Systems and methods for diabetes management

Abstract

Systems, devices, and methods are provided for incorporating medication delivery devices into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose monitor, an integrated insulin pen, and software. The integrated management system may generate multiple reports that may include data related to analyte values (e.g., glucose values) and medications delivered (e.g., insulin delivered). The medication delivery device may also provide feedback to the user.

Description

[Technical Field]

[0001] The subject matter described herein relates generally to systems, devices, and methods relating to integrated systems for diabetes management, such as integrated platforms that link insulin pens to a common viewing platform to enable data sharing among multiple participants. [Background technology]

[0002] Detecting and / or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, and hemoglobin A1C, can be critical to the health of individuals with diabetes. Patients with diabetes mellitus are at risk for complications, including loss of consciousness and cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to ensure they remain within a clinically safe range and can also use this information to determine whether and when they need to lower their glucose levels with insulin or when they need to increase their glucose levels with additional glucose.

[0003] Additionally, clinical data is emerging that shows a strong correlation between frequency of glucose monitoring 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 the hassle, caution about testing, and the pain and expense associated with glucose testing.

[0004] For patients who rely on medications (e.g., insulin) to treat and manage their diabetes, it would be desirable to have access to a system, device, or method that can integrate glucose data with insulin administration data to provide more actionable insights for both patients, caregivers, and healthcare professionals (HCPs). Manually logging insulin administration is time-consuming and often results in inaccurate administration logs. Furthermore, sharing these manual logs with healthcare professionals is cumbersome for patients and presents workflow challenges.

[0005] Diabetes management often requires the use of multiple medications with different delivery frequencies (i.e., daily, weekly, etc.) and administration routes (oral vs. injectable). However, managing the combination of medications, delivery frequencies, and administration routes can be challenging and create significant cognitive load for users, often resulting in poor concordance of medication regimens. Studies have shown that insulin-dependent patients with type 1 diabetes miss doses up to 24% of mealtime bolus doses of rapid-acting insulin and 36% of once-daily basal doses of long-acting insulin, contributing to poor glucose control and diabetes management. Existing medication logbooks are only as useful as users are willing to use them, and their effectiveness is directly correlated to users' willingness to record doses in the log and to refer to past logs. Today, however, the emergence of integrated dosing technologies, such as Bluetooth®-enabled insulin pens, allows users to automatically log doses in a companion application on their mobile phone without user intervention. While this approach is useful for daily management, it suffers from two notable drawbacks: (1) it does not directly correlate with blood glucose trends, and (2) insulin doses are often displayed in a tabular format, making them difficult to understand and interpret over long timescales.

[0006] For the above reasons and others, there is a need for improved systems, methods, and devices for integrated systems for diabetes management. Summary of the Invention

[0007] Exemplary embodiments of systems, devices, and methods for managing diabetes are provided herein. These embodiments include an integrated management system (IMS) comprising an analyte monitoring device, a medication delivery device, a reading device, monitoring software, and reporting software. In many embodiments, the analyte monitoring device (e.g., a continuous glucose monitor or a flash glucose monitor) and medication delivery device (e.g., an insulin pen) are communicatively coupled to the reading device, facilitating the transfer of information, such as analyte data and administration logs, to a computing device comprising the monitoring and / or reporting software. The integrated system may include a GUI display that provides instructions and assistance to a user to interface the medication delivery device with the monitoring software (e.g., on the reading device) and transfer information, such as administration logs, from the medication delivery device. The integrated system also includes reporting software capable of generating multiple reports incorporating data regarding analyte values and metrics and administered medication amounts and metrics.

[0008] The present method addresses both of these concerns by utilizing glucose data as an indicator of poor medication concordance and presenting this data in a manner that allows a skilled medical professional to quickly identify poor medication concordance conditions that could lead to glycemic compromise. In some embodiments, glucose data can be the only indicator of poor medication concordance.

[0009] Other systems, devices, methods, features, and advantages of the subject matter described herein will be apparent to one of ordinary skill in the art or will become apparent upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features, and advantages be included herein, be within the scope of the subject matter described herein, and be protected by the accompanying claims. Features of the example embodiments should not be construed as limiting the scope of the appended claims, unless expressly recited in the claims.

[0010] Details of the subject matter described herein, both in terms of its structure and operation, will become apparent from a review of the accompanying drawings, in which like reference numerals refer to like parts throughout the drawings. The drawings are not necessarily drawn to scale, with emphasis instead being placed upon illustrating the principles of the subject matter. Furthermore, the drawings are intended to convey concepts, and detailed attributes such as relative size and shape may be shown diagrammatically and not accurately. [Brief explanation of the drawings]

[0011] [Figure 1A] FIG. 1 is a block diagram of an exemplary embodiment of an integrated management system. [Figure 1B] FIG. 1 is a block diagram of an exemplary embodiment of an integrated management system. [Figure 2A] FIG. 1 is a schematic diagram illustrating an exemplary embodiment of a sensor control device. [Figure 2B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 3A] 1A and 1B are schematic diagrams illustrating exemplary embodiments of a drug delivery device. [Figure 3B] 1 is a block diagram illustrating an exemplary embodiment of a medication delivery device. [Figure 3C] 1 is a schematic diagram illustrating an exemplary embodiment of a medication delivery device comprising a smart button. [Figure 4A] FIG. 1 is a schematic diagram illustrating an exemplary embodiment of a display device. [Figure 4B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a display device. [Figure 5] FIG. 1 is a block diagram illustrating an exemplary embodiment of a user interface device. [Figure 6] FIG. 1 is a flow diagram illustrating a user experience of an exemplary embodiment of an integrated management system. [Figure 7] FIG. 1 is a flow diagram illustrating the user experience of adding a medication delivery device to the integrated management system. [Figure 8A] FIG. 10 is a block diagram illustrating an example embodiment of a "snapshot" report. [Figure 8B] FIG. 1 illustrates an exemplary embodiment of a "Snapshot" report. [Figure 8C] FIG. 1 illustrates an exemplary embodiment of a "Snapshot" report. [Figure 9A] FIG. 10 is a block diagram illustrating an example embodiment of a "Weekly Summary" report. [Figure 9B] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9C] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9D] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9E] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9F] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9G] FIG. 1 illustrates an example embodiment of a "Weekly Summary" report. [Figure 10A] FIG. 10 is a block diagram illustrating an example embodiment of a "Daily Log" report. [Figure 10B] FIG. 10 illustrates an exemplary embodiment of a "Daily Log" report. [Figure 10C]FIG. 10 illustrates an exemplary embodiment of a "Daily Log" report. [Figure 11A] FIG. 10 is a block diagram illustrating an example embodiment of a "daily pattern" report. [Figure 11B] FIG. 10 illustrates an exemplary embodiment of an Intraday Pattern report. [Figure 11C] FIG. 10 illustrates an exemplary embodiment of an Intraday Pattern report. [Figure 11D] FIG. 10 illustrates an exemplary embodiment of a "daily pattern" report GUI that may be displayed on a display device. [Figure 11E] FIG. 10 illustrates an exemplary embodiment of a "daily pattern" report GUI that may be displayed on a display device. [Figure 12A] FIG. 10 is a block diagram illustrating an example embodiment of a "Mealtime Patterns" report. [Figure 12B] FIG. 10 illustrates an exemplary embodiment of a "Mealtime Patterns" report. [Figure 12C] FIG. 10 illustrates an exemplary embodiment of a "Mealtime Patterns" report. [Figure 13A] FIG. 10 is a block diagram illustrating an example embodiment of a Device Details report. [Figure 13B] FIG. 1 illustrates an exemplary embodiment of a "Device Details" report. [Figure 14] FIG. 2 is a block diagram illustrating an example embodiment of an AGP report. [Figure 15A] FIG. 1 is a block diagram illustrating an exemplary embodiment of a patient dashboard GUI. [Figure 15B] FIG. 1 illustrates an exemplary embodiment of a patient dashboard GUI. [Figure 16A] FIG. 10 is a block diagram illustrating an example embodiment of a GUI associated with a data sources modal for associated pens. [Figure 16B] FIG. 10 illustrates an example embodiment of a GUI associated with a data sources modal for associated pens. [Figure 17A]FIG. 10 is a block diagram illustrating an example embodiment of alerts associated with an associated insulin pen. [Figure 17B] 1 illustrates an exemplary embodiment of alerts related to an associated insulin pen. [Figure 18A] FIG. 10 is a block diagram illustrating an exemplary embodiment of an “AGP Comparison” report. [Figure 18B] FIG. 10 is a block diagram illustrating an exemplary embodiment of an “AGP Comparison” report. [Figure 18C] FIG. 1 shows an exemplary AGP showing all data. [Figure 18D] FIG. 1 shows an exemplary AGP showing data excluding missed doses. [Figure 19] FIG. 1 illustrates an exemplary embodiment of a "Compare" report. [Figure 20A] FIG. 1 illustrates an exemplary embodiment of a GUI for use in interfacing a medical delivery device with a monitoring application. [Figure 20B] FIG. 1 illustrates an exemplary embodiment of a GUI for use in interfacing a medical delivery device with a monitoring application. [Figure 20C] FIG. 1 illustrates an exemplary embodiment of a GUI for use in interfacing a medical delivery device with a monitoring application. [Figure 20D] FIG. 1 illustrates an exemplary embodiment of a GUI for use in interfacing a medical delivery device with a monitoring application. [Figure 20E] 10 illustrates an exemplary embodiment of a GUI for use in managing a user's associated medication delivery devices and monitoring applications. [Figure 20F] 10 illustrates an exemplary embodiment of a GUI for use in managing a user's associated medication delivery devices and monitoring applications. [Figure 21A] FIG. 10 illustrates an exemplary embodiment of a GUI for use in downloading and viewing administration records. [Figure 21B]FIG. 10 illustrates an exemplary embodiment of a GUI for use in downloading and viewing administration records. [Figure 21C] FIG. 10 illustrates an exemplary embodiment of a GUI for use in editing medication administration. [Figure 21D] 10A-10C illustrate an exemplary embodiment of a GUI used to prompt a user to learn about the interaction of medication delivery devices. [Figure 22] FIG. 10 illustrates an exemplary embodiment of a GUI for use in customizing the name of a medication delivery device. [Figure 23A] FIG. 10 illustrates an exemplary embodiment of a GUI for use in applications related to transfer data errors. [Figure 23B] FIG. 10 illustrates an exemplary embodiment of a GUI for use in applications related to transfer data errors. [Figure 23C] FIG. 10 illustrates an exemplary embodiment of a GUI for use in applications related to transfer data errors. [Figure 24A] FIG. 10 illustrates an exemplary embodiment of an “Insulin Summary” report GUI. [Figure 24B] FIG. 10 illustrates an exemplary embodiment of an “Insulin Summary” report GUI. [Figure 24C] FIG. 10 illustrates an exemplary embodiment of an “Insulin Summary” report GUI. [Figure 25] FIG. 10 illustrates an exemplary method for displaying a missed mealtime dose alert or message. [Figure 26] FIG. 10 illustrates an exemplary method for displaying a correction dose alert or message. [Figure 27] FIG. 1 illustrates an exemplary method for displaying a congratulatory alert or message. [Figure 28A] FIG. 10 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28B] FIG. 10 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28C] FIG. 10 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28D] FIG. 10 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28E] FIG. 10 illustrates an example embodiment of a "Daily View" report GUI. [Figure 29A] FIG. 10 illustrates an exemplary method for displaying an analyte profile based on filtered data. [Figure 29B] FIG. 10 illustrates an exemplary method for displaying an analyte profile based on filtered data. [Figure 29C] FIG. 10 illustrates an exemplary method for displaying an analyte profile based on filtered data. [Figure 29D] FIG. 10 illustrates an exemplary method for displaying an analyte profile based on filtered data. [Figure 30A] FIG. 10 illustrates an exemplary method for displaying analyte metrics based on filtered data. [Figure 30B] FIG. 10 illustrates an exemplary method for displaying analyte metrics based on filtered data. [Figure 30C] FIG. 10 illustrates an exemplary method for displaying analyte metrics based on filtered data. [Figure 31A] 1 illustrates an exemplary method for providing feedback on a medication delivery device. [Figure 31B] 1 illustrates an exemplary method for providing feedback on a medication delivery device. [Figure 32A] 1 illustrates an exemplary method for providing tactile feedback on a medication delivery device. [Figure 32B] FIG. 1 illustrates an exemplary method for providing a safeguard against administering a dose greater than the recommended dose. [Figure 32C] FIG. 10 illustrates an exemplary method for adjusting alert parameters in response to drug administration. [Figure 32D]FIG. 1 illustrates an exemplary method for providing a safeguard against delayed dose administration. [Figure 32E] FIG. 1 illustrates an exemplary method for providing a safeguard against delayed dose administration. [Figure 32F] FIG. 1 illustrates an exemplary method for providing a safeguard against delayed dose administration. [Figure 32G] FIG. 1 illustrates an exemplary method for providing a safeguard against delayed dose administration. [Figure 32H] FIG. 1 illustrates an exemplary method for providing a safety measure when a zero dose is recommended. [Figure 32I] 10A-10C illustrate exemplary ways in which operations on a medication delivery device can affect the display of a reading device. [Figure 32J] 1 illustrates an exemplary method for providing a shortcut for a dosage on a medication delivery device. [Figure 33A] FIG. 2 is a side view of the cooperative pen. [Figure 33B] FIG. 1 is an end view of the cooperative pen. [Figure 34A] FIG. 1 illustrates a medication pen and a smart button. [Figure 34B] FIG. 1 illustrates a medication pen and a smart button. [Figure 34C] FIG. 1 illustrates a medication pen and a smart button. [Figure 34D] FIG. 1 illustrates a medication pen and a smart button. [Figure 35] FIG. 1 illustrates an exemplary drug pump. DETAILED DESCRIPTION OF THE INVENTION

[0012] Before describing the subject matter of the present disclosure in detail, it is to be understood that the present disclosure is not limited to particular embodiments described herein, as such may, of course, vary, and the scope of the present disclosure will be limited only by the appended claims. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0013] Generally, embodiments of the present disclosure include systems, devices, and methods related to integrated diabetes management. The integrated diabetes management system can include a smart delivery system, such as a linked smart insulin pen, a glucose sensor, software for receiving and processing data from the glucose sensor and smart delivery system, and a viewing platform for identifying and visualizing dosing analysis results. The integrated management system can also include reports containing insights into the effectiveness of various insulin doses and treatment advice, including dosing recommendations.

[0014] The integrated diabetes management software can be implemented as software and / or firmware instructions stored in a memory of a computing device for execution by at least one processor or processing circuitry of the computing device. The computing device can be owned by a user or a healthcare professional, and the user or healthcare professional can interact with the computing device through a user interface. According to some embodiments, the computing device can be a server or trusted computer system accessible over a network, and the integrated management software can be presented to the user in the form of an interactive web page. In this case, the presentation of the interactive web page can be via a browser running on a local display device (having a user interface) that is in communication with the server or trusted computer system over the network. In embodiments such as those described above, the integrated management software can be executed across multiple devices, or can be executed partly on the processing circuitry of the local display device and partly on the processing circuitry of the server or trusted computer system. Thus, when a description is provided that the integrated management system performs an action, those skilled in the art will understand that the action is performed according to instructions stored in computer memory (including instructions hard-coded in read-only memory) that, when executed by at least one processor of at least one computing device, cause the integrated management system to perform the action described in the instructions. In any case, the action may alternatively be performed by hardware (e.g., dedicated circuitry) hardwired to accomplish the action, rather than via instructions stored in memory.

[0015] Furthermore, as used herein, a system in which an integrated management system is implemented may be referred to as an integrated management system. The integrated management system may be configured solely for the purpose of providing integrated management, or may be a multi-function system having integrated management as just one aspect. For example, in some embodiments, the integrated management system may further have the function of monitoring a user's analyte levels. In some embodiments, the integrated management system may further have the function of delivering medication to a user, such as using an injection device or infusion device. In some embodiments, the integrated management system may have both the function of monitoring an analyte and the function of delivering medication.

[0016] The embodiments described herein, such as those described above, represent improvements in the field of computer-based dosing determination systems, analyte monitoring systems, and drug delivery systems. Specific features and potential advantages of embodiments of the present disclosure are described in further detail below.

[0017] Before describing embodiments of integrated management in detail, it is desirable to first describe an example of an integrated management system in which the integrated management application can be implemented. Exemplary Embodiments of an Integrated System 1A is a block diagram illustrating an exemplary embodiment of an integrated system 100. In this embodiment, the integrated management system 100 can deliver one or more medications, log medication administration, monitor one or more analytes, calculate and display analytical results, and provide treatment advice. This multi-functional example illustrates the high level of interconnectivity and performance provided by the system 100.

[0018] In this example, system 100 includes a sensor control device (SCD) 102 configured to collect analyte value information from a user, a medication delivery device (MDD) 152 configured to deliver medication to the user, and a display device 120 configured to present information to and receive input or information from the user. The structure and functionality of each device are described in detail below.

[0019] The system 100 is configured to enable highly interconnected and flexible communication between devices. The three devices 102, 120, and 152 can communicate directly with each other (without any intervening electronic devices) or indirectly with each other (through the cloud network 190 or through other devices and the network 190, in that order). In FIG. 1A, bidirectional communication between devices and between the devices and the network 190 is indicated by bidirectional arrows. However, those skilled in the art will understand that one or more devices (e.g., sensor control devices) may also engage in unidirectional communication, such as broadcast, multicast, or advertising. Whether bidirectional or unidirectional, communication may be wired or wireless. Furthermore, the protocols governing communication along each path may be the same or different, proprietary, or standard. For example, wireless communications between devices 102, 120, and 152 may be performed according to the BLUETOOTH (including BLUETOOTH Low Energy) standard, the Near Field Communication (NFC) standard, the WiFi (802.11x) standard, the mobile telephony standard, or the like. All communications over the various paths may be encrypted, and each device shown in FIG. 1A may be configured to encrypt and decrypt communications sent and received. In each case, the communication paths shown in FIG. 1A may be direct (e.g., BLUETOOTH or NFC) or indirect (e.g., Internet protocols such as WiFi or cellular). Note that an embodiment of system 100 need not necessarily have communication capabilities that encompass all of the paths shown in FIG. 1A.

