not required. PIDs with user interface electronics are commonly referred to as smart pens. PIDs can be used to deliver one dose and then be discarded, or can be durable and reused to deliver multiple doses over the course of a day, week, or month.Users practicing a multiple daily injection (MDI) treatment regimen often rely on PIDs.

[0095] The MDD may also include a pump and an infusion set. The infusion set includes a tubular cannula at least partially located within the recipient's body. The tubular cannula is in fluid communication with the pump, which can deliver the drug to the recipient's body through the cannula repeatedly in small increments over time. The infusion set can be applied to the recipient's body using an infusion set applicator, and the infusion set typically remains implanted for 2 to 3 days or longer. The pump device includes electronics for interfacing with a user and for controlling the slow infusion of the drug. Both the PID and the pump can store the drug in a drug reservoir.

[0096] The MDD 152 may be used as part of a closed-loop system (e.g., an artificial pancreas system that does not require user intervention to operate), a semi-closed-loop system (e.g., an insulin loop system that rarely requires user intervention to operate (e.g., to confirm changes in dosage)), or an open-loop system. For example, analyte levels of a diabetic patient may be monitored by the SCD 102 in a repetitive, automated manner, and this information may be sent to an application and incorporated into various analyses and reports.

[0097] In many embodiments, the integrated management system may include data for different types of insulin (e.g., rapid-acting (RA) insulin, short-acting insulin, intermediate-acting insulin (e.g., NPH insulin), long-acting (LA) insulin, ultra-long-acting insulin, and mixed insulin), and will be the same drug delivered by MDD 152. Types of insulin include human insulin and synthetic insulin analogs. Insulin may also include premixed preparations. However, the integrated management embodiments and drug delivery capabilities of MDD 152 described herein may be applied to other non-insulin drugs. Such drugs may include, but are not limited to, exenatide, exenatide sustained release, liraglutide, lixisenatide, semaglutide, pramlintide, metformin, SLGT1-i inhibitors, SLGT2-i inhibitors, and DPP4 inhibitors. The integrated management embodiments may also include combined therapies. Combination therapies may include, but are not limited to, insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs), insulin, and pramlintide.

[0098] For ease of describing the integrated management embodiments herein, MDD 152 is generally described in the form of a PID, particularly a smart pen. However, those skilled in the art will readily appreciate that MDD 152 may alternatively be configured as a pen cap, a pump, or any other type of drug delivery device.

[0099] In some embodiments, the IMS may include a connected pen cap. After the connected pen cap is attached to the insulin pen and paired with the display device, each time a dose of insulin is delivered, the connected pen cap may be displayed to the user, for example, via a display device. The dose data is automatically transmitted to the display device.

[0100] Figure 3A1 is a schematic diagram illustrating an example embodiment of an MDD 152 configured as a PID, particularly a smart pen. The MDD 152 may include a housing 154 for electronics, an injection motor, and a drug reservoir (see Figure 3B ), from which the drug can be delivered through the needle 156. The housing 154 may include a removable or detachable cap or cover 157, which, when attached, can shield the needle 156 when not in use and then be removed for injection. The MDD 152 may also include a user interface 158, which may be implemented as a single component (e.g., a touch screen for outputting information to a user and receiving input from a user) or as multiple components (e.g., a touch screen or display combined with one or more buttons, switches, or the like). The MDD 152 may also include an actuator 159, which may be moved, depressed, touched, or otherwise activated to begin delivering the drug from the internal reservoir through the needle 156 into the recipient's body. According to some embodiments, the cap 157 and actuator 159 may also include one or more safety mechanisms to prevent removal and / or actuation to mitigate the risk of harmful drug injection. Details of these safety mechanisms and others are described in U.S. Patent Publication No. 2019 / 0343385 (the '385 publication), the entire contents of which are incorporated herein for all purposes. Figure 3C 1 is a schematic diagram of an MDD 152 and a smart button configured to be mounted above an actuator of a delivery pen. The MDD 152 can be a disposable drug delivery pen, which can include a display 158 and a dose selector, such as a rotatable adjustment disk for selecting a dose. The smart button 2190 can be mounted above the medication selector and actuator 159 and snapped together with the pen 2180. After the smart button 2190 is paired with a reader device, the smart button 2190 can track the dose, store medication data and transmit it to the reader device. The drug can be delivered by pushing straight down on the smart button 2190 to inject the dose. The smart button 2190 can also include a display that can display the recommended dose and / or the dose administered. The terms "recommended dose" and "dose recommendation" are used interchangeably herein.

[0101] Figure 3Bis a block diagram depicting an example embodiment of an MDD 152 having electronics 160 coupled to a power source 161 and an electro-injection motor 162, which in turn is coupled to the power source 161 and a drug reservoir 163. A needle 156 is shown as being in fluid communication with the reservoir 163, and a valve (not shown) may be present between the reservoir 163 and the needle 156. The reservoir 163 may be permanent, or may be removable and replaced with another reservoir containing the same or a different drug. The electronics 160 may be implemented in one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), a processor or controller, a memory, a programmable gate array, etc.). In Figure 3B In an embodiment of the present invention, the electronic device 160 may include high-level functional units, including processing circuitry 164, memory 165, communication circuitry 166 configured to communicate with one or more devices external to the MDD 152 (e.g., the display device 120) in a wired and / or wireless manner, and user interface electronic devices 168.

[0102] MDD 152 can be implemented in a highly interconnected manner, where power supply 161 and Figure 3B 165 and communication circuit 166) can be communicatively coupled to each of the components shown in the figure, and those components (e.g., processing circuit 164, memory 165, and communication circuit 166) that transmit or receive data, information, or commands can be communicatively coupled to each other such component via (for example) one or more communication connections or buses 169. Processing circuit 164 can include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which can be a discrete chip or distributed among multiple different chips (and parts thereof). Processing circuit 164 can include on-board memory. Processing circuit 164 can interface with communication circuit 166 and perform analog-to-digital conversion, encoding and decoding, digital signal processing, and other functions that help convert data signals into a format suitable for wireless or wired transmission (e.g., in-phase and orthogonal). Processing circuit 164 can also interface with communication circuit 166 to perform the reverse functions necessary to receive wireless transmissions and convert them into digital data or information.

[0103] Processing circuit 164 may execute software instructions stored in memory 165. These instructions may cause processing circuit 164 to receive a selection or provision of a specified dose from a user (e.g., input via user interface 158 or received from another device), process a command to deliver the specified dose (e.g., a signal from actuator 159), and control motor 162 to cause delivery of the specified dose. These instructions may also cause processing circuit 164 to read and act on received transmissions, to process data or information received from other devices (e.g., calibration information, encryption or authentication information received from display device 120, etc.), to perform tasks to establish and maintain communications with display device 120, to interpret voice commands from a user, to cause communication circuit 166 to transmit, etc. In embodiments where MDD 152 includes user interface 158, the instructions may cause processing circuit 164 to control the user interface, read user input from the user interface (e.g., to enter a drug dose for administration or to enter confirmation of a recommended drug dose), to cause information to be displayed on the user interface, to format data for display, and so forth. The functionality encoded in instructions described herein may instead be implemented by MDD 152 using hardware or firmware designs that do not rely on execution of stored software instructions to achieve the described functionality.

[0104] Memory 165 may be shared by one or more of the various functional units present within MDD 152, or may be distributed among two or more of them (e.g., as separate memories present in different chips). Memory 165 may also be its own separate chip. Memory 165 is non-transitory and may be volatile (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

[0105] The communication circuitry 166 may be implemented as one or more components (e.g., transmitters, receivers, transceivers, passive circuits, encoders, decoders, and / or other communication circuits) that perform functions for communicating over corresponding communication paths or links. The communication circuitry 166 may include or be coupled to one or more antennas for wireless communication. Details of exemplary antennas may be found in the '385 disclosure, the entire contents of which are incorporated herein for all purposes. The power supply 161 may include one or more batteries, which may be rechargeable or single-use disposable batteries. Power management circuitry may also be included to regulate battery charging and monitor usage of the power supply 161, boost power, perform DC conversion, etc.

[0106] MDD 152 may also include an integrated or attachable in vitro blood glucose meter, including an in vitro test strip port (not shown) to receive an in vitro glucose test strip for performing in vitro blood glucose measurements.

[0107] Example embodiments of display devices The display device 120 can be configured to display information about the system 100 to the user, and accept or receive input from the user also about the system 100. The display device 120 can display the most recently measured analyte level to the user in any number of forms. The display device can display the user's historical analyte level and other metrics describing the user's analyte information (e.g., time in range, ambulatoryglucose profile (AGP), hypoglycemia risk level, etc.). The display device 120 can display drug delivery information, such as historical dosage information and administration time and date. The display device 120 can display alarms, warnings, or other notifications about analyte levels and / or drug delivery.

[0108] The display device 120 can be dedicated to the system 100 (e.g., an electronic device designed and manufactured for the primary purpose of interfacing with an analyte sensor and / or a drug delivery device), as well as a device as a multi-function general-purpose computing device, such as a handheld or portable mobile communication device (e.g., a smart phone or tablet) or a laptop computer, a personal computer or other computing device. The display device 120 can be configured as a mobile intelligent wearable electronic component, such as smart glasses, or a smart watch or wristband. The display device and its variants can be referred to as a "reader device", "reader", "handheld electronic device" (or handheld device), "portable data processing" device or unit, "information receiver", "receiver" device or unit (or simply receiver), "relay" device or unit, or "remote" device or unit, just to name a few examples.

[0109] Figure 4A 1 is a schematic diagram depicting an example embodiment of a display device 120. Here, the display device 120 includes a user interface 121 and a display device electronics 130 ( Figure 4B ) of the housing 124. The user interface 121 may be implemented as a single component (e.g., a touch screen capable of input and output) or multiple components (e.g., a display and one or more devices configured to receive user input). In this embodiment, the user interface 121 includes a touch screen display 122 (configured to display information and graphics and accept user touch input) and an input button 123, both of which are coupled to the housing 124.

[0110] Display device 120 may have software stored thereon (e.g., by the manufacturer or downloaded by the user in the form of one or more "applications" or other software packages) that interfaces with SCD 102, MDD 152, and / or a user. Additionally or alternatively, the user interface may be effected by a web page displayed on a browser or other Internet interface software executable on display device 120.

[0111] Figure 4B is a block diagram of an exemplary embodiment of a display device 120 having display device electronics 130. Here, the display device 120 includes: a user interface 121, which includes a display 122 and input components 123 (e.g., buttons, actuators, touch-sensitive switches, capacitive switches, pressure-sensitive switches, scroll wheels, microphones, speakers, etc.); processing circuitry 131; memory 125; communication circuitry 126 configured to communicate with and / or communicate from one or more other devices external to the display device 120; a power supply 127; and timing circuitry 128 (e.g., such as an oscillator and phase-locked loop for providing a clock or other timing to components of the SCD 102). Each of the above components may be implemented as one or more different devices or may be combined into a multi-function device (e.g., the processing circuitry 131, memory 125, and communication circuitry 126 are integrated on a single semiconductor chip). The display device 120 can be implemented in a highly interconnected manner, with the power supply 127 and the communication circuitry 128 being interconnected. Figure 4B Each of the components shown in the drawings is coupled, and those components that transmit or receive data, information, or commands (e.g., user interface 121, processing circuitry 131, memory 125, communication circuitry 126, and timing circuitry 128) can be communicatively coupled to each other such component via, for example, one or more communication connections or buses 129. Figure 4B is a simplified representation of typical hardware and functionality that resides within a display device, and one of ordinary skill in the art will readily recognize that other hardware and functionality (e.g., codecs, drivers, glue logic) may also be included.

[0112] Processing circuit 131 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be a discrete chip or distributed among multiple different chips (and portions thereof). Processing circuit 131 may include on-board memory. Processing circuit 131 may interface with communication circuit 126 and perform analog-to-digital conversion, encoding and decoding, digital signal processing, and other functions that help convert data signals into a format suitable for wireless or wired transmission (e.g., in-phase and quadrature). Processing circuit 131 may also interface with communication circuit 126 to perform the reverse functions necessary to receive wireless transmissions and convert them into digital data or information.

[0113] The processing circuit 131 may execute software instructions stored in the memory 125. These instructions may cause the processing circuit 131 to process the raw analyte data (or pre-processed analyte data) and arrive at a corresponding analyte level suitable for display to the user. These instructions may cause the processing circuit 131 to read, process and / or store dosage instructions from the user, and cause the dosage instructions to be transmitted to the MDD 152. These instructions may cause the processing circuit 131 to execute user interface software suitable for presenting an interactive set of graphical user interface screens to the user for the purpose of configuring system parameters (e.g., alarm thresholds, notification settings, display preferences, etc.), presenting current and historical analyte level information to the user, presenting current and historical drug delivery information to the user, collecting other non-analyte information from the user (e.g., information about meals, activities performed, drugs administered, etc.), and presenting notifications and alarms to the user. The instructions may also cause processing circuitry 131 to cause communication circuitry 126 to send, may cause processing circuitry 131 to read and act on received transmissions, read input from user interface 121 (e.g., to enter a medication dose to be administered or to confirm a recommended medication dose), display data or information on user interface 121, adjust the timing of timing circuitry 128, process data or information received from other devices (e.g., analyte data, calibration information, encryption or authentication information received from SCD 102, etc.), perform tasks to establish and maintain communications with SCD 102, interpret voice commands from a user, etc. The functionality encoded in the instructions described herein may alternatively be implemented by display device 120 using a hardware or firmware design that does not rely on executing stored software instructions to implement the functionality.

[0114] The memory 125 may be shared by one or more of the various functional units present in the display device 120, or may be distributed among two or more of them (e.g., as separate memories present in different chips). The memory 125 may also be its own separate chip. The memory 125 is non-temporary and may be volatile (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.). The communication circuit 126 may be implemented as one or more components (e.g., transmitters, receivers, transceivers, passive circuits, encoders, decoders, and / or other communication circuits) that perform functions for communicating on corresponding communication paths or links. The communication circuit 126 may include or be coupled to one or more antennas for wireless communication.

[0115] The power supply 127 may include one or more batteries, which may be rechargeable or single-use disposable batteries. A power management circuit may also be included to regulate battery charging and monitor the use of the power supply 127, boost power, perform DC conversion, etc.

[0116] Display device 120 may also include one or more data communication ports (not shown) for wired data communications with external devices such as computer system 170, SCD 102, or MDD 152. Display device 120 may also include an integrated or attachable in vitro blood glucose meter, including an in vitro test strip port (not shown) to receive an in vitro glucose test strip for performing in vitro blood glucose measurements.

[0117] Display device 120 may display measured analyte data received from SCD 102, and may also be configured to output alarms, warning notifications, glucose values, etc., which may be visual, audible, tactile, or any combination thereof. In some embodiments, SCD 102 and / or MDD 152 may also be configured to output alarms or warning notifications in a visible, audible, tactile form, or a combination thereof. Further details and other display embodiments may be found, for example, in U.S. Patent Publication No. 2011 / 0193704, which is incorporated herein by reference in its entirety for all purposes.

[0118] Example Embodiments Related to Integrated Management The following example embodiments relate to an integrated management system (IMS) that in many embodiments will be implemented as a set of software instructions stored and / or executed on one or more electronic devices. In some embodiments, the IMS is stored, executed, and presented to a user on the same single electronic device. In other embodiments, the IMS may be stored and executed on one device and presented to a user on a different electronic device. For example, the IMS may be stored and executed on a trusted computer system 180 and presented to a user via a web page displayed by an Internet browser executed on a display device 120.

[0119] Thus, there are many different embodiments involving the number and type of electronic devices used to store, execute and present the IMS or some portion thereof to a user.Regarding presentation to a user, a device configured to implement this capability will be referred to herein as a User Interface Device (UID) 200 . Figure 5200. In this embodiment, UID 200 includes a housing 201 coupled to a user interface 202. User interface 202 is capable of outputting information to a user and receiving input or information from a user. In some embodiments, user interface 202 is a touch screen. As shown here, user interface 202 includes a display 204 that can be a touch screen and an input component 206 (e.g., a button, an actuator, a touch-sensitive switch, a capacitive switch, a pressure-sensitive switch, a roller, a microphone, a touchpad, a soft key, a keyboard, etc.). Many of the devices described herein can be implemented as UID 200. For example, in many embodiments, display device 120 will be used as UID 200. In some embodiments, MDD 152 can be implemented as UID 200. In embodiments where SCD 102 includes a user interface, then SCD 102 can be implemented as UID 200. Computer system 170 can also be implemented as UID 200.

[0120] Example implementation of the user experience of an integrated management system such as Figure 6 As shown, in an exemplary method 300 of user experience, in step 302 the user can check the analyte level, such as the glucose level. As previously described, the user can scan the SCD 102, or otherwise achieve the transmission of the analyte level or data indicating the analyte level to the display device 120. In step 304, the user administers the drug (e.g., insulin) from the connected drug delivery device 152. The drug delivery device 152 can be an intelligent, connected insulin pen, a connected pen cap, a smart button, or an automated insulin delivery (AID) device in a closed-loop system, as previously described. In step 306, the user transmits dosage information from the drug delivery device 152 to the display device 120. The transmission can be accomplished by methods known in the art. For example, the display device 120 (e.g., a smart phone) can scan the connected drug delivery device 152, and the information can be transmitted via NFC. Alternatively, the dosage information can be transmitted automatically without any further action by the user. For example, scanning may not be required, and the dosage information can be transmitted via or another wireless communication protocol. For example, in the case of a connected pen cap, a connected insulin pen, or an AID device, after the administered dose is detected, the data can be automatically transmitted to the display device. The transmission of medication information can be referred to in many ways, including scanning, transmitting, downloading, uploading, exporting, importing, connecting, synchronizing, pairing, and other equivalent terms. Data can also be transmitted via a computer such as a computer. The wireless communication is automatically transmitted. The data transmitted may include data related to drug (e.g. insulin) injection, injection, event, note, record entry or other equivalent terms. The data may be referred to as insulin data, insulin record, insulin log, insulin dosage or other equivalent terms. After the dosage information has been transmitted, optionally, a notification may appear on a display device, such as a lock screen or banner notification, which includes a message that a log or other report or application has been updated, and may also include the amount of drug delivered and the delivery time. In step 308, the user and other people (e.g., caretaker, HCP) may then view the combined history in various displays and reports to visualize and help the user treat their diabetes, which may include analyte levels and drug dosages. In order to be able to transmit data from the drug delivery device 152 to the IMS, the drug delivery device 152 must first be added to the IMS. Figure 7 An exemplary method 320 for adding a drug delivery device 152 to an IMS and managing the connected drug delivery device 152 is described. In method 310, a user may add an insulin pen by selecting "Insulin Pen" from a menu (e.g., a drop-down menu). Fig. 20A As seen in the GUI 322 of FIG. 1 , the “Start” screen may include a cartoon depiction of the drug delivery device 152 in communication with the display device 120 and also list different tasks or capabilities of the IMS after the drug delivery device 152 is connected to the IMS. These include connecting a compatible smart pen to record insulin doses, reviewing and learning from past doses, and sharing reports with the user's health care team. After selecting “Start”, as shown in FIG. Fig. 20A As seen in the GUI 324 of FIG. 310 , the insulin pen settings may be opened and, in step 312, the user may be prompted to select the drug delivery device 152 they wish to connect. The drug delivery devices 152, such as insulin pens, may be listed by their brand name. After the user selects the appropriate drug delivery device and selects “Next”, the user may be prompted to select the drug delivery device 152 that they wish to connect. Fig. 20B As shown in the GUI 326 in FIG. 1 , a graphic or animation illustrating how to scan a drug delivery device 152 (e.g., an insulin pen) using a display device 120 (e.g., a smart phone) may be presented. In addition, the GUI 326 may also include text indicating scanning by holding the insulin pen display flat against the back of the phone. The GUI 326 may also provide text indicating that the user may need to slowly move the insulin pen around to find the correct point to effect connection / communication between the insulin pen and the phone. A link may also be provided to the user manual of the insulin pen, which contains more information about how to connect the insulin pen to the phone. After a successful connection has been effected, a prompt such as Fig. 20B328, which indicates that a new drug delivery device 152 has been added to the IMS. The name of the newly added drug delivery device may also appear on the GUI 328. After selecting "Next" in step 314, the user may be presented with a prompt to select a pen color for the newly connected drug delivery device 152. Selectable options with different colors 332 may appear on the GUI 330, such as Fig. 20C As shown. Fig. 20C After selecting "Next" in the GUI 334 of FIG. 314, the user may be prompted to select the type of medication contained in the newly connected medication delivery device 152. In the case where the medication delivery device 152 is an insulin pen, in step 316, the user may be prompted to select between different types of insulin, for example, select rapid-acting insulin, long-acting insulin, or other from the list 336. After selecting "Next" in step 318, the user may then be prompted to select the type of medication contained in the newly connected medication delivery device 152. In the case where the medication delivery device 152 is an insulin pen, in step 316, the user may be prompted to select between different types of insulin, for example, select rapid-acting insulin, long-acting insulin, or other from the list 336. Fig.20D The user may select a brand of the selected type of insulin in the GUI 338. A list of available brands 340 may be provided. Alternatively, the user may be able to add a new brand that is not included in the provided list. Fig.20D After selecting "next" in the GUI 342 of the user, the user can see an indication that the setup of the new drug delivery device 152 is complete. The GUI 342 may also include a reminder of the software to scan the connected drug delivery device 152 to transfer the insulin dose to the IMS. The GUI 342 may also include an animation showing how to scan the drug delivery device 152 (e.g., an insulin pen) using the display device 120 (e.g., a smart phone). In addition, the GUI may also include text indicating that the insulin pen display is kept flat against the back of the phone to scan. The GUI may also provide text indicating that the user may need to slowly move the insulin pen around to find the correct point to affect the connection / communication between the insulin pen and the phone.

[0121] Additional drug delivery devices may be connected in the same manner as described above. Additional drug delivery devices may be assigned a different color or other distinguishing feature or name than the previously connected drug delivery device. For example, a drug delivery device 152 that delivers rapid-acting insulin may be assigned a blue pen color, while a drug delivery device 152 that delivers long-acting insulin may be assigned a different color, such as red, silver, or black. The additional drug delivery device may be assigned a different color, such as red, silver, or black, by selecting an option to add another drug delivery device, such as a plus sign labeled "Add Another Pen" (see FIG. 1 ). Fig.20E 356), additional drug delivery devices can be added below the insulin pen menu.

[0122] Users can select the option "Manage your own insulin pen connection" under the insulin pen menu. Fig.20E350 and 368 of , the user may be presented with a window depicting the connected medication delivery device 152, as well as a description indicating the type and / or brand name 358 of insulin delivered by the medication delivery device 152, and details of the last scan 360, which may include the time of the scan and / or the amount of medication delivered. As previously described with respect to GUI 326, if the user selects the information icon, then the information icon is displayed. Fig.20F 364a, b may appear, which includes information about how to transfer insulin records and dosing information. The GUI 364a, b may include an animation of how to scan the drug delivery device 152 with a smart phone. Different GUIs may appear to indicate how to scan on the iOS system 364a and the Android system 364b. In addition, the GUI 364a, b may also include text indicating that the insulin pen display is held flat against the back of the phone to scan. The GUI 364a, b may also provide text indicating that the user may need to slowly move the insulin pen around to find the correct point to cause connection / communication between the insulin pen and the phone.

[0123] In some embodiments, drug delivery device 152 may be a The pen cap can be Wirelessly transmit dosage data. The drug delivery device 152 may need to use Instead of NFC pairing with the monitoring application. The monitoring application can remind the user to ensure that the display device 120 is enabled. The monitoring application may display a GUI that prompts the user to enter and / or confirm a code on the drug delivery device 152. The GUI may also include a picture, diagram, or animation to show where the code is located on the drug delivery device 152. After entering the code, the monitoring application may display a GUI that includes instructions to press and release a button on the drug delivery device 152 to pair the device with the display device 120. The instructions may include a text description, diagram, picture, or animation to help the user with the pairing. A window may appear on the display device 120 indicating that the drug delivery device 152 wishes to be paired with the display device 120. The user may need to select "pair" before the pairing is complete. After the drug delivery device has been paired with the display device 120, a GUI may be displayed that displays a confirmation that the pairing and / or setup is complete.

[0124] Once the medication delivery device 152 has been connected to the monitoring software on the display device 120, the monitoring software can be viewed from the medication delivery device 120 (e.g., via NFC or ) Download or otherwise transfer the dosage information to the software. Figures 21A-21CAs shown, in GUI 390, the monitoring software may indicate that it can accept downloads from a connected medication delivery device 152 (e.g., there may be a message in, for example, a banner indicating that it is "ready to scan"). After the user scans the medication delivery device 152 in step 316, a window 394 may open indicating that (one or more) new doses have appeared in the log. For example, window 394 in GUI 390 indicates that three doses were transferred from the medication delivery device to the monitoring software. Window 394 may also indicate which medication delivery device was scanned 396 and the type of insulin that was administered 398. In addition, after the first scan of the medication delivery device 152, as shown in FIG. Fig.21A As shown, a GUI 400 may appear that allows the user to select a default selection for an insulin type, which will be used as the default item the next time the user scans an insulin pen.

[0125] like Fig.21B As shown, the main screen 410 may include a button or link 412 to select a scan drug delivery device 152. The main screen 410 may also include an analyte profile, a time statistic within a range, the last reading of the analyte level, the average analyte level, a graph of the analyte readings for a time period (e.g., the day), and an indication of the current sensor life. The main screen 410 may also include an icon (e.g., a syringe icon) 414 along a graph of the analyte readings, which indicates when various drugs are administered. The icon 414 may be positioned along a graph of the analyte readings to correspond to / indicate the time when the drug is administered. In some embodiments, the user may view and edit insulin notes by tapping the syringe icon 414 in the main screen 410. The user may tap the syringe icon to view the dose, and if necessary, then further tap the pencil icon to edit the entry. In some embodiments, a syringe icon with a question mark may mark a dose in which no additional notes or annotations are added. In some embodiments, a syringe icon with a notepad may indicate a dose in which additional notes and annotations have been added. In some embodiments, an icon of a syringe without other annotations may mark a dose automatically transmitted from a connected drug delivery device 152. Icons indicating food (e.g., apple), exercise (e.g., runner), or comments (e.g., notepad) may also be indicated along or above the graph of the analyte readings, placed along the timeline (x-axis) according to when the food was consumed or the note was added.