[0020] 1A shows one each of the display device 120, the sensor control device 102, and the medication delivery device 152, those skilled in the art will understand that the system 100 may include a plurality of any of these devices. For example, by way of example only, the system 100 may include a single sensor control device 102 that communicates with multiple (e.g., two, three, four, etc.) display devices 120 and / or multiple medication delivery devices 152. Alternatively, the system 100 may include multiple sensor control devices 102 that communicate with a single display device 120 and / or a single medication delivery device 152. Furthermore, when multiple devices are included, the types of the devices may be the same or different among the multiple devices. For example, the system 100 may include multiple display devices 120, such as smartphones, handheld receivers, smartwatches, etc., each of which may be capable of communicating with either or both of the sensor control device 102 and the drug delivery device 152, and may be capable of communicating with each other.

[0021] The analyte data may be transferred between devices in system 100 autonomously (e.g., automatically according to a schedule) or in response to a request for the analyte data (e.g., a request for the analyte data is sent from a first device to a second device, and then the second device sends the analyte data to the first device). Other data communication technologies may also be employed to support more complex systems, such as cloud network 190.

[0022] 1B is a block diagram illustrating another exemplary embodiment of an integrated management system 100. In this example, the system 100 includes a sensor control device 102, a medication delivery device 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 via a cloud network 190. The sensor control device 102 and the medication delivery device 152 are configured to communicate with each other and with the display device 120-1, which can function as a communications hub for aggregating information from the sensor control device 102 and the medication delivery device 152, processing the aggregated information, displaying the aggregated information in a desired location, and forwarding some or all of the information to the cloud network 190 or the computer system 170. Conversely, the display device 120-1 can also receive information from the cloud network 190 or the computer system 170 and communicate some or all of the received information to the sensor control device 102, the medication delivery device 152, or both. The computer system 170 may be any suitable data processing device, such as a personal computer, a server terminal, a laptop computer, or a tablet terminal. The computer system 170 may include or present software for data management, data analysis, and data communication with components within the system 100. A user or medical personnel may use the computer system 170 to display and analyze test substance data measured by the sensor control device 102. Note that while FIG. 1B shows one sensor control device 102, one drug delivery device 152, and two display devices 120-1 and 120-2, those skilled in the art will understand that the system 100 may include multiple of any of these devices, and that if multiple devices are included, the types of the devices may be the same or different among the multiple devices.

[0023] 1B , according to some embodiments, trusted computer system 180 may reside, either physically or virtually via a secure connection, under the ownership of a manufacturer or distributor of components of system 100. Trusted computer system 180 may be used to authenticate devices (e.g., devices 102, 120-n, 152) of system 100 for securely storing user data, and may also serve as a server providing data analysis programs (e.g., accessible via a web browser) for performing analysis of users' analyte measurement data and medication histories. Trusted computer system 180 may also function as a data hub for data routing and exchange among all devices communicating with system 180 via cloud network 190. In other words, all devices of system 100 configured to communicate with cloud network 190 (e.g., directly via an internet connection or indirectly via other devices) may also communicate, directly or indirectly, with all other devices of system 100 configured to communicate with cloud network 190.

[0024] In the figure, display device 120-2 is shown in communication with 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 wearer of sensor control device 102. For example, the owner of display device 120-2 may be, in one example, the parent of a child wearing sensor control device 102, or, in another example, the caregiver of an elderly patient wearing sensor control device 102. System 100 may be configured to communicate analyte and medication data about the wearer via cloud network 190 (e.g., communicating via trusted computer system 180) to other users who are authorized to access the data.

[0025] Exemplary Embodiments of an Analyte Monitoring Device The analyte monitoring functionality of the integrated management system 100 may be achieved by including one or more devices configured to collect, process, and display user analyte data. Exemplary embodiments of such devices and methods of use are described in International Publication No. WO 2018 / 152241 and U.S. Patent Application Publication No. 2011 / 0213225, the entire contents of which are incorporated herein by reference for all purposes.

[0026] Analyte monitoring can be accomplished in a variety of ways. For example, a "Continuous Analyte Monitoring" device (e.g., a "Continuous Glucose Monitoring (CGM)" device) is a device that can continuously or repeatedly transmit data (e.g., automatically according to a schedule) from a sensor controlling device to a display device, with or without prompting. Another example is a "Flash Analyte Monitoring" device (e.g., a "Flash Glucose Monitoring" device or simply a "Flash" device), which can transfer data from the sensor controlling device in response to a user request for data received from the display device using Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocols.

[0027] Analyte monitoring devices that utilize sensors configured for placement partially or entirely within a user's body may be referred to as in vivo analyte monitoring devices. For example, an in vivo sensor may be placed within a user's body so that at least a portion of the sensor is in contact with bodily fluid (e.g., interstitial fluid (“ISF”), such as dermal fluid within the dermis layer or subcutaneous fluid deeper than the dermis layer, or blood) to measure the analyte concentration in the bodily fluid. In vivo sensors may use various types of sensor technologies (e.g., chemical, electrochemical, or optical). Some systems utilizing in vivo analyte sensors may operate without the need for finger-prick calibration.

[0028] On the other hand, an "in vitro" system is one in which a sensor is contacted with a biological sample outside the body (or more precisely, "ex vivo"). Typically, an in vitro system includes a port that receives an analyte test strip containing a user's bodily fluid, which can then be analyzed to determine the user's blood glucose level. Other ex vivo devices have also been proposed that attempt to measure analyte levels in a user's body noninvasively, for example, by using optical techniques that can measure analyte levels in the body without mechanically penetrating the user's body or skin. Many in vivo and ex vivo devices also include in vitro functionality (e.g., an in vivo display device that also includes a test strip port).

[0029] While the present subject matter will be described below through a description of a sensor configured to measure glucose concentrations, the detection and measurement of other analyte concentrations is also 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, and the like. Drug concentrations may also be monitored, for example, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, warfarin, and the like. The sensor may be configured to measure two or more different analytes simultaneously or non-simultaneously. In some embodiments, a sensor control device can be coupled to two or more sensors, with one of the sensors configured to measure a first analyte (e.g., glucose) and one or more other sensors configured to measure one or more different analytes (e.g., any of the analytes described herein). In other embodiments, a user can wear two or more sensor control devices configured to measure different analytes.

[0030] The embodiments described herein may be applied to any type of in vivo, in vitro, or ex vivo device configured to monitor analytes such as those described above.

[0031] In many embodiments, the sensor control device 102 controls the operation of the sensor. The sensor can be mechanically and communicatively coupled to the sensor control device 102 or can be communicatively coupled to the sensor control device 102 using wireless communication techniques. The sensor control device 102 can include electronic components and a power source that enable the sensor to detect and control the analyte. In some embodiments, the sensor or sensor control device 102 can be self-powered, eliminating the need for a battery. The sensor control device 102 can also include communication circuitry for communicating with other devices (e.g., a display device). Such other devices may or may not be near the user's body. The sensor control device 102 can be stationary on the user's body (e.g., placed on the user's skin, such as by being attached to the user's skin, or carried in the user's clothing). The sensor control device 102 can also be implanted within the user's body along with the sensor. The functionality of the sensor control device 102 may be divided into a first component (e.g., a component that performs sensor control) that is implanted within the body and a second component (e.g., a relay component that communicates with the first component and with external devices such as a computer or smartphone) that resides external to the body. In other embodiments, the sensor control device 102 may be external to the body and configured to non-invasively measure analyte levels of a user. Depending on the actual implementation or embodiment, the sensor control device may also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, an “in-body electronics” device or unit, an “in-body” device or unit, or a “sensor data communication” device or unit, as just a few examples.

[0032] In some embodiments, the sensor control device 102 includes a user interface (e.g., a touch panel) configured to process analyte data and display the resulting analyte values to a user. In such cases, the integrated management embodiments described herein may be implemented in whole or in part directly in the sensor control device 102. However, in many embodiments, it may be desirable to have a display device interconnected to the sensor control device that allows a user to view analyte values, for example, to minimize the physical form factor of the sensor control device 102 (e.g., to minimize its visibility on the user's body) or because the sensor control device may not be accessible to the user (e.g., if the device is entirely implanted).

[0033] FIG. 2A is a side view of an exemplary embodiment of a sensor control device 102. The sensor control device 102 can include a housing (mount) 103 for sensor electronics (FIG. 2B), which can be electrically coupled to an analyte sensor 101, which in this example is configured as an electrochemical sensor. According to some embodiments, the sensor 101 can be configured to be placed partially within a user's body (e.g., through the outermost surface of the skin) where it is in fluid contact with the user's bodily fluids and, in conjunction with the sensor electronics, to measure analyte-related data from the user. The housing 103 can be secured to the user's skin using an attachment structure 105, such as an adhesive patch. The sensor 101 can extend through the attachment structure 105 and protrude outside the housing 103. One skilled in the art will appreciate that other forms of attachment to the body and the housing 103 can be used in addition to or instead of adhesive, and all such other attachment forms are within the scope of the present disclosure.

[0034] The sensor control device 102 can be attached to the body in any desired manner. For example, an insertion device (not shown) (sometimes called an applicator) can be used to pierce all or part of the analyte sensor 101 through the outer surface of the user's skin and place it in contact with the user's bodily fluids. Similarly, the insertion device can also be used to place the sensor control device 102 on the skin. In other embodiments, the sensor 101 can be first placed with the insertion device, and then associated electronic components (e.g., wireless transmission circuitry, data processing circuitry, etc.) can be coupled to the sensor 101 (e.g., inserted into a mount). Such electronic component coupling can be performed manually or with the aid of a mechanical device. Examples of insertion devices are described in U.S. Patent Application Publication Nos. 2008 / 0009692, 2011 / 0319729, 2015 / 0018639, 2015 / 0025345, 2015 / 0173661, and 2018 / 0235520, the entire contents of which are incorporated herein by reference for all purposes.

[0035] FIG. 2B is a block diagram illustrating an exemplary embodiment of a sensor control device 102 having an analyte sensor 101 and sensor electronics 104. The sensor electronics 104 can be implemented on one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), a processor or controller, memory, a programmable gate array, etc.). In the embodiment of FIG. 1B, the sensor electronics 104 includes multiple higher-level functional units, including an analog front end (AFE) 110, a power supply 111, processing circuitry 112, memory 114, timing circuitry 115 (e.g., an oscillator and phase locked loop for providing timing information, such as a clock, to each component of the sensor control device 102), and communication circuitry 116. The AFE 110 provides an analog interface with the sensor 101 and is configured to convert the signal from analog to digital, digital to analog, or both (e.g., via an A / D converter). The power supply 111 is configured to provide power to each component of the sensor control device 102. The communication circuitry 116 is configured to communicate with one or more devices external to the sensor control device 102 (e.g., the display device 120, the drug delivery device 152, or both) in a wired, wireless, or both manner.

[0036] The sensor control device 102 may be implemented with a high degree of interconnectivity, i.e., a power source 111 is coupled to each component shown in Figure 2B, and each of the components responsible for communicating or receiving data, information, or commands (e.g., AFE 110, processing circuitry 112, memory 114, timing circuitry 115, communication circuitry 116) may be communicatively coupled to every other component responsible for such function, for example, via one or more communication connections (i.e., bus) 118.

[0037] The processing circuitry 112 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or may be distributed across (and portions of) many different chips. The processing circuitry 112 may include on-board memory. The processing circuitry 112 may interconnect with the communications circuitry 116 to perform functions such as analog-to-digital conversion, encoding and decoding, digital signal processing, and the like, that assist in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature phase). The processing circuitry 112 may also interconnect with the communications circuitry 116 to perform functions in the opposite direction, i.e., functions necessary to receive wireless transmissions and convert them into digital data or information.

[0038] Processing circuit 112 may execute instructions stored in memory 114. These instructions may cause processing circuit 112 to process raw analyte data (i.e., pre-processed analyte data) to derive a final calculated analyte value. In some embodiments, the instructions stored in memory 114, when executed, may cause processing circuit 112 to process the raw analyte data to determine one or more of a calculated analyte value, a calculated average analyte value within a predetermined time window, a calculated rate of change of the analyte value within a predetermined time window, and a determination of whether the calculated analyte metric exceeds a predetermined threshold condition. The instructions may also cause processing circuitry 112 to read and process received transmissions, adjust the timing of timing circuitry 115, process data or information received from other devices (e.g., calibration, encryption, or authentication information received from display device 120), perform tasks to establish and maintain communications with display device 120, recognize voice commands from a user, and transmit using communications circuitry 116. In embodiments in which sensor control device 102 includes a user interface, the instructions may also cause processing circuitry 112 to control the user interface, read user input from the user interface, display information on the user interface, format data for display, etc. Note that while the above functionality is described as being coded into instructions, such functionality may instead be implemented in sensor control device 102 using hardware or firmware designs that are capable of achieving their functions without relying on the execution of stored software instructions.

[0039] The memory 114 may be shared by one or more of the various functional units present in the sensor control device 102, or may be distributed among two or more of them (e.g., as separate memories present in different chips). The memory 114 may also be a standalone chip in its own right. The memory 114 is non-transitory memory and may be volatile memory (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

[0040] The communications circuitry 116 may be implemented as one or more components (e.g., communications circuitry such as a transmitter, receiver, transceiver, passive circuitry, encoder, decoder, etc.) that perform a function for communication over each communications path or link. The communications circuitry 116 may include or be coupled to one or more antennas for wireless communications.

[0041] The power supply 111 may include one or more batteries, which may be rechargeable or disposable, and may include a power management circuit to control battery charging, monitor the usage of the power supply 111, boost power, convert DC, etc.

[0042] Additionally, an optional temperature sensor (not shown) may collect readings or measurements of temperature on the skin (sensor temperature). The collected readings or measurements may be communicated from the sensor control device 102 to another device (e.g., the display device 120) (either as individual values or as an aggregate of measurements within an aggregation period). However, instead of or in addition to actually outputting temperature measurements to the user, the temperature readings or measurements may be linked to a software routine executed by the sensor control device 102 or the display device 120 to correct or complement the analyte measurements before outputting them to the user.

[0043] Exemplary Embodiments of a Medication Delivery Device Insulin delivery systems can be categorized by whether delivery is automated or manual. At one end of the spectrum, fully automated insulin delivery systems, such as fully closed-loop insulin delivery systems, determine and deliver insulin doses via an insulin pump at any given time based primarily on information from a glucose monitoring module, such as a CGM system. Meanwhile, fully manual insulin delivery systems require the user to determine the appropriate dose based on known information (e.g., health status, food intake, and a CGM system) and insulin delivery calculation methods. The user may then initiate insulin delivery with an insulin delivery module or device, such as a traditional insulin syringe, insulin pen, smart insulin pen, or insulin pump. In between are decision support systems (DSSs), which primarily receive information from a glucose monitoring module (such as a CGM system) and may determine a recommended insulin dose, but require the user to approve / deliver the dose via a corresponding insulin delivery module or device (MDD 152) (such as a traditional insulin syringe, insulin pen, smart insulin pen, or insulin pump). Systems for determining recommended dosing guidance are described in U.S. Patent Application Publication No. 2021 / 0050085 and U.S. Patent Application No. 17 / 591,229, the entire disclosures of which are expressly incorporated by reference into this specification for any purpose.

[0044] The medication delivery functionality of the integrated management system 100 may be achieved by including one or more medication delivery devices (MDDs) 152. The medication delivery device 152 may be any device configured to administer a particular medication. The medication delivery device 152 may also include a device (e.g., a pen cap) that transmits data regarding the administration to the integrated management system but does not itself deliver the medication. The medication delivery device 152 may be configured, for example, as a portable injection device (PID) capable of administering a single dose, such as a bolus dose, in a single injection. A portable injection device is essentially a manually operated syringe, where the medication is pre-filled or must be drawn into the syringe from a reservoir prior to injection. However, in many embodiments, the portable injection device includes electronic components for user interaction to deliver the medication. Portable injection devices are often referred to as medication pens, although they do not necessarily have a pen-like appearance. Portable injection devices with user interface electronics are also often referred to as smart pens. Portable injection devices can be used for a single dose and then disposed of, or they can be durable enough to be reused for multiple doses over the course of a day, week, or month. Portable injection devices are popular among users of multiple daily injection (MDI) therapy.

[0045] The drug delivery device may also include a pump and an infusion set. The infusion set includes a cannula tube, at least a portion of which is placed within the recipient's body. The cannula tube is in fluid communication with a pump, which allows repeated small doses of drug to be delivered through the cannula into the recipient's body over time. The infusion set may be attached to the recipient's body using an infusion set applicator, and in many cases, the infusion set remains implanted for 2-3 days or longer. The pump device includes electronic components for interacting with the user to control the gradual infusion of the drug. In both the portable injection device and the pump, the drug may be stored in a drug reservoir.

[0046] The drug delivery device 152 can function as part of a closed-loop system (e.g., an artificial pancreas system that can operate without user intervention), a semi-closed-loop system (e.g., an insulin loop system that can operate with little user intervention, such as confirming dosage changes), or an open-loop system. For example, the sensor control device 102 can repeatedly and automatically monitor analyte levels in a diabetic patient and transmit that information to an application for incorporation into various analyses and reports.