[0126] like Fig.21BAs shown, the logbook GUI 416 can also be accessed from the insulin pen menu. The logbook GUI 416 can include a list of various events recorded together with the time of the event, including the dose of the drug administered. For entries entered from the drug delivery device 152, a syringe icon can appear next to the amount of drug administered (e.g., expressed in units). The instances in which the drug delivery device 152 is filled can also be listed in the logbook. A fill dose (or "fill") refers to an injection of a drug (e.g., insulin) to clear air from the needle tip. A fill dose can also be referred to as an air injection, flow check, injection, or other equivalent terms. Manually added notes can also be included in the logbook.

[0127] The monitoring application may allow the user to edit the notes associated with a particular medication dosing event. If the user wants to edit the details about the insulin dose, the user may tap on the line entry in the log GUI 416, which links to the log details GUI 430, such as Fig. 21C . The analyte chart on the log details GUI 430 may include a vertical line or other highlight to indicate the dose being viewed. If the user wants to edit the details about the selected insulin dose, the user can tap the edit (pencil) icon 444, which is linked to the edit note GUI 450, where the user can edit the information associated with the various fields. The edit note GUI 450 includes a banner that prominently indicates the dose and the date and time of administration. It can also include various fields, such as dose type (insulin administered or primed) 452, insulin brand, number of units, delivery device name, food 454, exercise 456, and notes 458. The user can edit the type of insulin delivered by tapping the drop-down caret and selecting the insulin brand. The user can edit the dose from the therapeutic dose to the flow check (or prime) dose by tapping the drop-down caret icon to select the prime / flow check option. In some embodiments, after the user indicates that it is a prime dose, the banner at the top of the edit note screen will indicate that it is a prime dose, such as Fig. 21C GUI 460 is shown.

[0128] If there is an error, the monitoring application may request the user to confirm the details of the dose administered. The details may include the dose, type of medication, and the time it was delivered. Figures 23A-23CAs shown, if an error is detected in the delivered dose data, a window 1052 in the GUI 1050 or a window 1062 in the GUI 1060 may appear to prompt the user to confirm the details about the newly delivered dose. Alternatively, the error may be recorded in the log GUI 1070 and / or the log details GUI 1080. In some embodiments, the log GUI 1070 and / or the log details GUI 1080 may include an error indicator associated with a particular dose. The error indicator may be a missing dose 1072 and / or a different syringe icon (e.g., a syringe with an exclamation point or a question mark near it) 1074. The user may edit the dose entry with the error by tapping the edit (pencil) icon 444, which may be linked to the edit note GUI 1090, where the various fields may be edited as needed.

[0129] like Fig.21D As seen in the GUI 470 of FIG. 47A , the monitoring application can also prompt the user to learn more about new features of the monitoring application using a pop-up window 472. The prompt can notify the user of new features available by connecting a medication delivery device 152 (e.g., a smart insulin pen) and having the application track the user's insulin dosage. A similar window can also pop up when an update is available for the monitoring application.

[0130] The monitoring application may also allow the user to customize the name of the connected drug delivery device 152. Fig. 22 As shown, the user can navigate to the insulin settings GUI 480, where the user can tap or select the "Name" field 482, which will open the name GUI window 486. The user can tap or select the "New Name" field 488 and proceed to type in a new selected name for the device. Fig. 22 In , the user enters "Master Pen" as their custom name for the device. After the user selects "Save", the new name will be displayed in the "Current Name" field 490 in the updated GUI 492.

[0131] Insights and Alerts

[0132] If a dose appears to have been missed, the monitoring application can display an alarm, reminder, or prompt. In some embodiments, dose data is sent to the Automatically transmitted to the monitoring application. For example, based on rising glucose levels and no doses being recorded within a time period of, for example, 1 hour, optionally 2 hours, optionally 3 hours, the monitoring application may display a warning asking the user – “Did you miss a meal dose?”. In addition, the alert may indicate that the user's glucose is rising and the last recorded dose was X hours ago. The alert may also suggest that the user synchronize the drug delivery device 152 to update the medication data. The alert may also suggest that if the user missed a dose, the user should follow the advice of their HCP on what to do. In some embodiments, where the alert relates to a specific meal, the alert may ask the user if they missed their [breakfast / lunch / dinner] dose, and then instruct the user to typically take the dose before X:XX (e.g., the user typically takes the lunch dose before 1:30pm).

[0133] Users can set conditions for giving missed meal dose alerts or reminders to minimize the number of alerts that pop up on their devices. For each of breakfast, lunch, dinner, and long-acting doses, users can specify that missed dose reminders should only be displayed after a specific time of day. For example, a user can set a breakfast dose reminder to display after 10:00 a.m., a lunch dose to display after 1:30 p.m., and a dinner dose to display after 8:00 p.m. if no dose was detected during the time period before the indicated time.

[0134] like Fig.25 As shown, in exemplary method 1900, starting at step 1902, the system or application can receive analyte data. The data can be received from a server, a cloud, or from a sensor control device 102. In step 1904, the system can receive insulin data from the subject (e.g., from MDD 152). For example, the system or application can receive insulin data from the subject, such as via Insulin data is automatically received wirelessly from a connected pen, connected pen cap, or other drug delivery device 152 without requesting the data. In other embodiments, the system or application can check the latest insulin dosage data by requesting delivery information from different sources, including but not limited to the MDD 152, MDD-related applications, or interfaces storing the latest insulin delivery information (e.g., MDD application web servers), or by checking the memory of various applications to obtain the latest insulin delivery information.

[0135] In step 1906, the system or application can determine whether a meal has been taken. The determination can be made by analyzing the received analyte data and determining whether the analyte level rises above a high threshold or whether the rate of change of the analyte level is greater than a minimum rate of change threshold. Meal dose detection is described in more detail in U.S. Patent Publication No. 2021 / 0030323, U.S. Patent Publication No. 2021 / 0050085, and U.S. Application Serial No. 17 / 591,229, all of which are expressly incorporated herein by reference for all purposes. The high threshold analyte level can be 175 mg / dL, or 180 mg / dL, or 180 mg / dL, or 190 mg / dL, or 200 mg / dL, or 210 mg / dL, or 220 mg / dL, or 230 mg / dL, or 240 mg / dL, or 250 mg / dL, or 260 mg / dL, or 270 mg / dL. The high threshold analyte level may be set by the user.If the system determines that no meal was consumed, the system returns to step 1902 and receives additional analyte data.

[0136] If the system or application determines that a meal has been taken, then in step 1908, the system can analyze the received insulin dosage data to determine whether an insulin dosage has been recorded or received for a period of time. The period of time can be at least 1 hour, such as about 1 hour, or about 2 hours, or about 3 hours. The period of time can be optionally set by the user, rather than the default time set by the system. If an insulin dosage has been recorded within this period of time, the system determines that no dosage has been missed, and the system returns to step 1904 and receives additional insulin dosage data.

[0137] In some embodiments, the time period can be set for each meal by setting the time when the user should have taken the meal dosage. The system can also check to see whether the insulin dosage has been recorded or received before the set time of each meal. For example, if there is no record or reception of the breakfast dosage before 10:30 in the morning, the system can determine that the user has missed their breakfast dosage. Similarly, the lunch time dosage can have the time of 2:30pm, if the user will usually have taken the lunch dosage by then. And if the user usually has taken the dinner dosage by then, the dinner dosage can have the time of 7:30pm. These times can be set by the user to be consistent with their personal dietary habits.

[0138] If the system or application determines that no insulin dose has been recorded or received within the time period or before the set time for a particular meal, the system or application may display an alert interface associated with the missed meal dose at step 1910. In some embodiments, the text of the alert interface may be customized by the user.

[0139] Correction Dose Reminder If a period of time has passed since their last insulin dose and their glucose levels are still elevated, the monitoring application can display an alert, reminder, or prompt to the user to consider a correction dose. In some embodiments, dose data is sent to the user via Automatically transmitted to the monitoring application. Users can set the conditions under which correction dose alerts or reminders are given in order to minimize the number of alerts that pop up on their devices. Users can configure alerts to appear only when their glucose level is above a high threshold, such as above about 250 mg / dL, and the time period since the last insulin dose is longer than a minimum time threshold, such as about 2 hours.

[0140] The user can also customize the message that appears in the reminder. For example, the message may indicate that the dose they took X hours (e.g., 2 hours) ago did not lower their glucose enough, and now is a good time to take an additional X units of insulin or take a walk in the park. The default message may be to follow the advice of their HCP to correct the high glucose with therapy or exercise.

[0141] like Fig.26 As shown, in exemplary method 1920, starting at step 1922, the system or application can receive analyte data. The data can be received from a server, a cloud, or from the sensor control device 102. In step 1924, the system or application can receive insulin data of the subject (e.g., from the MDD 152). For example, the system or application can receive insulin data of the subject, such as via Insulin data is automatically received wirelessly from a connected pen, connected pen cap, or other drug delivery device 152 without requesting the data. In other embodiments, the system or application can check the latest insulin dosage data by requesting delivery information from different sources, including but not limited to the MDD 152, MDD-related applications, or interfaces storing the latest insulin delivery information (e.g., MDD application web servers), or by checking the memory of various applications to obtain the latest insulin delivery information.

[0142] In step 1926, the system or application may determine whether the received analyte level is above a high threshold, which may indicate that the user's glucose is outside the target range. The high threshold analyte level may be at least 175 mg / dL, for example, the high threshold analyte level may be 175 mg / dL, or 180 mg / dL, or 180 mg / dL, or 190 mg / dL, or 200 mg / dL, or 210 mg / dL, or 220 mg / dL, or 230 mg / dL, or 240 mg / dL, or 250 mg / dL, or 260 mg / dL, or 270 mg / dL. The high threshold analyte level may be set by the user. If the system determines that the analyte level is not above the high threshold, the system returns to step 1922 and receives additional analyte data.

[0143] If the system or application determines that the analyte level is above the high threshold, then in step 1928, the system or application can analyze the received insulin dosage data to determine whether a period of time has passed since the insulin dosage has been recorded or received. The period of time can be at least 2 hours, for example, the period of time can be about 2 hours, alternatively about 2.5 hours, alternatively about 3 hours. The period of time can be optionally set by the user, rather than the default time set by the system. If the period of time since the last insulin dosage was recorded has not passed, the system returns to step 1924 and receives additional insulin dosage data.

[0144] If the system or application determines that the period of time has passed since the last insulin dose, the system or application may display an alert interface associated with the correction dose in step 1930. In some embodiments, the text of the alert interface may be customizable by the user.

[0145] The monitoring app may also display a congratulatory prompt or message when an insulin dose causes glucose levels to return to the target range within a specified time period. For example, the prompt or window may say "Your glucose victory! You are back in range 2 hours after your last insulin dose." The user may have the option to add a note (by typing or speaking text) with details about what they did that may have helped them reach their target range.

[0146] The user can set the conditions for displaying the prompt or window by setting the maximum glucose level and the time limit to return to the target range. For example, the user can set the target range to below 180 mg / dL and set the time after the dose reaches the target to 2 hours. Fig. 27As shown, in exemplary method 1940, starting at step 1942, the system or application can receive analyte data. The data can be received from a server, a cloud, or from the sensor control device 102. In step 1944, the system can receive insulin data from the subject (e.g., from the MDD 152). For example, the system can receive insulin data from the subject, such as via Insulin data is automatically received wirelessly from a connected pen, connected pen cap, or other drug delivery device 152 without requesting the data. In other embodiments, the system or application can check the latest insulin dosage data by requesting delivery information from different sources, including but not limited to the MDD 152, MDD-related applications, or interfaces storing the latest insulin delivery information (e.g., MDD application web servers), or by checking the memory of various applications to obtain the latest insulin delivery information.

[0147] In step 1946, the system or application can determine whether the received analyte level is below a high threshold, which can indicate that the user's glucose is within the target range. The high threshold analyte level can be 190 mg / dL, or 185 mg / dL, or 180 mg / dL, or 175 mg / dL, or 170 mg / dL. The high threshold analyte level can be set by the user. If the system or application determines that the analyte level is not below the high threshold, the system or application can return to step 1942 and receive additional analyte data.

[0148] If the system determines that the analyte level is below the high threshold, then in step 1948, the system can analyze the received insulin dosage data to determine whether a period of time has passed since the insulin dosage has been recorded or received. The period of time can be at least 2 hours, such as about 2 hours, or about 2.5 hours, or about 3 hours. The period of time can be optionally set by the user, rather than a default time set by the system. If the period of time since the last insulin dosage was recorded has not passed, the system returns to step 1944 and receives additional insulin dosage data.

[0149] If the system determines that the period of time has elapsed since the last insulin dose, the system may display an alert interface associated with the analyte level being within the target range in step 1950. In some embodiments, the text of the alert interface may be customizable by the user.

[0150] Report

[0151] The monitoring application can transmit data, including analyte levels from the SCD 102 and medication data / logs from the drug delivery device 152, to a reporting application. The reporting application can generate a plurality of reports that summarize and highlight various aspects and history of the analyte and medication data. The reporting application can be run on a display device or on a separate computing device. In some embodiments, the monitoring application can include instructions that, when executed by one or more processors, generate and display reports including insulin data in the monitoring application.

[0152] Figures 8A-8C An exemplary embodiment of an insulin dosage interface 502 is shown as part of an analyte monitoring system report GUI 500. According to one aspect of the embodiment, the GUI 500 is a snapshot report covering a predetermined time period 504 (e.g., 14 days) and includes multiple report sections on a single report GUI, including: a sensor usage interface section 506, a glucose trend interface 508, which may include an AGP chart 511, a low glucose events chart 513 and other related glucose metrics (e.g., a glucose management indicator 515); a health information interface 510.

[0153] AGP chart 511 can display glucose readings at the 5th, 25th, 50th (median), 75th and 95th percentiles per hour, which are presented on a "typical" date based on all dates within the selected time range. AGP chart 511 can also include two horizontal lines indicating the boundaries of the target range defined in the glucose statistics and target section and the time portion within the range. Report 500 can also include a section 517 that lists metrics and / or statistics related to average glucose. Metrics section 517 can list average glucose, percentage of time above the target range, percentage of time in the target range, and percentage of time below the target range. Low glucose event chart 513 can include a chart of events in which the glucose level of the object drops below a low threshold (e.g., 72 mg / dL). The chart can show glucose concentration (mg / dL) relative to time, so that the time of the low event period in a day is easily apparent. Report 500 can also include a section 519 that lists metrics and / or statistics related to low glucose events. Low glucose event metrics section 519 can list the number of low glucose events and the average duration of low glucose events.

[0154] The sensor usage interface 506 may include a percentage time sensor activity chart 521 and a metrics section 523. The metrics section 523 may include a percentage of time the sensor has been active and an average scan / view metric (e.g., indicating the average sum of the number of scans and the number of views). The percentage time sensor activity chart 521 may include a chart of the percentage of time the sensor is active relative to the time of the day (e.g., from 12am to 12am). The axis of the percentage time sensor activity chart 521 may be aligned with the corresponding axis of one or more other charts (e.g., average glucose trend chart 511, low glucose event chart 513) so that the user can visually associate data between multiple charts from two or more parts of the report GUI through a common unit (e.g., time of day) from the aligned axes. The health information interface 510 may include a carbohydrate section 512, an insulin administration section 502, and a comment section 514. The carbohydrate section 512 may include information about the user's average daily carbohydrate intake recorded by the user, and may include the average total number of carbohydrates consumed by the user during the time period 504.

[0155] Insulin administration portion 502 can include a list of the drug dosage (e.g., insulin dosage) used during time period 504. This list can include separate entries for quick-acting insulin 516, long-acting insulin 518 and daily insulin total amount 520. Entry can include an icon indicating insulin type and / or insulin type (e.g., quick-acting, long-acting, basis, etc.) and / or the brand name of insulin and / or the average amount of insulin used. When a plurality of insulin pens are connected, the drug dosage portion of display 502 can include different icons for different types of insulin pens, e.g., different colors and / or icons. For example, a quick-acting pen can have a light green icon 516, and a long-acting insulin pen can have a dark green icon 518.

[0156] In certain embodiments, the amount of insulin dosage can be manually input by the user and / or determined by the dosage calculator, rather than directly transmitted from the connected drug delivery device 152. The amount of insulin dosage can have been input into a monitoring application or a report application. In the case of manually inputting the amount of insulin dosage, the report 500 can record the amount of the rapid-acting insulin 516 and the long-acting insulin 518 delivered, but the brand name of insulin can not be listed. The units / day and the average daily total insulin (units / day) used for each type of insulin can also be displayed in the insulin dosage interface 502. For the rapid-acting insulin dosage 516, the dosage can be listed as the total dosage (in units / day) used, but can also be divided into different components, which can include meal size, correction amount, user changes and manual input.

[0157] The annotation interface 514 may include additional information about the user's analyte and medication patterns presented in a narrative format. For example, the annotation section 514 may include an indication of the trend of the number of tests per day compared to the previous reporting period, fluctuations detected during the reporting period, and the ratio of the average daily dose of corrected insulin.

[0158] The report 500 may also include a list of sources 522 of the information provided. The sources may include the name of the glucose monitoring device and also include the name (e.g., brand name) of the insulin delivery device. If the patient uses more than one insulin delivery device, the source portion 525 may list all of the medication delivery devices, or may include the name of the first connected pen and the number (value) of additional medical devices, but may not include the name of any specific insulin pen.

[0159] Figures 9A-9G An exemplary embodiment of another analyte monitoring system report GUI 600 including information about the administered insulin dose is shown. According to one aspect of the embodiment, the GUI 600 is a weekly summary report of a time period 613 including multiple report sections, wherein each report section represents a different day of the week. The time period can be one week or multiple weeks, such as 7 days, 14 days (see, e.g., Figures 9B-9C ), 21 days, 28 days (see e.g. Figure 9D-9G ), 32 days, 36 days, etc. Each report section may include a glucose trend graph 601a-601n for each day of a time period 613, which may include the user's measured glucose level over a twenty-four hour period, and health information interfaces 606, 608, 610, 612. For each day of the time period 613, the health information interface may include information about the user's average daily glucose 606a-606bb, carbohydrate intake 608a-608bb, insulin dose 610a-610bb, and hypoglycemic ("low") events 612a-612bb.

[0160] In certain embodiments, glucose trend graph 601a-601bb can include sensor usage mark, to indicate that scanning, checking or both have occurred at a specific time during a 24-hour period. Glucose trend graph 601a-601bb can also include color coding to highlight the part of trend graph outside target range. For example, trend graph 601a-601bb can include that the area below the curve is colored as a specific color, or the part of the figure is changed into a specific color, or otherwise highlight the area of ​​the corresponding color of the part outside the target range. The area below the curve of the upper part of target range 603 can be colored as yellow or orange, and the area below the curve of the part below target range 605 can be colored as red.

[0161] The "low" event columns 612a-612bb can list the number of low events detected when the user's analyte level is below a lower threshold (e.g., 80 mg / dL for glucose, or 75 mg / dL). Low events can also be highlighted in the glucose trend graph by shading the area under the curve of the low events with a different color (e.g., red).

[0162] Similarly, the total carbohydrate amount 608a-608bb of daily intake can be listed in the health information interface 604. These carbohydrate entries can be distinguished from the insulin dosage entry by appearing with different colors, such as orange and / or with different icons, such as apples. If there is no value of carbohydrate amount available, the total carbohydrate entry 608a-608bb can be blank, dash or multiple dashes. In addition, the carbohydrate amount of intake can also be included in the glucose trend graph 602a-602bb. Similar to insulin dosage, the amount of carbohydrates in different meals or snacks can be recorded when or close to intake, and the amount can be listed in the orange frame. If insulin is administered while or about the same time as a meal (carbohydrate intake), the amount of insulin may appear below the amount of carbohydrates taken on the glucose trend graph.

[0163] Insulin dosage column 610a-610bb interface can include the total amount of insulin applied on that day for each of different types of insulin. The total dose of different insulin types can be distinguished by different colors. For example, the total rapid-acting insulin applied can be represented by a light green frame, and the total long-acting insulin applied can be represented by a dark green frame. If no value is available, the entry of the amount of insulin applied can be represented by a short dash or multiple short dashes. The specific dose of different insulins can also be recorded in glucose trend graph 601a-601bb. For example, the frame containing the dose can appear in the glucose trend graph at or near the time of the applied dose. Similar to the total amount of insulin, these frames can be color-coded to allow the user to quickly determine which insulin has been applied. For example, the rapid-acting insulin dose applied can be in a light green frame, and the total long-acting insulin dose applied can be in a dark green frame. The long-acting insulin dose can be displayed on the glucose trend graph, or it may not be displayed on the glucose trend graph. In addition, when the rapid-acting dose is applied at the same or approximately the same time as the long-acting dose, the long-acting dose can appear below the frame entry of the rapid-acting dose on the glucose trend graph. The insulin brand names of the different types of insulin administered may also be displayed in a legend 630 , which may be located at the bottom of the weekly summary report 600 .

[0164] In certain embodiments, medication information can be manually input by the user, rather than directly transmitted from the connected drug delivery device 152. The amount of insulin dosage can have been input into monitoring application or report application. In the case of manually inputting insulin dosage, report 600 can record the amount of the rapid-acting insulin delivered, but the brand name of insulin can not be listed in legend 630, although legend 630 can include the icon corresponding to the specific type of insulin used. In certain embodiments, medication information can be automatically transmitted from the connected delivery device. The source 632 of data can include the name of the equipment providing analyte data level and the number of additional combined glucose devices, but can not include the name of any specific insulin pen. The administration unit / day of each type of insulin and the average daily insulin total amount (unit / day) can also be displayed in insulin dosage interface 610. The insulin dosage used on the glucose trend graph can be displayed below the carbohydrate entry, if they are close in time. In other embodiments, the brand name of insulin can be included in the weekly summary report 600, for example, in legend 630.

[0165] The report may also list the source 632 of the data, including the name of the device providing the analyte data level and the name of the primary drug delivery device. When data from multiple connected insulin pens are included in the weekly summary report, the source 632 may include the name of the first connected pen and the number (value) of additional medical devices.

[0166] Figures 10A-10C An exemplary embodiment of another analyte monitoring system report GUI 700 including information about multiple types of insulin administered in a daily log report is shown. According to one aspect of the embodiment, the GUI 700 is a daily log report that may include glucose trend graphs 702a-702c, scan or view sections 704a-704c, carbohydrate rows 706a-706c, insulin dosage administration rows 708a-708c, note rows 710a-710c, and legend 730 for each day of a time period 701. The time period may be one week or more weeks, such as 7 days, 14 days (see, e.g., Fig. 10B ), 21 days, 28 days (see e.g. Fig. 10B ), 32 days, 36 days, etc. Figures 10A-10CThe example of the first page or screen of report 700 is shown, and it contains the chart and information for the first 3 days of the time period.Glucose trend graphs 702a-702c can include the glucose level of the user in the 24-hour period.In certain embodiments, glucose trend graphs 702a-702c can include sensor use mark, to indicate that scanning (scan), viewing (or view) (view) or both have occurred at the specific time during the 24-hour period.In certain embodiments, the glucose level of scanning or viewing can be listed when scanning or viewing the scanning in the part 704a-704c.Glucose trend graphs 702a-702c can also include the event mark of record, such as the carbohydrate intake mark of record and the insulin dosage mark of record, and blood sugar event mark, such as low glucose event mark.Below glucose trend graphs 702a-702c, report 700 can include multiple rows with additional information, including rows corresponding to scan or view 704a-704c, carbohydrate 706a-706c, insulin 708a-708c used and notes 710a-710c. In the scan or view rows 704a-704c, the glucose levels of note can be listed in the row in a position corresponding to the time when the glucose level was recorded. For example, the peak glucose level of a period (or "episode") above the target range can be recorded and color-coded with a first color, such as orange, and the low glucose level of a hypoglycemic episode can be color-coded with a second color, such as red. In the carbohydrate rows 706a-706c, the carbohydrate amount can be listed in the row in a position corresponding to the time when the carbohydrate was recorded.

[0167] For rows 708a-708c for insulin administration, the amount of insulin injected can be displayed in a row below each glucose trend graph 702 for each hourly time block. Each drug delivery device can appear in a separate row. For example, Fig. 10B As shown, the insulin dose from the fast-acting pen may appear in the first row, and the insulin dose from the insulin pen containing long-acting insulin may appear in another row, wherein the long-acting insulin dose row may appear below the fast-acting insulin dose row. The amount of the fast-acting insulin dose may appear in a white frame with a black outline. User corrections or changes may appear before the amount of the dose. The amount of the long-acting insulin dose may appear in a dark green frame. The source 754 of the data may include the name of the device providing the analyte data level and the name of the first connected insulin pen, as well as several additional merged glucose devices.

[0168] In some embodiments, the amount of insulin dosage can be manually input by the user and / or determined by the dosage calculator, rather than being directly transmitted from the connected drug delivery device 152. The amount of insulin dosage can have been input into a monitoring application or a reporting application. In the case of manually inputting the amount of insulin dosage, the daily record report can record the amount of the rapid-acting insulin and long-acting insulin 618 delivered, but their brand names may not be listed next to the respective icons of insulin. In some embodiments, medication information can be automatically transmitted from the connected delivery device. The source 754 of data can include the name of the device providing the analyte data level and the number of additional combined glucose devices, but the name of any specific insulin pen may not be included. If the medication data of a specific insulin type of a specific date is input, only the row of the specific insulin type is displayed. If there is no data for a specific day, the row for the insulin type may not appear below the glucose trend graph 702. In addition to the glucose trend graphs 702a-702c, color-coded icons and the brand name or type of insulin may appear next to the insulin dosage row. As in other report embodiments, different icons and different colors can be used for rapid-acting and long-acting insulin pens. For example, rapid-acting insulin can be depicted with a light green solid syringe icon. Long-acting insulin can be depicted with a dark green, wider syringe icon. When there is insulin dosage data for a specific day, only one line appears for that day. If the user switches insulin brands in a connected pen during a specific day, daily record report 700 can also include notes. When the insulin brand changes, notes can appear, which include old and new insulin brand names. Then, the new insulin brand name can be listed in the text near the glucose trend graph 702. In other embodiments, the brand name of insulin can be included in the daily record report 700, for example, in legend 730.

[0169] Note lines 710a-710c may also be included in the daily log report 700. An annotation may include text added about an event (e.g., exercise). The text may appear in a line in a position corresponding to the time the note was recorded.

[0170] Figures 11A-11D An example embodiment of a daily pattern report GUI 770 is described. The daily pattern report 770 includes a dynamic glucose profile 772 of the user, a portion reflecting the amount of carbohydrates 774 consumed during different time periods of the day, and a portion reflecting the dosage of different types of insulin 778a-778b. The daily pattern report 770 shows a time period 771 for multiple days (e.g., 14 days (see Fig. 11B ) or 28 days (see Fig. 11C)), a graphical representation of the time period of 1 day (i.e., 24 hours) of glucose measurements organized according to the time of day. Glucose measurements can be displayed as individual points, or can be averaged into a gradient pattern representing the density of measurements within a specific range. Dynamic glucose atlas 772 can include a representation of the user's target glucose range, and a median over time, which is represented by a mean line or median line and a line representing 10 percentiles, 25 percentiles, 75 percentiles, and 90 percentiles. Daily mode report 770 can also have an indication of daily average glucose levels 785. Above dynamic glucose atlas 772, a row 773 can appear, in which the average glucose level of each time period can be listed. Each time period can be about 2 hours, or about 3 hours, or about 4 hours. Notable glucose levels (e.g., the highest average glucose level) can be highlighted with different colors to help users easily see which time period has the highest glucose level.

[0171] In addition to the measured glucose levels, the daily pattern report 770 may include other average daily information, such as carbohydrates 790, rapid-acting insulin 802, and long-acting insulin 804. The portion 774 reflecting the amount of carbohydrates consumed during different time periods of the day may include a graph of the daily average amount of carbohydrates consumed 790 and time (x-axis) and the amount of carbohydrates (y-axis (grams)), which may include icons (e.g., apples) to mark the amount of carbohydrates consumed during different time periods of the day. The total amount of carbohydrates consumed during a particular time period of the day 794 may be listed at the top of the graph (e.g., in parentheses) along with the number of meals or snacks consumed during that time period.

[0172] The part of the dosage of different types of insulin 778a-778b reflecting daily pattern report 770 can include the row of each type of insulin used by the drug delivery device 152 connected, for example, the top row for quick-acting insulin 778a and the bottom row for long-acting insulin 778b.For each type of insulin (quick or quick-acting 802 (including " other insulins ") and long-acting 804), the number (in brackets) of the entry of the icon representing insulin type, the average daily dosage 803,805, the average dosage of each period of a day and this period 810 of a day can be reported in insulin row 778a-778b.The brand name of insulin can also be listed optionally.As other embodiments discussed herein, the light green syringe icon can be used to represent the insulin pen comprising quick-acting insulin, and the dark green syringe icon can be used to represent the insulin pen comprising long-acting insulin.The source 812 of data can include the name of the equipment providing analyte data level and the name of the first connected insulin pen, and many extra connection devices (for example, extra insulin pens).

[0173] In some embodiments, where only a single insulin pen is connected, only a single line 778 of insulin dosage may appear, along with a corresponding icon (e.g., a light green syringe icon for a rapid-acting insulin pen) and the brand name or type of insulin delivered. Where only a single insulin pen is connected, the data source 812 may include only the name of the device providing the analyte data level and the name of the connected insulin pen, without any digital indication that an additional device is connected.

[0174] In some embodiments, the amount of insulin dosage may have been entered into a monitoring application or a reporting application. In the case of manually inputting the amount of insulin dosage, a daily pattern report 770 can record the amount of rapid-acting insulin and long-acting insulin delivered, but the brand name of insulin may not be listed near their respective icons. In some embodiments, medication information can be automatically transmitted from a connected delivery device. The source 812 of data may include the name of the device providing the analyte data level and the number of additional combined glucose devices, but may not include the name of any specific insulin pen. The administration units / day and average daily insulin total amount (units / day) of each type of insulin may also be displayed. In other embodiments, the brand name of insulin may be included in a daily pattern report 770, such as in a legend. By monitoring applications, reporting applications or other applications, a daily pattern report GUI 1700 also may be available on a display device 120. As Fig.11DAs shown, the daily mode report GUI 1700 may include a user's dynamic glucose map 772, a multi-day period or number of days 771 displayed in the GUI 1700, an insulin summary section 1778, and an alternative time period 1774a-1774d to be selected and displayed. The dynamic glucose map 772 has been described in detail with respect to other embodiments and reports. The dynamic glucose map 772 can also indicate how many days of glucose data are available in the time period 771. The dynamic glucose map 772 can also include a syringe above or below the figure to indicate the time of applying the dose. Alternatively, the dose can be drawn along the center line of the dynamic glucose map to indicate the time of applying them. The insulin summary section 1778 can include a graphical representation of the amount of insulin taken during the time period 771. In some embodiments, the figure can be a bar graph of the average number of insulin units administered over time (x axis). The figure can include both rapid-acting insulin doses and basal doses. The insulin summary section can also indicate how many days of medication data are available in the time period 771. The x-axis (time) of the figure in the insulin summary part 1778 can be aligned with the x-axis (time) of the dynamic glucose map 772, wherein the amount of the average dose of different meals and the basal dose are drawn at the average time place that they are applied during the time period 771. Therefore, the user can easily see the correlation between their insulin dosage and their glucose map in the time period relevant to different doses.GUI 1700 can also include tabs 1774a-1774b with different time periods, and the user can select these tabs to display daily mode report.For example, the time period tab 1774a-1774d can be 1 day, 7 days, 14 days, 30 days or 90 days.

[0175] Or, if Fig.11DAs seen in the GUI 1720 of FIG. 1700 , the user can select a time period in a drop-down menu 1775. In this case, the GUI 1700 can include a date range 1775, and the user can scroll forward and backward in time by tapping a forward or backward insertion symbol. In some embodiments, when the user selects a time period of 1 day, a daily curve graph can be displayed, which shows the glucose and insulin data of the selected single day. For the daily curve graph, instead of a dynamic glucose spectrum, the daily curve graph can display the glucose spectrum of that day, while also highlighting the target range of the user. The glucose spectrum graph can also be included in the syringe icon above or below the figure to indicate the time when insulin is administered. Alternatively, a dose can be drawn along the center line of the glucose spectrum to indicate the time when they are administered. The insulin summary part can display a graphical representation of the amount of insulin administered in a day (contrary to the average dose number (or administration number) of multiple day periods). In some embodiments, the figure can be a bar graph of the number of insulin units administered relative to time (x axis). The figure can include both rapid-acting insulin dosage and basal dosage. The x-axis (time) of the graph in the insulin summary section can be aligned with the x-axis (time) of the glucose map, where the doses of different meals and the basal dose are plotted at the time of day they are administered. Thus, the bars in the bar graph can be aligned with the syringe icon in the glucose map at the same time.

[0176] like Fig.11E As shown, if the user requests more information by, for example, tapping the "i" icon, a window 1800 including a daily pattern report showing an illustration 1806 of the user's glucose and insulin patterns over a period of time may be displayed. Window 1800 may also include a target range, such as 70-180 mg / dL. The user may also be able to select the type of insulin data to display - rapid-acting 1802 or long-acting 1804.

[0177] Fig.28A -D shows an exemplary embodiment of another analyte system report GUI 2000 that includes information about multiple types of insulin administered in the daily view report GUI 2000. According to one aspect of the embodiment, the daily view report GUI 2000 may include a glucose profile 2010a-g, a time-in-range metric 2012a-g, a list of total rapid-acting insulin administered 2014a-g, a list of total long-acting insulin administered 2016a-g, and a list of total amount of carbohydrates consumed 2016a-g for each day of a time period 2002. The time period 2002 may be one week or multiple weeks, such as 7 days, 14 days, 21 days, 28 days, 32 days, 36 days, etc. Fig.28A-B shows an example of the first page or screen of the report 2000, which contains graphs and information for the first 7 days of the time period. The daily view report GUI 2000 may also list the time 2020 that the sensor was active during the time period, the average number of scans or views per day during the time period 2022, a legend 2024 for the symbols used in the report 2000, and the sources 2026 of the data used in the report 2000.

[0178] Glucose spectra 2010a-g may include user glucose levels during a twenty-four hour period. In some embodiments, glucose spectra 2010a-g may optionally include sensor usage marks (e.g., circles) 2066 to indicate that scanning, viewing, or both have occurred at a specific time during a twenty-four hour period. In some embodiments, the glucose levels scanned or viewed may be listed in the scanned or viewed portion when scanning or viewing. Each daily spectra may represent a midnight to midnight period, wherein the date is displayed in the same box as the spectra. In addition to displaying the date, each spectra may also indicate a corresponding date in a week. Each spectra may also include an indication of a target glucose range (e.g., a line indicating the upper and lower boundaries of a shaded area or an indication target region), to show which parts of each daily spectra are within a target range 2056. The chart portions outside the target range 2056 may also be color-coded as a further indication of a reading or analyte level outside the target range 2056. Color coding may correspond to the colors used in the time graphical representations within the range described in other reports. For example, the portion of the graph above the target range 2056 at a "high" level (e.g., 181-250 mg / dL) can be color-coded yellow. The portion of the graph below the target range 2056 at a "low" level (e.g., 54-69 mg / dL) can be color-coded red. The portion of the graph below the target range 2056 at a "very low" level (e.g., <54 mg / dL) can be color-coded dark red or maroon. The color coding can include coloring the area below the curve (e.g., the area between the curve and the high threshold, low threshold, or very low threshold) a particular color, or changing the portion of the graph to a particular color, or otherwise highlighting the area with a corresponding color.

[0179] Glucose graphs 2010a-g may also optionally include recorded event markers (e.g., recorded exercise events 2064), recorded carbohydrate intake markers, and recorded insulin dosage markers, as well as glycemic event markers, such as low glucose event markers. The recorded event markers may be listed above or below the glucose graph when the event is recorded.

[0180] like Fig.28B-E, in some embodiments, instead of including numbers in glucose atlas 2010a-g, report 2000 can include multiple rows, which have additional information below glucose atlas 2010a-g, including rows corresponding to carbohydrates 2038a-e consumed, quick-acting insulins 2034a-e received and long-acting insulins 2036a-e received. In carbohydrate row 2038, the quantity of carbohydrates 2058 can be listed in row 2038 in a position corresponding to the time of recording carbohydrates. Similarly, in quick-acting row 2034, the amount of quick-acting insulin 2060 can be listed below the time of application. In long-acting insulin row 2036, the amount of long-acting insulin 2062 applied can be listed under the time of application. In some embodiments, where the medication data is obtained from a connected pen or a connected pen cap, report 2000 can include long-acting insulin row 2036. The color coding of these entries may be the same as the listings for carbohydrates, rapid-acting insulin, and long-acting insulin in the total 2018, 2014, and 2016 listings.

[0181] In certain embodiments, report 2000 may additionally or alternatively include rows and notes indicating scans or views. In the scan or view rows, glucose levels worthy of note may be listed in the row in a position corresponding to the time when the glucose levels were recorded. For example, peak glucose levels above the target range 2056 period may be recorded, and color-coded as a first color, such as orange, and low glucose levels of hypoglycemic episodes may be color-coded as a second color, such as red. Optionally, glucose levels worthy of note may be included in the glucose atlas 2010a-g.

[0182] In some embodiments, Fig.28D As shown, where an insulin pump is used to administer basal insulin, the report may additionally or alternatively include an insulin delivery graph 2042c located below or above the glucose map 2010, which shows when insulin is delivered and the amount of insulin delivered, in place of the long-acting insulin row 2036 showing discrete doses. The insulin delivery graph 2042c may have an x-axis of time and a y-axis of units / hour. The time axes of the insulin delivery graph 2042c and the glucose map 2010 may be aligned. When an insulin pump is the source of the basal dose information, a list of the total long-acting insulin 2016c administered may include the name of the pump system and the percentage of time the pump is active. Fig.28D Depicted are single-day entries from the Daily View Report 2000.

[0183] In some embodiments, Fig.28EAs shown, in the case where an insulin pump is used to administer insulin, the report can additionally or optionally include an insulin delivery graph 2044c located below or above the glucose map 2010, which shows how much insulin has been delivered and the delivery mode of the insulin pump, in place of the long-acting insulin line 2036 showing discrete doses. In some embodiments, the insulin graph 2044c can have an x-axis of time and a y-axis of units / hour. The insulin graph 2044c can include a trace 2052 of the amount of insulin delivered and a time period when the pump is operating for automatic delivery 2046, maximum delivery 2048, or automatic pause 2050 or if insulin is manually delivered 2054. When the insulin pump is the source of the basal dose information, the list of the total long-acting insulin 2016c administered can include the name of the pump system and the percentage of time the pump is active. Fig.28E Depicted are single-day entries from the Daily View Report 2000.

[0184] The time-in-range metric 2012a-g may be the percentage of time spent in the target range 2056 for the day.

[0185] The list of total rapid-acting insulin 2014a-g administered per day may be determined from data automatically transmitted from a connected medication delivery device 152 (such as a connected pen, a connected pen cap, or an insulin pump). Alternatively, in some embodiments, the list of total rapid-acting insulin 2014a-g administered per day may be determined from insulin doses manually recorded by the user.

[0186] The list of total long-acting insulin 2016a-g administered per day can be determined from data automatically transmitted from a connected drug delivery device 152 (e.g., a connected pen, a connected pen cap, or an insulin pump). Alternatively, in some embodiments, the list of total long-acting insulin 2016a-g administered per day can be determined from insulin doses manually recorded by the user.

[0187] A list of total amounts of carbohydrates consumed 2016a-g can be determined from carbohydrates logged by the user. Alternatively, a list of total amounts of carbohydrates consumed 2016a-g can be determined from logged meals and snacks, where the carbohydrate content of meals and snacks is estimated by a program.

[0188] Figures 12A-12CAn example embodiment of a meal time pattern report GUI 850 is depicted. The meal time pattern report 850 may include a graphical and numerical representation of glucose level information for a particular time period (i.e., morning (breakfast, e.g., 6 a.m.-10 a.m.), midday (lunch, e.g., 10 a.m.-4 p.m.), evening (dinner, e.g., 4 p.m.-10 p.m.), and nighttime (bedtime, e.g., 10 p.m.-6 a.m.)) that may be associated with a meal in a day. Vertical lines may be displayed to depict the hours before (pre-meal) 852 and after (post-meal) 854 of a respective meal. In addition, these representations may include numerical indications of glucose levels before (858a-858d) and after (860a-860d) the ingestion time of a particular meal of each day within the meal time pattern time period 856, as well as average pre-meal 859a-859d and average post-meal glucose levels 861a-861d listed above the table for each time period. Additionally, a representation of the amount of carbohydrates 864a-864d consumed each day during the meal time pattern period may be reported, as well as an average amount of carbohydrates ingested 865a-865d for the entire period.

[0189] Meal time mode report 850 can also include the amount of insulin administered. The amount of insulin administered each day in the meal time mode time period 862a-862d can be displayed in, for example, column 862, and the average amount of insulin administered in the time period of the day 863a-863d can be displayed in the row above the table. An icon corresponding to the type of insulin administered (e.g., a light green syringe icon for rapid-acting insulin) can also be displayed to indicate the type of insulin administered.

[0190] In the case where a drug delivery device 152 has been connected to the IMS, the source 874 of the data may also be displayed, including the name of the device providing the analyte data level and the name of the primary drug delivery device. The insulin brand name of the type of insulin administered may also be optionally displayed in a legend 876, which may be located at the bottom of the meal time pattern report 850.

[0191] In some embodiments, the amount of insulin dosage can be manually input by the user and / or determined by the dosage calculator, rather than directly transmitted from the connected drug delivery device 152. The amount of insulin dosage can have been input into a monitoring application or a report application. In the case of manually inputting the amount of insulin dosage, the meal time pattern report 850 can record the amount of the rapid-acting insulin 872 delivered, but the brand name can not be listed in the report. In some embodiments, medication information can be automatically transmitted from the connected delivery device. The source 874 of data can include the name of the equipment providing the analyte data level and the number of additional combined glucose devices, but the name of any specific insulin pen can not be included. The insulin brand name of the type of insulin administered can not be displayed in the legend 876, which can be located at the bottom of the meal time pattern report 850. On the contrary, the legend 876 lists insulin as, for example, "rapid-acting" without a brand name. In other embodiments, the brand name of insulin can be included in the meal time pattern report 850, for example, in the legend 876.

[0192] The meal time pattern report 850 may also include multiple graphs 868a-868d of glucose levels for each time period of the day, i.e., morning (breakfast, e.g., 6 a.m. - 10 a.m.), midday (lunch, e.g., 10 a.m. - 4 p.m.), evening (dinner, e.g., 4 p.m. - 10 p.m.), and nighttime (bedtime, e.g., 10 p.m. - 6 a.m.). Each graph 868a-868d may include a vertical line describing the start time of the meal and may span a time range of about 1 hour before the start of the meal to about 3 hours after the start of the meal. The graph may also include data points on the vertical lines, which indicate multiple glucose levels scanned or recorded at or just before the start of the meal, which are listed in columns 858a-858d. The average glucose level of the multiple glucose levels scanned or recorded indicated at or just before the start of the meal at the top of columns 858a-858d may be highlighted in each graph. In addition, charts 868a-868d can include data points indicating glucose levels after a meal, such as at least about 2 hours after the start of a meal, which are listed in columns 860a-860d. The average glucose level of multiple glucose levels scanned or recorded after a meal (e.g., at least about 2 hours after the start of a meal) can also be highlighted in the chart, which is indicated at the top of columns 860a-860d. Charts 858a-858d can also highlight target ranges before a meal, such as about 70 mg / dL to about 130 mg / dL, and target ranges after a meal, such as about 100 mg / dL to about 180 mg / dL, so that it is easy to understand at a glance whether the recorded glucose level is within or outside the target range.

[0193] Figures 13A-13B An example embodiment of a device detail report GUI 900 is described. The device detail report 900 may include glucose settings 910 for a primary glucose device, insulin settings for a first connected insulin pen 930, and insulin settings for a second (or additional) connected insulin pen 940. Glucose (or "blood sugar") settings 910 may include a target range (e.g., 70–180 mg / dL) and alarm settings for hypoglycemia (e.g., 70 mg / dL), hyperglycemia (e.g., 240 mg / dL), and signal loss. The target range may include a low threshold and a high threshold, and may be set from a monitoring application or reader. Glucose settings 910 may also optionally include calculator settings and reminders. The device detail report 900 may also include details about a primary glucose device 916 that receives data about analyte levels or indicating analyte levels from an SCD 102, including the name of the device (and any icons associated with the device), the current software version on the device, the current operating system version, and the model of the smartphone on which the relevant application is running. If SCD 102 is used in conjunction with a reader or meter, device details 916 may include the serial number of the reader or meter.

[0194] The device details report 900 may also include details of any connected drug delivery devices 152 (e.g., connected insulin pens). The connected drug delivery devices 152 may be listed below the main glucose device. If more than one drug delivery device is connected, each drug delivery device may be displayed as its own device. For each connected drug delivery device, the insulin pen settings 930, 940 may include the insulin type, the last scan (e.g., the date and time stamp of the last insulin value), and the pen color. The insulin pen settings 930, 940 may also optionally include calculator settings, notes, and / or reminders. The device details report 900 may also include details 935, 945 about the insulin pen near its corresponding settings. The details 935, 945 may include a colored icon or picture of the insulin pen, the brand name of the insulin pen, or the type of insulin and the serial number.

[0195] Fig.14 An exemplary embodiment of an AGP report GUI 950 is shown. The AGP report 950 may include a glucose statistics and goal section 952, a time in range section 954, a dynamic glucose profile 956 for the user, and a daily glucose profile section 958. The AGP report 950 shows various statistics and graphs for a period of multiple days (e.g., 14 days or 28 days) 960. The source 962 of the information may be listed and may include the name of the primary glucose device (e.g., brand name), the first connected pen, and the number of additional devices.

[0196] The glucose statistics and targets or glucose metrics 952 section may include any one or more of the following metrics: the number of days for which statistics are reported, the amount of time that the sensor is active (reported as a percentage), the amount of time that the detected analyte level is within various ranges (reported as a percentage), average glucose, glucose management index (GMI), and glucose variability. The amount of time in various ranges may include the amount of time within the target range (e.g., 70-180 mg / dL), below a low threshold (e.g., below 70 mg / dL), below a lower threshold (e.g., below 54 mg / dL), above a high threshold (e.g., above 180 mg / dL), and above an upper threshold (e.g., above 250 mg / dL).

[0197] The time in range portion 954 may include a time in range (also referred to as time in range and / or time in target) GUI, wherein each time in range includes a plurality of bars or bar portions, wherein each bar or bar portion indicates the amount of time that the user's analyte level is within a predefined analyte range associated with the bar or bar portion. In some embodiments, for example, the amount of time may be represented as a percentage of the predefined amount of time. The time-in-range GUI portion 954 may include a single bar that includes up to five bar portions that include (from top to bottom): a first bar portion that indicates that the user's glucose range is "very high" or above 250 mg / dL for a predefined amount of time; a second bar portion that indicates that the user's glucose range is "high" or between 180 and 250 mg / dL for a predefined amount of time; a third bar portion that indicates that the user's glucose range is within the "target range" or between 70 and 180 mg / dL for a predefined amount of time; a fourth bar portion that indicates that the user's glucose range is "low" or between 54 and 69 mg / dL for a predefined amount of time; and a fifth bar portion that indicates that the user's glucose range is "very low" or less than 54 mg / dL for a predefined amount of time. The time-in-range GUI 954 may display text adjacent to each bar portion indicating the actual amount of time, such as in hours and / or minutes.

[0198] according to Fig.14One aspect of the embodiment shown, each bar portion of time GUI 954 in scope may include different colors. In certain embodiments, the bar portion may be separated by a dotted line or dotted line and / or be inserted with a digital mark to indicate the scope reflected by the adjacent bar portion. In certain embodiments, the time in the scope reflected by the bar portion may be further expressed as percentage, actual time amount (e.g., 4 hours and 19 minutes) or both. In addition, those skilled in the art will recognize that the time percentage associated with each bar portion can change according to the user's analyte data. In some embodiments of time GUI 954 in scope, the target range may be configured by the user. In other embodiments, the target range of time GUI 954 in scope cannot be modified by the user.

[0199] The AGP report 950 may also include an AGP portion 956 similar to the AGP chart 511. The AGP chart may display the 5th, 25th, 50th (median), 75th, and 95th percentile glucose readings per hour, presented above a "typical" day based on all days in the selected time range. The AGP chart may also include two horizontal lines indicating the target range defined in the glucose statistics and the boundaries of the target portion 952 and the time within range portion 954. For example, the first line may correspond to the lower boundary of the target range (e.g., 70 mg / dL) and the second line may correspond to the upper boundary of the target range (e.g., 250 mg / dL). The first and second lines may also be color-coded and correspond to the same color (e.g., green) as the target range bar portion in the time within range portion 308. The data or portion of the AGP within the respective concentration range may also be color-coded and correspond to the same color as the target range bar portion in the time within range portion (308). For example, the data points or portions of the AGP within the target range may be green, the data points or portions of the AGP within the high concentration range may be orange, the data points or portions of the AGP within the high range may be orange, the data points or portions of the AGP within the low range may be red, and the data points or portions of the AGP within the very low range may be dark red or maroon. Therefore, the AGP graph easily illustrates the amount of time spent within the target range (or the amount of readings falling within the target range).

[0200] The AGP report 950 may also include a daily glucose profile section 958. The daily glucose profile section 958 displays multiple daily profiles 958-1–958-14, one for each day of the time period 960. Each daily profile may represent a midnight to midnight period, with the date displayed in the same box as the profile. In addition to displaying the date, each profile may also indicate a corresponding day of the week. Each profile may also include an indication of a target glucose range (e.g., a shaded area or lines indicating the upper and lower boundaries of the target area) to show which portions of each daily profile are within the target range. Portions of the chart outside the target range may also be color-coded as a further indication of a reading or analyte level outside the target range. The color coding may correspond to the color used in the time-in-range 954 portion. For example, portions of the chart above the target range in a "high" level (e.g., 181-250 mg / dL) may be color-coded yellow. Portions of the chart below the target range in a "low" level (e.g., 54-69 mg / dL) may be color-coded red. The portion of the graph below the target range in "very low" levels (e.g., <54 mg / dL) can be color-coded as dark red or maroon. The color coding can include coloring the area below the curve (e.g., the area between the curve and the high threshold, low threshold, or very low threshold) a particular color, or changing the portion of the graph to a particular color, or otherwise highlighting the area with a corresponding color.

[0201] Fig.19 An example embodiment of a comparison report GUI 1020 is depicted. The comparison report 1020 may include two sections 1022a, b that display metrics for a first and second time period 1024a, b. The metrics for the first and second time periods may be displayed side by side to allow for easy analysis and comparison of different time periods. Each section of the comparison report 1020 may include a glucose metric section 1026a, b, a time-in-range section 1028a, b, a dynamic glucose graph section 1030a, b, and a low glucose event section 1032a, b. The comparison report 1020 shows various statistics and charts for two time periods (e.g., 14 days each). In some embodiments, for example, a banner may also appear in the header to notify the viewer whether any glucose threshold levels have been adjusted.

[0202] The comparison report GUI 1020 may report the dates 1024a,b in which the various metrics were reported, as well as the amount of time 1034a,b (reported as a percentage) that the sensor was active.

[0203] The glucose metrics section 1026a,b may include, for example, average glucose, glucose management index (GMI), and glucose variability.

[0204] The time-in-range portions 1028a,b may include a time-in-range (also referred to as time-in-range and / or time-in-target) graphical representation, each of which includes a plurality of bars or bar portions, wherein each bar or bar portion indicates the amount of time that the user's analyte level is within a predefined analyte range associated with the bar or bar portion. In some embodiments, for example, the amount of time may be represented as a percentage of the predefined amount of time. The time-in-range graphs 1028a,b may each include a single bar that includes a plurality of vertically stacked bar portions. In some embodiments, the chart may include 5 bar portions: a first bar portion indicating the amount of time that the user's glucose range was "very high" or above 250 mg / dL for a predefined amount of time; a second bar portion indicating the amount of time that the user's glucose range was "high" or between 180 and 250 mg / dL for a predefined amount of time; a third bar portion indicating the amount of time that the user's glucose range was within the "target range" or between 70 and 180 mg / dL for a predefined amount of time; a fourth bar portion indicating the amount of time that the user's glucose range was "low" or between 54 and 69 mg / dL for a predefined amount of time; and a fifth bar portion indicating the amount of time that the user's glucose range was "very low" or less than 54 mg / dL for a predefined amount of time. The time-in-range charts 1028a,b may also optionally each display text adjacent to each bar portion indicating an actual amount of time, such as in hours and / or minutes. In some embodiments, the time in range reflected by the bar portions may be further expressed as a percentage, an actual amount of time (e.g., 4 hours and 19 minutes), or both. Furthermore, those skilled in the art will recognize that the time percentage associated with each strip portion may vary depending on the user's analyte data.