[0047] In many embodiments, the integrated management system can include data for various 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 premixed insulins), and the drugs included in the drug data included in the integrated management system are the same as the drugs delivered by the drug delivery device 152. Types of insulin include human insulin and synthetic insulin analogue formulations. Premixed formulations of insulin are also possible. However, the integrated management embodiments and drug delivery functions of the drug delivery device 152 described herein can be applied to drugs other than insulin. Such agents may include, but are not limited to, exenatide, sustained-release formulations of exenatide, liraglutide, lixisenatide, semaglutide, pramlintide, metformin, SGLT1-i inhibitors, SGLT2-i inhibitors, and DPP4 inhibitors. Integrated management embodiments may also include combination therapies, including, but not limited to, insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA) or insulin and pramlintide.

[0048] For ease of describing the integrated management embodiments, the medication delivery device 152 is described in many places herein as being in the form of a portable injection device, and in particular a smart pen, although those skilled in the art will readily appreciate that the medication delivery device 152 may alternatively be configured as a pen cap, a pump, or any other type of medication delivery device.

[0049] In some embodiments, the integrated management system can include an associated pen cap that, when attached to an insulin pen, pairs with the display device, and can then automatically transmit administration data from the associated pen cap to the display device, for example, via Bluetooth, every time an insulin dose is administered.

[0050] FIG. 3A is a schematic diagram illustrating an exemplary embodiment of a portable injection device, specifically a medication delivery device 152 configured as a smart pen. The medication delivery device 152 can include a housing 154 for electronics, an injection motor, and a medication reservoir (see FIG. 3B) from which medication can be delivered through a needle 156. The housing 154 can include a removable cap or cover 157 that protects the needle 156 when not in use and can be removed for subsequent injections. The medication delivery device 152 can also include a user interface 158. The user interface 158 can be implemented as a single component (e.g., a touch panel for outputting information to a user and receiving input from a user) or as multiple components (e.g., a combination of a touch panel or display with one or more buttons, switches, etc.). The medication delivery device 152 can also include an actuator 159. Actuator 159 can be moved, depressed, touched, or otherwise actuated to initiate delivery of medication from the internal reservoir through needle 156 and into the recipient's body. According to some embodiments, cap 157 and actuator 159 can also include one or more safety mechanisms to prevent removal or activation to reduce the risk of adverse health effects from medication injection. Details of these safety mechanisms and more are described in U.S. Patent Application Publication No. 2019 / 0343385 (the "'385 Publication"), the entire contents of which are incorporated herein by reference for all purposes. FIG. 3C is a schematic diagram of a medication delivery device 152 and a smart button configured to fit over the actuator of a delivery pen. Medication delivery device 152, which may be a single-use medication delivery pen, can include a display 158 and a dose selector, such as a rotatable dial, for selecting a dose. A smart button 2190 fits over the dose selector and actuator 159 and can be snapped onto pen 2180.After the smart button 2190 is paired with the reading device, the smart button 2190 may track administration, store administration data, and transmit administration data to the reading device. Medication may be delivered by pressing straight down on the smart button 2190 to inject a dose. The smart button 2190 may also include a display capable of displaying a recommended dose and / or dosage amount. The terms "recommended dose" and "dose recommendation" may be used interchangeably herein.

[0051] FIG. 3B is a block diagram illustrating an exemplary embodiment of a medication delivery device 152 having electronic components 160. Electronic components 160 are coupled to a power source 161 and a powered injection motor 162, which is coupled to the power source 161 and a medication reservoir 163. While needle 156 is shown in fluid communication with reservoir 163, a valve (not shown) may be present between reservoir 163 and needle 156. Reservoir 163 may be a permanent reservoir or may be a removable reservoir that can be replaced with another reservoir containing the same or a different medication. Electronic components 160 may be implemented on one or more semiconductor chips (e.g., an application-specific integrated circuit (ASIC), a processor or controller, memory, a programmable gate array, etc.). In the embodiment of FIG. 3B, electronic components 160 may comprise multiple higher-level functional units. Such higher-level functional units include processing circuitry 164, memory 165, communication circuitry 166, and user interface electronics 168. The communication circuitry 166 is configured to communicate with one or more devices external to the medication delivery device 152 (e.g., the display device 120) via wires, wirelessly, or both.

[0052] The medication delivery device 152 may be implemented with a high degree of interconnectivity, i.e., a power source 161 is coupled to each component shown in Figure 3B, and each of the components responsible for communicating or receiving data, information, or commands (e.g., processing circuitry 164, memory 165, communication circuitry 166) may be communicatively coupled to all other components responsible for such functionality, for example, via one or more communication connections (i.e., bus) 169.

[0053] The processing circuitry 164 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or may be distributed across (and portions of) many different chips. The processing circuitry 164 may include on-board memory. The processing circuitry 164 may interconnect with the communications circuitry 166 to perform functions such as analog-to-digital conversion, encoding and decoding, digital signal processing, and the like, that assist in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature phase). The processing circuitry 164 may also interconnect with the communications circuitry 166 to perform the reverse functions, i.e., functions necessary to receive wireless transmissions and convert them into digital data or information.

[0054] The processing circuitry 164 may execute software instructions stored in memory 165. These instructions may cause the processing circuitry 164 to receive a selection or specification of a designated dose from a user (e.g., entered via user interface 158 or received from another device), process a command (e.g., a signal from actuator 159) to deliver the designated dose, and control motor 162 to deliver the designated dose. The instructions may also cause the processing circuitry 164 to read and process received transmissions, process data or information received from other devices (e.g., calibration, encryption, or authentication information received from display device 120), perform tasks to establish and maintain communications with display device 120, recognize voice commands from the user, and transmit using communications circuitry 166. In embodiments in which medication delivery device 152 includes a user interface 158, the instructions may also cause the processing circuitry 164 to control the user interface, read user input from the user interface (e.g., input of a medication dose to be administered or input confirming a recommended dosage), display information on the user interface, format the data for display, etc. Although the above functionality is described as being coded and contained in instructions, such functionality may alternatively be implemented in the drug delivery device 152 using a hardware or firmware design that is capable of achieving such functionality without relying on the execution of stored software instructions.

[0055] The memory 165 may be shared by one or more of the various functional units present in the drug delivery device 152, or may be distributed among two or more of them (e.g., as separate memories present in different chips). The memory 165 may also be a standalone chip in its own right. The memory 165 is non-transitory memory and may be volatile memory (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

[0056] The communications circuitry 166 may be implemented as one or more components (e.g., communications circuitry such as transmitters, receivers, transceivers, passive circuits, encoders, decoders, etc.) that perform functions for communication over each communications path or link. The communications circuitry 166 may include or be coupled to one or more antennas for wireless communications. Exemplary antenna details are described in the '385 publication, the entire contents of which are incorporated herein by reference for all purposes.

[0057] The power supply 161 can include one or more batteries, which may be rechargeable or disposable, and may include a power management circuit to control battery charging, monitor the usage status of the power supply 161, boost power, convert DC, etc.

[0058] Additionally, the drug delivery device 152 may also include an integrated or attached in-vitro glucose meter, which may include an in-vitro test strip port (not shown) for receiving an in-vitro glucose test strip for performing in-vitro measurements of blood glucose.

[0059] Exemplary Embodiments of a Display Device The display device 120 can be configured to display information about the system 100 to the user and to accept or receive input from the user regarding the system 100. The display device 120 can display recent analyte measurements to the user in any number of formats. The display device can display the user's past analyte values and other metrics representative of the user's analyte information (e.g., time in range (TIR), ambulatory glucose profile (AGP), hypoglycemia risk level, etc.). The display device 120 can display drug delivery information, such as past dosing information, the date and time of dosing, etc. The display device 120 can display notifications, such as alarms or alerts, related to analyte values and drug delivery.

[0060] Display device 120 can be a dedicated device for system 100 (e.g., an electronic device designed and manufactured primarily to interface with analyte sensors and / or drug delivery devices), or it can be a multi-function general-purpose computing device, such as a handheld or portable mobile communication device (e.g., a smartphone or tablet), or a laptop, personal computer, or other computing device. Display device 120 can also be configured as a mobile smart wearable electronics assembly, such as monocular or binocular smart glasses, a smart watch, or a wristband. Display devices and variations thereof may also be referred to as "reader devices," "readers," "handheld electronics" (or handhelds), "portable data processing" devices or units, "information receivers," "receiver" devices or units (or simply receivers), "relay" devices or units, or "remote" devices or units, to name just a few examples.

[0061] 4A is a schematic diagram illustrating an exemplary embodiment of display device 120. In this example, display device 120 includes user interface 121 and housing 124, which holds display device electronics 130 (FIG. 4B). User interface 121 can be implemented as a single component (e.g., a touch panel configured to provide input and output) or multiple components (e.g., a display and one or more devices configured to receive user input). In this embodiment, user interface 121 includes touch panel display 122 (configured to display information and graphical images and to receive user input via touch) and input buttons 123, both of which are coupled to housing 124.

[0062] The display device 120 may store software (e.g., by a manufacturer or downloaded by a user in the form of one or more software packages such as "apps") that interfaces with the sensor control device 102, the medication delivery device 152, and / or the user on the display device 120. Additionally or alternatively, the user interface may be influenced by web pages displayed on internet interfacing software, such as a browser, executable on the display device 120.

[0063] 4B is a block diagram illustrating an exemplary embodiment of a display device 120 including display device electronics 130. In this example, display device 120 includes a user interface 121, processing circuitry 131, memory 125, communication circuitry 126, power supply 127, and timing circuitry 128 (e.g., an oscillator and phase-locked loop circuit for providing timing information, such as a clock, to the components of display device 120). User interface 121 includes a display 122 and input components 123 (e.g., buttons, actuators, touch-sensitive switches, capacitive switches, pressure-sensitive switches, jog wheels, microphones, speakers, etc.). Communication circuitry 126 is configured for one-way or two-way communication with one or more other devices external to display device 120. Each of these components can be implemented individually as one or more devices, or can be combined into a single multi-function device (e.g., processing circuitry 131, memory 125, and communication circuitry 126 integrated on a single semiconductor chip). Display device 120 may be implemented in a highly interconnected manner, such that a power source 127 is coupled to each component shown in FIG. 4B , and each of the components responsible for communicating or receiving data, information, or commands (e.g., user interface 121, processing circuitry 131, memory 125, communications circuitry 126, timing circuitry 128) may be communicatively coupled to all other components responsible for such functionality, for example, via one or more communications connections (i.e., bus) 129. Note that FIG. 4B is a simplified diagram of typical hardware and functionality present in a display device, and those skilled in the art will readily recognize that other hardware and functionality (e.g., codecs, drivers, glue logic) may also be present.

[0064] Processing circuitry 131 may include one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or may be distributed across (and portions of) many different chips. Processing circuitry 131 may include on-board memory. Processing circuitry 131 may interconnect with communications circuitry 126 to perform functions such as analog-to-digital conversion, encoding and decoding, digital signal processing, and the like, that assist in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature phase). Processing circuitry 131 may also interconnect with communications circuitry 126 to perform the reverse functions, i.e., functions necessary to receive wireless transmissions and convert them into digital data or information.

[0065] Processing circuitry 131 may execute software instructions stored in memory 125. These instructions may cause processing circuitry 131 to process raw analyte data (i.e., unprocessed analyte data) to derive corresponding analyte values suitable for display to a user. These instructions may also cause processing circuitry 131 to read, process, store, and communicate administration instructions from a user to drug delivery device 152. These instructions may also cause processing circuitry 131 to execute user interface software adapted to present interactive graphical user interface screens to a user for purposes of changing system parameters (e.g., alarm thresholds, notification settings, display preferences, etc.), presenting current and past analyte value information to a user, presenting current and past drug delivery information to a user, collecting other non-analyte information from a user (e.g., information about meals consumed, activities performed, medications administered, etc.), and presenting notifications and alarms to a user. The instructions may also cause processing circuitry 131 to transmit using communications circuitry 126, read and process received transmissions, read input from user interface 121 (e.g., entering a drug dose to be administered or approving a recommended dosage), display 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 information, or authentication information received from sensor control device 102), perform tasks to establish and maintain communications with sensor control device 102, recognize voice commands from a user, etc. Note that while the above functionality is described as being coded into instructions, such functionality may instead be implemented in display device 120 using hardware or firmware designs that are capable of realizing functions without relying on the execution of stored software instructions.

[0066] Memory 125 may be shared by one or more of the various functional units present in display device 120, or may be distributed among two or more of them (e.g., as separate memories present in different chips). Memory 125 may also be a standalone chip in its own right. Memory 125 is non-transitory memory and may be volatile memory (e.g., RAM, etc.) and / or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

[0067] The communications circuitry 126 may be implemented as one or more components (e.g., communications circuitry such as a transmitter, receiver, transceiver, passive circuitry, encoder, decoder, etc.) that perform a function for communication over each communications path or link. The communications circuitry 126 may include or be coupled to one or more antennas for wireless communications.

[0068] The power supply 127 may include one or more batteries, which may be rechargeable or disposable, and may include power management circuitry to control battery charging, monitor power supply 127 usage, boost power, convert DC, etc.

[0069] Display device 120 may also include one or more data communication ports (not shown) for wired data communication with external devices such as computer system 170, sensor control device 102, or drug delivery device 152. Display device 120 may also include an integrated or attached in-vitro glucose meter, which may include an in-vitro test strip port (not shown) for receiving in-vitro glucose test strips for performing in-vitro measurements of blood glucose.

[0070] The display device 120 can display analyte measurement data received from the sensor control device 102 and can also be configured to output alarms, alert notifications, glucose values, and the like. Such output can be visual, audible, tactile, or any combination thereof. Additionally, in some embodiments, the sensor control device 102, the drug delivery device 152, or both can be configured to output alarm or alert notifications that are visual, audible, tactile, or any combination thereof. Further details and other display embodiments are described, for example, in U.S. Patent Application Publication No. 2011 / 0193704, the entire contents of which are incorporated herein by reference for all purposes.

[0071] Exemplary Embodiments of Integrated Management The following exemplary embodiments relate to an integrated management system (IMS). In many embodiments, the integrated management system is implemented as a set of software instructions stored and / or executed on one or more electronic devices. In some embodiments, the integrated management system is stored, executed, and presented to a user on the same electronic device. In other embodiments, the integrated management system is stored and executed on one device and presented to a user on a different electronic device. For example, the integrated management system may be stored and executed on trusted computer system 180 and presented to a user via a web page displayed via an internet browser running on display device 120.

[0072] Accordingly, there are many different embodiments regarding the number and types of electronic devices used to store, execute, and present the integrated management system, or portions thereof, to a user. With respect to user presentation, a device configured to implement user presentation functionality will be referred to herein as a user interface device (UID) 200. FIG. 5 is a block diagram illustrating an exemplary embodiment of a user interface device 200. In this embodiment, the user interface device 200 includes a housing 201 coupled to a user interface 202. The user interface 202 is configured to output information to a user and to input or receive information from a user. In some embodiments, the user interface 202 is a touch panel. As shown, the user interface 202 includes a display 204 (which may be a touch panel) and input components 206 (e.g., buttons, actuators, touch-sensitive switches, capacitive switches, pressure-sensitive switches, jog wheels, a microphone, a touchpad, softkeys, a keyboard, etc.).

[0073] Many of the devices described herein can be implemented as user interface devices 200. For example, in many embodiments, the display device 120 is utilized as the user interface device 200. In some embodiments, the medication delivery device 152 can also be implemented as a user interface device 200. Also, in embodiments in which the sensor control device 102 includes a user interface, the sensor control device 102 can be implemented as a user interface device 200. Furthermore, the computer system 170 can also be implemented as a user interface device 200.

[0074] Exemplary Embodiments of Integrated Management System User Experience As shown in FIG. 6 , in the exemplary user experience method 300, a user may check an analyte value, such as a glucose level, at step 302. As described above, the user may transfer the analyte value or data indicative of the analyte value to the display device 120, such as by scanning the sensor control device 102. At step 304, the user administers a medication (e.g., insulin) from an associated medication delivery device 152. As previously described, the medication delivery device 152 may be an associated smart insulin pen, an associated pen cap, a smart button, or an automated insulin delivery (AID) device included in a closed-loop system. Then, at step 306, the user transfers administration information from the medication delivery device 152 to the display device 120. This transfer may be performed by methods known in the art. For example, the display device 120 (e.g., a smartphone) may scan the associated medication delivery device 152 and transfer the information via NFC. Alternatively, the administration information may be transferred automatically without requiring further user interaction. For example, administration information can be automatically transferred via a wireless communication protocol such as "BLUETOOTH" without the need for scanning. For example, in the case of a linked pen cap, linked insulin pen, or AID device, data can be automatically transferred to a display device upon detecting that an administration has occurred. There are many ways to describe the transfer of medication information, including, for example, scan, transfer, download, upload, export, import, connect, sync, pair, and other similar terms. Data can also be automatically transferred via wireless communication such as "BLUETOOTH."The transferred data may include data regarding medication (e.g., insulin) injections, shots, events, notes, log entries, or other similar terms. Such data may be referred to as insulin data, insulin records, insulin logs, insulin doses, or other similar terms. After the transfer of the administration information, a notification (e.g., a lock screen notification or a banner notification) may optionally appear on the display device. The notification may include a message that a report or application, such as a logbook, has been updated, and may also include the amount of medication delivered and the delivery time. Next, in step 308, the user or others (e.g., caregivers, healthcare professionals) view a comprehensive history (which may include analyte values and medication doses) on various displays and reports to visualize and assist the user's diabetes care.