[0205] according to Fig.19In one aspect of the illustrated embodiment, each bar portion of the time-in-range chart 1028a, b may include a different color. In some embodiments, the bar portions may be separated by dashed or dotted lines and / or inserted with digital markers to indicate the range reflected by the adjacent bar portions. In some embodiments, the "very high" portion may be orange, the "high" portion may be yellow, the "target range" may be green, the "low" portion may be red, and the "very low" portion may be dark red or maroon. In other portions of the comparison report 1020, such as the dynamic glucose map portion 1030a, b and the low glucose event portion 1032a, b, the color scheme may be followed. For example, the analyte levels displayed in the charts in the dynamic glucose map portion 1030a, b and the low glucose event portion 1032a, b may be color-coded according to the concentration range into which the analyte level falls. For example, an analyte level of 156 mg / dL may be green in the dynamic glucose map, while an analyte level of 48 mg / dL may be dark red or maroon in the dynamic glucose map or the low glucose event chart. In some embodiments of the time-in-range graphs 1028a, b, the target range may be configurable by the user. In other embodiments, the target range of the time-in-range GUIs 1028a, b may not be modifiable by the user.

[0206] Each section of the comparison report 1020 may also include an AGP section 1030a, b, similar to the AGP chart 511 shown in FIG. 8. The AGP chart may display the 5th, 25th, 50th (median), 75th, and 95th percentile glucose readings per hour, presented above a "typical" day based on all days in the selected time range. The AGP chart may also include two horizontal lines indicating the boundaries of the target range defined in the glucose statistics and target sections 1026a, b and the time-in-range chart 1028a, b. For example, the first line may correspond to the lower boundary of the target range (e.g., 70 mg / dL), and the second line may correspond to the upper boundary of the target range (e.g., 250 mg / dL). The first and second lines may also be color-coded and correspond to the same color (e.g., green) as the target range bar portion in the time-in-range section 308. The AGP graph may employ the same color coding as in the time-in-range GUIs 1028a, b, such that glucose levels in the "very high" range (e.g., approximately 250 mg / dL) may be colored orange, glucose levels in the "high" range (e.g., between 180 mg / dL and 250 mg / dL) may be colored yellow, glucose levels in the "target range" (e.g., between 70 mg / dL and 180 mg / dL) may be colored green, glucose levels in the "low" range (e.g., between 54 mg / dL and 70 mg / dL) may be colored red, and glucose levels in the "very low" range (e.g., below 54 mg / dL) may be colored dark red or maroon. Thus, each AGP graph may easily illustrate the amount of time spent in the target range or the number of readings that fell within the target range for each time period 1024a, b.

[0207] Each part of the comparison report 1020 can also include a low glucose event section 1032a, b. The low glucose event section 1032a, b can each include a chart of events in which the glucose level of the object drops to a low threshold (e.g., 70mg / dL) and a very low threshold (e.g., 54mg / dL). Each chart can also include a line representing a low threshold (e.g., 70mg / dl) and a very low threshold (e.g., 54mg / dl). The chart can show glucose concentration (mg / dL) relative to time, so that the time of the low event period in a day is easily obvious. As previously described, the chart of the glucose level in the low glucose event section 1032a, b can be color-coded with the same color as in the time-in-range GUI 1028a, b, so that the glucose level between the low threshold and the very low threshold (e.g., between 54mg / dl and 70mg / dl) can be colored red, and the glucose level below the very low threshold (e.g., below 54mg / dl) can be colored dark red or maroon. Color coding can include coloring the area below the curve as a specific color, or changing the portion of the chart to a specific color, or otherwise highlighting the area with a corresponding color. Low glucose events section 1032a, b can also list metrics and / or statistics related to low glucose events. In certain embodiments, low glucose events metric section 1032a, b can list the number of low glucose events, and optionally list the average duration of low glucose events.

[0208] Figures 15A-15B An example embodiment of a GUI associated with a patient dashboard 970 is described. The dashboard 970 can allow a user to display combined insulin data from different sources (e.g., a connected pen and manually entered insulin data). The user can select different columns to include in the patient dashboard display, including the average rapid-acting insulin (units) administered per day, the average long-acting insulin (units) administered per day, and the average total insulin (units) administered per day. Other parameters that can be displayed on the patient dashboard include average glucose (mmol / L), sensor low glucose event average duration (min), percentage below target, percentage in target, percentage above target, low glucose events, standard deviation (mmol / L), estimated A1c % and estimated A1c mmol / mol.

[0209] Figures 16A-16BAn exemplary embodiment of a GUI for a data source modal 980 with a connected pen is described. In modal 980, users can use the show / hide icon 982 to select the (one or more) connected pens they want to include in the report. The default value can be set to display any connected pens and data during the reporting period. Each connected pen can be presented as its own device in modal 980. The connected devices can appear in the order of the date 986 according to the last upload, which is the date of the last insulin timestamp. The list of devices (insulin pens) can include insulin pen brand names, insulin pen serial numbers, and insulin pen images. The pen image can be located above the brand name. Modal 980 can also display estimated device time 988. If the estimated device time 988 is unknown or the same as the device time used for uploading at the time of uploading, it can be blank. The date of capturing insulin data in the last 90 days from the report end date 990 can be displayed in different colors, such as green, to distinguish it from glucose-related data. Using this GUI, HCP or other users can determine which data sources are included in any report described here.

[0210] Figures 17A-17B Described is an exemplary warning 1002 for reporting information about a connected pen, such as a prompt information warning. Warning 1002 can be displayed as an unobtrusive non-pop-up box in a portion of the screen (e.g., the lower right corner) for a period of time. If the report includes insulin pen data, warning 1002 can appear for about 1 minute, or until the user dismisses the warning. Warning 1002 can show the number of total sources 1004 (including both glucose and insulin sources) and the number of connected pens 1006. If there is only a combined glucose device and no connected insulin delivery device, warning 1002 may not be displayed. Warning 1002 can indicate that data from some devices may not be included in the report. The report can only include insulin data from the connected pen.

[0211] Fig.24A-C describes an exemplary embodiment of an insulin summary report GUI 1840. The insulin summary report GUI 1840 may include tabs 1842a-1842d with different time periods that a user may select to display a daily mode report. For example, the time period tabs 1842a-1842d may be 1 day, 7 days, 14 days, 30 days, or 90 days. The GUI 1840 may also include a graphical representation of a date range 1844 and a total daily dose 1848 currently being displayed, and a legend 1846 of the graphical representation 1848. The graphical representation 1848 may be a bar chart, wherein time is on the x-axis, and the total units used are on the y-axis. The graphical representation may include both quick-acting and long-acting doses. If the selected time period is 14 days 1842b, the unit of the x-axis may be a single day, wherein each day has a bar showing the total amount of quick-acting and quick-acting insulin used that day. In some embodiments, the user can select an entry for the day by tapping on the entry and a window with details for that day (eg, the total number of units of rapid-acting and fast-acting insulin administered that day).

[0212] In some embodiments, the user can access the daily insulin report GUI 1860 by tapping the details window for that day or by selecting Daily Insulin Report via a menu. Fig. 24B 1842a, and can display the date 1854 of the data displayed in the graphical representation 1858. The representation 1858 can be a bar chart with time on the x-axis and the total units administered on the y-axis, wherein the amount of each dose is plotted at the time at which it is administered. The graphical representation can include both quick-acting and long-acting doses. In the legend 1856, below each of the quick-acting and long-acting symbols or colors, the GUI 1850 can list the total amount of each type of insulin injected on that day 1854.

[0213] Fig.24C An example embodiment of an insulin usage report GUI 1870 is shown, which summarizes the insulin usage of a selected time period. For example, the time period tabs 1842a-1842d can be 1 day, 7 days, 14 days, 30 days or 90 days. GUI 1870 can display a date range 1872 for displayed insulin usage. For selected date range 1872, where the selected date range exceeds one day, GUI 1870 can also display an average daily total dose 1874 of use, an average daily total quick-acting amount 1876 of use, and an average daily total long-acting amount 1878 of use.

[0214] Fig.18A-18D depicts an exemplary embodiment of a GUI for a comparative graph report. By utilizing medication data from a connected drug delivery device and glucose data from a continuous glucose monitor as input, in many embodiments, the GUI or report can include multiple glucose graphs over a selected time period. Figures 18A-18B As seen in FIG. 1 , in some embodiments, the GUI or report may include two, alternatively two or more, alternatively three, alternatively three or more versions of the glucose profiles 1010 , 1012 , 1014 for a selected time period.

[0215] In some embodiments, the glucose profiles 1010, 1012, 1014 may each be an AGP chart or a portion of an AGP. Fig.14 As described, the AGP can display the 5th, 25th, 50th (median), 75th and 95th percentile glucose readings per hour presented on a "typical" 24-hour day based on all days in the selected time range. Alternatively, the AGP can display other percentiles, such as the 10th, 25th, 50th (median), 75th and 90th percentile glucose readings per hour presented on a "typical" 24-hour day based on all days in the selected time range. The AGP chart can also include two horizontal lines, which indicate the boundaries of the target range. For example, the first line can correspond to the lower boundary of the target range (e.g., 70 mg / dL), and the second line can correspond to the upper boundary of the target range (e.g., 180 mg / dL). The first and second lines can also be color-coded. The color can correspond to the same color used in other reports described herein, for example, the same color (e.g., green) as the target range bar portion in the time-in-range portion 308. Therefore, the AGP chart easily illustrates the amount of time spent in the target range (or the number of readings falling within the target range). Other exemplary AGP charts may be found, for example, in US2018 / 0235524, US 2014 / 0188400, US2014 / 0350369, US2018 / 0226150, all of which are expressly incorporated herein by reference in their entirety for all purposes.

[0216] In other embodiments, the glucose spectrum can be drawn as a plurality of daily traces in a single chart or figure. In certain embodiments, the glucose spectrum can also be converted into AGP except being drawn as a plurality of daily traces in the same chart or figure. In certain embodiments, a plurality of charts can be any type of representation of glucose data, including modal day coverage or time series diagram. These charts can also present data from other analyte data based on time or other data based on time (such as insulin medication events or insulin delivery data or meal event data) associated with the patient, or based on data from other analyte data based on time or other data based on time associated with the patient. Although exemplary charts are described based on glucose data, any patient data can be represented in these exemplary formats. GUI or report can include time filter, which allows the user to define the time period of analysis and display in a plurality of glucose spectrums 1010,1012,1014. The time period can be the last 7 days, or the last two weeks, or the last month, or the last two months, or the last three months, or the last 6 months, or the last 9 months, or the last year.

[0217] The first graph 1010 of the plurality of glucose graphs may display all glucose level measurements for a selected time period. See, e.g. Fig.18C The first graph 1010 may represent a complete set of glucose level measurements, which may include measurements taken after a glucose level altering medication is administered and after a dose of the glucose level altering medication is omitted or the dose information is not received by the program or application.

[0218] The second graph 1012 of the plurality of glucose graphs may display only specific data for a selected time period associated with the administration of a glucose-lowering drug. See, e.g. Fig.18D. The specific data may only include glucose level measurements taken after or during a time window associated with the administration of a drug that changes glucose levels. The specific data associated with the administration of a drug that changes glucose levels may include glucose data or glucose level measurements taken in a window defined by a fixed time in a day. If the dose of the drug that changes glucose levels is associated with a specific window, glucose data may be included from the window. Even if the window does not occur just or just after the dose is administered, the window may still be associated with the dose. In some embodiments, the window may be a fixed time of the day. For example, only when a rapid-acting insulin dose is administered within a fixed time window, the glucose level from the fixed time window (e.g., from about 7am to about 12pm) may be included. The length of the fixed time window may be related to the treatment window of the type of drug administered. For example, a basal or long-acting insulin dose may have a 24-hour fixed time window, and a rapid-acting insulin dose may have a 5-hour fixed time window. In other embodiments, the window may be a variable time of the day, wherein the first time point in the variable time window is the nearest glucose value of the time of the dose following the timestamp of the drug dose or the record, and the variable time window extends for the treatment window of the administered drug dose. For example, the treatment window may be about 5 hours for rapid-acting insulin and about 24 hours for long-acting insulin. Administration of a drug that changes glucose levels may come from a connected drug delivery device. In other embodiments, the drug delivery device is not connected and the user may record the dosage. The record of drug administration may be provided by a connected drug delivery device, or by some other means, such as manually entering a drug administration event. The specific data of the second glucose map 1012 may not include glucose level measurements during a time window after missed drug administration, or measurements during a time window associated with drug administration. A portion or share of the glucose level measurements after a missed dose, such as glucose level measurements during a time window after a missed drug administration, or alternatively, measurements from a window not associated with drug administration, may be cut from a data set including all glucose level measurements within a selected time period, and the remaining glucose level measurements may be used to generate a second glucose map in the plurality of glucose maps 1012. Thus, a second glucose map in the plurality of glucose maps 1012 may reflect the user's blood sugar when the user remembers to take the medication. As in the comparison Fig.18D and Fig.18C The diagram of insulin being used when seen Fig.18D ) has much less distribution or variability in the data in the AGP graph containing ) than in the AGP of the graph containing all the data (including data after missed doses).

[0219] The third map 1014 of multiple glucose maps can be a display of only specific data within a selected time period when, for example, a user or caregiver does not apply a drug that changes glucose levels. Specific data can be displayed in the third map in multiple glucose maps 1014, and can only include glucose level measurements taken during the time window after the missed drug is applied. The third map in multiple glucose maps 1014 may contain data cut from a complete data set to generate the second map in multiple glucose maps. The length of the portion or portion of the glucose level measurement after the missed dose is cut out can depend on the type and characteristics of the glucose level-changing drug. Compared with the second map and the first map, the measured glucose level displayed in the third map 1014 can have a higher glucose level measurement (e.g., a higher median) and / or higher variability because there is no drug in the user's body to help control glucose levels. Therefore, the glucose level associated with the missed dose may lead to high glucose. In addition, when all glucose data are aggregated and plotted together, the high glucose level caused by the missed dose can mask low glucose events after the dose is administered. Glucose maps (e.g., 1012) that display only data from the time window after administration of a glucose-lowering drug dose more directly highlight the effects of those drugs on blood glucose, thereby helping a trained health care professional to potentially titrate the current dosage regimen. Maps (e.g., 1014) that highlight glucose levels where doses were missed can more directly highlight the impact of poor dosage consistency on a subject's blood glucose.

[0220] Thus, the first graph 1010 showing glucose levels from which no data has been removed and the third graph 1014 showing glucose levels measured after a missed dose may display higher glucose level measurements (e.g., a higher median) and / or higher variability compared to the second graph 1012 showing glucose levels measured after administration of a glucose-lowering medication.

[0221] In some embodiments, multiple glucose profiles may be displayed side by side (e.g., Fig.18A ) or one above the other (e.g., as in Fig.18B In certain embodiments, a glucose map may be displayed as a single graph (e.g., three graphs in the same column as seen in FIG. 1 ), which can be presented in a joint display, which can enable the HCP to easily and quickly identify the difference between the traces. In certain embodiments, a glucose map may be displayed as a transparent overlay on other glucose maps to form a single graph. In other embodiments, problematic areas may be highlighted in the glucose map to show how poor consistency or current dosage regimen affect glucose results. Multiple maps may be presented in any order or spatial arrangement.

[0222] The connected drug delivery device data may also include a dose timestamp. If the connected drug delivery device data does not submit a dose to the program that creates the glucose map, the program may assume that the user has not taken a regularly scheduled dose, i.e., a missed dose. In the case of a missed dose, a predefined portion or share of glucose data may be removed from a data set containing all glucose level measurements (which may be used to create the first glucose map 1010), leaving only glucose data that may be associated with the administered drug dose (which may be used to create the second glucose map 1012). This excised portion or share may then be used to create the third glucose map 1014.

[0223] The length of each glucose data portion or share (or the time window in which data is excluded) of the excision can depend on the pharmacodynamics and pharmacodynamic profile (profile) of the user's drug. For example, if a person takes basal insulin injection medication once a day on Monday, but forgets to take medication on Tuesday, the data from the connected drug delivery device can display the dosage timestamp on Monday, but do not display for Tuesday. As a result, the glucose data from Monday can be included in the generation of the second glucose map 1012, but the glucose data from Tuesday can not be included in the data displayed in the second glucose map. However, the Tuesday data can be used to generate the third glucose map 1014. In this example, the glucose data of one day can be excluded, because the long-acting basal insulin has a pharmacodynamic glucose-lowering action time of about 24 hours. If alternatively, the meal time rapid-acting insulin dosage is omitted, then the glucose data of a smaller portion or share can be excised from the generation of the second glucose map, and it can be used for the generation of the third glucose map. This is because rapid-acting insulin has a pharmacodynamic hypoglycemic action time of about 6 hours.

[0224] In some embodiments, the plurality of graphs may include at least 2 graphs, optionally at least 3 graphs, optionally at least 4 graphs, optionally at least 5 graphs, optionally at least 6 graphs, optionally at least 7 graphs, optionally at least 8 graphs. Each of the plurality of graphs may display a different data set. In some embodiments, in the case where a person has a treatment regimen that includes both a basal insulin dose and a bolus dose, 5 graphs may be generated and / or displayed. The first graph may be a display or presentation of all glucose measurements from a time period, the second graph may include glucose measurements taken during a time window associated with or after the administration of (one or more) basal insulin doses, the third graph may include glucose measurements taken during a time window associated with or after the omission of administration of (one or more) basal insulin doses, the fourth graph may include glucose measurements taken during a time window associated with or after the administration of (one or more) bolus insulin doses, and the fifth graph may include glucose measurements taken during a time window associated with or after the omission of administration of (one or more) bolus insulin doses.

[0225] The medicine that changes glucose level can be the medicine that reduces glucose or the medicine that raises glucose.Embodiments described herein relate to the medicine that reduces glucose, such as insulin, but this framework can be extended to the medicine that raises glucose, such as glucagon.The medicine that reduces glucose level can be a type of insulin.The type of insulin includes rapid-acting insulin, short-acting insulin, intermediate-acting insulin (such as NPH insulin), mixed insulin (such as premixed insulin), long-acting insulin and ultra-long-acting insulin.Although the example presented here is for insulin medication, the method can be extended to any medicine that changes glucose with known glucose reduction time sent from the drug delivery device connected.These can include but are not limited to SGLT2 inhibitors, GLP1 receptor agonists, biguanides (such as metformin), alpha-glucosidase inhibitors, thiazolidinediones, DPP4 inhibitors and combinations thereof.

[0226] The length of the portion or portion or time window from which the data can be cut after missing a once-daily, long-acting or basal insulin dose can be about 1 day, or about 20 hours to about 28 hours, or about 22 hours to about 40 hours, or about 20 hours to about 38 hours, or about 20 hours to about 36 hours.

[0227] The part or share or the length of the time window that can therefrom excise data after the Semilente Insulin dosage of omission can be about 2 hours of using glucose-lowering medicine, or about 2.5 hours, or about 3 hours, or about 3.5 hours, or about 4 hours, or about 4.5 hours, or about 5.0 hours, or about 5.5 hours, or about 6.0 hours, or about 6.5 hours, or about 7.0 hours, or about 2.0 hours and about 7.0 hours between, or about 3.0 hours and about 7.0 hours between, or about 4.0 hours and about 7.0 hours between.In certain embodiments, the part or share or the length of the time window that can be excised from it data can be defined or determined by medicine, such as defined or determined by the insulin action time of mealtime insulin.In certain embodiments, the part or share or the length of the time window that can be excised from it data can be preset by the system or estimated.In other embodiments, the part or share or the length of the time window that can be excised from it data can be manually input.

[0228] The length of the portion or portion or time window from which the data may be excised after a missed intermediate-acting insulin dose may be about 12 hours, or between about 8 hours and about 16 hours, or between about 10 hours and about 14 hours.

[0229] The length of the portion or portion or time window from which the data may be excised after a missed dose of Ultra-lente insulin may be from about 36 hours to about 42 hours, or between about 32 hours and about 44 hours.

[0230] In some embodiments, the user can use filters to customize the GUI or report to display different data sets. Data can be used to illustrate different types of non-adhesion. The filter can include a selection to display specific data within a selected time period when taking a recommended dose of a drug that changes glucose levels, when taking an insufficient dose of a drug that changes glucose levels, and when taking an excessive dose of a drug that changes glucose levels. When glucose levels change drug underdosage, i.e., when taking a glucose level change drug that is less than the recommended amount, a chart of specific data within a selected time period, and / or when glucose levels change drug overdosage, i.e., when more than the recommended amount of glucose level change drug, a chart of specific data within a selected time period, compared with a chart showing specific data within a selected time period when taking the recommended amount of glucose level change drug, can help HCPs to be sure that patients follow the recommended medication regimen, rather than changing their dosage.

[0231] In some embodiments, the filter may also include an option to display specific data for a selected time period when a later meal dose is taken (i.e., a dose is taken in a time period after the start of a meal). In some embodiments, a later meal dose or an additional meal dose may be when a dose is provided at least one hour after a meal but within three hours after a meal. In some embodiments, the filter may also include an option to display specific data for a selected time period when an additional meal dose is taken (i.e., an additional dose is taken during a meal). Specific data for a selected time period when a medication that changes glucose levels is taken in a time period after the start of a meal, and / or a chart of specific data for a selected time period when an additional dose of a medication that changes glucose levels is taken during a meal, may help HCPs reduce patients' fear of hypoglycemic episodes.

[0232] In addition to other methods described herein, if a dose is taken outside a preset time period, non-compliance can be determined. For example, if a dose is omitted or taken outside a time window from a prescribed medication time, non-compliance of a basic dose can be determined. In some embodiments, the time window can be about 30 minutes, or about 1 hour, or about 90 minutes after the prescribed medication time. For a single dose, each meal can have an associated time window. For example, the associated time window for breakfast can be about 6am to about 11am, the associated time window for lunch can be about 11pm to about 4pm, and the associated time window for dinner can be about 4pm to about 10pm. The time period associated with staying overnight can be 10pm to about 6am. If the recommended dose is given within the associated time window, it can be determined that the dose is correct. If no dose is administered during the associated time window, it can be determined that the dose is omitted. If an additional dose exceeding a single dose is taken within the associated time period, it can be determined that the dose is an additional dose. If the dose administered within the time period is different from the recommended dose, it can be determined that the dose is non-compliant. In addition, omissions and additional doses can also be determined as non-compliant.

[0233] In other embodiments, the filter may include a selection to display specific data for a selected time period when an alarm is enabled. The alarm may be a low glucose alarm that is set to notify the user when the analyte level is below a low threshold, a high glucose alarm that is set to notify the user when the analyte level is above a high threshold, or both. The low threshold or the high threshold may be set by the user or may be set by the system. The low threshold or the high threshold may be set to different values ​​for different time periods. The alarm may be enabled at different thresholds. Thus, a first graph may include a glucose map that includes all analyte levels for a time period, regardless of whether the alarm is enabled. A second graph may include a glucose map that includes only analyte levels for a time period in which at least one alarm is enabled. A third graph may optionally be included that includes a glucose map that includes only analyte levels for a time period in which at least one alarm is not enabled or at least one alarm is disabled. As Fig.29A As shown, in exemplary method 2200, starting from step 2202, the system or application can receive time-related data or time-related analyte data characterizing analyte levels. The data can be received from a server, a cloud, or from a sensor control device 102. In step 2204, the system or application can determine a subset of the time-related data based on a filtering criterion. In some embodiments, the filtering criterion can be to enable at least one alarm. The system can also receive time-related dosage data for the dosage of the drug that changes glucose received by the object over a period of time, and the filtering criterion can include the dosage consistency of the drug that changes glucose. In some embodiments, dosage consistency includes a recommended dose, a missed dose, an insufficient dose, an excessive dose, a later meal dose, or an extra meal dose. In step 2206, the system or method can display a first analyte spectrum based on the time-related data and a second analyte spectrum based on a subset determined according to the filtering criterion.

[0234] In certain embodiments, filtering criteria can be based on the type of a day. For example, the type of a day can be a weekday, weekend day, working day, vacation day, day when a user or an individual exercises, or a day when a user or an individual does not exercise. In certain embodiments, filtering criteria can be based on the dosage compliance or dosage non-compliance of a user or a person. For example, filtering criteria can be based on whether a user or a person takes a basal insulin dosage or misses its basal insulin dosage. In certain embodiments, filtering criteria can be based on whether a user or a person misses at least one single dose of a meal.

[0235] In an alternative approach, Fig.29BAs shown, in exemplary method 2210, starting from step 2212, the system or application can receive the time-dependent data or time-dependent analyte data of the analyte level characterizing the object.Data can be received from a server, a cloud or from the sensor control device 102.In step 2214, the system or application can determine the first subset of time-dependent data based on filtering criteria.In some embodiments, filtering criteria can be to enable at least one alarm.The system can also receive the dosage data related to the time of the dosage or dosage quantity of the medicine for changing glucose received by the object within a period of time, and the filtering criteria can include the dosage consistency of the medicine for changing glucose.In some embodiments, dosage consistency includes recommended dose, missed dose, insufficient dose, excessive dose, later meal dose or extra meal dose.

[0236] In step 2216, the system may determine a second subset of the time-correlated analyte data based on the filtering criteria. In some embodiments, the second subset of data may include data that does not satisfy the filtering criteria. For example, if the filtering criteria is whether at least one alarm is enabled, the first subset of the time-correlated analyte data may be data during which at least one alarm is enabled, and the second subset of the time-correlated analyte data may be data during which at least one alarm is not enabled (or when at least one alarm is disabled).

[0237] In step 2218, the system or method may display a first analyte profile based on a first subset of the time-correlated analyte data and a second analyte profile based on a second subset of the time-correlated analyte data based on the filtering criteria.