[0075] Before data can be transferred from the medication delivery device 152 to the integrated management system, the medication delivery device 152 must first be added to the integrated management system. FIG. 7 illustrates an exemplary method 310 for adding a medication delivery device 152 to the integrated management system and managing the associated medication delivery device 152. In method 310, a user can add an insulin pen by selecting “insulin pen” from a menu, such as a pull-down menu. As seen in GUI 322 of FIG. 20A , a “Let’s get started” screen can include a pictorial representation of the medication delivery device 152 communicating with the display device 120 and can list various tasks or functions that the integrated management system will perform after connecting the medication delivery device 152 to the integrated management system. These tasks or functions can include connecting a compatible smart pen to record insulin doses, reviewing and tracking past doses, and sharing reports with the user’s healthcare team. Selecting “Let’s get started” opens the insulin pen settings, as seen in GUI 324 of FIG. 20A , and can prompt the user to select the medication delivery device 152 they want to connect to the integrated management system in step 312. Medication delivery devices 152, e.g., insulin pens, may be listed by their respective brand names. After the user selects the appropriate medication delivery device and selects "Next," a graphical image or animation may be presented showing how to scan the medication delivery device 152 (e.g., insulin pen) with the display device 120 (e.g., smartphone), as seen in GUI 326 of FIG. 20B. Additionally, GUI 326 may include text instructing the user to hold the insulin pen display directly toward the back of the smartphone to scan. Furthermore, GUI 326 may display text indicating that the user may need to slowly move the insulin pen until the correct position is found, which will affect the connection / communication between the insulin pen and the smartphone.A link to the insulin pen's user manual, which contains further information on how to link the insulin pen with a smartphone, may also be provided. If the linking is successful, a GUI 328 may appear, as shown in FIG. 20B, indicating that a new medication delivery device 152 has been added to the integrated management system. The name of the newly added medication delivery device may also be displayed in GUI 328. If the user selects "Next," the user may be prompted to select a pen color for the newly linked medication delivery device 152 in step 314. As shown in FIG. 20C, various color options 332 may be displayed in GUI 330. If the user selects "Next" in GUI 334 of FIG. 20C, the user may be prompted to select the type of medication packaged in the newly linked medication delivery device 152. If the medication delivery device 152 is an insulin pen, the user may be prompted to select a type of insulin from various types of insulin (e.g., rapid-acting insulin, long-acting insulin, etc.) in list 336 in step 316. If the user selects "Next," then in step 318, the user may be prompted to further select a brand of insulin of the selected type in GUI 338 of FIG. 20D. A list of available brands 340 may be provided. Alternatively, the user may be allowed to add a new brand that is not included in the provided list. If the user selects "Next" in GUI 342 of FIG. 20D, then the user may be shown an indication that the setup of the new medication delivery device 152 is complete. The GUI 342 may also include a reminder to scan the associated medication delivery device 152 to transfer the insulin doses to the integrated management system software. The GUI 342 may also include an animation showing how to scan the medication delivery device 152 (e.g., an insulin pen) with the display device 120 (e.g., a smartphone).Additionally, the GUI may include text instructing the user to hold the insulin pen display directly towards the back of the smartphone to scan, and may also post text indicating that the user may need to slowly move the insulin pen until the correct position is found, which will affect the connection / communication between the insulin pen and the smartphone.

[0076] Additional medication delivery devices can be associated in a similar manner. The additional medication delivery devices can be assigned a different color or other identifying feature or name than the previously associated medication delivery device. For example, a medication delivery device 152 that delivers fast-acting insulin can be assigned a pen color of blue, while a medication delivery device 152 that delivers long-acting insulin can be assigned a color other than blue, such as red, silver, or black. Additional medication delivery devices can be added under the insulin pen menu by selecting the option to add another medication delivery device (e.g., a plus sign labeled "Add Insulin Pen") (see reference numeral 356 in FIG. 20E).

[0077] A user can select the option "Manage your insulin pen's associations" under the insulin pen menu. The user can then be presented with windows such as GUI 350 and GUI 368 in FIG. 20E. This window includes a representation of the associated medication delivery device 152, along with a description 358 indicating the type and / or brand of insulin delivered by the medication delivery device 152 and details 360 of the last scan (e.g., the time of the scan and the amount of medication delivered). As noted above with respect to GUI 326, a user can select the information icon "i" to display GUIs 364a and 364b, as shown in FIG. 20F, which contain information on how to transfer insulin logs and administration information. GUIs 364a and 364b can include an animation showing how to scan the medication delivery device 152 with a smartphone. The GUIs displayed to instruct the scanning process can be different for GUI 364a on an iOS system than for GUI 364b on an Android system. Additionally, GUI 364a, 364b may include text instructing the user to hold the insulin pen display directly toward the back of the smartphone to scan, and may also display text in GUI 364a, 364b indicating that the user may need to slowly move the insulin pen until the correct position is found that will result in connection / communication between the insulin pen and the smartphone.

[0078] In some embodiments, the medication delivery device 152 may be a pen cap, such as a Dialoq®, capable of wirelessly transferring dosage data via Bluetooth. In this case, pairing of the medication delivery device 152 with the monitoring application may need to be performed using Bluetooth rather than NFC. The monitoring application may prompt the user to ensure that Bluetooth is enabled on the display device 120. The monitoring application may display a GUI that prompts the user to enter and / or accept a verification code for the medication delivery device 152. The GUI may also include a picture, diagram, or animation indicating where the code is located on the medication delivery device 152. Once the code is entered, the monitoring application may display a GUI that includes instructions to press and release a button on the medication delivery device 152 to pair the device with the display device 120. The instructions may include explanatory text, diagrams, pictures, or animations to assist the user in completing the pairing. A window may be displayed on the display device 120 indicating that the medication delivery device 152 is seeking to pair with the display device 120. Alternatively, the pairing may be completed only after the user selects "pair." Once the medication delivery device is paired with the display device 120, a GUI may be displayed confirming successful pairing and / or setup.

[0079] Once the medication delivery device 152 is linked to the monitoring software on the display device 120, administration information is transferred from the medication delivery device 152 to the software, such as by download (e.g., via NFC or Bluetooth). As shown in FIGS. 21A-21C, in GUI 390, the monitoring software may indicate its readiness to receive a download from the linked medication delivery device 152 (e.g., a banner may display a message indicating that the monitoring software is "ready to scan"). When the user scans the medication delivery device 152 in step 306, a window 394 may open indicating that a new administration has appeared in the logbook. For example, window 394 in GUI 390 may indicate that three administrations have been transferred from the medication delivery device to the monitoring software. Window 394 may also indicate the scanned medication delivery device 396 and the type of insulin administered 398. Furthermore, after the initial scan of the medication delivery device 152, a GUI 400, such as that shown in FIG. 21A, may be displayed. GUI 400 allows the user to select a default insulin type, which will become the default insulin type the next time the user scans the insulin pen.

[0080] As shown in FIG. 21B , the home screen 410 can include a button or link 412 for selecting a scan of the medication delivery device 152. The home screen 410 can also include a display showing the analyte profile, a "time in range" statistic, the previous analyte reading, the average analyte reading, a graph of the analyte readings over a period of time (e.g., the current day), and the current sensor age. Additionally, the home screen 410 can include icons (e.g., syringe icons) 414 along the analyte reading graph that indicate when various medications were administered. The location of the icons 414 along the analyte reading graph corresponds to the time the medication was administered. In some embodiments, the user can view or edit insulin notes by tapping the syringe icon 414 on the home screen 410. The user can tap the syringe icon to view the dosage and, if necessary, tap the pencil icon to edit the entry. In some embodiments, a syringe icon with a question mark may indicate that the dose has no additional comments or notes. In some embodiments, a syringe icon with a notepad may indicate that the dose has additional comments or notes. In some embodiments, an empty syringe icon may indicate that the dose was automatically transferred from an associated medication delivery device 152. Additionally, icons representing meals (e.g., an apple icon), exercise (e.g., a runner icon), or comments (e.g., a notepad icon) may also be displayed alongside or above the test substance reading graph. The icons are positioned along the time axis (x-axis) according to when meals and notes were consumed.

[0081] The insulin pen menu also provides access to a logbook GUI 416, as seen in FIG. 21B. The logbook GUI 416 may include a log listing of various events, such as the amount of medication administered, along with the time the event occurred. If the log entry is imported from a medication delivery device 152, a syringe icon may also be displayed next to the amount of medication administered (e.g., units (u)). Note that priming of the medication delivery device 152 may also be recorded in the logbook listing. A priming dose (prime) refers to the injection of medication (e.g., insulin) to deflate the needle tip. Priming may also be referred to by other similar terms, such as an airshot, flow check, or squirt. The logbook may also include manually added notes.

[0082] The monitoring application may also allow users to edit notes associated with specific medication administration events. A user wishing to edit detailed information about an insulin administration can tap the corresponding entry line in the logbook GUI 416. Each entry line links to a "Logbook Details" GUI 430, as shown in FIG. 21C. The analyte graph on the "Logbook Details" GUI 430 may include highlighting, such as a vertical line, representing the currently viewed administration. To edit detailed information about a selected insulin administration, a user can tap the edit (pencil) icon 444. This icon 444 links to an "Edit Notes" GUI 450, where the user can edit the information associated with various fields. The "Edit Notes" GUI 450 includes a banner that prominently displays the dose amount and the date and time of administration. The "Edit Notes" GUI 450 may also include various fields, such as the type of administration (either insulin dose or prime amount) 452, insulin brand, number of units, delivery device name, meal 454, exercise 456, and comments 458. The user can edit the type of insulin delivered by tapping the drop-down caret icon and selecting an insulin brand. The user can also change the type of this dose from a therapeutic dose to a flow check (i.e., prime) dose by tapping the drop-down caret icon and selecting the "Priming (Flow Check)" option. In some embodiments, when the user indicates that this dose is a prime dose, a banner at the top of the "Edit Notes" screen will indicate that this dose is a prime dose, as seen in GUI 460 in FIG. 21C.

[0083] If an error occurs, the monitoring application may prompt the user to review detailed information about the administration that was administered. The detailed information may include the amount administered, the type of medication, and the delivery time. As seen in FIGS. 23A-23C, if an error is detected in the data for a newly transferred administration(s), window 1052 of GUI 1050 or window 1062 of GUI 1060 may be displayed to prompt the user to review detailed information about the administration. Alternatively, the error may be noted in the "Logbook" GUI 1070, the "Logbook Details" GUI 1080, or both. In some embodiments, the "Logbook" GUI 1070, the "Logbook Details" GUI 1080, or both, may include an error indicator associated with the particular administration. The error indicator may be the missed dose 1072, a special syringe icon (e.g., a syringe icon with an exclamation mark or question mark next to it) 1074, or both. The user can edit an administration entry with an error by tapping the edit (pencil) icon 444. The user can also go to the "Edit Notes" GUI 1090 linked to the administration entry to edit individual fields, if desired.

[0084] As seen in GUI 470 of Figure 21D, the monitoring application can also prompt the user to learn more about new features in the monitoring application via a pop-up window 472. This prompt can inform the user about new features that become available by linking the monitoring application to a medication delivery device 152 (e.g., a smart insulin pen) and allowing the monitoring application to track the user's insulin doses. A similar window can also pop up if there are updates available for the monitoring application.

[0085] The monitoring application may also allow a user to define a name for the associated medication delivery device 152. As seen in FIG. 22, a user can navigate to the insulin "Settings" GUI 480 and tap or select the "Name" field 484 to open a "Name" GUI window 486. The user can tap or select the "New Name" field 488 and type a new name for the device. FIG. 22 shows the user entering "Home Pen" as the user-defined name for the device. If the user selects "Save," the new name will appear in the "Current Name" field 490 of the updated GUI 492.

[0086] Insights and Alerts Hints for forgetting to take a mealtime dose If a missed dose is suspected, the monitoring application may display an alert, hint, or prompt. In some embodiments, administration data is automatically transferred to the monitoring application via Bluetooth. For example, if a dose is not logged within a certain time (e.g., 1 hour, 2 hours, or 3 hours) after a glucose level rises, the monitoring application may display an alert asking the user, "Did you miss a mealtime dose?" The alert may further indicate that the user's glucose is elevated and that the last logged dose was X hours ago. The alert may also suggest that the user synchronize the medication delivery device 152 to update the administration data. The alert may also suggest that the user seek advice from a healthcare professional if a dose has been missed. In some embodiments, if the alert is related to a specific meal, the alert may ask whether the user missed a [breakfast / lunch / dinner] dose and further indicate that the user typically takes this mealtime dose by X:XX (e.g., the user typically takes their lunchtime dose by 1:30 PM).

[0087] Users can minimize the number of alerts that pop up on their devices by configuring conditions for alerts or hints that warn of missed mealtime administration. For breakfast, lunch, dinner, and long-acting administrations, users can specify that hints about missed doses only appear after a certain time. For example, a user can configure the device to display a hint about a breakfast dose after 10:00 AM if no dose is detected within a certain time before 10:00 AM; a hint about a lunch dose after 1:30 PM if no dose is detected within a certain time before 1:30 PM; and a hint about a dinner dose after 8:00 PM if no dose is detected within a certain time before 8:00 PM.

[0088] As shown in FIG. 25 , the exemplary method 1900 can begin at step 1902, in which a system or application receives test substance data. The data can be received from a server, the cloud, or the sensor control device 102. Then, at step 1904, the system can receive the subject's insulin data (e.g., from the medication delivery device 152). For example, the system or application can automatically receive insulin data wirelessly (e.g., via Bluetooth) from the medication delivery device 152, such as an integrated pen or integrated pen cap, without requesting the insulin data. In other embodiments, the system or application can also check for the most recent insulin administration data from various sources (including, but not limited to, the medication delivery device 152, a medication delivery device-related application, or an interface that stores the most recent insulin delivery information (e.g., a web server for the medication delivery device application)), or by checking the memory of various applications for the most recent insulin delivery information.

[0089] In step 1906, the system or application may determine whether a meal has been ingested. This determination may be made by analyzing the received analyte data to determine whether the analyte value has risen above an upper threshold or whether the rate of change in the analyte value is greater than a minimum rate-of-change threshold. Further details regarding mealtime dosing detection are provided in U.S. Patent Application Publication Nos. 2021 / 0030323, 2021 / 0050085, and 17 / 591229, the entire disclosures of which are expressly incorporated herein by reference for all purposes. The upper analyte threshold 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 upper analyte threshold may be set by the user. If the system determines that a meal has not been consumed, the system returns to step 1902 to receive more analyte data.

[0090] On the other hand, if the system or application determines that a meal was consumed, then in step 1908, the system can analyze the received insulin administration data to determine whether insulin administration was recorded or received during a period of time. This period of time can be at least one hour, such as about one hour, or about two hours, or about three hours. Optionally, the period of time can be user-configurable rather than being a system-set default. If insulin administration was recorded during this period of time, the system determines that no doses were missed and returns to step 1904 to receive further insulin administration data.

[0091] In some embodiments, the period can be set for each meal by the user by taking a prandial dose and setting the appropriate time for each meal. The system can also check whether an insulin dose has been recorded or received before the set time for each meal. For example, if a breakfast dose has not been recorded or received by 10:30 AM, the system can determine that the user has missed a breakfast dose. Similarly, if the user typically takes a lunch dose by 2:30 PM, the lunch dose can be set to 2:30 PM. And if the user typically takes a dinner dose by 7:30 PM, the dinner dose can be set to 7:30 PM. These times can be set by the user to suit their individual eating habits.

[0092] If the system or application determines that no insulin doses have been recorded or received for a particular meal within the period or by the set time, the system or application may display an alert interface related to missed mealtime doses in step 1910. In some embodiments, the text of the alert interface may be user customizable.

[0093] Hints for correction doses The monitoring application can display an alert, hint, or prompt to the user to consider a correction dose if a certain amount of time has passed since the last insulin dose and glucose levels remain high. In some embodiments, administration data is automatically transferred to the monitoring application via Bluetooth. The user can minimize the number of alerts that pop up on their device by configuring the conditions under which the correction dose alert or hint is issued. The user can configure the alert to appear only if the glucose level is above a high threshold (e.g., about 250 mg / dL) and the time since the last insulin dose is above a minimum time threshold (e.g., about 2 hours).

[0094] Users can also customize the message displayed in the hint. For example, a message could indicate that the dose taken X hours ago (e.g., 2 hours ago) did not lower glucose levels sufficiently, and it's time to take X units of additional insulin or go for a walk in the park. The default setting might be a message encouraging the user to seek medical advice or exercise to get out of the high glucose situation.

[0095] As shown in FIG. 26 , the exemplary method 1920 can begin at step 1922, in which a system or application receives analyte data. The data can be received from a server, the cloud, or the sensor control device 102. Then, at step 1924, the system or application can receive the subject's insulin data (e.g., from the medication delivery device 152). For example, the system or application can automatically receive insulin data wirelessly (e.g., via Bluetooth) from the medication delivery device 152, such as an integrated pen or integrated pen cap, without requesting the insulin data. In other embodiments, the system or application can also check for the most recent insulin administration data. Such data checks can be performed by requesting delivery information from various sources (including, but not limited to, the medication delivery device 152, a medication delivery device-related application, or an interface that stores the most recent insulin delivery information (e.g., a web server for the medication delivery device application)) or by checking the memory of various applications for the most recent insulin delivery information.

[0096] In step 1926, the system or application may determine whether the received analyte value exceeds an upper threshold value. The upper threshold value may be a threshold that indicates the user's glucose value is outside the target range. The upper analyte value threshold may be at least 175 mg / dL. For example, the upper analyte value threshold 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 upper analyte value threshold may be set by the user. If the system determines that the analyte value is not above the upper threshold value, the system returns to step 1922 to receive additional analyte data.