[0238] It will be appreciated that the report and GUI described herein may include any mixing of the described chart or spectrum. Any mixing or subset of these charts (e.g., only two of three charts) may also be presented in a GUI or report. For example, a GUI or report may include a glucose spectrum when enabling at least one alarm and a glucose spectrum when disabling at least one alarm, and may not include a glucose spectrum comprising all data, regardless of the alarm state.

[0239] By separating and presenting glucose data based on the presence or absence of an alarm, users and their care providers will be able to directly see the impact they are having on their blood sugar. The ability to visualize the glucose profile when the alarm is enabled may be particularly useful for people on treatments that may cause hypoglycemia. A comparison of the profiles with and without the alarm enabled compared to having the low glucose alarm off can show the user how enabling and taking action on the low glucose alarm can alleviate a hypoglycemic situation.

[0240] In some embodiments, the indication of alarm occurrence can be added to any one of the glucose spectrum in the relevant time window. The alarm can be indicated to occur by including an icon such as a bell or an alarm clock on the glucose spectrum. The alarm can include the time to meet the alarm condition, regardless of whether the alarm is enabled. For example, the glucose spectrum of the data in which the alarm is not enabled includes that the alarm occurs and can demonstrate the frequency of the alarm at the time of the day and how the alarm is omitted by the user who closes or disables the alarm, thereby causing bad glucose control.

[0241] In some embodiments, a comparative glucose map may be presented that shows alarms enabled at different thresholds. For example, a glucose map with a low glucose alarm threshold enabled at 70 mg / dL may be presented relative to a glucose map with a low glucose alarm threshold enabled at 90 mg / dL.

[0242] In some embodiments, for any of the various filtering criteria described herein, the user can select additional filtering criteria to further customize the displayed chart or metric. For example, when the low glucose alarm has been enabled, the user can select a first-level filter to display data or metrics. Then, the user can select additional filters or second-level filters related to dosage consistency. For example, the user can choose to display data or metrics that the user has taken medication. Such a presentation can indicate that the user's current medication is causing hypoglycemia and should be reduced. Medication information collected from a connected device (e.g., a connected pen or pump) or from user input. In another example, the user can additionally choose to add an indication that the alarm occurred (or the time when the alarm condition has been met) to the display, which can highlight the opportunity to adjust its medication dosage.

[0243] like Fig.29CAs shown, in exemplary method 2220, starting from step 2222, the system or application can receive time-related analyte data or time-related data that characterizes the analyte level of the object. The data can be received from a server, a cloud, or from the sensor control device 102. In step 2224, the system or application can determine a first subset of time-related data based on a first filtering criterion. In step 2226, the system or method can determine a second subset of time-related data based on a second filtering criterion. The filtering criterion of any step can be to enable at least one alarm, wherein different filtering criteria are different types of alarms or alarms with different thresholds. The system can also receive time-related dose data for the dose of the glucose-changing drug received by the object over a period of time, and the filtering criteria can include the dose consistency of the glucose-changing drug. In some embodiments, the dose consistency includes a recommended dose, a missed dose, an insufficient dose, an excessive dose, a late meal dose, or an extra meal dose. In step 2228, the system or method can display a first analyte map based on a first subset of the time-related analyte data and a second analyte map based on a second subset of the time-related analyte data based on the filtering criteria.

[0244] In an alternative embodiment, if Fig.29D As shown, in exemplary method 3220, starting from step 3202, the system or application can receive time-related data of an analyte and an additional analyte or time-related data of an analyte level and an additional analyte level characterizing a subject. In some embodiments, the analyte can be glucose. In some embodiments, the additional analyte can be ketones, ketone bodies, beta-hydroxybutyrate, or lactate.

[0245] In step 3224, the system or application may determine a subset of the time-related data based on a first filtering criterion associated with at least one determined level of the additional analyte. In some embodiments, the first filtering criterion may be based on when the analyte level of at least one determined additional analyte is above a threshold. In some embodiments, if the additional analyte is a ketone, a ketone body, or beta-hydroxybutyrate, the threshold may be at least 1 mmol / L, such as about 1 mmol / L to 2 mmol / L, or about 1 mmol / L, or about 1.1 mmol / L, or about 1.2 mmol / L, or about 1.3 mmol / L, or about 1.4 mmol / L, or about 1.5 mmol / L, or about 1.6 mmol / L, or about 1.7 mmol / L, or about 1.8 mmol / L, or about 1.9 mmol / L, or about 2.0 mmol / L. In some embodiments, if the additional analyte is lactate, the threshold value can be about 3 mmol / L to 5 mmol / L, or about 3.5 mmol / L to 4.5 mmol / L, or about 3 mmol / L, or about 3.25 mmol / L, or about 3.5 mmol / L, or about 3.75 mmol / L, or about 4 mmol / L, or about 4.25 mmol / L, or about 4.5 mmol / L, or about 4.75 mmol / L, or about 5.0 mmol / L.

[0246] In step 3226, the system or method can display a first analyte profile based on the time-dependent data and a second analyte profile based on the subset determined according to the filtering criteria. In some embodiments, the analyte displayed in the first and second analyte profiles is the same analyte, such as glucose.

[0247] In some embodiments, the method may optionally include a step of determining whether the activity level of a person, user, or object is below a high activity threshold before displaying the second analyte pattern. For example, when a high glucose alarm has been enabled, a user may select a first-order filter to display data or metrics. Then, the user may select an additional filter or a second-order filter associated with dosage consistency. If presented with a distribution of the times of day when the alarm occurs, the figure may highlight the opportunity to increase the meal insulin dose.

[0248] In some embodiments, various filtering criteria may be selected via a drop-down menu or list of options.

[0249] In certain embodiments, various filtering criteria can be used together with any one of the reports describing different glucose data described herein. In addition, various filtering criteria can be used together with any glucose report, insulin report or meal / exercise report or its combination. In the case of an alarm filter, the filter can be used in association with any report of remote sensing data, wherein the alarm is associated with one of the data. In other embodiments, the data associated with the alarm are included in the report. In certain embodiments, the data associated with the alarm are not included in the report. For example, the insulin medication report can be filtered according to whether the glucose alarm is enabled. The display can also include the indication of the insulin dosage (and optionally, amount) aligned with the glucose alarm occurrence (or the situation when the alarm condition is met) time.

[0250] In some embodiments, any analyte metric calculation and / or condition indication can be filtered based on filtering criteria. For example, a report containing an A1c laboratory measurement result can be filtered. In some embodiments, a user can choose to analyze only data from a certain time period (e.g., 1 month) before an A1c value greater than a certain threshold (e.g., 6.5%, 7%, 7.5%, or 8%). Similarly, data can be filtered based on the time when the user viewed the detected analyte level, for example, by accessing a GUI that displays the most recent analyte level in a mobile application or on a reader device. The user can choose to view data within a period of time (e.g., about 2 hours, about 3 hours, about 4 hours, between about 1-5 hours, between about 2-5 hours, between about 2-4 hours) after the user has viewed the detected analyte level.

[0251] like Fig. 30A As shown, in exemplary method 2230, starting from step 2232, the system or application can receive time-related analyte data or time-related data characterizing the analyte level of the object. The data can be received from a server, a cloud or from the sensor control device 102. In step 2234, the system or application can determine a subset of the time-related data based on a filtering criterion. In some embodiments, the filtering criterion can be to enable at least one alarm. The system can also receive dosage data for the dosage of the drug that changes glucose received by the object over a period of time, and the filtering criterion can include the dosage consistency of the drug that changes glucose. In some embodiments, the dosage consistency includes a recommended dose, a missed dose, an insufficient dose, an excessive dose, a later meal dose or an extra meal dose. In step 2236, the system or method can display a first analyte measurement based on the time-related data and a second analyte measurement based on the subset determined according to the filtering criterion.

[0252] In an alternative approach, Fig. 30BAs shown, in exemplary method 2240, starting from step 2242, the system or application can receive time-related data or time-related analyte data characterizing the analyte level of the object. The data can be received from a server, a cloud or from the sensor control device 102. In step 2244, the system or application can determine a first subset of the time-related data based on the filtering criteria. In some embodiments, the filtering criteria can be to enable at least one alarm. The system can also receive dosage data for the dosage of the drug that changes glucose received by the object over a period of time, and the filtering criteria can include the dosage consistency of the drug that changes glucose. In some embodiments, the dosage consistency includes a recommended dose, a missed dose, an insufficient dose, an excessive dose, a late meal dose or an extra meal dose. In step 2246, the system can determine a second subset of the time-related analyte data based on the filtering criteria. In some embodiments, the second data subset can include data that does not meet the filtering criteria. For example, if the filtering criteria is whether to enable at least one alarm, the first subset of the time-related analyte data can be data during which at least one alarm is enabled, and the second subset of the time-related analyte data can be data during which at least one alarm is not enabled (or when at least one alarm is disabled).

[0253] In step 2248, the system or method may display a first analyte metric based on a first subset of the time-correlated analyte data and a second analyte metric based on a second subset of the time-correlated analyte data based on a filtering criterion.

[0254] like Fig. 30C As shown, in exemplary method 2250, starting from step 2252, the system or application may receive time-related data or time-related analyte data characterizing the analyte level of the object. The data may be received from a server, a cloud, or from the sensor control device 102. In step 2254, the system or application may determine a first subset of the time-related data based on a first filtering criterion. In step 2256, the system or method may determine a second subset of the time-related data based on a second filtering criterion. The filtering criterion of any step may be to enable at least one alarm, wherein different filtering criteria are different types of alarms or alarms with different thresholds. The system may also receive dosage data for the dosage of the glucose-changing drug received by the object over a period of time, and the filtering criterion may include the dosage consistency of the glucose-changing drug. In some embodiments, the dosage consistency includes a recommended dose, a missed dose, an insufficient dose, an excessive dose, a late meal dose, or an extra meal dose. In step 2258, the system or method may display a first analyte metric based on a first subset of the time-related analyte data and a second analyte metric based on a second subset of the time-related analyte data based on the filtering criterion.

[0255] The analyte measurement calculation that can be filtered can include the time measurement in the range. The time measurement in the range can include multiple ranges. As described elsewhere, the time measurement in the range can be displayed in a chart, such as a bar chart, a histogram, a pie chart and other known charts. In some embodiments, the time GUI part 954 in the range may include a single bar, which includes up to five bar parts, which include (from top to bottom): a first bar part, which indicates that the glucose range of the user is "very high" or higher than 250mg / dL for a predefined amount of time; a second bar part, which indicates that the glucose range of the user is "high" or between 180 and 250mg / dL for a predefined amount of time; a third bar part, which indicates that the glucose range of the user is within the "target range" or between 70 and 180mg / dL for a predefined amount of time; a fourth bar part, which indicates that the glucose range of the user is "low" or between 54 and 69mg / dL for a predefined amount of time; and a fifth bar part, which indicates that the glucose range of the user is "very low" or less than 54mg / dL for a predefined amount of time. The time-in-range GUI 954 may display text adjacent to each bar portion that indicates the actual amount of time, such as in hours and / or minutes.

[0256] In some embodiments, different filtered glucose maps or metrics can be displayed on the same graph. In other embodiments, different filtered glucose maps or metrics can be displayed on different graphs, which are displayed on a single GUI or in a single report.

[0257] Meals can be identified or recorded by the subject, and the meal start time can be determined based on manual input. Alternatively, the meal start time can be estimated by many methods. Exemplary methods are described in U.S. Application Serial No. 16 / 944,736 and U.S. Application Serial No. 17 / 591,229; see also Harvey, RA et al., "Design of the Glucose Rate Increase Detector-A Meal Detection Module for the Health Monitoring System," JDiabetes Sci Techol. 2014 Mar; 8 (2): 307-320, which is hereby expressly incorporated by reference in its entirety for all purposes. If it is determined that a dose is taken a period of time after the meal start time (e.g., about 30 minutes, or about 45 minutes, or about 60 minutes, or about 90 minutes after the estimated meal start), a later dose can be determined. In other embodiments, if the glucose level from the CGM is >70 mg / dl and there is a >70 mg / dl increase within two hours, it can be determined that a meal has been taken. In this case, a late meal bolus may be defined when the glucose level from the CGM increases by >50 mg / dl from baseline before the insulin dose. A missed meal bolus may be defined when no insulin dose was taken within two hours before the glucose level began to rise. In some embodiments, a missed meal bolus may be defined by a glucose increase of 80 mg / dl within ≤2 hours without an insulin dose within the previous 1 hour.

[0258] In some embodiments, GUI or report can also include at least some analyte metrics related to each of the multiple glucose atlases.The at least some analyte metrics can include, but are not limited to, the average or median analyte level of the time period, standard deviation (SD), CV ([(SD of glucose) / (average glucose)] × 100), the display of the time in the range of the time period, the GMI index of the time period, the number of high and / or low offsets or the count of their duration respectively lower than the high and / or low threshold, the number of very high and / or very low offsets or the count of their duration respectively lower than the very high and / or very low threshold, the multiple dosage indexes corresponding to the dosage of the administered drug, as described in other reports and embodiments in this specification.In certain embodiments, the pattern analysis of the glucose atlas can be based on various inclusions or exclusions.For example, it is possible to determine a "low" pattern for a window associated with drug administration, but not for a window not associated with drug delivery.Dose guidance or delivery can be based on these patterns determined only from the window associated with drug administration.In certain embodiments, recommendations can be made based on the type of (multiple) patterns determined or detected. Further details of pattern analysis are described in WO 2021 / 026004, which is expressly incorporated herein by reference in its entirety for all purposes.

[0259] The methods described herein are not limited to metrics or graphs to be displayed, but can also be used in processes such as automatic insulin (or other drug) delivery processes, insulin (or other drug) dosage guidance systems, and treatment guidance systems. In some embodiments, if associated with a missed drug dose as described herein, the data used as input or feedback in these systems may include or exclude different glucose (or analyte) readings. For example, a treatment guidance system can provide treatment change recommendations based on glucose data that excludes glucose data associated with a missed drug dose. In other embodiments, the automatic insulin delivery system can utilize an adaptive model; the adaptive processing can be based on glucose data that does not include glucose data where the drug dose is missed.

[0260] In other embodiments, multiple graphs may be presented in a comparative profile report. In many embodiments, a GUI or report may include multiple analyte profiles over a selected time period by utilizing medication data from, for example, a connected drug delivery device and analyte data from a continuous analyte monitor as input. Figures 18A-18BAs shown, in some embodiments, the GUI or report can include two, optionally two or more, optionally three, optionally four, optionally five, optionally six, optionally six or more versions of the analyte profile within a selected time period. The analyte can be, but is not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, glycosylated hemoglobin (HbA1c), creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine, glucose, glucose derivatives, glutamine, growth hormone, hormone, ketone, ketone body, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The analyte profile can be any of the different types of charts described with respect to other embodiments, such as a glucose profile.

[0261] In some embodiments, the plurality of graphs may include at least 2 graphs, optionally at least 3 graphs, optionally at least 4 graphs, optionally at least 5 graphs, optionally at least 6 graphs, optionally at least 7 graphs, optionally at least 8 graphs. Each of the plurality of graphs may display a different data set. In some embodiments, in the case where a person takes multiple medications at a time, the graph may be a display or presentation of all data from a time period, and two graphs may be displayed for each type of medication taken. For each medication, a first graph may include analyte measurements taken during a time window after or associated with medication administration, and a second graph may include analyte measurements taken during a time window after or associated with missed medication administration. Therefore, for a person taking n medications, a plurality of graphs including 2n+1 graphs may be presented. As previously explained with respect to other embodiments, the time window after or associated with medication administration may be determined by the duration of action of the medication administered.

[0262] Check whether the drug is taken

[0263] Using a connected drug delivery device, it is easy to determine whether the drug was delivered to the patient. For unconnected drug delivery devices (such as syringes), the system can use another device to determine whether the drug was delivered. The system can provide a UI in which the patient can record any time they take the medication. In addition, the system can include predefined time windows of the day when the patient usually takes the medication, and if no medication record is made in this time window, the system can prompt the patient to confirm whether they took the medication. For oral medications, a connected medicine box or similar device can be used to determine whether the medication was taken. The system can provide a combination of a connected device and a UI device, wherein if the connected device does not indicate that the medication was taken, the system can prompt the patient to confirm that they did not (or did) take the medication.

[0264] When taking a medication after a typical or prescribed time window of the day, glucose data associated with the time of the day can be excluded. Similarly, glucose data associated with the time of the day for a late dose can also be excluded. Glucose data associated with these time periods of the day can be included in some form of data analysis; for example, to illustrate the impact on glucose metrics when taking a dose in the evening. In this case, glucose during the time period of the day associated with the late dose can only be included in the metric calculation and can be compared with a metric calculated using glucose data from only the time period of the day for taking a dose on time.

[0265] Feedback mechanisms on drug delivery devices

[0266] Feedback Related to Recommended Dosages In some embodiments, a medication dosage calculation module in a DSS system may be linked to an interface or display of MDD 152. As described elsewhere, MDD 152 may be a smart pen, pen cap, or pump that delivers a medication that alters glucose levels, such as insulin. The DSS system may receive a recommended medication dosage from the medication dosage calculation module of the DSS system. The recommended dosage may be communicated to MDD 152. When a user enters or selects a dosage on MDD 152, MDD 152 may provide feedback to the user as to whether the dosage entered on MDD 152 is the same, lower, or higher than the recommended dosage from the medication dosage calculation module.

[0267] In some embodiments, the feedback provided can be visual feedback. For example, in the case where the MDD 152 is a connected insulin pen 2152, such as Fig.33A -33D, the user can use the rotatable adjustment disk or knob 2154 to enter the dose, and the dose entered using the adjustment disk or knob 2154 can be displayed in the display 2156 and / or 2158 to indicate the amount selected for manual injection. The background color of the display 2156 and / or 2158 can be a different color depending on the dose entered. For example, when the amount entered is the same as the recommended dose, the background color can be a first color, such as green. If the amount entered is higher than the recommended dose, the background color can be a second color, such as red. If the amount entered is lower than the recommended dose, the background color can be a third color, such as gray.

[0268] In some embodiments, MDD 152 may be a smart button configured to fit over an actuator of a delivery pen or a pen cap configured to attach to a pen (e.g., to a needle tip, body, or medication selector (e.g., dial)). Figures 34A-34DAs shown, the drug pen 2180, which can be a disposable drug delivery pen, can include a display 2186 and a medication selector, such as a rotatable adjustment disk 2184, to select a dose. The pen cap or smart button 2190 can be assembled above the medication selector 2184 or other parts of the pen (such as the needle end or the body), and snap together with the pen 2180. After the pen cap or smart button 2190 is paired with the reader device, the pen cap or smart button 2190 can track the dose, store the medication (dosing) data and transmit it to the reader device. The drug can be delivered by directly pushing down on the pen cap or smart button 2190 to inject the dose. The pen cap or smart button 2190 can also include a display 2196 that can display the recommended dose and / or the dose applied. The background color of the display 2196 can be a different color depending on the dose input. For example, when the amount input is the same as the recommended dose, the background color can be a first color, such as green. If the amount input is higher than the recommended dose, the background color can be a second color, such as red. If the amount entered is below the recommended dose, the background color may be a third color, such as gray.

[0269] Similarly, if the MDD 152 is an insulin pump 2172, Fig.35 As shown, the pump may include at least one button or keyboard 2174 for entering a dose. The dose entered may be shown on a display 2176. Similar to the example of a connected pen, if the dose entered is the same as the recommended dose, the display 2176 may have a first background color, such as green. If the dose entered is higher than the recommended dose, the display may have a different color (e.g., red) background. If the dose entered is lower than the recommended dose, the display may be another different color, such as gray.

[0270] In some embodiments, the feedback provided can be auditory feedback. For example, if the dose entered is the same as the recommended dose, the MDD 152 can emit a first sound, such as a single short beep or ring. If the dose entered is higher than the recommended dose, the MDD 152 can emit a second sound, such as a long beep. If the dose entered is lower than the recommended dose, the MDD 152 can emit a third sound, such as a series of short beeps.

[0271] In some embodiments, the feedback provided may be tactile feedback. For example, if the dose entered is the same as the recommended dose, the MDD 152 may not vibrate. If the dose entered is higher than the recommended dose, the MDD 152 may vibrate for a first time period. If the dose entered is lower than the recommended dose, the MDD 152 may vibrate for a second time period that is different from the first time period. In some embodiments, if the dose entered is the same as the recommended dose, the MDD 152 may vibrate for a third time period that is different from the first and second time periods. Alternatively, the MDD 152 may emit different vibration patterns depending on the relationship between the dose entered and the recommended dose.

[0272] In some embodiments, the medication dosing calculation module may determine a recommended dosing range having an upper limit and a lower limit. Alternatively, the medication dosing calculation module may recommend a nominal value within the recommended dosing range. The visual, auditory, and tactile feedback mechanisms described above may be used by comparing the input dose to the recommended dose range to determine whether the input dose is within the recommended dose range, greater than the upper limit of the recommended dose range, or less than the lower limit of the recommended dose range.

[0273] like Fig.31A As shown, in exemplary method 2270, starting from steps 2272 and 2274, one or more processors of MDD 152 can receive a dose recommendation (step 2272) and a dose input by a user (step 2274). In step 2276, the one or more processors can compare the input dose with the dose recommendation. In step 2278, the one or more processors can provide feedback on the delivery device based on the comparison.

[0274] As described elsewhere, the comparison can be whether the dose entered is the same as, greater than, or less than the dose recommendation.

[0275] like Fig.31B As shown, in exemplary method 2280, starting from steps 2282 and 2284, one or more processors of MDD 152 can receive a dosage recommendation (step 2282) and a dosage input by a user (step 2284). In step 2286, one or more processors can determine whether the input dosage is the same as the dosage recommendation. If the input dosage is the same as the dosage recommendation, in step 2288, a first type of feedback can be provided on MDD 152. In different embodiments, the feedback can be visual, auditory, or tactile, as described with respect to other embodiments.

[0276] If the entered dose is different or not equal to the dose recommendation, then in step 2290, the one or more processors may determine whether the entered dose is greater than the dose recommendation. If the entered dose is greater than the dose recommendation, then in step 2292, a second type of feedback may be provided on the MDD 152. In different embodiments, the feedback may be visual, auditory, or tactile, as described with respect to other embodiments. Alternatively, in step 2290, the one or more processors may determine whether the entered dose is less than the dose recommendation.

[0277] If the entered dose is not greater than (ie, less than) the dose recommendation, then in step 2294, a third type of feedback may be provided on the MDD 152. In various embodiments, the feedback may be visual, audible, or tactile, as described with respect to other embodiments.

[0278] The steps in any of the methods described herein are optional and may be excluded from the method or completed in an order different from the order in which they appear in the figure. For example, the method may only determine whether the dose input is the same as the dose recommendation. If it is the same as the dose recommendation, one or more processors may provide feedback on the delivery device. If the dose input is different from (i.e., lower or higher than) the dose recommendation, in some embodiments, one or more processors may not provide feedback on the delivery device. In another example, the method may only determine whether the dose input is different from (e.g., higher than) the dose recommendation, and not determine whether the dose input is equal to the dose recommendation.

[0279] As described above, the feedback can be visual (e.g., a different colored background), auditory (e.g., a different sound), or tactile (e.g., a different vibration). The feedback provided based on the comparison of the amount of the dose entered with the dose recommendation can be different depending on whether the amount of the dose entered is the same, greater than, or less than the dose recommendation.

[0280] Safety measure to prevent higher than recommended dosages Haptic feedback on the drug delivery device In another embodiment, as a safety measure to prevent higher or lower than recommended dosages, the MDD 152 may include tactile feedback when the user enters a dosage that is higher or lower than the dosage recommendation. For example, with an insulin pen connected, if the user uses the rotatable adjustment dial or knob 2154 to enter a dosage that is higher than the dosage recommendation, such as Figures 33A-33BAs shown, the adjustment disk or knob 2154 can be configured to set itself to a dosage recommendation or a nominal recommended value within the recommended medication range by default. Alternatively or additionally, if the input dose is higher than the dosage recommendation, the adjustment disk or knob 2154 can be configured to have an increased rotational resistance compared to rotating or dialing the knob 2154 to the dosage recommendation. The adjustment disk or knob 2154 can alternatively be configured to rebound to the dosage recommendation if it is adjusted to a dose above the dosage recommendation. For example, the adjustment disk or knob 2154 can be elastically biased to the dosage recommendation.

[0281] In another example, MDD 152 can be an insulin pump that includes at least one button for inputting a dose to be administered. The at least one button can be configured to have increased resistance to downward movement (e.g., more difficult to push or select downward) when a dose above or below the dose recommendation is input. For example, Fig.35 As shown, the insulin pump 2172 may include "+" and "-" buttons or a numeric keypad 2174 that allow the user to enter the dose to be delivered. The buttons or keypad may be configured to have increased resistance to downward movement if the dose entered is out of range.

[0282] like Fig.32A As seen in the exemplary method 3000, beginning at step 3002, one or more processors of the MDD 152 can receive a dosage recommendation. In step 3004, the one or more processors can also determine a dosage input using a medication selector of the MDD 152. In step 3006, the one or more processors can determine whether the input dosage is different from the dosage recommendation, i.e., whether the input dosage is higher or lower than the dosage recommendation. In step 3008, if the input dosage is different from the dosage recommendation, the one or more processors can provide tactile feedback on the MDD 152.

[0283] As described elsewhere, the tactile feedback may be increased resistance, springback, rebound, and other known tactile feedback mechanisms.

[0284] Locking When Input Above Dose Recommendation In another embodiment, as another safety measure to prevent over or under recommended medication, the MDD 152 can be configured to mechanically lock the MDD 152 to prevent any medication from being delivered to the user. In some embodiments, the MDD 152 can be locked only when the difference between the input dose and the dose recommendation is greater than a predetermined number of units. The predetermined number of units can be about 1 unit, or about 2 units, or about 3 units, or about 4 units.

[0285] In some embodiments, the MDD 152 can be locked by mechanically locking the medication selector. For example, if the MDD 152 is a connected pen 2152, the rotatable adjustment disk 2154 can be mechanically locked so that it can no longer rotate. Alternatively, the MDD 152 can be locked by mechanically locking or disengaging the syringe.