[0097] On the other hand, if the system or application determines that the analyte value is above the upper threshold, then in step 1928, the system or application may analyze the received insulin administration data to determine whether a certain period of time has elapsed since the last recorded or received insulin administration. This certain period of time may be at least about two hours, for example, the certain period of time may be about two hours, or about 2.5 hours, or about three hours. Optionally, the certain period of time may be user-configurable rather than being a system-set default. If the certain period of time has not yet elapsed since the last recorded insulin administration, the system returns to step 1924 to receive more insulin administration data.

[0098] On the other hand, if the system or application determines that the period of time has elapsed since the last insulin dose, the system or application may display an alert interface related to a correction dose in step 1930. In some embodiments, the text of the alert interface may be user customizable.

[0099] Congratulatory message The monitoring application can also display a congratulatory alert or message if insulin administration brings glucose levels back into target range within a specified time. For example, an alert or window could say, "Glucose goal achieved! Back in target range 2 hours after last insulin dose." The application can also provide an option for the user to add notes (typed or spoken to text) with more information about actions the user took that may have helped them reach their target range.

[0100] The user can set the conditions for displaying the alert or window by setting the maximum glucose value and the time limit for returning to the target range. For example, the user can set the target range to less than 180 mg / dL and the time limit for returning to the target range after administration to 2 hours.

[0101] As shown in FIG. 27 , the exemplary method 1940 can begin at step 1942, in which a system or application receives analyte data. The data can be received from a server, the cloud, or the sensor control device 102. Then, at step 1944, the system can receive the subject's insulin data (e.g., from the medication delivery device 152). For example, the system can automatically receive insulin data wirelessly (e.g., via Bluetooth) from the medication delivery device 152, such as an integrated pen or integrated pen cap, without requesting the insulin data. In other embodiments, the system or application can also check for the most recent insulin administration data. Such data checks can be performed by requesting delivery information from various sources (including, but not limited to, the medication delivery device 152, a medication delivery device-related application, or an interface that stores the most recent insulin delivery information (e.g., a web server for the medication delivery device application)) or by checking the memory of various applications for the most recent insulin delivery information.

[0102] In step 1946, the system or application may determine whether the received analyte value is below an upper threshold. The upper threshold may be a threshold that indicates the user's glucose value is within a target range. The upper analyte value threshold may be 190 mg / dL, or 185 mg / dL, or 180 mg / dL, or 175 mg / dL, or 170 mg / dL. The upper analyte value threshold may be set by the user. If the system or application determines that the analyte value is not below the upper threshold, the system or application returns to step 1942 to receive additional analyte data.

[0103] On the other hand, if the system determines that the analyte value is below the upper threshold, then in step 1948, the system may analyze the received insulin administration data to determine whether a certain period of time has elapsed since the last recorded or received insulin administration. This certain period of time may be at least two hours, such as about two hours, or about 2.5 hours, or about three hours. Optionally, the certain period of time may be user-configurable rather than being a system-set default. If the certain period of time has not yet elapsed since the last recorded insulin administration, the system returns to step 1944 to receive more insulin administration data.

[0104] On the other hand, if the system determines that the period of time has elapsed since the last insulin administration, the system may display an alert interface related to the analyte value being within the target range in step 1950. In some embodiments, the text of the alert interface may be customizable by the user.

[0105] Report The monitoring application can transfer data, including analyte values from the sensor control device 102 and administration data / logs from the medication delivery device 152, to a reporting application. The reporting application can generate multiple reports that summarize and highlight various aspects of the analyte and medication data and history. The reporting application can run on a display device or other computing device. In some embodiments, the monitoring application can include instructions that, when executed by one or more processors, generate and display reports that include the insulin data within the monitoring application.

[0106] 8A-8C illustrate an exemplary embodiment of an insulin dosage interface 502, which is shown as part of a report GUI 500 of a analyte monitoring system. In one aspect of this embodiment, the GUI 500 is a snapshot report over a predetermined time period 504 (e.g., 14 days) and includes multiple report sections on a single report GUI. These report sections include a sensor usage frequency interface section 506, a glucose trends interface 508, and a health information interface 510. The glucose trends interface 508 can include associated glucose metrics (e.g., a glucose management indicator (GMI) 515), such as an AGP graph 511 and a low glucose events graph 513.

[0107] The AGP graph 511 can display percentiles of hourly glucose readings for a "typical" day based on all days within a selected time frame. The percentiles of glucose readings are presented as the 5th, 25th, 50th (median), 75th, and 95th percentiles. The AGP graph 511 can also include two horizontal lines that represent the upper and lower limits of the target ranges defined in the "Glucose Statistics and Targets" and "Time in Range" sections. Finally, the report 500 can include a section 517 that lists metrics, statistics, or both related to average glucose readings. The metrics section 517 can list the average glucose reading, the percentage of time above the target range, the percentage of time in the target range, and the percentage of time below the target range. The low glucose event graph 513 can include a graph of events in which the subject's glucose readings fell below a lower threshold (e.g., 72 mg / dL). The low glucose event graph may show glucose concentration (mg / dL) versus time to show at a glance when low glucose events occurred. The report 500 may also include a section 519 that provides metrics, statistics, or both related to the low glucose events. The low glucose event metrics section 519 may include the number of low glucose events and the average duration of the low glucose events.

[0108] The sensor usage frequency interface 506 may include a sensor active time percentage graph 521 and a metrics section 523. The metrics section 523 may include the percentage of time the sensor was active and an average scans / views metric (e.g., showing the average of the total number of scans and views). The sensor active time percentage graph 521 may include a graph showing the percentage of time the sensor was active versus time (e.g., midnight to midnight). Note that the sensor active time percentage graph 521 may align one of its axes with one or more other graphs (e.g., average glucose value trend graph 511 or low glucose events graph 513). This allows a user to visually understand correlations between data in multiple graphs in two or more columns in the report GUI by using a common unit (e.g., time) on the aligned axes between the graphs.

[0109] The health information interface 510 may include a carbohydrate section 512, an “insulin administered” section 502, and a comments section 514. The carbohydrate section 512 may include information logged by the user about the user's average daily carbohydrate intake and may include an average total amount of carbohydrates consumed by the user during the time period 504.

[0110] The "Administered Insulin" section 502 may include a list of medication doses (e.g., insulin doses) administered during the time period 504. This list may include separate entries for rapid-acting insulin 516, long-acting insulin 518, and total daily insulin 520. The entries may include an icon indicating the type of insulin, the type of insulin (e.g., rapid-acting, long-acting, basal, etc.), the brand name of the insulin, and / or an average insulin dose. If multiple insulin pens are connected, the medication dose section 502 of the display may include different icons (e.g., icons with different colors or pictures) for each type of insulin pen. For example, a rapid-acting insulin pen may be represented by a light green icon 516, and a long-acting insulin pen may be represented by a dark green icon 518.

[0111] In some embodiments, the insulin dose may be manually entered by the user or calculated by a dose calculator rather than transferred directly from the linked medication delivery device 152. The insulin dose may be entered into a monitoring or reporting application. If the insulin dose is manually entered, the report 500 may include the dose of rapid-acting insulin 516 and / or long-acting insulin 518, but not the brand name of the insulin. The insulin dosage interface 502 may also display the number of units per day administered by insulin type and the average total daily insulin dose (units / day). The rapid-acting insulin dose 516 may be listed as the total dose administered (units / day), or may be broken down into items such as mealtime doses, corrections, user overrides, and manual entries.

[0112] The comments interface 514 may provide additional spoken information about the user's test substance and medication patterns. For example, the comments section 514 may include an indication of the trend in the number of tests per day compared to the previous reporting period, any variability detected during the reporting period, and the percentage of insulin corrections taken as a percentage of the average daily dose.

[0113] The report 500 may also include a list of sources 522 of the listings. The source may include the name of the glucose monitoring device and may 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 section 522 may list all medication delivery devices, as well as the name of the first linked insulin pen and the number of other medical devices (but not the specific names of the other insulin pens).

[0114] 9A-9G illustrate an exemplary embodiment of a report GUI 600 for another analyte monitoring system that includes information about administered insulin doses. According to one aspect of this embodiment, GUI 600 is a "weekly summary" report for a time period 613, including multiple report sections separated by days of the week. This time period can be one or several weeks, such as 7 days, 14 days (e.g., see FIGS. 9B and 9C), 21 days, 28 days (e.g., see FIGS. 9D-9G), 32 days, 36 days, etc. Each report section can then include glucose trend graphs 601a-601n for each day in time period 613 and health information interfaces 606, 608, 610, and 612. Glucose trend graph 601 can include the user's glucose measurements over a 24-hour period. The health information interface may include information regarding the user's daily average glucose values 606a-606bb, carbohydrate intake 608a-608bb, insulin doses 610a-610bb, and hypoglycemic events (“low events”) 612a-612bb for each day in the time period 613.

[0115] In some embodiments, the glucose trend graphs 601a-601bb can include a sensor usage indicator. The sensor usage indicator indicates that a scan, a view, or both occurred at a particular time during the 24-hour period. The glucose trend graphs 601a-601bb can also be color-coded to highlight portions of the graph that are outside of the target range. For example, the trend graphs 601a-601bb can highlight the areas under the curve that are outside of the target range by painting the area under the curve a particular color or by changing the color of the portion of the graph that is outside the target range to a particular color. The area under the curve that is above the target range 603 can be painted, for example, yellow or orange, and the area under the curve that is below the target range 605 can be painted, for example, red.

[0116] The "Low" events 612a-612bb column may include the number of low events detected when the user's analyte value falls below a low threshold (e.g., 80 mg / dL or 75 mg / dL for glucose). Low events may also be highlighted on the glucose trend graph by highlighting the area under the curve during the low event with a darker color (e.g., red).

[0117] Similarly, the health information interface 604 may also include total carbohydrate intake 608a-608bb for each day. This carbohydrate entry may be displayed in a different color, e.g., orange, and may include a different icon, e.g., an apple, to distinguish it from the insulin dose entry. If a carbohydrate value is not available, the total carbohydrate entry 608a-608bb may be blank or contain one or more dashes. Additionally, the glucose trend graphs 601a-601bb may include carbohydrate intake. Similar to insulin doses, the carbohydrate amounts of various meals and snacks may be listed in orange boxes and noted at or near the time of the meal or snack. If insulin doses are administered simultaneously with or around meals (carbohydrate intake), the insulin dose may also be displayed below the carbohydrate intake on the glucose trend graph.

[0118] The insulin dose column interface 610a-610bb can include the total amount of insulin administered that day for each insulin type. The total insulin dose for each insulin type can be differentiated by different colors. For example, the total amount of administered rapid-acting insulin can be shown in a light green rectangle, and the total amount of administered long-acting insulin can be shown in a dark green rectangle. If an administered insulin value is not available, the administered insulin amount entry can be displayed as one or more dashes. Individual doses of various insulins can also be included in the glucose trend graphs 601a-601bb. For example, a dose rectangle can be displayed on the glucose trend graph at or near the time of administration. This rectangle can also be color-coded, similar to the total amount of insulin, to allow the user to quickly identify which insulin was administered. For example, the administered dose of rapid-acting insulin can be shown in a light green rectangle, and the administered dose of long-acting insulin can be shown in a dark green rectangle. The long-acting insulin dose may or may not be displayed on the glucose trend graph. Additionally, if a rapid-acting insulin dose was administered simultaneously with, before, or after a long-acting insulin dose, the long-acting insulin dose may be displayed on the glucose trend graph below the rapid-acting insulin dose entry box. The brand name of each insulin type administered may also be displayed in legend 630 at the foot of the "Weekly Summary" report 600.

[0119] In some embodiments, the dosing information may be manually entered by the user rather than transferred directly from the connected medication delivery device 152. The insulin doses may be entered into a monitoring or reporting application. If the insulin doses were manually entered, the report 600 will include the amount of rapid-acting insulin delivered, but the legend 630 may not include the brand name of the insulin. Instead, the legend 630 may include an icon corresponding to the specific insulin type administered. In some embodiments, the dosing information may be automatically transferred from the connected delivery device. The data source field 632 may include the name of the device providing the analyte data value and the number of other glucose measuring devices integrated into the data, but may not include the names of individual insulin pens. The insulin dosage interface 610 may also display the number of units administered per day by insulin type and the average total daily insulin amount (units / day). If the insulin administration and carbohydrate logging are performed close in time, the amount of insulin administered may be displayed below the carbohydrate entry in the glucose trend graph. In other embodiments, the “Weekly Summary” report 600 may include the brand name of the insulin, for example, in the legend 630 .

[0120] The report may also list the data source 632, including the name of the device that provided the analyte data value and the name of the primary medication delivery device. If the data included in the Weekly Summary report was from multiple linked insulin pens, the source 632 may also include the name of the first linked pen and the number of other medical devices (numerical value).

[0121] 10A-10C illustrate an exemplary embodiment of a report GUI 700 for another analyte monitoring system that includes information about multiple types of insulin administered as a "Daily Log" report. According to one aspect of this embodiment, GUI 700 is a "Daily Log" report for each day in a time period 701 and can include glucose trend graphs 702a-702c, "Scan / View" sections 704a-704c, "Carbohydrate" rows 706a-706c, "Insulin Administered" rows 708a-708c, "Notes" rows 710a-710c, and a legend 730. The time period can be one week or several weeks, such as 7 days, 14 days (e.g., see FIG. 10B), 21 days, 28 days (e.g., see FIG. 10C), 32 days, 36 days, etc. 10A-10C show an example of the first page (screen) of report 700, including graphs and information for the first three days of the time period. Glucose trend graphs 702a-702c can include the user's glucose values over a 24-hour period. In some embodiments, glucose trend graphs 702a-702c can include sensor usage indicators to indicate that a scan, a view, or both occurred at a particular time during the 24-hour period. In some embodiments, the scanned or viewed glucose values can be noted in the "Scans / Views" section 704a-704c at the time of the scan or view. Glucose trend graphs 702a-702c can also include event log indicators, such as a carbohydrate intake log indicator and an insulin dose log indicator, and glucose event indicators, such as a low glucose event indicator. Additionally, report 700 may include multiple rows containing additional information below glucose trend graphs 702a-702c, such as rows 704a-704c for "Scan / View," rows 706a-706c for "Carbohydrates," rows 708a-708c for "Insulin Administered," and rows 710a-710c for "Notes."The "Scan / View" rows 704a-704c may include notable glucose values in a location corresponding to the time the glucose value was logged. For example, if a glucose bout occurs that exceeds the target range, the peak glucose value may be color-coded in a first color, such as orange, and if a hypoglycemic episode occurs, the low glucose value may be color-coded in a second color, such as red. The "Carbohydrate" rows 706a-706c may include carbohydrate amounts in a location corresponding to the time the carbohydrates were logged.

[0122] Regarding the "Administered Insulin" rows 708a-708c, the amount of insulin injected can be displayed in hourly blocks in the lower row of each glucose trend graph 702. Separate rows can be displayed for each medication delivery device. For example, as shown in FIG. 10C, insulin doses from a rapid-acting insulin pen can be displayed in one row, and insulin doses from an insulin pen containing long-acting insulin can be displayed in a separate row. The row for long-acting insulin doses can then be displayed below the row for rapid-acting insulin doses. Rapid-acting insulin doses can be displayed as white boxes with black borders. User corrections or changes can be displayed before the dose. Long-acting insulin doses, on the other hand, can be displayed as dark green boxes. The data source field 754 can include the name of the device providing the analyte data value, the name of the first linked insulin pen, and the number of other glucose measurement devices integrated into the data.

[0123] In some embodiments, insulin doses can be manually entered by a user or calculated using a dose calculator rather than transferred directly from an associated medication delivery device 152. Insulin doses can be entered into a monitoring or reporting application. If insulin doses are manually entered, the “Daily Log” report can include the rapid-acting and long-acting insulin 618 doses, but without the brand name of the insulin next to each icon. In some embodiments, administration information can be automatically transferred from an associated delivery device. The data source field 754 can include the name of the device providing the analyte data value and the number of other glucose measuring devices integrated with the data, but can omit the names of individual insulin pens. A row for a particular type of insulin can be displayed only if administration data for that type of insulin was entered on that day. If no data for a type of insulin is available on that day, the row for that type of insulin can be hidden below the glucose trend graph 702. Color-coded icons and the brand or type of insulin can also be displayed next to the insulin dose rows, alongside the glucose trend graphs 702a-702c. As with other report embodiments, different icons and colors can be used for rapid-acting and long-acting insulin pens. For example, rapid-acting insulin can be represented by a light green filled syringe icon, while long-acting insulin can be represented by a dark green filled syringe icon. Rows can be configured to appear on a particular day only if insulin administration data is available for that day. Additionally, if a user switches insulin brands for linked pens, a note to that effect can be included in the "Daily Log" report 700 for the day the switch occurred. The note displayed when switching insulin brands can include the old and new insulin brand names.Additionally, the updated insulin brand name may be displayed in subsequent text adjacent to the glucose trend graph 702. In other embodiments, the "Daily Log" report 700 may also include the insulin brand name, for example, in the legend 730.

[0124] "Notes" rows 710a-710c may also be included in the "Daily Log" report 700. Notes may contain text that adds information about the event. The text may appear in the "Notes" row at the location corresponding to the time the note was logged.