[0286] In some embodiments, the amount of the dose entered may be communicated to the reader device, and one or more processors of the reader device may display a notification or alert regarding the higher dose entered, and may require the user to confirm the higher dose on the GUI of the DSS module.

[0287] like Fig.32B As shown, in exemplary method 3020, beginning at step 3022, one or more processors of MDD 152 may receive a dosage recommendation. In step 3024, one or more processors of MDD 152 may also determine a dosage input using a medication selector of MDD 152. In step 3026, the one or more processors may determine whether the input dosage differs from the dosage recommendation, i.e., whether the input dosage is higher or lower than the dosage recommendation. In step 3028, if the input dosage differs from the dosage recommendation, the one or more processors may lock MDD 152 to prevent it from delivering medication.

[0288] Adjusting Alarms When Above a Given Dose Recommendation In some embodiments, if a user sets and / or delivers an insulin dose that is different from the dose recommendation or outside the recommended range, the DSS system can adjust alarm parameters. For example, if the dose delivered by or entered on the MDD 152 is higher than the dose recommendation by a first predetermined amount or lower than the dose recommendation by a second predetermined amount, the DSS system can adjust the urgency or nature of the low and / or high glucose alarms for a period of time after the insulin dose is delivered. Examples of adjusting the urgency of an alarm include increasing the low glucose threshold of an impending low or high glucose alarm, lowering the high glucose threshold, or increasing the prediction range (the time period over which the predicted glucose level is determined) of an impending low or high glucose alarm. Examples of adjusting the nature of an alarm include reducing the alarm snooze period, increasing the volume of the alarm, extending the sounding of an audible alarm, or requiring additional confirmation to clear the alarm.

[0289] like Fig.32CAs shown, in exemplary method 3040, one or more processors of the reader device may determine a recommended dose in step 3042. In step 3044, the one or more processors may also receive a dose delivered by or input on the MDD 152. Then, in step 3046, the one or more processors may determine whether the delivered dose is different from the dose recommendation. In step 3048, if the delivered or input dose is different from the dose recommendation, the one or more processors may adjust the alarm parameters.

[0290] In some embodiments, the low glucose threshold can be increased to a higher concentration. Alternatively or additionally, the high glucose threshold can be reduced to a lower concentration. Alternatively or additionally, the time period for predicting an alarm can be increased, for example, by at least about 20 minutes, alternatively by at least about 30 minutes, alternatively by at least about 40 minutes, alternatively by at least about 50 minutes, alternatively by at least about 60 minutes. In some embodiments, the nap period is reduced to a shorter time period. For example, the nap period can be reduced by at least 3 minutes, for example, the nap period can be reduced by about 15 minutes, or by about 10 minutes, or by about 5 minutes, or by about 3 minutes. In some embodiments, the volume of the audible alarm can be increased. In some embodiments, the DSS can enable the requirement for the user to confirm the warning.

[0291] Safety measures when taking medications later Time-out features on drug delivery devices

[0292] The DSS may also include safeguards to prevent late doses (e.g., doses administered after a meal has been started). In some embodiments, the MDD 152 may include a timeout feature such that after a predetermined amount of time has passed since the determination of the dose recommendation, the MDD 152 may be disabled such that a dose of medication may not be delivered. For example, a medication selector of the MDD 152 may be set to a zero dose and / or may be locked. The MDD 152 may also be prohibited from delivering any medication until a new dose recommendation is determined and communicated to the MDD 152.

[0293] like Fig.32DAs shown, in exemplary method 3060, in step 3062, one or more processors of MDD 152 may receive a dosage recommendation from a medication dosage calculation module at a first time T1. In step 3064, one or more processors of MDD 152 may receive dosage data of a dosage input on MDD 152 at a second time T2. In step 3066, one or more processors of MDD 152 may determine whether the difference between T2 and T1 is greater than a predetermined amount of time, such as at least about 20 minutes, or at least about 30 minutes, or at least about 40 minutes, or at least about 50 minutes, or at least about 60 minutes. If the difference between T2 and T1 is greater than the predetermined amount of time, then in step 3068, one or more processors may change the configuration of the drug delivery device. For example, the medication selector of MDD 152 may be changed to a locked configuration. Alternatively or additionally, if MDD 152 is an insulin pump, the medication selector may be set to zero dose.

[0294] In another embodiment, if Fig.32E As shown, in exemplary method 3070, in step 3072, one or more processors of MDD 152 may receive a dosage recommendation from a medication dosage calculation module at time T1. In step 3074, one or more processors of MDD 152 may determine whether a dose has been administered within a predetermined time since the dosage recommendation was determined at time T1. If a dose has not been administered, then in step 3076, one or more processors of MDD 152 may change a configuration of MDD 152. For example, a medication selector of MDD 152 may be changed to a locked configuration. Alternatively or additionally, the medication selector may be set to a zero dose.

[0295] Updating the Display on the Medication Delivery Device Additional safeguards for late dosing can include the medication dosage calculation module taking into account the delay or time delay of the current dose relative to the recommended dosing time. The medication dosage calculation module can calculate a new dosage recommendation. This new dosage recommendation can then be transmitted to the MDD 152, which can be displayed on the delivery device.

[0296] like Fig.32FAs shown, in exemplary method 3080, in step 3082, one or more processors of the reader device may determine a recommended dose at a first time T1. In some embodiments, the medication calculation module may determine the dose recommendation. In step 3084, one or more processors of the reader device may determine whether a dose has been administered during a predetermined time since the dose recommendation was determined at the first time T1. If a dose has not been administered, then in step 3086, one or more processors of the reader device may determine a new dose recommendation. In step 3088, the new dose recommendation may be communicated to MDD 152. In some embodiments, MDD 152 may display the new dose recommendation. In some embodiments, the reader device may display the new dose recommendation.

[0297] In some embodiments, the predetermined period of time can be at least about 20 minutes, or at least about 30 minutes, or at least about 40 minutes, or at least about 50 minutes, or at least about 60 minutes.

[0298] In another embodiment, the new dosage recommendation is a periodically updated function of the first dosage recommendation at fixed time intervals since the previous recommendation. Figure 32G As shown, in exemplary method 3090, in step 3092, one or more processors of the reader device may determine a first dosage recommendation. In some embodiments, the medication calculation module may determine the dosage recommendation. In step 3095, the one or more processors may determine whether the dosage recommendation is below a threshold. If the first dosage recommendation is below a threshold, such as zero units, in some embodiments, the process stops providing dosage recommendations (step 3093). Otherwise, in step 3095, the one or more processors may wait for a first time period (such as 20 minutes) to pass (step 3091). Then, in step 3094, the one or more processors of the reader device may determine whether the dose has been delivered. If so, the process stops providing dosage recommendations (step 3093). Otherwise, in step 3096, the process determines a new dosage recommendation by considering factors including the time elapsed since the previous time period. In step 3098, if the dosage recommendation is below a threshold, the process stops providing dosage recommendations (step 3093). Otherwise, the one or more processors will wait for a second time period (such as 5 minutes) to pass (step 3099). Then, in step 3097, one or more processors of the reader device may determine whether the dose has been delivered. If so, the process stops providing dose recommendations (step 3093). Otherwise, the process returns to step 3096. In some embodiments, an additional timeout may be provided such that if the time elapsed since the first dose recommendation exceeds a third time period (such as 5 hours), the process stops providing dose recommendations.

[0299] Other safety features

[0300] Lockout when zero dose allowed

[0301] The DSS may include other safety features. In some embodiments, when the dosage recommendation is determined to be zero (0), the MDD 152 may lock the MDD 152 so that the drug cannot be delivered before further action is taken or before a non-zero dosage recommendation is received. The medication calculation module may determine that the dosage recommendation should be zero based on several factors, including active insulin on board and / or the risk of hypoglycemia exceeding a threshold. Exemplary methods for determining the risk of hypoglycemia may be found in U.S. Patent Publication No. 2014 / 0088392, U.S. Patent Publication No. 2014 / 0187887, U.S. Patent Publication No. 2014 / 0188400, and U.S. Patent Publication No. 2014 / 0350369, all of which are expressly incorporated herein by reference in their entirety for all purposes.

[0302] like Fig.32H As shown, in exemplary method 3100, in step 3102, MDD 152 may receive a dosage recommendation from a reader device. In step 3104, one or more processors of MDD 152 may determine whether the dosage recommendation is equal to a dosage of zero (0). In step 3106, one or more processors of MDD 152 may lock MDD 152, thereby preventing any drug from being delivered from the device until further action is taken or until a non-zero dosage recommendation is received.

[0303] Actions on the Pen Triggering GUI on the Reader Device In some embodiments, a set of actions on the MDD 152 may trigger an application module on the reader device to display a specific user interface or dialog menu. For example, the set of actions may include when a user enters a dose that is higher than a certain number of increments during a first predetermined time period. Alternatively, the set of actions may include when a user enters a dose that is higher or lower than the dose recommendation (suggested dose) within a second predetermined amount of time. In response to the set of actions, a user interface such as a dialog menu may be displayed on the reader device that may present possible dose guidance options (e.g., additional dose guidance). In some embodiments, depending on the time of day and the user's previous patterns, a dialog menu for meal dose recommendations or post-meal correction doses may be presented. In some embodiments, if the user pattern and the specific time of day are not within the time period (e.g., 1 hour) of the basal dose previously taken by the user, the basal dose guidance may not be displayed. As Fig.32IAs shown, in exemplary method 3120, in step 3122, one or more processors of the reader device may determine a recommended dose. In step 3124, the reader device may receive dosage data for a dose entered using a medication selector on the MDD 152. In step 3126, one or more processors of the reader device may determine whether the dose entered is different from the dose recommendation. For example, the dose entered may be several units higher or lower than the dose recommendation. In step 3128, one or more processors of the reader device may cause the display of a GUI related to the dose recommendation. For example, the GUI may include a recommended dose guidance option or may include a warning about insufficient or overdosage of medication. In some embodiments, the dose guidance may be a recommended meal dose based on the time of day at which the dose is entered. In some embodiments, the dose guidance may be a recommended correction dose based on the time of day at which the dose is entered. In some embodiments, the dose guidance may be a recommended basal dose based on the time of day at which the dose is entered.

[0304] Shortcuts on the Drug Delivery Device In some embodiments, the MDD 152 may include shortcuts for specific dosage recommendations. Figures 33A-33B A single shortcut button or multiple shortcut buttons 2158a-e in Fig.34C 2188a-e in, and Fig.35 2178a-e in. For example, MDD 152 may include shortcut buttons for each of breakfast, lunch, dinner, basal, snack, and / or correction doses. When the button is pressed or selected, one or more processors of MDD 152 may retrieve the amount of the corresponding recommended medication dose determined by the medication dosage calculation module and may display the dosage recommendation. Fig.32J As seen in the exemplary method 3140, in step 3142, the MDD 152 may receive a dosage recommendation for at least one meal type. In step 3144, one or more processors of the MDD 152 may assign the dosage recommendation for at least one meal type to one of a plurality of buttons on the MDD 152. In response to a user selecting one of the plurality of buttons (step 3146), the MDD 152 may display the dosage recommendation (step 3148). More specifically, in response to a user selecting a button corresponding to a dosage recommendation (step 3146), the MDD 152 may display the dosage recommendation (step 3148). In an optional step, the MDD 152 may also set a dose to the displayed dosage recommendation associated with the selected button.

[0305] In other methods, the MDD 152 may receive multiple dosage recommendations for different meal types. One or more processors of the MDD 152 may assign each of the recommended dosages for different meal types to a different button on the MDD 152. In response to the user selecting one of the multiple buttons, the MDD 152 may display the dosage recommendation for the corresponding meal type. In an optional step, the MDD 152 may also set the dosage to the displayed dosage recommendation associated with the selected button.

[0306] Steps in any method described herein are optional and may be excluded from the method or performed in an order different from the order in which they appear in the figures.

[0307] Provided are systems, devices and methods for incorporating a drug delivery device into an integrated management system. The integrated management system can be an integrated diabetes management system and can include a glucose monitor, a connected insulin pen and software. The integrated management system can generate multiple reports that can include data related to analyte levels (e.g., glucose levels) and the drug delivered (e.g., the insulin delivered). The drug delivery device can also provide feedback to the user.

[0308] Various aspects of the subject matter are set forth below in a review and / or supplement to the embodiments described so far, with emphasis on the interrelationship and interchangeability of the following embodiments. In other words, it is important to note that each feature of an embodiment can be combined with each and every other feature unless explicitly stated otherwise or logically unsound. The embodiments described herein are restated and expanded in the following paragraphs without explicit reference to the drawings.

[0309] In many embodiments, an analyte monitoring system includes a drug delivery device configured to deliver a certain amount of drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-related data characterizing an analyte level of the subject and time-related dosage data of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a dosage recommendation of the drug based on at least a calculated analyte level, the calculated analyte level being based on the time-related data characterizing the analyte level of the subject, communicate the dosage recommendation of the drug to the drug delivery device, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to provide feedback based on a comparison between the dosage recommendation and a dosage input using the medication selector.

[0310] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of a drug inputted by the medication selector may be inputted and / or selected by a user. The time-related data characterizing the analyte of a subject (or referred to as a "subject") may be data representing / reflecting the analyte concentration of the subject over time. The dose data may be the amount and timing of the dose of a drug received by the subject during the time period. Throughout the specification, the dose data of the dose of a drug received by the subject may simply be referred to as the dose of a drug received by the subject. The comparison between the dose recommendation and the dose inputted using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose inputted using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the dose inputted using the medication selector. The first memory and the second memory referred to herein are part of an analyte monitoring system. The first memory may be part of a drug delivery device. The second memory may be part of a reader device.

[0311] In some embodiments, the feedback includes visual feedback.

[0312] In some embodiments, the feedback includes tactile feedback.

[0313] In some embodiments, the feedback includes tactile feedback.

[0314] In some embodiments, the drug delivery device is a pen. In some embodiments, the drug delivery device further comprises a pen cap. In some embodiments, the display is on the pen cap.

[0315] In some embodiments, the drug delivery device further comprises a smart button. In some embodiments, the display is on the smart button.

[0316] In some embodiments, the medication selector is a rotatable knob.

[0317] In some embodiments, the drug delivery device is a pump. In some embodiments, the medication selector is at least one button.

[0318] In some embodiments, the display of the medication delivery device has a background color, and wherein if the dose entered using the medication selector is equal to the dose recommendation of the medication, the feedback includes the background color of the display of the medication delivery device being a first color. In some embodiments, the first color is green.

[0319] In some embodiments, if the dosage input using the medication selector is greater than the dosage recommendation of the medication, the feedback includes the background color of the display of the medication delivery device being a second color. In some embodiments, the second color is red.

[0320] In some embodiments, if the dose entered using the medication selector is less than the dose recommendation of the medication, the feedback includes the background color of the display of the medication delivery device being a third color. In some embodiments, the third color is gray.

[0321] In some embodiments, if the dose entered using the medication selector is equal to the dose recommendation for the medication, the feedback comprises a first pattern, wherein if the dose entered using the medication selector is greater than the dose recommendation for the medication, the feedback comprises a second pattern, and wherein if the dose entered using the medication selector is less than the dose recommendation for the medication, the feedback comprises a third pattern. In some embodiments, the first, second, and third patterns are different vibration patterns. In some embodiments, the first, second, and third patterns are different auditory patterns. In some embodiments, the first, second, and third patterns are different light patterns. In some embodiments, the light pattern comprises a flashing pattern of light.

[0322] In some embodiments, the dosage recommendation is a single dose.

[0323] In some embodiments, the dose recommendation includes a dose recommendation range, the dose recommendation range including an upper limit and a lower limit, and wherein if the dose entered using the medication selector is within the upper limit and the lower limit of the dose recommendation range, or is equal to the upper limit or the lower limit, the feedback includes that the background color of the display of the drug delivery device is a first color. In some embodiments, if the dose entered using the medication selector is greater than the dose recommendation of the drug, the feedback includes that the background color of the display of the drug delivery device is a second color. In some embodiments, if the dose entered using the medication selector is less than the dose recommendation of the drug, the feedback includes that the background color of the display of the drug delivery device is a third color.

[0324] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0325] In many embodiments, a method includes the steps of: receiving, by one or more processors of a drug delivery device, a dose recommendation; receiving, by the one or more processors of the drug delivery device, dose data of a dose input on the drug delivery device; comparing the input dose with the dose recommendation; and providing feedback on the drug delivery device based on the comparison.

[0326] In some embodiments, the comparing step includes determining whether the entered dose is equal to the dose recommendation.

[0327] In some embodiments, in response to determining that the inputted dose is equal to the dose recommendation, first feedback is provided on the drug delivery device. In some embodiments, the first feedback is a first color background of a display of the drug delivery device.

[0328] In some embodiments, the comparing step includes determining whether the input dose is greater than the dose recommendation. In some embodiments, in response to determining that the input dose is greater than the dose recommendation, second feedback is provided on the drug delivery device, wherein the second feedback is different from the first feedback.

[0329] In some embodiments, the comparing step includes determining whether the input dose is greater than the dose recommendation. In some embodiments, in response to determining that the input dose is greater than the dose recommendation, second feedback is provided on the drug delivery device, wherein the second feedback is different from the first feedback.

[0330] In some embodiments, the comparing step includes determining whether the inputted dose is less than the dose recommendation. In some embodiments, in response to determining that the inputted dose is less than the dose recommendation, third feedback is provided on the drug delivery device.

[0331] In some embodiments, the feedback is visual, auditory, or tactile.

[0332] In many embodiments, an analyte monitoring system includes a drug delivery device configured to deliver an amount of a drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dose recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-dependent data characterizing an analyte level of an object and a dose of a drug received by the object over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the one or more processors to: determine a dose recommendation of a drug based at least on a calculated analyte level, the calculated analyte level being based on the time-dependent data characterizing an analyte of the object, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to provide tactile feedback through the medication selector based on a comparison between the dose recommendation and a dose entered using the medication selector. The medication selector referred to throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of a drug entered by the medication selector may be entered and / or selected by a user. The time-dependent data of the analyte characterizing the subject may be data representing / reflecting the concentration of the analyte of the subject over time. The dosage data may be the amount and timing of the dose of the drug received by the subject during the time period. Throughout the specification, the dosage data of the dose of the drug received by the subject may be simply referred to as the dose of the drug received by the subject. The comparison between the dose recommendation and the dose entered using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose entered using the medication selector. The dose recommendation may correspond to a time similar to or the same as the time of the dose entered using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0333] In some embodiments, the tactile feedback includes increased resistance when the medication selector is set to a dose higher than the dosage recommendation.

[0334] In some embodiments, the haptic feedback includes increased resistance when the medication selector is set to a dose below the dosage recommendation.

[0335] In some embodiments, the medication selector is a rotatable knob configured to be turned in a first direction to increase the amount of the dose, and wherein the tactile feedback includes a bias to turn in a second direction opposite to the first direction when the medication selector is turned to a dose that is higher or optionally lower than the dose recommendation.

[0336] In some embodiments, the drug delivery device is a pen.

[0337] In some embodiments, the drug delivery device is a pump.

[0338] In some embodiments, the medication selector is at least one button, and optionally wherein the at least one button is configured to have increased resistance to downward movement when a dose higher than the dosage recommendation is selected.

[0339] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0340] In many embodiments, a method includes the steps of receiving, by one or more processors of a drug delivery device, a dose recommendation; receiving, by one or more processors of the drug delivery device, a dose input on the drug delivery device; comparing the input dose to the dose recommendation; and providing tactile feedback on the drug delivery device if the input dose differs from the dose recommendation.

[0341] In some embodiments, the tactile feedback includes increased resistance of the medication selector.

[0342] In some embodiments, the entered dosage is entered using a medication selector, and wherein the medication selector is configured to be set to the dosage recommendation by default.

[0343] In some embodiments, the dose input is input using a medication selector. In some embodiments, the medication selector is a rotatable adjustment disk. In some embodiments, the rotatable adjustment disk is configured to rebound to the setting of the dosage recommendation. For example, the rotatable adjustment disk can be elastically biased to the setting of the dosage recommendation. In some embodiments, the rotatable adjustment disk is configured to have resistance when rotated to an amount above the dosage recommendation.

[0344] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver a certain amount of drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-related data characterizing an analyte level of the subject and dosage data for a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a dosage recommendation for the drug based at least on a calculated analyte level, the calculated analyte level being based on the time-related data characterizing the analyte level of the subject, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to lock the drug delivery device to prevent drug delivery when the medication selector is set to a dosage different from the dosage recommendation.

[0345] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0346] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the medication selector when the medication selector is set to a dose different than the dose recommendation.

[0347] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the drug delivery device when the medication selector is set to a dose that is a predetermined number of units higher than the dose recommendation.

[0348] In some embodiments, the predetermined number of units is about 2 units.

[0349] In some embodiments, the second instructions further cause the one or more processors of the reader device to display a GUI including a notification that the dose is a predetermined number of units greater than the dose recommendation.

[0350] In some embodiments, the second instructions further cause a second one or more processors of the reader device to request confirmation from the subject regarding the dose, the dose being a predetermined number of units greater than the dose recommendation.

[0351] In some embodiments, the drug delivery device is a pen, and wherein the medication selector is a rotatable knob.

[0352] In some embodiments, the drug delivery device is a pump, and wherein the medication selector is at least one button.

[0353] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0354] In many embodiments, a method includes the steps of: receiving, by one or more processors of a drug delivery device, a dose recommendation; receiving, by one or more processors of the drug delivery device, a dose entered on the drug delivery device; comparing the entered dose to the dose recommendation; and if the entered dose is higher than the dose recommendation, locking the drug delivery device to prevent drug delivery.

[0355] In some embodiments, the step of locking the drug delivery device includes locking a medication selector.

[0356] In some embodiments, the drug delivery device is locked when the medication selector is set to a dose that is a predetermined number of units higher than the dose recommendation. In some embodiments, the predetermined number of units is about 2 units.

[0357] In some embodiments, the drug delivery device is a pen, and wherein the medication selector is a rotatable knob.

[0358] In some embodiments, the drug delivery device is a pump, and wherein the medication selector is at least one button.

[0359] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver a certain amount of drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-related data characterizing an analyte level of the subject and dosage data for a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a dosage recommendation for the drug based on at least a calculated analyte level and the dosage of the drug received by the subject over a period of time, the calculated analyte level being based on the time-related data characterizing the analyte level of the subject, and transmit the dosage recommendation to the drug delivery device, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to lock the drug delivery device to prevent delivery of the drug when the dosage recommendation is equal to zero.

[0360] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0361] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the medication selector when the dosage recommendation is equal to zero.

[0362] In some embodiments, the dosage recommendation is determined to be zero based on active insulin determination.

[0363] In some embodiments, the dosage recommendation is determined to be zero based on a determination of a risk of hypoglycemia based at least on a calculated analyte level based on time-dependent data characterizing the subject's analyte level and a dose of the medication received by the subject over a time period.

[0364] In some embodiments, the drug delivery device is a pen, and optionally, wherein the medication selector is a rotatable knob. In some embodiments, the pen further comprises a delivery button and a plunger mechanically coupled to the delivery button, wherein the delivery button is decoupled from the plunger when the dose recommendation is zero.

[0365] In some embodiments, the drug delivery device is a pump, and wherein the medication selector is at least one button.

[0366] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0367] In many embodiments, a method includes the steps of: receiving, by one or more processors of a drug delivery device, a dose recommendation; determining whether the dose recommendation is equal to zero; and if the dose recommendation is determined to be a zero dose, locking the drug delivery device to prevent drug delivery. Locking of the drug delivery device may include decoupling a portion of the drug delivery device required for drug delivery from the drug delivery device.

[0368] In some embodiments, the step of locking the drug delivery device includes locking a medication selector.

[0369] In some embodiments, the dosage recommendation is determined to be zero based on active insulin determination.

[0370] In some embodiments, the dosage recommendation is determined to be zero based on a determination of risk of hypoglycemia based on at least the calculated analyte level and the dose of the drug received by the subject during the time period. The calculated analyte level may also be based on time-dependent data characterizing the analyte of the subject.

[0371] In some embodiments, the drug delivery device is a pen, and / or wherein the medication selector is a rotatable knob.

[0372] In some embodiments, the pen further comprises a delivery button and a plunger mechanically coupled to the delivery button, wherein the step of locking the drug delivery device comprises decoupling the delivery button from the plunger. In many embodiments, the analyte monitoring system comprises: a drug delivery device configured to deliver an amount of a drug to a subject, the drug delivery device comprising: a display; a medication selector; and a first wireless communication circuit configured to receive a dose recommendation from a reader device and communicate a dose of the drug received by the subject; and a reader device comprising: a display; a second wireless communication circuit configured to receive time-dependent data characterizing an analyte level of the subject and dose data of a dose of the drug received by the subject from the drug delivery device; and one or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine a dose recommendation of the drug based at least on a calculated analyte level, the calculated analyte level being based on the time-dependent data characterizing the analyte level of the subject, compare the dose recommendation of the drug to a corresponding amount of the drug delivered by the drug delivery device, and adjust an alarm parameter if the corresponding amount of the drug delivered is different from the dose recommendation. The corresponding amount of the drug delivered may be an amount of a dose of the drug delivered at the same or similar time as the time corresponding to the dosage recommendation.

[0373] The medication selector mentioned throughout this application may also be referred to as a medication selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of a drug inputted by the medication selector may be inputted and / or selected by a user. The time-dependent data characterizing the analyte of an object may be data representing / reflecting the analyte concentration of the object over time. The dosage data may be the amount and timing of the dose of a drug received by the object during the time period. Throughout the specification, the dosage data of the dose of a drug received by the object may be simply referred to as the dose of a drug received by the object. The comparison between the dose recommendation and the dose inputted using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose inputted using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose inputted using the medication selector. The first memory and the second memory referred to herein are part of an analyte monitoring system. The first memory may be part of a drug delivery device. The second memory may be part of a reader device.

[0374] In some embodiments, the alarm parameter is a low glucose threshold, and wherein the low glucose threshold is increased to a higher concentration when the amount of drug delivered is above the dosage recommendation.

[0375] In some embodiments, the alarm parameter is a high glucose threshold, and wherein the high glucose threshold is lowered to a lower concentration when the amount of drug delivered is below the dosage recommendation.