[0125] 11A-11D illustrate an exemplary embodiment of a "Daily Pattern" report GUI 770. The "Daily Pattern" report 770 includes a user's ambulatory glucose profile 772, a section 774 showing carbohydrate consumption by time of day, and sections 778a, 778b showing insulin doses by insulin type. The "Daily Pattern" report 770 shows a graphical representation of a single day or 24-hour period, with glucose measurements organized by time over a multi-day period 771, e.g., 14 days (see FIG. 11B) or 28 days (see FIG. 11C). Glucose measurements can be displayed as individual points or averaged with a gradient pattern showing the density of measurements within a particular range. The ambulatory glucose profile 772 can include a representation of the user's target glucose range, a median value over time represented by a mean or median line, and lines representing the 10th, 25th, 75th, and 90th percentiles. The "Daily Pattern" report 770 may also include a display of daily average glucose values 785. Above the ambulatory glucose profile 772, a line 773 listing average glucose values for each time period may be displayed. The time periods may be about two hours, or about three hours, or about four hours in duration. Notable glucose values (e.g., the highest average glucose values) may also be highlighted in different colors to help the user easily identify which time periods had the highest glucose values.

[0126] In addition to glucose measurements, the "Daily Pattern" report 770 may also include other daily average information, such as daily carbohydrate average 790, daily rapid-acting insulin average 802, and daily long-acting insulin average 804. The carbohydrate consumption by time of day section 774 may include the average daily carbohydrate intake 790 and a graph of time (x-axis) versus carbohydrate amount (y-axis in grams). The graph may include an icon (e.g., an apple icon) indicating carbohydrate consumption by time of day. The total amount of carbohydrates consumed during a particular time period 794 may then be listed at the top of the graph, along with the number of meals or snacks consumed during that time period (e.g., in parentheses).

[0127] The "Daily Pattern" report 770's sections 778a, 778b showing insulin doses by insulin type may include one row for each type of insulin administered via the associated medication delivery device 152, e.g., an upper row 778a for rapid-acting insulin and a lower row 778b for long-acting insulin. The "Insulin" rows 778a, 778b may include, for each insulin type (rapid-acting or fast-acting 802 (including "other insulin") and long-acting 804), an icon representing the insulin type, average daily doses 803, 805, average doses for each time period, and the number of entries for that time period (shown in parentheses) 810. Optionally, the brand name of the insulin may also be included. As with other embodiments described herein, a light green syringe icon may be used to indicate an insulin pen filled with fast-acting insulin, and a dark green syringe icon may be used to indicate an insulin pen filled with long-acting insulin. The data source field 812 can include the name of the device that provided the test substance data value, the name of the first linked insulin pen, and the number of other linked devices (e.g., other insulin pens) that are integrated into the data.

[0128] In some embodiments where only one insulin pen is connected, only one insulin dose row 778 may be displayed, along with a corresponding icon (e.g., a light green syringe icon for a rapid-acting insulin pen) and the brand or type of insulin delivered. If only one insulin pen is connected, the data source field 812 may include only the name of the device that provided the analyte data value and the name of the connected insulin pen, and no numbers to indicate other connected devices.

[0129] In some embodiments, insulin doses can be entered into a monitoring or reporting application. If insulin doses were entered manually, the "Daily Pattern" report 770 can include the doses of rapid-acting and long-acting insulin, but without listing the brand name of the insulin near each icon. In some embodiments, administration information can be automatically transferred from an associated delivery device. The data source field 812 can include the name of the device providing the analyte data values and the number of other glucose monitoring devices integrated into the data, but can omit the name of the individual insulin pen. The number of units administered per day by insulin type and the average total daily insulin dose (units / day) can also be displayed. In other embodiments, the "Daily Pattern" report 770 can include the brand name of the insulin, for example, in a legend.

[0130] The "Daily Pattern" report GUI 1700 may also be available on the display device 120 via an application, such as a monitoring application or a report generation application. As seen in FIG. 11D , the "Daily Pattern" report GUI 1700 may include the user's ambulatory glucose profile 772, the time period (multiple day period) or number of days 771 currently displayed in the GUI 1700, an insulin summary section 1778, and other time periods 1774a-1774d that can be selected to display instead of the current time period. The ambulatory glucose profile 772 is described in detail in the descriptions of other embodiments and reports. The ambulatory glucose profile 772 may also indicate the number of days during the time period 771 for which glucose data was available. The ambulatory glucose profile 772 may also include a syringe above or below the graph to indicate the time of administration. Alternatively, the dose may be displayed graphically along a median line of the ambulatory glucose profile, indicating when the dose was administered. The insulin summary section 1778 can include a graph showing the amount of insulin administered during the time period 771. In some embodiments, this graph can be a bar graph of the average number of insulin units administered versus time (x-axis). The graph can include both rapid-acting insulin doses and basal doses. The insulin summary section can also indicate the number of days during the time period 771 for which administration data was available. The x-axis (time) of the graph in the insulin summary section 1778 can be aligned with the x-axis (time) of the ambulatory glucose profile 772, and the average dose and basal dose per meal can be plotted at the respective average administration times. Each average administration time is the average over the time period 771 of the times administrations were administered. Thus, the user can easily see the correlation between the insulin administration and the glucose profile for each associated time period for each insulin administration.The GUI 1700 may also include tabs 1774a-1774d with various time periods that a user can select for displaying the "Intra-Day Pattern" report. For example, the time period tabs 1774a-1774d may be 1 day, 7 days, 14 days, 30 days, or 90 days.

[0131] Alternatively, as seen in GUI 1720 of FIG. 11D , the user can select a time period in a drop-down menu 1775. In such a case, GUI 1700 can include a date range 1775, and the user can scroll forward or backward in time by tapping the forward or backward caret icons. In some embodiments, if the user selects “1 Day” as the time period, a daily graph can be displayed showing glucose and insulin data for the selected individual day. The daily graph can display the glucose profile for that day instead of the ambulatory glucose profile, while also highlighting the user’s target range. This glucose profile graph can also include a syringe icon above or below the graph to indicate the time of insulin administration. Alternatively, doses can be plotted along the median line of the glucose profile, indicating when they were administered. The insulin summary section can display a graph showing the amount of insulin administered that day (rather than the average number of doses over a multi-day period). In some embodiments, this graph can be a bar graph of the number of insulin units administered versus time (x-axis). The graph can include both rapid-acting insulin doses and basal doses. The x-axis (time) of the graph in the insulin summary section can be aligned with the x-axis (time) of the glucose profile, allowing for a graph showing meal doses and basal doses at their respective administration times. Therefore, each bar in the bar graph and the syringe icon in the glucose profile graph would be aligned at the same time.

[0132] If the user requests more information (e.g., by tapping the "i" icon), window 1800, as shown in FIG. 11E, can be displayed. Window 1800 includes a description 1806 that the "Daily Pattern" report shows the user's glucose and insulin patterns over a period of time. Window 1800 can also include a target range (e.g., 70-180 mg / dL). The user can also select the type of insulin data they want to view (either rapid-acting 1802 or long-acting 1804).

[0133] 28A-28D illustrate an exemplary embodiment of a report GUI 2000 of another analyte monitoring system that includes information about multiple types of insulin administered in a "Daily View" report GUI 2000. According to one aspect of these embodiments, the "Daily View" report GUI 2000 can include glucose profiles 2010a-2010g, "Time in Range" metrics 2012a-2012g, total rapid-acting insulin administered items 2014a-2014g, total long-acting insulin administered items 2016a-2016g, and total carbohydrates ingested items 2018a-2018g for each day in a time period 2002. The time period 2002 can be a week or several weeks, such as 7 days, 14 days, 21 days, 28 days, 32 days, 36 days, etc. 28A and 28B show an example of the first page (screen) of report 2000, which includes graphs and information for the first seven days of the period. The "Daily View" report GUI 2000 can also list the hours 2020 that the sensor was active during the period, the average number of scans / views per day during the period 2022, a legend 2024 of the symbols used in report 2000, and the source 2026 of the data used in report 2000.

[0134] The glucose profiles 2010a-2010g may include the user's glucose values over a 24-hour period. In some embodiments, the glucose profiles 2010a-2010g may optionally include a sensor usage indicator (e.g., a circle) 2066 to indicate that a scan, a view, or both occurred at a specific time during the 24-hour period. In some embodiments, the glucose values from the scan or view may be listed in the "Scan / View" section at the time of the scan or view. Each daily profile may represent the time from midnight to midnight for the date displayed in the same frame as the profile. Each profile may also display the day of the week in addition to the date. Each profile may also include an indicator of the target glucose range (e.g., a shaded area or lines indicating the upper and lower limits of the target range) to indicate which portion of each daily profile was within the target range 2056. Portions of the graph that fall outside the target range 2056 can be color-coded to further highlight readings (analyte values) that fall outside the target range 2056. The color-coding can correspond to colors used in other reports to represent "time in range" graphical representations. For example, portions of the graph with "high" levels (e.g., 181-250 mg / dL) that are above the target range 2056 can be color-coded yellow. Meanwhile, portions of the graph with "low" levels (e.g., 54-69 mg / dL) that are below the target range 2056 can be color-coded red. Furthermore, portions of the graph with "very low" levels (e.g., <54 mg / dL) can be color-coded dark red or maroon. Color-coding can include highlighting ranges of interest with corresponding colors, such as by painting the area under the curve (e.g., the area between the high, low, or very low threshold and the curve) a particular color or by changing the relevant portion of the graph to a particular color.

[0135] Optionally, the glucose profiles 2010a-2010g may also include event log marks, such as exercise event records 2064, carbohydrate intake log marks, insulin dose log marks, and glucose event marks, such as low glucose event marks, etc. The event log marks may be placed above or below the glucose graph at the time the event was logged.

[0136] As shown in FIGS. 28B-28E , in some embodiments, instead of including numbers in the glucose profiles 2010a-2010g, the report 2000 may include multiple rows of additional information below the glucose profiles 2010a-2010g, such as rows 2038a-2038e corresponding to "Carbohydrates Consumed," rows 2034a-2034e corresponding to "Rapid-Acting Insulin Received," and rows 2036a-2036e corresponding to "Long-Acting Insulin Received." The "Carbohydrates" row 2038 may include the amount of carbohydrates 2058 corresponding to the time the carbohydrates were logged. Similarly, the "Rapid-Acting" row 2034 may include the amount of fast-acting insulin administered 2060 below the time of administration. Similarly, the "Long-Acting Insulin" row 2036 may include the amount of long-acting insulin administered 2062 below the time of administration. In some embodiments where the administration data comes from an associated pen or an associated pen cap, report 2000 may include a "long acting insulin" row 2036. The color coding of these entries may be the same as the total carbohydrates field 2018, the total rapid acting insulin field 2014, and the total long acting insulin field 2016.

[0137] Additionally or alternatively, in some embodiments, the report 2000 may also include lines indicating "Scan / View" and "Notes." The "Scan / View" line may include notable glucose values at locations corresponding to the time the glucose value was recorded. For example, if an episode occurs in which the glucose value exceeds the target range 2056, the peak glucose value may be color-coded in a first color, such as orange, and if an episode of hypoglycemia occurs, the low glucose value may be color-coded in a second color, such as red. Optionally, notable glucose values may also be included in the glucose profiles 2010a-2010g.

[0138] Additionally or alternatively, in some embodiments where basal insulin is administered using an insulin pump, as shown in FIG. 28D , the report can include an insulin delivery graph 2042 above or below the glucose profile 2010, showing when and how much insulin was delivered, instead of the “long acting insulin” row 2036 showing individual doses. The insulin delivery graph 2042 can have time on the x-axis and units per hour on the y-axis. The time axis of the insulin delivery graph 2042 can be aligned with the time axis of the glucose profile 2010. If basal administration information is obtained from an insulin pump, the total long acting insulin administered field 2016 can include the name of the pump system and the percentage of time the pump was running. Note that FIG. 28D shows the entries for one day in the daily view report 2000.

[0139] Additionally or alternatively, in some embodiments where insulin was administered using an insulin pump, as seen in FIG. 28E , instead of the “long acting insulin” row 2036 showing individual doses, the report can include an insulin delivery graph 2044 above or below the glucose profile 2010 showing the amount of insulin delivered and the delivery mode of the insulin pump. In some embodiments, the insulin graph 2044 can have time on the x-axis and units per hour on the y-axis. The insulin graph 2044 can include a trace 2052 of the amount of insulin delivered, as well as time intervals 2046 when the pump was operating in automatic delivery mode, maximum delivery mode 2048, or automatic pause mode 2050, or time intervals when insulin was delivered manually 2054. If basal dosing information is obtained from an insulin pump, the total amount of long acting insulin administered field 2016 can include the name of the pump system and the percentage of time the pump was operating. FIG. 28E shows entries for one day in the daily display report 2000.

[0140] The "time in range" metric 2012a-2012g may be the percentage of time that was within the goal range 2056 for that day. The total amount of fast-acting insulin administered for each day 2014a-2014g can be determined from data automatically transferred from an associated medication delivery device 152, such as an associated pen, an associated pen cap, or an insulin pump. Alternatively, in some embodiments, the total amount of fast-acting insulin administered for each day 2014a-2014g can be determined from insulin doses manually logged by the user.

[0141] The total amount of long acting insulin administered for each day 2016a-2016g can be determined from data automatically transferred from an associated medication delivery device 152, such as an associated pen, associated cap, or insulin pump. Alternatively, in some embodiments, the total amount of long acting insulin administered for each day 2016a-2016g can be determined from insulin doses manually logged by the user.

[0142] The total carbohydrate intake items 2018a-2018g can be derived from carbohydrates manually logged by the user, or alternatively, the total carbohydrate intake items 2018a-2018g can be derived from logged meals and snacks by programmatically estimating the carbohydrate content of the meals and snacks.

[0143] 12A-12C illustrate an exemplary embodiment of a "Mealtime Patterns" report GUI 850. The "Mealtime Patterns" report 850 may include graphical and numerical representations of glucose level information for specific time periods that may be associated with meals: morning (breakfast, e.g., 6 AM - 10 AM), midday (lunch, e.g., 10 AM - 4 PM), afternoon (dinner, e.g., 4 PM - 10 PM), and evening (midnight snack, e.g., 10 PM - 6 AM). Vertical lines may also be displayed separating the hours before (pre-meal) 852 and the hours after (post-meal) 854 each meal. Further, the representation of such glucose level information may include numerical representations 858a-858d of glucose levels before a particular meal was consumed and numerical representations 860a-860d of glucose levels after a particular meal was consumed for each day within mealtime pattern period 856, as well as average pre-meal glucose values 859a-859d and average post-meal glucose values 861a-861d for that time period above the table. Additionally, the report may also include representations 864a-864d of the amount of carbohydrates ingested for each time period on each day within the mealtime pattern period, as well as average carbohydrate intake for each time period for the entire period 865a-865d.

[0144] The "Mealtime Pattern" report 850 can also include the amount of insulin administered. For example, column 862 can display the amount of insulin administered on each day within the mealtime pattern period 862a-862d, and the upper column of the table for that period can display the average insulin dose for that time period 863a-863d. 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.

[0145] The data source 874 may also be displayed to include the name of the device that provided the analyte data value, and may also display the name of the primary medication delivery device if the medication delivery device 152 is linked to an integrated management system. Optionally, the brand name of the insulin type administered may also be displayed in a legend 876 at the foot of the "Mealtime Patterns" report 850.

[0146] In some embodiments, insulin doses may be manually entered by a user or calculated using a dose calculator rather than transferred directly from an associated medication delivery device 152. The insulin doses may be entered into a monitoring or reporting application. If the insulin doses were manually entered, the "Mealtime Patterns" report 850 may include the dose of rapid-acting insulin 872, but may not include the brand name. In some embodiments, the administration information may be automatically transferred from an associated delivery device. The data source field 874 may include the name of the device providing the analyte data value and the number of other glucose measuring devices integrated into the data, but may not include the name of the individual insulin pen. Additionally, a legend 876, which may be located at the base of the "Mealtime Patterns" report 850, may not display the brand name of the insulin type administered. In this case, the legend 876 may not include the brand name of the insulin, but may simply list, for example, "rapid-acting." In other embodiments, the Mealtime Patterns report 850 may also include the brand name of the insulin, for example, in legend 876.

[0147] The "Mealtime Patterns" report 850 may also include multiple glucose value graphs 868a-868d for each time period: morning (breakfast, e.g., 6:00 AM - 10:00 AM), midday (lunch, e.g., 10:00 AM - 4:00 PM), afternoon (dinner, e.g., 4:00 PM - 10:00 PM), and evening (supper, e.g., 10:00 PM - 6:00 AM). Each graph 868a-868d may include a vertical line indicating the start of the meal, and may span a time period from approximately one hour before the start of the meal to approximately three hours after the start of the meal. The graphs may further include multiple data points on the vertical line representing multiple glucose values (listed in columns 858a-858d) scanned or recorded at or just before the start of the meal. Each graph may also highlight a glucose value (shown at the top of columns 858a-858d) that is an average of multiple glucose values scanned or recorded at or just before the start of the meal. Additionally, graphs 868a-868d may include data points representing post-meal glucose values, e.g., glucose values at least about two hours after the start of a meal (values listed in columns 860a-860d). Each graph may also highlight post-meal glucose values, e.g., averages of multiple glucose values at least about two hours after the start of a meal (values listed at the top of columns 860a-860d). Graphs 858a-858d may also highlight pre-meal target ranges, e.g., about 70 mg / dL to about 130 mg / dL, and post-meal target ranges, e.g., about 100 mg / dL to about 180 mg / dL, to enable a user to see at a glance whether a recorded glucose value is within or outside the target range.

[0148] 13A and 13B illustrate an exemplary embodiment of a "Device Details" report GUI 900. The "Device Details" report 900 can include glucose settings 910 for a primary glucose measuring device, insulin settings for a first associated insulin pen 930, and insulin settings for a second (or additional) associated insulin pen 940. The glucose settings 910 can include a target range (e.g., 70-180 mg / dL) and alarm settings for low glucose (e.g., 70 mg / dL), high glucose (e.g., 240 mg / dL), and signal loss. The target range, including low and high thresholds, can be set from the monitoring application or the reader. Optionally, the glucose settings 910 can also include calculator settings and notification features. The "Device Details" report 900 can also include detailed information 916 about a primary glucose measuring device that receives analyte values or data indicative of analyte values from the sensor control device 102. Such details 916 may include the name of the device (and an icon associated with the device), the current software version of the device, the current operating system version, and the model of the smartphone running the associated application. If the sensor control device 102 is being used in combination with a reader or metering device, the device details 916 may include the serial number of the reader or metering device.

[0149] The "Device Details" report 900 can also include detailed information about any linked medication delivery devices 152 (e.g., linked insulin pens). Linked medication delivery devices 152 can be listed under the primary glucose measurement device. If more than one medication delivery device is linked, each device can be displayed separately. The insulin pen settings 930, 940 can include the type of insulin, the last scan (e.g., the date and timestamp of the last insulin value), and the pen color for each linked medication delivery device. Optionally, the insulin pen settings 930, 940 can also include calculator settings, notes, and notifications. The "Device Details" report 900 can also include detailed information 935, 945 about the insulin pen near each insulin pen setting 930, 940. The detailed information 935, 945 can include a color icon or illustration of the insulin pen, the brand name or insulin type of the insulin pen, and the serial number.

[0150] 14 illustrates an exemplary embodiment of an AGP report GUI 950. The AGP report 950 may include a "Glucose Statistics and Goals" section 952, a "Time in Range" section 954, the user's ambulatory glucose profile 956, and a "Daily Glucose Profile" section 958. The AGP report 950 may show various statistics and graphs for a multi-day period 960 (e.g., 14 or 28 days). Additionally, an information source 962 may be listed, which may include the name (e.g., brand name) of the primary glucose measuring device, the name (e.g., brand name) of any associated primary pens, and the number of other devices.

[0151] The "Glucose Statistics and Targets" (or "Glucose Metrics") section 952 may include one or more metrics, which may include any one or more of the following: a multi-day reporting period for the statistics, the length of time the sensor was active (reported as a percentage), the length of time the detected analyte value was within various ranges (reported as a percentage), the average glucose value, the glucose management index (GMI), and the variability of the glucose values. The length of time within the various ranges may include the length of time within the target range (e.g., 70-180 mg / dL), the length of time below a lower threshold (e.g., below 70 mg / dL), the length of time below a lower threshold (e.g., below 54 mg / dL), the length of time above a higher threshold (e.g., above 180 mg / dL), and the length of time above a higher threshold (e.g., above 250 mg / dL).

[0152] The "Time-in-Range" section 954 can include multiple "Time-in-Ranges" (Time-in-Range, Time-in-Target) GUIs. Each "Time-in-Range" GUI includes multiple bars or multiple rectangular segments making up a bar, each of which correlates to a predefined analyte range and indicates the amount of time the user's analyte value is within that analyte range. In some embodiments, for example, the amount of time within the analyte range can be expressed as a percentage of the predefined amount of time. The "Time-in-Range" GUI section 954 can include a bar made up of up to five rectangular segments. The rectangles include (from top to bottom): a first rectangle indicating a portion of the predefined length of time during which the user's glucose range is "very high" (i.e., above 250 mg / dL); a second rectangle indicating a portion of the predefined length of time during which the user's glucose range is "high" (i.e., between 180 and 250 mg / dL); a third rectangle indicating a portion of the predefined length of time during which the user's glucose range is within the "target range" (i.e., between 70 and 180 mg / dL); a fourth rectangle indicating a portion of the predefined length of time during which the user's glucose range is "low" (i.e., between 54 and 69 mg / dL); and a fifth rectangle indicating a portion of the predefined length of time during which the user's glucose range is "very low" (i.e., below 54 mg / dL). The "Time Within Range" GUI 954 may display text next to each rectangular portion indicating the actual length of time (eg, in hours and / or minutes).

[0153] According to one aspect of the embodiment shown in FIG. 14 , each of the squares in the “Time in Range” GUI 954 may be a different color. In some embodiments, the ranges represented by adjacent squares may be indicated by dashed or dotted lines separating the squares, by numerical scale marks, or both. In some embodiments, the “Time in Range” represented by the squares may be further represented as a percentage, an actual amount of time (e.g., 4 hours and 19 minutes), or both. Furthermore, one skilled in the art will recognize that the percentage of time associated with each square may vary depending on the user's analyte data. In some embodiments of the “Time in Range” GUI 954, a target range may be set by the user. In other embodiments, the target range of the “Time in Range” GUI 954 may not be changed by the user.

[0154] The AGP report 950 may also include an AGP column 956 similar to the AGP graph 511. The AGP graph may display percentiles of hourly glucose readings for a "typical" day based on all days within the selected time frame. The percentiles of glucose readings are presented as the 5th, 25th, 50th (median), 75th, and 95th percentiles. The AGP graph may also include two horizontal lines. These lines represent the upper and lower limits of the target range defined in the "Glucose Statistics and Targets" column 952 and the "Time in Range" column 954. For example, one line may correspond to the lower limit of the target range (e.g., 70 mg / dL) and the second line may correspond to the upper limit of the target range (e.g., 250 mg / dL). The first and second lines may also be color-coded to correspond to the same color (e.g., green) as the target range rectangle in the "Time in Range" column 954. Additionally, data points or graph sections within each concentration range in the AGP can be color-coded to correspond to the same color as each rectangle in the "Time in Range" column (954). For example, AGP data points or graph sections within the target range can be colored green, AGP data points or graph sections within the high concentration range can be colored orange, AGP data points or graph sections within the low concentration range can be colored red, and AGP data points or graph sections within the very low concentration range can be colored dark red or maroon. In this way, the AGP graph can clearly indicate the length of time within the target range (or the number of readings within the target range).

[0155] 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 through 958-14, one for each day in the time period 960. Each daily profile may represent the time period from midnight to midnight of the following day displayed in the same frame as the profile. Each profile may also display the day of the week in addition to the date. Each profile may also include a target glucose range indicator (e.g., a shaded area or lines indicating the upper and lower limits of the target range) to indicate which portions of each daily profile were within the target range. Readings (analyte values) that fall outside the target range may be color-coded to more clearly indicate these readings. The color coding may correspond to the colors used in the "Time in Range" column 954. For example, portions of the graph with "high" levels (e.g., 181-250 mg / dL) that are above the target range may be color-coded yellow. Meanwhile, portions of the graph with "low" levels (e.g., 54-69 mg / dL) that are below the target range can be color-coded red. Additionally, portions of the graph with "very low" levels (e.g., <54 mg / dL) can be color-coded dark red or maroon. Color-coding can include highlighting the range of interest with a corresponding color, such as by painting the area under the curve (e.g., the area between the high, low, or very low threshold and the curve) a particular color or by changing that portion of the graph to a particular color.

[0156] 19 illustrates an exemplary embodiment of a “Comparison” report GUI 1020. The “Comparison” report 1020 may include two sections: a section 1022a displaying metrics for a first time period 1024a and a section 1022b displaying metrics for a second time period 1024b. To facilitate analysis and comparison between different time periods, the metrics for the first time period 1024a and the second time period 1024b may be displayed side-by-side. The sections of the “Comparison” report 1020 may include “Glucose Metrics” sections 1026a, 1026b, “Time in Range” sections 1028a, 1028b, “Ambulatory Glucose Profile” sections 1030a, 1030b, and “Low Glucose Events” sections 1032a, 1032b. The “Comparison” report 1020 displays various statistics and graphs for two time periods (e.g., 14 days each). In some embodiments, a banner may be displayed, for example in the header, to notify viewers when a glucose threshold adjustment has been made.

[0157] The "Compare" report GUI 1020 can include multi-day report aggregation periods 1024a, 1024b for various metrics, as well as the length of time the sensor was active (expressed in the report as a percentage) 1034a, 1034b.

[0158] The "Glucose Metrics" sections 1026a, 1026b may include, for example, average glucose values, glucose management index (GMI), and glucose value variability.

[0159] The "Time in Range" sections 1028a, 1028b can include multiple graphical representations of time-in-ranges (time-in-range, time-in-target). Each graphical representation of time-in-ranges includes multiple bars or multiple rectangular segments making up a single bar, each of which correlates to a predefined analyte range and indicates the length of time the user's analyte value was within that analyte range. In some embodiments, for example, the length of time within the analyte range can be expressed as a percentage of the predefined length of time. Each of the time-in-range graphs 1028a, 1028b can include a bar made up of multiple rectangular segments stacked one on top of the other. In some embodiments, the graph can include five rectangular segments. The rectangular portions include a first rectangular portion indicating the length of time during which the user's glucose range was "very high" (i.e., above 250 mg / dL); a second rectangular portion indicating the length of time during which the user's glucose range was "high" (i.e., between 180 and 250 mg / dL); a third rectangular portion indicating the length of time during which the user's glucose range was within the "target range" (i.e., between 70 and 180 mg / dL); a fourth rectangular portion indicating the length of time during which the user's glucose range was "low" (i.e., between 54 and 69 mg / dL); and a fifth rectangular portion indicating the length of time during which the user's glucose range was "very low" (i.e., below 54 mg / dL). Optionally, each of the time within range graphs 1028a, 1028b may also display text next to each rectangular portion indicating the actual length of time (e.g., in hours and / or minutes). In some embodiments, the "time within range" indicated by the rectangular portion may be further expressed as a percentage, an actual length of time (e.g., 4 hours and 19 minutes), or both.Additionally, one skilled in the art will recognize that the percentage of time associated with each rectangle may vary depending on the user's analyte data.

[0160] According to one aspect of the embodiment shown in FIG. 19 , the rectangles in the graphs 1028a, 1028b representing time within a range can be different colors. In some embodiments, the ranges represented by adjacent rectangles can be indicated by dashed or dotted lines separating the rectangles, by numerical scales, or both. In some embodiments, "Very High" can be orange, "High" can be yellow, "Target Range" can be green, "Low" can be red, and "Very Low" can be dark red or maroon. This color scheme can be replicated in other portions of the "Comparison" report 1020, such as the "Ambulatory Glucose Profile" sections 1030a, 1030b and the "Low Glucose Events" sections 1032a, 1032b. For example, the analyte values displayed in the graphs in the "Ambulatory Glucose Profile" sections 1030a, 1030b and the "Low Glucose Events" sections 1032a, 1032b can be color-coded according to the concentration range within which the analyte values fall. For example, an analyte value of 156 mg / dL may be colored green in the ambulatory glucose profile, and an analyte value of 48 mg / dL may be colored dark red or maroon in the ambulatory glucose profile or low glucose event graph. In some embodiments of the "Time in Range" graphs 1028a, 1028b, the target ranges may be user-configurable. In other embodiments, the target ranges in the "Time in Range" GUIs 1028a, 1028b may not be user-configurable.

[0161] Sections 1022a, 1022b of the "Comparison" report 1020 may also include AGP columns 1030a, 1030b similar to the AGP graph 511 displayed in FIGS. 8A-8C. The AGP graph may display percentiles of hourly glucose readings for a "typical" day based on all days within the selected time frame. Percentiles of glucose readings are presented: 5th, 25th, 50th (median), 75th, and 95th percentiles. The AGP graph may also include two horizontal lines that indicate the upper and lower limits of the target range defined in the "Glucose Statistics and Targets" columns 1026a, 1026b and the time-in-range graphs 1028a, 1028b. For example, a first line may correspond to the lower limit of the target range (e.g., 70 mg / dL) and a second line may correspond to the upper limit of the target range (e.g., 250 mg / dL). The first and second lines may also be color-coded to correspond to the same color (e.g., green) as the target range rectangles in the "Time in Range" columns 1028a and 1028b. The same color coding as in the "Time in Range" GUIs 1028a, 1028b can be used for the AGP graph, with glucose values in the "Very High" range (e.g., above 250 mg / dL) colored orange, glucose values in the "High" range (e.g., between 180 mg / dL and 250 mg / dL) colored yellow, glucose values in the "Target Range" (e.g., between 70 mg / dL and 180 mg / dL) colored green, glucose values in the "Low" range (e.g., between 54 mg / dL and 70 mg / dL) colored red, and glucose values in the "Very Low" range (e.g., below 54 mg / dL) colored dark red or maroon. In this way, the AGP graph can clearly indicate 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, 1024b.

[0162] Sections 1022a, 1022b of the "Comparison" report 1020 may also include "Low Glucose Events" sections 1032a, 1032b. Each "Low Glucose Events" section 1032a, 1032b may include a graph of events in which the subject's glucose level fell below a low threshold (e.g., 70 mg / dL) and / or a very low threshold (e.g., 54 mg / dL). Each graph may also include lines indicating the low threshold (e.g., 70 mg / dL) and the very low threshold (e.g., 54 mg / dL). The graphs in this section may be plotted as glucose concentration (mg / dL) versus time to indicate at a glance when low glucose events occurred. As described above, the same color coding as in the "Time in Range" GUIs 1028a, 1028b can be used for the glucose value graphs in the "Low Glucose Events" sections 1032a, 1032b, with glucose values between the low and very low thresholds (e.g., 54 mg / dL to 70 mg / dL) colored red and glucose values below the very low threshold (e.g., less than 54 mg / dL) colored dark red or maroon. The color coding can include highlighting the range of interest with a corresponding color, such as by painting the area under the curve or by changing that portion of the graph to a particular color. The "Low Glucose Events" sections 1032a, 1032b can also include metrics, statistics, or both related to the low glucose events. In some embodiments, the low glucose event metric sections 1032a, 1032b can include the number of low glucose events and, optionally, the average duration of the low glucose events.

[0163] 15A and 15B illustrate an exemplary embodiment of a GUI associated with a patient dashboard 970. The dashboard 970 allows a user to view comprehensive insulin data that integrates insulin data from different sources (e.g., linked pens, manual entry, etc.). The user can select various columns to include in the patient dashboard display, such as average rapid-acting insulin dose per day (units), average long-acting insulin dose per day (units), average total insulin dose per day (units), etc. Other parameters that may be displayed on the patient dashboard include average glucose value (mmol / L), average duration of sensor-sensed low glucose events (minutes), % below target, % in target range, % above target, low glucose events, standard deviation (mmol / L), estimated A1c (%), and estimated A1c (mmol / mol).

[0164] 16A and 16B illustrate an exemplary embodiment of a GUI for a data source modal 980 for linked pens. In the modal 980, a user can use a show / hide icon 982 to select which linked pens to include in the report. By default, the report can be set to display all linked pens that contributed data during the report collection period. The modal 980 can display each linked pen by device. Linked devices can be displayed in order by last upload date 986, which is the date of the last insulin timestamp. The device (insulin pen) entry can include the insulin pen brand name, insulin pen serial number, and an image of the insulin pen. The pen image can be positioned above the brand name. The modal 980 can also display an estimated device time 988. If the estimated device time 988 is unknown or is the same as the time of the upload using that device, the estimated device time 988 can be left blank. Insulin data capture dates 990 for the 90 days prior to the last report compilation date may be displayed in a different color, such as green, to distinguish them from glucose-related data. Using this GUI, a user, such as a healthcare professional, may specify the data sources to include in any of the reports described herein.

[0165] 17A and 17B illustrate an exemplary alert 1002, e.g., a toast alert, for providing information about linked pens. The alert 1002 may not pop up but may instead be displayed as a timed box in a non-obtrusive portion of the screen, e.g., the lower right corner. The alert 1002 may be displayed for approximately one minute or until the user dismisses the alert 1002 if the report includes insulin pen data. The alert 1002 may display the number 1004 of all data sources (including both glucose and insulin data sources) and the number 1006 of linked insulin pens. The alert 1002 may be hidden if the report only integrates glucose measurement devices and no linked insulin delivery devices. The alert 1002 may indicate that the report data may not include data from all devices. The report may also include only insulin data from linked pens.

[0166] 24A-24C illustrate an exemplary embodiment of an "Insulin Summary" report GUI 1840. The "Insulin Summary" report GUI 1840 may also include tabs 1842a-1842d with various time periods that the user can select for displaying the "Daily Pattern" 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 currently displayed date range 1844, a graphical representation of total doses by day 1848, and a legend 1846 for the graphical representation 1848. The graphical representation 1848 may be a bar graph with time on the x-axis and total units administered on the y-axis. The graphical representation may include both rapid-acting and long-acting doses. If the selected time period is 14 days 1842b, the x-axis units may be "days," with one bar representing each day, showing the total amount of rapid-acting and ultra-rapid-acting insulin administered on that day. In some embodiments, the user may tap to select a day's entry, which may cause a window to appear showing details about that day (e.g., the total number of units of rapid-acting and ultra-rapid-acting insulin administered that day).

[0167] In some embodiments, a user can access the "Daily Insulin" report GUI 1860 for a day by tapping the "Details" window for that day or by selecting the Daily Insulin Report from the menu. As seen in FIG. 24B , the "Daily Insulin" GUI 1850 can display the date 1854 of the data displayed in the graphical representation 1858, with "1 Day" 1842a selected as the display time period. The graphical representation 1858 can be a bar graph with time on the x-axis and total units administered on the y-axis, with each dose indicated by its time position. The graphical representation can include both rapid-acting and long-acting doses. The GUI 1850 can include the total amount of each insulin type injected for that day 1854 in the legend 1856 below the symbol or color indicating the rapid-acting or long-acting insulin.