[0376] In some embodiments, the alarm parameter is a time period for predicting the alarm, and wherein the time period for predicting the alarm is increased when the corresponding amount of the delivered drug is different from the dosage recommendation. In some embodiments, the time period for predicting the alarm is increased by at least about 20 minutes when the corresponding amount of the delivered drug is different from the dosage recommendation.

[0377] In some embodiments, the alarm parameter is a snooze period, and wherein the snooze period is reduced to a shorter period of time when the corresponding amount of drug delivered differs from the dosage recommendation.

[0378] In some embodiments, the alarm parameter is a volume of an audible alarm, and wherein the volume increases when the corresponding amount of drug delivered differs from the dosage recommendation.

[0379] In some embodiments, the alarm parameter is a duration of the audible alarm, and wherein the duration is increased when the corresponding amount of drug delivered differs from the dosage recommendation.

[0380] In some embodiments, the alarm parameter is a requirement for confirmation of the alarm, and wherein the requirement for confirmation of the alarm is enabled when the corresponding amount of drug delivered differs from the dosage recommendation.

[0381] In some embodiments, the instructions, when executed, further cause the one or more processors to display additional information regarding the amount of drug delivered.

[0382] In some embodiments, the alarm parameter is a tactile parameter, and wherein if the corresponding amount of the drug delivered is above the dosage recommendation, the alarm parameter is adjusted to cause the reader device to vibrate. In some embodiments, the alarm parameter is a tactile parameter, and wherein if the corresponding amount of the drug delivered is below the dosage recommendation, the alarm parameter is adjusted to cause the reader device to vibrate.

[0383] In some embodiments, the alarm parameter is an audible parameter, and wherein the alarm parameter is adjusted to cause the reader device to emit a sound if the corresponding amount of the drug delivered is above the dosage recommendation. In some embodiments, the alarm parameter is an audible parameter, and wherein the alarm parameter is adjusted to cause the reader device to emit a sound if the corresponding amount of the drug delivered is below the dosage recommendation.

[0384] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0385] In many embodiments, a method includes the steps of determining, by one or more processors of a reader device, a dose recommendation; receiving, by one or more processors of the reader device, dose data of a dose input or delivered by a drug delivery device; comparing the input or delivered dose to the dose recommendation; and adjusting, by the one or more processors of the reader device, an alarm parameter if the input or delivered dose differs from the dose recommendation.

[0386] In some embodiments, the alarm parameter is a low glucose threshold, and wherein the low glucose threshold is increased to a higher concentration when the amount of drug delivered is above the dosage recommendation.

[0387] In some embodiments, the alarm parameter is a high glucose threshold, and wherein the high glucose threshold is lowered to a lower concentration when the amount of drug delivered is below the dosage recommendation.

[0388] In some embodiments, the alarm parameter is a time period for predicting the alarm, and wherein the time period for predicting the alarm is increased when the corresponding amount of the delivered drug is different from the dosage recommendation. In some embodiments, the time period for predicting the alarm is increased by at least about 20 minutes when the corresponding amount of the delivered drug is different from the dosage recommendation.

[0389] In some embodiments, the alarm parameter is a snooze period, and wherein the snooze period is reduced to a shorter period of time when the corresponding amount of the delivered drug differs from the dosage recommendation. When the corresponding amount of the delivered drug differs from the dosage recommendation, the snooze period can be reduced, for example, by at least 5 minutes.

[0390] In some embodiments, the alarm parameter is a volume of the audible alarm, and wherein the volume increases when the corresponding amount of drug delivered differs from the dosage recommendation.

[0391] In some embodiments, the alarm parameter is a duration of the audible alarm, and wherein the duration is increased when the corresponding amount of drug delivered differs from the dosage recommendation.

[0392] In some embodiments, the alarm parameter is a requirement for confirmation of the alarm, and wherein the requirement for confirmation of the alarm is enabled when the corresponding amount of drug delivered differs from the dosage recommendation.

[0393] In some embodiments, the method further comprises the step of displaying additional information regarding the amount of drug delivered.

[0394] In some embodiments, the alarm parameter is a tactile parameter, and wherein if the corresponding amount of the drug delivered is above the dosage recommendation, the alarm parameter is adjusted to cause the reader device to vibrate. In some embodiments, the alarm parameter is an audible parameter, and wherein if the corresponding amount of the drug delivered is above the dosage recommendation, the alarm parameter is adjusted to cause the reader device to emit a sound.

[0395] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver a certain amount of drug to a subject, the drug delivery device including: a display; a medication selector; and a first wireless communication circuit configured to communicate a recommended dose of the drug entered using the medication selector from the drug delivery device before delivering the input dose of the drug; a reader device including: a display; a second wireless communication circuit configured to receive time-related data characterizing an analyte level of the subject and the communicated recommended dose of the drug entered using the medication selector from the drug delivery device before delivering the input dose of the drug; and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine a dose recommendation of the drug based on at least a calculated analyte level, the calculated analyte level being based on the time-related data characterizing the analyte level of the subject, compare the dose recommendation of the drug with the recommended dose of the drug entered using the medication selector, and if the recommended dose of the drug is different from the dose recommendation of the drug, cause a graphical user interface to be displayed on the display, the graphical user interface including additional dose guidance.

[0396] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0397] In some embodiments, the suggested dose of a drug is greater than the dose recommendation.

[0398] In some embodiments, the suggested dose of a drug is less than the dose recommendation.

[0399] In some embodiments, if the suggested drug dosage is entered within a predetermined amount of time to determine the dosage recommendation, the graphical user interface is displayed.

[0400] In some embodiments, if a suggested dosage of a medication is entered after a predetermined amount of time to determine the dosage recommendation, the graphical user interface is displayed.

[0401] In some embodiments, additional dosage instructions involve entering a time of day for a recommended dose of a medication.

[0402] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0403] In many embodiments, a method includes the steps of determining, by one or more processors of a reader device, a dose recommendation (i.e., a recommended dose); receiving, by one or more processors of a reader device, a dose input on a drug delivery device; comparing the input dose to the dose recommendation; and displaying a user interface associated with the dose recommendation if the input dose differs from the dose recommendation. The dose recommendation may be a suggestion regarding the amount and / or timing of a dose of a drug. The dose recommendation may be referred to as a dose recommendation throughout the specification.

[0404] In some embodiments, if the entered dose is within a predetermined amount of time to determine the dose recommendation, the user interface is displayed.

[0405] In some embodiments, if the dose entered is after a predetermined amount of time to determine the dose recommendation, the user interface is displayed.

[0406] In some embodiments, the user interface includes additional dosage guidance related to the time of day corresponding to the dosage entered on the drug delivery device.

[0407] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver a quantity of a drug to a subject, the drug delivery device including: a display; at least one button; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-dependent data characterizing an analyte level of the subject and dosage data of a dosage of the drug received by the subject from the drug delivery device over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a dosage recommendation for the drug for at least one meal type based on at least a calculated analyte level, the calculated analyte level being based on the time-dependent data characterizing the analyte level of the subject, and transmit the dosage recommendation for the drug for at least one meal type to the drug delivery device, wherein the instructions stored in the first memory, when executed, cause the first one or more processors of the drug delivery device to display the dosage recommendation for the drug for the at least one meal type on the display of the drug delivery device when the at least one button is selected.

[0408] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0409] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a dosage recommendation for each of a plurality of meal types, and wherein the at least one button includes a plurality of buttons, wherein each meal type corresponds to a corresponding button in the plurality of buttons, wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display a dosage recommendation for one of the plurality of meal types in response to selection of a corresponding button in the plurality of buttons. Each meal type may correspond to, for example, may be assigned to a corresponding button. A dosage recommendation for a meal type may be displayed in response to selecting a corresponding button. In some embodiments, the plurality of meal types include breakfast, lunch, dinner, and snacks.

[0410] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a dose recommendation for the basal dose, and wherein the at least one button includes a plurality of buttons, wherein the dose recommendation for the basal dose corresponds to a corresponding button of the plurality of buttons, wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the dose recommendation for the basal dose in response to selection of the corresponding button of the plurality of buttons.

[0411] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a dosage recommendation for a correction dose, and wherein the at least one button includes a plurality of buttons, wherein the recommended dosage for the correction dose corresponds to a corresponding button of the plurality of buttons, and wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the dosage recommendation for the correction dose in response to selection of the corresponding button of the plurality of buttons.

[0412] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0413] In many embodiments, a method includes the following steps: receiving, by one or more processors of a drug delivery device, a dosage recommendation for at least one meal type; assigning, by one or more processors of the drug delivery device, the dosage recommendation for the at least one meal type to one of a plurality of buttons on the drug delivery device; and displaying the dosage recommendation on the drug delivery device in response to selection of the one of the plurality of buttons on the drug delivery device.

[0414] In some embodiments, the method further comprises the step of setting, by the one or more processors of the drug delivery device, a medication selector of the drug delivery device to a dosage recommendation. In some embodiments, the receiving step comprises receiving, by the one or more processors of the drug delivery device, a dosage recommendation for each of a plurality of meal types. In some embodiments, the plurality of meal types comprises at least two of breakfast, lunch, dinner, and snacks.

[0415] In some embodiments, the method further comprises the following steps: receiving, by the one or more processors of the drug delivery device, a dose recommendation for a basic dose; and assigning, by the one or more processors of the drug delivery device, the dose recommendation for the basic dose to one of a plurality of buttons on the drug delivery device.

[0416] In some embodiments, the method further comprises the following steps: receiving, by the one or more processors of the drug delivery device, a dosage recommendation for a correction dose; and assigning, by the one or more processors of the drug delivery device, the dosage recommendation for the correction dose to one of a plurality of buttons on the drug delivery device.

[0417] In many embodiments, analyte monitoring includes: a drug delivery device configured to deliver a certain amount of drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to a first memory; a reader device including: a display; a second wireless communication circuit configured to receive time-related data characterizing an analyte level of the subject and dosage data for a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a dosage recommendation for the drug based at least on a calculated analyte level, the calculated analyte level being based on the time-related data characterizing the analyte level of the subject and the dosage of the drug received by the subject over a period of time, wherein the instructions in the first memory, when executed, cause the first one or more processors to change a configuration of the drug delivery device to prevent the drug delivery device from delivering the drug when a predetermined time has passed since the dosage recommendation for the drug was determined.

[0418] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0419] In some embodiments, after a predetermined time has passed, the medication selector is changed to a locked configuration. In the locked configuration, the medication selector cannot be adjusted to a different dose by the user. In some embodiments, after a predetermined time has passed, the medication selector is changed to a zero dose.

[0420] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0421] In many embodiments, a method includes the following steps: receiving, by one or more processors of a drug delivery device, dosage data of a dosage recommendation at a first time; receiving, by one or more processors of the drug delivery device, dosage data of a dosage input on the drug delivery device at a second time; determining, by one or more processors of the drug delivery device, whether a difference between the second time and the first time is greater than a predetermined amount of time; and changing, by one or more processors of the drug delivery device, a configuration of the drug delivery device if the difference between the second time and the first time is greater than the predetermined amount of time.

[0422] In some embodiments, after a predetermined time has passed, the medication selector of the drug delivery device is changed to a locked configuration.

[0423] In some embodiments, after a predetermined time has passed, the medication selector of the drug delivery device goes to zero.

[0424] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver a dose of a drug to a subject, the drug delivery device including: a display; a medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device at a first time T1; and a first one or more processors coupled to a first memory, the first memory storing instructions that, when executed by the first one or more processors, cause the first one or more processors to: determine whether a dose has been delivered within a predetermined time period from the first time T1; a reader device including: a display; a second wireless communication circuit configured to receive time-dependent data characterizing an analyte level of the subject and a dose recommendation for the subject; Dosage data of a dose of a drug received by a subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determine a recommended dose of the drug based at least on a calculated analyte level and the dose of the drug received by the subject over a period of time, the calculated analyte level being based on time-related data characterizing the analyte level of the subject, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to change a configuration of a drug delivery device to prevent the drug delivery device from delivering the drug if it is determined that a dose has not been delivered within a predetermined time period from a first time T1.

[0425] In some embodiments, the medication selector is changed to the locked configuration after a predetermined period of time has elapsed since the first time T1.

[0426] In some embodiments, the medication selector is changed to zero dose after a predetermined period of time has elapsed since the first time T1.

[0427] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0428] In many embodiments, a method includes the following steps: receiving, by one or more processors of a drug delivery device, dosage data of a dosage recommendation at a first time; determining, by one or more processors of the drug delivery device, whether a dose has been delivered within a predetermined time period from the first time T1; and if it is determined that a dose has not been delivered within the predetermined time period from the first time T1, changing a configuration of the drug delivery device.

[0429] In some embodiments, the step of changing the configuration of the drug delivery device includes changing a medication selector of the drug delivery device to a locked configuration.

[0430] In some embodiments, the step of changing the configuration of the drug delivery device includes changing a medication selector of the drug delivery device to a zero dose.

[0431] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver an amount of a drug to a subject, the drug delivery device including: a display; a medication selector; and wireless communication circuitry configured to receive a dose recommendation from a reader device and transmit the administered dose to the reader device; a reader device including: a display; wireless communication circuitry configured to receive time-dependent data characterizing an analyte level of the subject and dose data of doses of the drug received by the subject from the drug delivery device over a period of time; and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine a dose recommendation for the drug based on at least a calculated analyte level, the calculated analyte level being based on the time-dependent data characterizing the analyte level of the subject at a first time, determine whether a dose has been administered during a predetermined time period since the dose recommendation was determined at the first time, determine a new dose recommendation for the drug based on at least the calculated analyte level, the at least calculated analyte level being based on the time-dependent data characterizing the analyte level of the subject at a second time; and transmit the new dose recommendation to the drug delivery device.

[0432] The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0433] In some embodiments, the drug delivery device further comprises one or more processors coupled to an additional memory storing instructions that, when executed by the one or more processors, cause the dosage recommendation to be displayed on a display of the drug delivery device.

[0434] In some embodiments, the new dosage recommendation is lower than the dosage recommendation.

[0435] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0436] In many embodiments, a method includes the steps of: determining, by one or more processors of a reader device, a dosage recommendation for a first time T1; receiving, by one or more processors of the reader device, whether a dose has been delivered within a predetermined time period since the first time T1; if it is determined that a dose has not been delivered within the predetermined time period since time T1, determining, by the one or more processors of the reader device, a new dosage recommendation; and transmitting the new dosage recommendation to a drug delivery device.

[0437] In some embodiments, the method further comprises the step of displaying the new dosage recommendation on the drug delivery device.

[0438] In some embodiments, the method further comprises the step of displaying the new dosage recommendation on the reader device.

[0439] In some embodiments, the predetermined period of time is at least about 20 minutes.

[0440] In some embodiments, the new dosage recommendation is lower than the dosage recommendation.

[0441] In many embodiments, an analyte monitoring system includes: a drug delivery device configured to deliver an amount of a drug to a subject, the drug delivery device including: a display; a medication selector; and wireless communication circuitry configured to receive a dose recommendation from a reader device and transmit the administered dose to the reader device; a reader device including: a display; wireless communication circuitry configured to receive time-dependent data characterizing an analyte level of the subject, and receive dose data of doses of the drug received by the subject from the drug delivery device over a period of time; and one or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine a first dose recommendation of the drug based on at least a calculated analyte level, the calculated analyte level based on the time-dependent data characterizing the analyte level of the subject at a first time, determine whether the first dose recommendation is below a threshold, if it is determined that the first dose recommendation is not below the threshold, determine whether a dose has been administered during a predetermined time period from the first time, if it is determined that the dose has not been administered within the predetermined time period, determine a second dose recommendation of the drug at a second time based on at least the calculated analyte level, the calculated analyte level based on the time-dependent data characterizing the analyte level of the subject. The medication selector mentioned throughout this application may also be referred to as a dose selector. The medication selector is configured to receive an input indicating a dose of a drug to be administered. The dose of the drug input by the medication selector may be input and / or selected by a user. The time-related data characterizing the analyte of the object may be data representing / reflecting the analyte concentration of the object over time. The dose data may be the amount and timing of the dose of the drug received by the object during the time period. Throughout the specification, the dose data of the dose of the drug received by the object may be simply referred to as the dose of the drug received by the object. The comparison between the dose recommendation and the dose input using the medication selector may involve comparing the amount of the dose recommendation with the amount of the dose input using the medication selector. The dose recommendation may correspond to a time similar to or the same time as the time of the dose input using the medication selector. The first memory and the second memory referred to herein are part of the analyte monitoring system. The first memory may be part of the drug delivery device. The second memory may be part of the reader device.

[0442] In some embodiments, the instructions further cause the one or more processors to: determine whether the second dose recommendation is below a threshold, if it is determined that the dose is not below the threshold, determine whether the dose has been administered during a second predetermined time period since the second time, and if it is determined that the dose has not been administered within the second predetermined time period, modify the second dose recommendation at a third time based on at least a calculated analyte level, wherein the at least calculated analyte level is based on time-related data characterizing the analyte level of the subject.

[0443] In some embodiments, the system further comprises a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

[0444] In many embodiments, a method includes the steps of determining, by one or more processors of a reader device, a first dosage recommendation of a drug based on at least a calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of a subject at a first time, determining, by the one or more processors of the reader device, whether the first dosage recommendation is below a threshold, determining, by the one or more processors of the reader device, if it is determined that the first recommended dose is not below the threshold, whether a dose has been administered during a predetermined time period from the first time, and determining, by the one or more processors of the reader device, a second dosage recommendation of the drug at a second time based on at least the calculated analyte level, if it is determined that the dose has not been administered within the predetermined time period.

[0445] In some embodiments, the method further comprises the steps of determining, by the one or more processors of the reader device, whether the dose has been administered during a second predetermined time period since the second time if it is determined that the second dose recommendation is not below a threshold, and modifying, by the one or more processors of the reader device at a third time, the second dose recommendation based on at least a calculated analyte level based on time-dependent data characterizing the analyte level of the subject if it is determined that the dose has not been administered within the second predetermined time period.

[0446] In many embodiments, a system for displaying a metric associated with a subject includes: wireless communication circuitry configured to receive time-dependent data characterizing an analyte level of the subject; a display configured to visually present information; a memory; and one or more processors coupled to the wireless communication circuitry, the display, and the memory, wherein the memory stores instructions characterizing the analyte level of the subject and the time-dependent data, wherein the instructions, when executed by the one or more processors, cause the system to: determine a subset of the time-dependent data based on a filtering criterion selected by the subject, wherein the filtering criterion includes the activation of at least one alarm; and display a first glucose map and a second glucose map on a single graphical object interface, wherein the first glucose map displays a glucose level associated with the time-dependent data over a first time period, and wherein the second glucose map displays a subset of the time-dependent data over the first time period. The activation of an alarm may be referred to herein as the output or activation of an alarm.

[0447] In some embodiments, the at least one alarm is a low glucose alarm. In some embodiments, the low glucose alarm has a threshold of about 70 mg / dL.

[0448] In some embodiments, the at least one alarm is a high glucose alarm.In some implementations, the high glucose alarm has a threshold of about 180 mg / dL.

[0449] In some embodiments, the instructions, when executed by the one or more processors, further cause the system to: display, on at least one of the first glucose map and the second glucose map, occurrences of the at least one alarm within the first time period.

[0450] In some embodiments, the wireless communication circuit is further configured to receive dosage data for a dosage of a drug received by the subject over a period of time, and wherein the memory further stores the dosage of a drug that changes glucose levels received by the subject over a period of time, wherein the instructions, when executed by the one or more processors, further cause the system to: display an instance of the dosage of the drug received during the first time period on at least one of the first glucose map and the second glucose map.

[0451] In some embodiments, the instructions, when executed by the one or more processors, further cause the system to: determine a second subset of time-related data based on a filter criterion selected by the subject, wherein the second subset of time-related data includes time-related data when the at least one alarm is disabled, and display a third glucose map on the single graphical object interface, wherein the third glucose map displays the second subset of time-related data within the first time period. In such embodiments, the first subset may include time-related data when the at least one alarm is enabled. Disabling an alarm may involve silencing an alarm or turning off an alarm. In some embodiments, the instructions, when executed by the one or more processors, further cause the system to: display an occurrence of the at least one alarm in the first time period on at least one of the first glucose map, the second glucose map, and the third glucose map. In some embodiments, the wireless communication circuit is further configured to receive a dose of a drug received by the subject over a period of time, and wherein the memory further stores a dose of a drug that changes glucose levels received by the subject over a period of time, wherein the instructions, when executed by the one or more processors, further cause the system to: display an instance of a dose of a drug received within the first time period on at least one of the first, second, and third glucose maps. In some embodiments, examples of medication doses received during the first time period are displayed on the second glucose graph.

[0452] In some embodiments, the wireless communication circuit is further configured to receive dosage data for dosages of a drug received by the subject over a period of time, and wherein the memory further stores dosages of a glucose level-altering drug received by the subject over a period of time, wherein the instructions cause the one or more processors to determine at least one dosage recommendation, and wherein the filtering criteria further include dosage consistency of the glucose-altering drug. In some embodiments, the wireless communication circuit is further configured to receive dosage data for a dosage regimen for the subject, and wherein the at least one dosage recommendation is determined at least in part based on the dosage regimen. In some embodiments, dosage consistency includes a missed dose, an underdose with respect to at least one dosage recommendation, an overdose with respect to at least one dosage recommendation, a late meal dose, or an extra meal dose.

[0453] In some embodiments, the first glucose map and the second glucose map each include the trace of the median glucose level. In some embodiments, the first glucose map and the second glucose map each also include the upper trace of the 95th percen...

Claims

1. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and time-dependent dosage data of a drug received by the subject over a period of time; as well as a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, Transmitting dosage recommendations of medications to drug delivery devices, Wherein the instructions stored in the first memory, when executed, cause the first one or more processors to provide feedback based on a comparison between the dosage recommendation and a dosage input using the medication selector.

2. A method comprising the following steps: receiving, by one or more processors of a drug delivery device, a dosage recommendation; receiving, by the one or more processors of the drug delivery device, dose data for a dose input on the drug delivery device; Compare the entered dose to the dose recommendations; as well as Feedback is provided on the drug delivery device based on the comparison.

3. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, Wherein the instructions stored in the first memory, when executed, cause the first one or more processors to provide tactile feedback via the medication selector based on a comparison between the dosage recommendation and a dosage input using the medication selector.

4. A method comprising the following steps: receiving, by one or more processors of a drug delivery device, a dosage recommendation; receiving, by one or more processors of the drug delivery device, a dose input on the drug delivery device; Compare the entered dose to the dose recommendations; as well as If the entered dose differs from the dose recommendation, tactile feedback is provided on the drug delivery device.

5. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, Wherein the instructions stored in the first memory, when executed, cause the first one or more processors to lock the medication delivery device to prevent delivery of the medication when the medication selector is set to a dose different than the dose recommendation.

6. A method comprising the following steps: receiving, by one or more processors of a drug delivery device, a dosage recommendation; receiving, by one or more processors of the drug delivery device, a dose input on the drug delivery device; Compare the entered dose to the dose recommendations; as well as If the dose entered is higher than the dose recommendation, the drug delivery device is locked to prevent delivery of the drug.

7. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level and the dose of the drug received by the subject during the period of time, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, and Deliver the recommended dose to the drug delivery device, Wherein the instructions stored in the first memory, when executed, cause the first one or more processors to lock the drug delivery device to prevent delivery of the drug when the dosage recommendation is equal to zero.

8. A method comprising the following steps: receiving, by one or more processors of a drug delivery device, a dosage recommendation; Determine if the dosage recommendation is equal to zero; as well as If the dose recommendation is determined to be a zero dose, the drug delivery device is locked to prevent delivery of the drug.

9. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; and a first wireless communication circuit configured to receive a dosage recommendation from a reader device and to transmit a dosage of a medication received by a subject; and Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data of a dosage of a drug received by the subject from a drug delivery device; and One or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, comparing a dosage recommendation of the drug to a corresponding amount of the drug delivered by the drug delivery device, and If the corresponding amount of drug delivered differs from the dosage recommendation, the alarm parameters are adjusted.

10. The system according to claim 9, wherein: The alarm parameter is a low glucose threshold, and wherein the low glucose threshold is increased to a higher concentration when the amount of drug delivered is above the dosage recommendation.

11. The system according to claim 9, wherein: The alarm parameter is a high glucose threshold, and wherein the high glucose threshold is lowered to a lower concentration when the amount of drug delivered is below the dosage recommendation.

12. The system of claim 9, wherein the alarm parameter is a time period for predicting the alarm, and wherein the time period for predicting the alarm is increased when the corresponding amount of the delivered drug differs from the recommended dose.

13. The system of claim 12, wherein the time period for predicting an alarm increases by at least about 20 minutes when the corresponding amount of the delivered drug differs from the recommended dose.

14. The system of claim 9, wherein the alarm parameter is a snooze period, and wherein the snooze period is reduced to a shorter period of time when the corresponding amount of the drug delivered differs from the recommended dose.

15. The system of claim 9, wherein the alarm parameter is a volume of the audible alarm, and wherein the volume increases when the corresponding amount of the drug delivered differs from the recommended dose.

16. The system of claim 9, wherein the alarm parameter is a duration of the audible alarm, and wherein the duration increases when the corresponding amount of drug delivered differs from a recommended dose.

17. The system of claim 9, wherein the alarm parameter is a requirement for confirmation of the alarm, and wherein the requirement for confirmation of the alarm is enabled when the corresponding amount of the drug delivered differs from a recommended dose.

18. The system of claim 9, wherein the instructions, when executed, further cause the one or more processors to display additional information regarding the amount of drug delivered.

19. The system according to claim 9, wherein: The alarm parameter is a tactile parameter, and wherein the alarm parameter is adjusted to cause the reader device to vibrate if the corresponding amount of drug delivered is above the dosage recommendation.

20. The system of claim 9, wherein: The alarm parameter is an audible parameter, and wherein the alarm parameter is adjusted to cause the reader device to emit a sound if the corresponding amount of drug delivered is above the dosage recommendation.

21. The system of claim 9, further comprising a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

22. A method comprising the steps of: determining, by one or more processors of the reader device, a dosage recommendation; receiving, by one or more processors of the reader device, dosage data for a dosage input or delivered by a drug delivery device; Compare the dose entered or delivered to the dosage recommendations; as well as If the input or delivered dose differs from the dose recommendation, the alarm parameters are adjusted by one or more processors of the reader device.

23. The method according to claim 22, wherein: The alarm parameter is a low glucose threshold, and wherein the low glucose threshold is increased to a higher concentration when the amount of drug delivered is above the dosage recommendation.

24. The method according to claim 22, wherein: The alarm parameter is a high glucose threshold, and wherein the high glucose threshold is lowered to a lower concentration when the amount of drug delivered is below the dosage recommendation.

25. The method of claim 22, wherein the alarm parameter is a time period for predicting the alarm, and wherein the time period for predicting the alarm is increased when the corresponding amount of drug delivered differs from a recommended dose.

26. The method of claim 25, wherein the time period for predictive alert increases by at least about 20 minutes when the corresponding amount of drug delivered differs from the recommended dose.

27. The method of claim 22, wherein the alarm parameter is a snooze period, and wherein the snooze period is reduced to a shorter period of time when the corresponding amount of the drug delivered differs from the recommended dose.

28. The method of claim 22, wherein the alarm parameter is a volume of an audible alarm, and wherein the volume increases when the corresponding amount of drug delivered differs from a recommended dose.

29. The method of claim 22, wherein the alarm parameter is a duration of the audible alarm, and wherein the duration increases when the corresponding amount of drug delivered differs from a recommended dose.

30. The method of claim 22, wherein the alarm parameter is a requirement for confirmation of the alarm, and wherein the requirement for confirmation of the alarm is enabled when the corresponding amount of drug delivered differs from a recommended dose.

31. The method of claim 22, further comprising the step of displaying additional information regarding the amount of drug delivered.

32. The method of claim 22, wherein the alarm parameter is a tactile parameter, and wherein if the corresponding amount of drug delivered is above a recommended dose, the alarm parameter is adjusted to cause the reader device to vibrate.

33. The method of claim 22, wherein the alarm parameter is an audible parameter, and wherein the alarm parameter is adjusted to cause the reader device to emit a sound if the corresponding amount of the drug delivered is above the recommended dose.

34. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; and a first wireless communication circuit configured to transmit a suggested dosage of a medication input using a medication selector from a medication delivery device prior to delivering the input dose of the medication; Reader device, including: monitor; a second wireless communication circuit configured to receive, from a medication delivery device, time-dependent data representative of the subject's analyte level and the communicated suggested dosage of the medication input using the medication selector prior to delivery of the input dose of the medication; and One or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determining a dosage recommendation for the drug based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, Compare the dosage recommendation for the medication to the recommended dosage for the medication entered using the Medication Selector, and The graphical user interface is caused to be displayed on the display, the graphical user interface including additional dosage guidance if the suggested dosage of the medication is different from the dosage recommendation of the medication.

35. A method comprising the steps of: determining, by one or more processors of the reader device, a dosage recommendation; receiving, by one or more processors of the reader device, a dose input on the drug delivery device; Compare the dose entered with the recommended dose; as well as If the entered dose is different from the recommended dose, a user interface associated with the dose recommendation is displayed.

36. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; at least one button; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of a drug received by the subject from the drug delivery device over a period of time; as well as a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a dosage recommendation of the medication for at least one meal type based on at least a calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, and transmitting a dosage recommendation of the medication for at least one meal type to a medication delivery device, Wherein the instructions stored in the first memory, when executed, cause the first one or more processors of the medication delivery device to display a dosage recommendation of the medication for the at least one meal type on a display of the medication delivery device when the at least one button is selected.

37. A system according to claim 36, wherein the second instruction, when executed, causes the second one or more processors to determine dosage recommendations for each of a plurality of meal types, and wherein the at least one button includes a plurality of buttons, wherein each meal type corresponds to a corresponding button of the plurality of buttons, and wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display dosage recommendations for one of the plurality of meal types in response to selection of a corresponding button of the plurality of buttons.

38. The system of claim 37, wherein: The multiple meal types include breakfast, lunch, dinner and snacks.

39. The system of claim 36, wherein the second instructions, when executed, cause the second one or more processors to determine a dose recommendation for a basal dose, and wherein the at least one button comprises a plurality of buttons, wherein the dose recommendation for the basal dose corresponds to a respective button of the plurality of buttons, wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the dose recommendation for the basal dose in response to selection of the respective button of the plurality of buttons.

40. The system of claim 36, wherein the second instructions, when executed, cause the second one or more processors to determine a dosage recommendation for a correction dose, and wherein the at least one button comprises a plurality of buttons, wherein the recommended dosage for the correction dose corresponds to a respective button of the plurality of buttons, wherein the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the dosage recommendation for the correction dose in response to selection of the respective button of the plurality of buttons.

41. The system of claim 36, further comprising a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in contact with a bodily fluid of the subject.

42. A method comprising the steps of: receiving, by one or more processors of a drug delivery device, a dosage recommendation for at least one meal type; assigning, by one or more processors of the medication delivery device, a dosage recommendation for the at least one meal type to one of a plurality of buttons on the medication delivery device; as well as In response to selection of the one of the plurality of buttons on the drug delivery device, a dosage recommendation is displayed on the drug delivery device.

43. The method of claim 42, further comprising the step of setting, by one or more processors of the drug delivery device, a dose selector of the drug delivery device to the dose recommendation.

44. The method of claim 42, wherein the receiving step includes receiving, by one or more processors of the medication delivery device, dosage recommendations for each of a plurality of meal types.

45. The method of claim 44, wherein the plurality of meal types comprises at least two of breakfast, lunch, dinner, and snacks.

46. ​​The method according to claim 42, further comprising the steps of: receiving, by the one or more processors of the drug delivery device, a dosage recommendation for a basal dose; A dose recommendation for the basal dose is assigned by the one or more processors of the drug delivery device to one of a plurality of buttons on the drug delivery device.

47. The method according to claim 42, further comprising the steps of: receiving, by the one or more processors of the drug delivery device, a dosage recommendation for a correction dosage; A dosage recommendation for the correction dose is assigned by the one or more processors of the drug delivery device to one of a plurality of buttons on the drug delivery device.

48. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor: Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device; and a first one or more processors coupled to the first memory; Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a dosage recommendation for the medication based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject and the dosage of the medication received by the subject over the period of time, Wherein the instructions in the first memory, when executed, cause the first one or more processors to change a configuration of the drug delivery device to prevent the drug delivery device from delivering the drug when a predetermined time has elapsed since a dosage recommendation for the drug was determined.

49. A method comprising the steps of: receiving, by one or more processors of a drug delivery device, dosage data for a dosage recommendation at a first time; receiving, by one or more processors of the drug delivery device, dosage data for a dose input on the drug delivery device at a second time; determining, by one or more processors of the drug delivery device, whether a difference between the second time and the first time is greater than a predetermined amount of time; as well as If the difference between the second time and the first time is greater than a predetermined amount of time, the configuration of the drug delivery device is changed by one or more processors of the drug delivery device.

50. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor: Medication selector; a first wireless communication circuit configured to receive a dosage recommendation from a reader device at a first time T1; and A first one or more processors coupled to a first memory, the first memory storing instructions that, when executed by the first one or more processors, cause the first one or more processors to: determining whether a dose has been delivered during a predetermined time period starting from a first time T1, Reader device, including: monitor; a second wireless communication circuit configured to receive time-dependent data indicative of an analyte level of the subject and dosage data indicative of a dosage of the drug received by the subject over a period of time; and a second one or more processors coupled to a second memory, the second memory storing instructions that, when executed by the second one or more processors, cause the second one or more processors to: determining a recommended dose of the drug based at least on the calculated analyte level and the dose of the drug received by the subject during the period of time, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject, Therein, the instructions stored in the first memory when executed cause the first one or more processors to change the configuration of the drug delivery device to prevent the drug delivery device from delivering the drug if it is determined that a dose has not been delivered during the predetermined time period since the first time T1.

51. A method comprising the steps of: receiving, by one or more processors of a drug delivery device, dosage data for a recommended dosage at a first time; determining, by one or more processors of the drug delivery device, whether a dose has been delivered during a predetermined time period since a first time T1; as well as If it is determined that no dose has been delivered during said predetermined time period since the first time T1 , the configuration of the drug delivery device is changed.

52. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; and wireless communications circuitry configured to receive a dosage recommendation from a reader device and to transmit an administered dosage to the reader device; Reader device, including: monitor; wireless communication circuitry configured to receive time-dependent data indicative of an analyte level in a subject and dosage data indicative of a dosage of a drug received by the subject from a drug delivery device over a period of time; and One or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determining a dosage recommendation for the drug based at least on a calculated analyte level based on time-dependent data characterizing the analyte level of the subject at a first time, determining whether a dose has been administered during a predetermined period of time since the dose recommendation was first determined, determining a new dosage recommendation for the drug based on at least the calculated analyte level, the calculated analyte level being based on the time-dependent data characterizing the analyte level of the subject at the second time; and The new dosage recommendation is communicated to the drug delivery device.

53. A method comprising the following steps determining, by one or more processors of the reader device, a dosage recommendation at a first time T1; receiving, by one or more processors of the reader device, whether a dose has been delivered during a predetermined time period since a first time T1; determining, by one or more processors of the reader device, a new dose recommendation if it is determined that a dose has not been delivered during said predetermined time period since time T1; as well as The new dosage recommendation is communicated to the drug delivery device.

54. An analyte monitoring system comprising: A drug delivery device, configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: monitor; Medication selector; and wireless communications circuitry configured to receive a dosage recommendation from a reader device and to transmit an administered dosage to the reader device; Reader device, including: monitor; wireless communication circuitry configured to receive time-dependent data indicative of an analyte level of a subject and to receive dosage data of a dosage of a drug received by the subject from a drug delivery device over a period of time; as well as One or more processors coupled to a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determining a first recommended dose of the drug based on at least a calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject at a first time, determining whether the first recommended dose is below a threshold, If it is determined that the first recommended dose is not below the threshold, determining whether the dose has been administered during a predetermined time period from the first time, If it is determined that a dose has not been administered within the predetermined time period, a second recommended dose of the drug at a second time is determined based at least on the calculated analyte level based on time-dependent data characterizing the analyte level of the subject.

55. A method comprising the following steps determining, by one or more processors of the reader device, a first recommended dose of the medication based on at least the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject at the first time, determining, by the one or more processors of the reader device, whether the first recommended dose is below a threshold, If it is determined that the first recommended dose is not below the threshold, determining, by the one or more processors of the reader device, whether a dose has been administered during a predetermined time period since the first time, and If it is determined that a dose has not been administered within the predetermined time period, determining, by the one or more processors of the reader device, a second recommended dose of the drug at a second time based at least on the calculated analyte level, the calculated analyte level being based on time-dependent data characterizing the analyte level of the subject.

56. A system for displaying a metric associated with an object, the system comprising: wireless communication circuitry configured to receive time-dependent data indicative of an analyte level of a subject; a display configured to visually present information; Memory; and one or more processors coupled to wireless communication circuitry, a display, and a memory, wherein the memory stores instructions and time-dependent data characterizing an analyte level of a subject, wherein the instructions, when executed by the one or more processors, cause the system to: determining a subset of the time-related data based on a filter criterion selected by the subject, wherein the filter criterion includes activation of at least one alarm; as well as A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with the time-dependent data during a first time period, and wherein the second glucose map displays the subset of the time-dependent data during the first time period.

57. The system of claim 56, wherein: The at least one alarm is a low glucose alarm.

58. The system of claim 57, wherein: The low glucose alarm has a threshold of approximately 70 mg / dL.

59. The system of claim 56, wherein: The at least one alarm is a high glucose alarm.

60. The system of claim 59, wherein the high glucose alarm has a threshold of approximately 180 mg / dL.

61. The system of claim 56, wherein the instructions, when executed by the one or more processors, further cause the system to: The occurrence of the at least one alarm within the first time period is displayed on at least one of the first glucose map and the second glucose map.

62. The system of claim 56, wherein the wireless communication circuitry is further configured to receive dosage data of dosages of medication received by the subject over a period of time, and wherein the memory further stores dosages of the glucose level-altering medication received by the subject over a period of time, in, The instructions, when executed by the one or more processors, further cause the system to: An example of a dose of medication received during the first time period is displayed on at least one of the first glucose map and the second glucose map.

63. The system of claim 56, wherein the instructions, when executed by the one or more processors, further cause the system to: A second subset of the time-dependent data is determined based on a filter criterion selected by the subject, wherein: a second subset of the time-related data includes time-related data when the at least one alarm is disabled, and A third glucose map is displayed on the single graphical object interface, wherein the third glucose map displays a second subset of the time-dependent data within the first time period.

64. The system of claim 63, wherein: The instructions, when executed by the one or more processors, further cause the system to: The occurrence of the at least one alarm in the first time period is displayed on at least one of the first glucose map, the second glucose map, and the third glucose map.

65. The system of claim 64, wherein the wireless communication circuitry is further configured to receive dosage data of dosages of medication received by the subject over a period of time, and wherein the memory further stores dosages of the glucose level-altering medication received by the subject over a period of time, in, The instructions, when executed by the one or more processors, further cause the system to: An example of a dose of medication received during the first time period is displayed on at least one of the first, second, and third glucose graphs.

66. The system of claim 65, wherein examples of doses of medication received during the first time period are displayed on the second glucose graph.

67. The system of claim 56, wherein: The wireless communication circuitry is also configured to receive doses of a medication received by the subject over a period of time, and wherein the memory also stores doses of a glucose level-altering medication received by the subject over a period of time, wherein the instructions cause the one or more processors to determine at least one recommended dose, and wherein the filtering criteria also include consistency of doses of the glucose-altering medication.

68. The system of claim 67, wherein the wireless communication circuitry is further configured to receive dosage data for a dosage regimen for the subject, and wherein the at least one recommended dosage is determined at least in part based on the dosage regimen.

69. The system of claim 67, wherein: Dosage consistency includes a missed dose, an underdose with respect to the at least one recommended dose, an overdose with respect to the at least one recommended dose, a late meal dose, or an extra meal dose.

70. The system of claim 56, wherein the first glucose profile and the second glucose profile each comprise a trace of a median glucose level.

71. The system of claim 70, wherein the first glucose profile and the second glucose profile each further comprise an upper trace of the 95th percentile of glucose levels per hour and a lower trace of the 5th percentile of glucose levels per hour.

72. The system of claim 71, wherein the first glucose profile and the second glucose profile each further include a second upper trace at the 75th percentile of glucose levels per hour and a second lower trace at the 25th percentile of glucose levels per hour.

73. The system of claim 70, wherein the first glucose profile and the second glucose profile each further include data indicating a 75th percentile of glucose levels per hour and a second lower trace indicating a 15th percentile of glucose levels per hour.

74. The system of claim 56, wherein the first glucose map and the second glucose map each comprise a plurality of traces, wherein a trace in the plurality of traces corresponds to a day in a first time period, and wherein the plurality of traces are displayed in an overlapping mode.

75. The system of claim 56, wherein the instructions, when executed by the one or more processors, further cause the system to: determining a first analyte metric based on the time-dependent data for the first time period, and determining a second analyte metric based on the subset of the time-dependent data for the first time period; and A first analyte metric and a second analyte metric are displayed on the single graphical object interface.

76. The system of claim 56, wherein the instructions, when executed by the one or more processors, further cause the system to: determining at least one first analyte statistic based on the time-dependent data for the first time period, and determining at least one second analyte statistic based on the subset of the time-dependent data for the first time period; and The at least one first analyte statistical data and the at least one second analyte statistical data are displayed on the single graphical object interface.

77. A system according to claim 76, wherein the at least one first analyte statistic comprises a first glucose management indicator, a first average glucose, a first standard deviation, or a combination thereof, and / or wherein the at least one second analyte statistic comprises a second glucose management indicator, a second average glucose, a second standard deviation, or a combination thereof.

78. The system of claim 56, wherein the instructions, when executed by the one or more processors, further cause the system to: determining a first risk of hypoglycemia based on the time-correlated data for the first time period, and determining a second risk of hypoglycemia based on the subset of the time-correlated data for the first time period; and The first risk of hypoglycemia and the second risk of hypoglycemia are displayed on the single graphical object interface.

79. A method for displaying a metric associated with an object, the method comprising: receiving time-dependent data characterizing an analyte level of a subject; determining a subset of the time-related data based on filtering criteria selected by the subject, wherein the filtering criteria includes enabling at least one alarm; as well as A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with the time-dependent data during a first time period, and wherein the second glucose map displays the subset of the time-dependent data during the first time period.

80. The method of claim 79, wherein: The at least one alarm is a low glucose alarm.

81. The method of claim 80, wherein: The low glucose alarm has a threshold of approximately 70 mg / dL.

82. The method of claim 79, wherein: The at least one alarm is a high glucose alarm.

83. The method of claim 82, wherein the high glucose alarm has a threshold of about 180 mg / dL.

84. The method of claim 79, further comprising the steps of: The occurrence of the at least one alarm during the first time period is displayed on at least one of the first and second glucose graphs.

85. The method of claim 79, further comprising the steps of: receiving dosage data of dosages of a medication received by a subject over a period of time; storing dosage data of dosages of a glucose level-altering medication received by a subject over a period of time; as well as An example of a dose of medication received during the first time period is displayed on at least one of the first glucose map and the second glucose map.

86. The method of claim 79, further comprising the steps of: determining a second subset of the time-related data based on a filter criterion selected by the subject, wherein the second subset of the time-related data includes time-related data when the at least one alarm is disabled, and A third glucose map is displayed on the single graphical object interface, wherein the third glucose map displays a second subset of the time-dependent data within the first time period.

87. The method according to claim 86, further comprising the steps of: The occurrence of the at least one alarm in the first time period is displayed on at least one of the first glucose map, the second glucose map, and the third glucose map.

88. The method according to claim 87, further comprising the steps of: receiving dosage data of dosages of a medication received by a subject over a period of time; storing dosage data of dosages of a glucose level-altering medication received by a subject over a period of time; as well as An example of a dose of medication received during the first time period is displayed on at least one of the first, second, and third glucose graphs.

89. The method of claim 88, wherein examples of doses received by the subject during the first time period are displayed on the second glucose graph.

90. The method of claim 79, wherein: The wireless communication circuit is further configured to receive dosage data of dosages of the medication received by the subject over a period of time, and wherein the memory further stores dosages of the glucose level-altering medication received by the subject over a period of time, and wherein the filtering criteria further includes dosage consistency.

91. The method of claim 90, wherein dosage consistency comprises a recommended dose, a missed dose, an underdose, an overdose, a late meal dose, or an extra meal dose.

92. The method of claim 79, wherein the first glucose profile and the second glucose profile each comprise a trace of median glucose levels.

93. The method of claim 92, wherein the first glucose profile and the second glucose profile each further comprise an upper trace of the 95th percentile of glucose levels per hour and a lower trace of the 5th percentile of glucose levels.

94. The method of claim 94, wherein the first glucose profile and the second glucose profile each further include a second upper trace at the 75th percentile of glucose levels per hour and a second lower trace at the 25th percentile of glucose levels per hour.

95. The method of claim 92, wherein the first glucose profile and the second glucose profile each further include data indicating a 75th percentile of glucose levels per hour and a second lower trace indicating a 15th percentile of glucose levels per hour.

96. The method of claim 79, wherein the first glucose map and the second glucose map each comprise a plurality of traces, wherein a trace in the plurality of traces corresponds to a day in a first time period, and wherein the plurality of traces are displayed in an overlapping mode.

97. The method of claim 79, further comprising the steps of: determining a first analyte metric based on the time-dependent data for the first time period, and determining a second analyte metric based on the subset of the time-dependent data for the first time period; as well as A first analyte metric and a second analyte metric are displayed on the single graphical object interface.

98. The method of claim 79, further comprising the steps of: determining at least one first analyte statistic based on the time-dependent data for the first time period, and determining at least one second analyte statistic based on the subset of the time-dependent data for the first time period; as well as The at least one first analyte statistical data and the at least one second analyte statistical data are displayed on the single graphical object interface.

99. A method according to claim 98, wherein at least one first analyte statistic comprises a first glucose management indicator, a first average glucose, a first standard deviation, or a combination thereof, and / or wherein at least one second analyte statistic comprises a second glucose management indicator, a second average glucose, a second standard deviation, or a combination thereof.

100. The method according to claim 79, further comprising the steps of: determining a first risk of hypoglycemia based on the time-correlated data for the first time period, and determining a second risk of hypoglycemia based on the subset of the time-correlated data for the first time period; as well as The first risk of hypoglycemia and the second risk of hypoglycemia are displayed on the single graphical object interface.

101. A system for displaying metrics associated with an object, the system comprising: wireless communication circuitry configured to receive time-dependent data indicative of an analyte level of a subject; a display configured to visually present information; Memory; and one or more processors coupled to wireless communication circuitry, a display, and a memory, wherein the memory stores instructions and time-dependent data characterizing an analyte level of the subject, wherein the instructions, when executed by the one or more processors, cause the system to: determining a subset of the time-related data based on a filtering criterion selected by the subject; determining a first analyte metric based on the time-dependent data for the first time period, and determining a second analyte metric based on the subset of the time-dependent data for the first time period; as well as The first analyte metric and the second analyte metric are displayed on a single graphical object interface.

102. A method for displaying a metric associated with an object, the method comprising: receiving time-dependent data characterizing an analyte level of a subject; determining a subset of the time-related data based on a filtering criterion selected by the subject; determining a first analyte metric based on the time-dependent data for the first time period, and determining a second analyte metric based on the subset of the time-dependent data for the first time period; as well as The first analyte metric and the second analyte metric are displayed on a single graphical object interface.

103. A system for displaying a metric associated with an object, the system comprising: wireless communication circuitry configured to receive time-dependent data characterizing glucose of the subject and time-dependent data characterizing another analyte of the subject; a display configured to visually present information; as well as Memory; and one or more processors coupled to wireless communication circuitry, a display, and a memory, wherein the memory stores instructions and time-dependent data characterizing an analyte level of the subject, wherein the instructions, when executed by the one or more processors, cause the system to: determining a subset of the time-dependent data characterizing glucose based at least on a first filtering criterion associated with at least one determined level of the additional analyte; as well as A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with the time-related data during a first time period, and wherein the second glucose map displays at least the subset of the time-related data characterizing glucose during the first time period based on the first filtering criteria.

104. The system of claim 56, wherein the first filtering criterion comprises the at least one determined additional analyte level being above a threshold value.

105. The system of claim 104, wherein the additional analyte is a ketone or a ketone body.

106. The system of claim 104, wherein the additional analyte is beta-hydroxybutyrate.

107. The system of claim 104, wherein the additional analyte is lactate.

108. The system of claim 107, wherein: The wireless communication circuitry is further configured to receive data characterizing an activity of the subject, and wherein the first filtering criteria further includes the determined activity level of the subject being below a high activity threshold.

109. A method for displaying metrics associated with an object, comprising the steps of: receiving time-dependent data characterizing an analyte level of a subject; determining a subset of the time-dependent data characterizing glucose based at least on a first filtering criterion associated with at least one determined level of the additional analyte; as well as A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with the time-related data during a first time period, and wherein the second glucose map displays at least the subset of the time-related data characterizing glucose during the first time period based on the first filtering criteria.

110. The method of claim 109, wherein the first filtering criterion comprises at least one determined analyte level of the additional analytes being above a threshold value.

111. The method of claim 110, wherein the additional analyte is a ketone or a ketone body.

112. The method of claim 110, wherein the additional analyte is β-hydroxybutyrate.

113. The method of claim 110, wherein the additional analyte is lactate.

114. The method of claim 113, wherein: The wireless communication circuitry is further configured to receive data characterizing an activity of the subject, and wherein the first filtering criteria further includes the determined activity level of the subject being below a high activity threshold.

115. A system for displaying metrics associated with an object, the system comprising: wireless communication circuitry configured to receive time-dependent data representative of glucose of a subject; a display configured to visually present information; as well as a memory, and one or more processors coupled to the wireless communication circuitry, the display, and the memory, wherein the memory stores instructions and time-dependent data characterizing an analyte level of a subject, wherein the instructions, when executed by the one or more processors, cause the system to: determining a subset of the time-dependent data characterizing glucose based on at least a first filtering criterion; and A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with time-related data over a period of time, and wherein the second glucose map displays at least the subset of the time-related data characterizing glucose over the period of time based on the first filtering criteria.

116. The system of claim 115, wherein the first filtering criteria comprises a type of day.

117. A system according to claim 116, wherein the type of day is a weekday.

118. The system of claim 116, wherein the type of day is a weekend day.

119. The system of claim 116, wherein: The type of day is the weekday of the object.

120. The system of claim 116, wherein: The type of day is the object's holiday.

121. The system of claim 116, wherein: The type of day is the day on which the subject exercises.

122. The system of claim 116, wherein: The type of day was the day on which the subject did not exercise.

123. The system of claim 116, wherein: The day type was the day on which the subject missed a basal insulin dose.

124. The system of claim 116, wherein: A day type was a day on which the subject received at least one basal insulin dose.

125. The system of claim 116, wherein: A day type was a day on which the subject missed at least a single insulin dose.

126. The system of claim 115, wherein: The wireless communication circuitry is also configured to receive data characterizing the activity of the subject.

127. A method for displaying metrics associated with an object, comprising the steps of: receiving time-dependent data characterizing an analyte level of a subject; determining a subset of the time-dependent data characterizing glucose based on at least a first filtering criterion; as well as A first glucose map and a second glucose map are displayed on a single graphical object interface, wherein the first glucose map displays glucose levels associated with time-related data over a period of time, and wherein the second glucose map displays at least the subset of the time-related data characterizing glucose over the period of time based on the first filtering criteria.

128. The method of claim 127, wherein the first filtering criteria comprises a type of day.

129. The method of claim 128, wherein the type of day is a weekday.

130. The method of claim 128, wherein the type of day is a weekend day.

131. The method of claim 128, wherein the type of day is a workday for the subject.

132. The method of claim 128, wherein the type of day is a holiday for the subject.

133. The method of claim 128, wherein the type of day is a day on which the subject exercises.

134. The method of claim 128, wherein the type of day is a day on which the subject does not exercise.

135. The method of claim 128, wherein the type of day is a day on which the subject misses a basal insulin dose.

136. The method of claim 128, wherein the type of day is a day on which the subject receives at least one basal insulin dose.

137. The method of claim 128, wherein the type of day is a day on which the subject misses at least a single insulin dose.

138. The method of claim 137, wherein: The wireless communication circuitry is also configured to receive data characterizing the activity of the subject.

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