[0168] 24C illustrates an example embodiment of an "Insulin Usage" report GUI 1870 summarizing insulin usage for 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. The GUI 1870 can display the currently displayed "Insulin Usage" date range 1872. If the selected date range 1872 is more than one day, the GUI 1870 can also display the average total dose per day 1874, the average total rapid-acting dose per day 1876, and the average total long-acting dose per day 1878 for that date range 1872.

[0169] 18A-18D illustrate an exemplary embodiment of a "Profile Comparison" report GUI. Utilizing administration data from an associated medication delivery device and glucose data from a continuous glucose monitor as input, in many embodiments, a GUI or report can be generated that includes multiple glucose profiles over a selected time period. As seen in FIGS. 18A and 18B, in some embodiments, the GUI or report can include multiple versions of the glucose profile 1010, 1012, 1014 over the selected time period. The number of versions can be two, more than two, three, or more than three.

[0170] In some embodiments, each glucose profile 1010, 1012, 1014 can be an ambulatory glucose profile (AGP) graph or part of an AGP. As discussed in the discussion of the exemplary diagram of FIG. 14, the AGP can display percentiles of hourly glucose readings for a "typical" 24-hour day based on all days within a selected time frame. Percentiles of glucose readings are presented at the 5th, 25th, 50th (median), 75th, and 95th percentiles. Alternatively, the AGP can display percentiles of hourly glucose readings for a "typical" 24-hour day based on all days within a selected time frame: the 10th, 25th, 50th (median), 75th, and 90th percentiles. The AGP graph can also include two horizontal lines indicating the upper and lower limits of the target range. For example, a first line can correspond to the lower limit of the target range (e.g., 70 mg / dL) and a second line can correspond to the upper limit of the target range (e.g., 180 mg / dL). The first and second lines can also be color-coded. The colors can correspond to the same colors used in other reports described herein, such as the same color (e.g., green) used for the target range rectangle in the "Time in Range" column 954. In this way, the AGP graph can clearly indicate the amount of time spent within the target range (or the number of readings within the target range). Other exemplary AGP graphs can be found in U.S. Patent Application Publication Nos. 2018 / 0235524, 2014 / 0188400, 2014 / 0350369, and 2018 / 0226150. The entire disclosures of the above patents are expressly incorporated herein by reference for all purposes.

[0171] In other embodiments, the glucose profile can be a single graph or chart plotting multiple days of daily trajectories. In some embodiments, the glucose profile can be a single graph or chart plotting multiple days of daily trajectories and can be converted to AGP. In some embodiments, the multiple graphs can be any type of representation of glucose data, such as overlaid daily modals or time series plots. The graphs can also present or be based on other time-based analyte data associated with the patient, such as insulin administration events, insulin delivery data, or meal event data. Note that while graphs based on glucose data are described as exemplary graphs, any patient data can be represented in these exemplary formats.

[0172] The GUI or report may include a time filter that allows the user to define the time period over which the multiple glucose profiles 1010, 1012, 1014 will be analyzed and displayed. This time period may be the last seven days, or the last two weeks, or the last month, or the last two months, or the last three months, or the last six months, or the last nine months, or the last year.

[0173] A first profile 1010 of the multiple glucose profiles may display all glucose measurements for a selected time period. See, for example, FIG. 18C. The first profile 1010 may represent all glucose measurements in a set of glucose measurements. The set of glucose measurements may include measurements taken after administration of a glucose level-regulating medication, measurements taken after a missed dose of a glucose level-regulating medication, and measurements taken after a program or application did not receive administration information.

[0174] A second profile 1012 of the multiple glucose profiles may display only specific data associated with a glucose-lowering drug for a selected time period. See, for example, FIG. 18D . This specific data may include only glucose measurements taken within a certain time range after (or associated with) administration of a glucose-lowering drug. The specific data associated with administration of a glucose-lowering drug may include glucose data (glucose measurements) obtained within a specified time range by defining a fixed time. If administration of a glucose-lowering drug is associated with a specific time range, glucose data for that time range may be included. The time range associated with a certain administration event may not be a time range immediately after the administration event. In some embodiments, the time range may be a fixed time period. For example, glucose values for a fixed time range may be included only if administration of a rapid-acting insulin was performed within that fixed time range (e.g., from approximately 7:00 AM to approximately 12:00 AM). The length of the fixed time range may be related to the therapeutic time range of the administered drug type. For example, the fixed time window for the administration of basal or long-acting insulins can be 24 hours, and the fixed time window for rapid-acting insulins can be 5 hours. In other embodiments, the time window can be a variable time window. In this case, the variable time window can begin with the glucose value obtained most recently after the administration timestamp or the logged administration time and extend by the therapeutic time window of the administered drug. For example, the therapeutic time window can be approximately 5 hours for rapid-acting insulins and approximately 24 hours for long-acting insulins. The administration of glucose-level-modifying drugs can be delivered by an associated drug delivery device. In other embodiments, the drug delivery device can be unlinked and the dosage can be logged by the user. The drug administration record can be obtained by the associated drug delivery device or by other means, such as manually entering drug administration events.The specific data for the second glucose profile 1012 can exclude glucose measurements in a time range after a missed dose or measurements in a time range not associated with a drug administration. A tranche of glucose measurements after a missed dose, such as glucose measurements in a time range after a missed dose or measurements in a time range not associated with a drug administration, can also be extracted from a data set including all glucose measurements for a selected period, and the remaining glucose measurements can be used to generate the second glucose profile 1012 of the multiple glucose profiles. Thus, the second glucose profile 1012 of the multiple glucose profiles can reflect the user's blood glucose levels when the user remembers to administer a dose. Comparing FIG. 18D with FIG. 18C shows that the spread (variability) of data in the AGP graph for the profile with insulin administration (FIG. 18D) is much smaller than the spread (variability) of data in the AGP for the profile including all data (including data after the missed dose).

[0175] The third profile 1014 of the plurality of glucose profiles may display only specific data for a selected period of time when a glucose-level-regulating medication was not administered (e.g., by the user or a caregiver). This specific data may be displayed in the third profile 1014 of the plurality of glucose profiles and may include only glucose measurements taken in a time period after the missed dose. The third profile 1014 of the plurality of glucose profiles may include data that was tranched from the entire data set when the second profile 1014 of the plurality of glucose profiles was generated. The length of the post-missed dose glucose measurement portion (tranche) may vary depending on the type and characteristics of the glucose-level-regulating medication. The glucose measurements displayed in the third profile 1014 may be higher (e.g., have a higher median), have greater variability, or both, compared to the second profile 1014 and the first profile 1014 because they are measured when the user is not present with a medication to assist in glucose control. Therefore, the glucose values associated with the missed dose may be elevated. Furthermore, when all glucose data is aggregated and graphed, high glucose values due to missed doses may mask low glucose events following drug administration. Glucose profiles (e.g., reference number 1012) that display only data from the time period after a glucose-lowering medication is administered may more directly reveal the effect of the administered medication on blood glucose levels, potentially allowing trained medical personnel to adjust the current medication regimen. Profiles (e.g., reference number 1014) that reveal glucose values following missed doses may more directly reveal the impact of poor concordance of medication administration on a subject's blood glucose levels.

[0176] Therefore, the first profile 1010, which displays glucose values without data removal, and the third profile 1014, which displays glucose values measured after a missed dose, are expected to have higher glucose measurements (e.g., a higher median), greater variability, or both, compared to the second profile 1012, which displays glucose values measured after a glucose-lowering medication is administered.

[0177] In some embodiments, multiple glucose profiles can be presented in a side-by-side display. Side-by-side display can be side-by-side (e.g., three graphs in the same row, as seen in FIG. 18A ) or side-by-side (e.g., three graphs stacked in the same column, as seen in FIG. 18B ), allowing a healthcare professional to easily and quickly identify differences between graph trajectories. In some embodiments, a glucose profile can be displayed with other glucose profiles overlaid as transparent layers in a single plot. In other embodiments, problem areas in a glucose profile can be highlighted to clearly indicate poor concordance of medication administration or how a current dosing regimen is affecting glucose results. Note that multiple profiles can be presented in any order or spatial arrangement.

[0178] The data from the associated drug delivery device may also include a dose timestamp. If the data from the associated drug delivery device does not provide a dose to a program that creates a glucose profile, the program can infer that the user did not take a regularly scheduled dose, i.e., missed a dose. In the event of a missed dose, a predefined portion (tranche) of glucose data can be removed from the dataset containing all glucose measurements (which can be used to create a first glucose profile 1010), leaving only glucose data that can be associated with the administered medication (which can be used to create a second glucose profile 1012). The removed portion (tranche) can then be used to create a third glucose profile 1014.

[0179] The length of each tranche of glucose data (or the length of the time window from which data is truncated) can vary depending on the pharmacokinetic and pharmacodynamic profiles of the user's medications. For example, if a user takes a once-daily basal insulin injection on Monday but forgets to take it on Tuesday, data from the linked drug delivery device would show Monday's administration timestamp but not Tuesday's administration timestamp. Thus, Monday's glucose data can be included in the data generating the second glucose profile 1012, while Tuesday's glucose data can be excluded from the data displayed in the second glucose profile. However, Tuesday's data can be used in generating the third glucose profile 1014. In this example, a long-acting basal insulin has a pharmacodynamic glucose-lowering duration of action of approximately 24 hours, so one day's worth of glucose data can be omitted. On the other hand, if a user forgets to take a mealtime dose of rapid-acting insulin, a smaller tranche of glucose data can be truncated from the data generating the second glucose profile and used to generate the third glucose profile. This is because rapid-acting insulin has a pharmacodynamic glucose-lowering duration of action of approximately 6 hours.

[0180] In some embodiments, the plurality of graphs can include at least two graphs, or at least three graphs, or at least four graphs, or at least five graphs, or at least six graphs, or at least seven graphs, or at least eight graphs. Each of the plurality of graphs can display a different data set. In some embodiments, five graphs can be generated, displayed, or both, if a person's treatment plan includes both basal and bolus insulin doses. A first graph may display (present) all glucose measurements over a period of time, a second graph may include glucose measurements taken after administration of (one or more) basal insulin doses or in a time range associated with (one or more) basal insulin doses, a third graph may include glucose measurements taken after missed administration of (one or more) basal insulin doses or in a time range associated with missed administration of (one or more) basal insulin doses, a fourth graph may include glucose measurements taken after administration of (one or more) bolus insulin doses or in a time range associated with missed administration of (one or more) bolus insulin doses, and a fifth graph may include glucose measurements taken after missed administration of (one or more) bolus insulin doses or in a time range associated with missed administration of (one or more) bolus insulin doses.

[0181] The glucose-lowering drug may be either a glucose-lowering drug or a glucose-elevating drug. While the embodiments described herein relate to glucose-lowering drugs such as insulin, it is believed that this framework can be generalized to glucose-elevating drugs such as glucagon. The glucose-lowering drug may be a type of insulin. The types of insulin include rapid-acting insulin, short-acting insulin, intermediate-acting insulin (e.g., NPH insulin), premixed insulin (e.g., premixed insulin), long-acting insulin, and ultra-long-acting insulin. While examples are provided herein relating to insulin administration, the methodology can be generalized to any glucose-lowering drug delivered from an associated drug delivery device and with a known glucose-lowering time. Such glucose-lowering drugs include, but are not limited to, SGLT2 inhibitors, GLP1 receptor agonists, biguanides (e.g., metformin), α-glucosidase inhibitors, thiazolidinediones, DPP4 inhibitors, and combinations thereof.

[0182] The length of the data portion (tranche) or time range that can be cut from the data after a missed dose of once-daily, long-acting, or basal insulin can be about 1 day, or about 20 to about 28 hours, or about 22 to about 40 hours, or about 20 to about 38 hours, or about 20 to about 36 hours.

[0183] The length of the data portion (tranche) or time range that can be trimmed from the data after a missed dose of rapid-acting insulin can be about 2 hours, 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 to about 7.0 hours, or about 3.0 hours to about 7.0 hours, or about 4.0 hours to about 7.0 hours after administration of the glucose-lowering drug. In some embodiments, the length of the data portion (tranche) or time range that can be trimmed from the data can be defined or determined by the drug, for example, the insulin action time of mealtime insulin. In some embodiments, the length of the data portion (tranche) or time range that can be trimmed from the data can be preset or estimated by the system. In other embodiments, the length of the data portion (tranche) or time range that can be trimmed from the data can be manually entered.

[0184] The length of the data portion (tranche) or time range that can be cut out from the data after a missed dose of intermediate-acting insulin can be about 12 hours, or about 8 to about 16 hours, or about 10 to about 14 hours.

[0185] The length of the data portion (tranche) or time range that can be cut out from the data after a missed dose of ultra-long acting insulin can be about 36 hours to about 42 hours, or about 32 hours to about 44 hours.

[0186] In some embodiments, a user can use filters to customize the GUI or report to display different data sets. This data can be used to explain various types of non-adherence. Specific data that can be selected for display using filters can include specific data for glucose-regulating drug administration at the recommended dose, specific data for glucose-regulating drug bolus underdose, and specific data for glucose-regulating drug bolus overdose over a selected time period. A graph showing specific data for glucose-regulating drug bolus underdose (i.e., glucose-regulating drug administration at a dose less than the recommended dose) over a selected time period, a graph showing specific data for glucose-regulating drug bolus overdose (i.e., glucose-regulating drug administration at a dose greater than the recommended dose) over a selected time period, or both, can be displayed in comparison with a graph showing specific data for glucose-regulating drug administration at the recommended dose over a selected time period to assist a healthcare professional in persuading a patient to adhere to the recommended dosing regimen and not change the dosage.

[0187] In some embodiments, the specific data that can be selected for display using a filter can include specific data regarding delayed prandial administration (i.e., administration administered a certain period of time after the start of a meal) during a selected time period. In some embodiments, delayed prandial administration or excessive prandial administration refers to administration administered at least one hour after a meal but not more than three hours after a meal. In some embodiments, the specific data that can be selected for display using a filter can include specific data regarding excessive prandial administration (i.e., administration of additional doses at mealtimes) during a selected time period. By displaying a graph showing specific data regarding administration of a glucose level-regulating drug a certain period of time after the start of a meal during a selected time period, a graph showing specific data regarding administration of an additional glucose level-regulating drug at mealtime during a selected time period, or both, a healthcare professional can be helped to alleviate a patient's anxiety about hypoglycemic events.

[0188] In addition to other methods described herein, non-adherence can also be determined to have occurred if an administration is performed outside of a predetermined time period. For example, non-adherence to basal administration can be determined to have occurred if a basal dose is missed or if the dose is administered at a time outside the prescribed administration time window. In some embodiments, the time window can be approximately 30 minutes, approximately 1 hour, or approximately 90 minutes after the prescribed administration time. In the case of bolus administration, time windows can be associated with each meal. For example, the time window associated with breakfast can be from approximately 6:00 AM to approximately 11:00 AM, the time window associated with lunch can be from approximately 11:00 AM to approximately 4:00 PM, and the time window associated with dinner can be from approximately 4:00 PM to approximately 10:00 PM. Furthermore, the time window associated with evening can be from approximately 10:00 PM to approximately 6:00 AM. If the recommended dose is administered within these time windows, it can be determined that the administration was successful. If the administration is not performed within these time windows, it can be determined that a missed dose has occurred. If an additional dose is administered in addition to the first dose during these time periods, it can be determined that more doses than necessary have been administered. If the dose administered during this period differs from the recommended dose, it can be determined that there has been poor adherence. In addition, missed doses and administration of more doses than necessary can also be determined as poor adherence.

[0189] In other embodiments, the filter may include a selection for displaying specific data over a selected time period when an alarm is enabled. The alarm may be a low glucose alarm configured to notify the user when an analyte value falls below a low threshold, a high glucose alarm configured to notify the user when an analyte value exceeds an high threshold, or both. The low or high threshold may be set by the user or by the system. The low or high threshold may be set to different values for different time periods. Multiple alarms may be enabled at different thresholds. Thus, a first graph may include a glucose profile including all analyte values for a certain period, regardless of whether an alarm is enabled or disabled. A second graph may include a glucose profile including only analyte values for periods when at least one alarm was enabled. Optionally, a third graph may be included including a glucose profile including only analyte values for periods when at least one alarm was not enabled or when at least one alarm was disabled.

[0190] As shown in FIG. 29A , in exemplary method 2200, starting at step 2202, a system or application may receive time-correlated data characteristic of time-correlated analyte data or analyte values. The data may be received from a server, a cloud, or the sensor control device 102. In step 2204, the system or application may determine a subset of the time-correlated data based on filtering criteria. In some embodiments, the filtering criteria may be the activation of at least one alarm. The system may also receive time-correlated dosage data regarding glucose-regulating drug doses received by the subject over a period of time. The filtering criteria may include a concordance of glucose-regulating drug doses. In some embodiments, the concordance of drug doses includes recommended doses, missed doses, under-bolus doses, over-bolus doses, late mealtime doses, or more mealtime doses than required. In step 2206, the system or method may display a first analyte profile based on the time-correlated data and a second analyte profile based on the subset determined based on the filtering criteria.

[0191] In some embodiments, the filtering criteria may be based on day type. For example, the day type may be a weekday, a weekend day, a workday, a vacation day, a day on which the user or person exercised, or a day on which the user or person did not exercise. In some embodiments, the filtering criteria may be based on the user's or person's adherence to medication or non-adherence to medication. For example, the filtering criteria may be based on whether the user or person took a basal insulin dose or whether they missed a basal insulin dose. In some embodiments, the filtering criteria may be based on whether the user or person missed at least one mealtime bolus dose.

[0192] In an alternative method, as shown in FIG. 29B , in exemplary method 2210, starting at step 2212, a system or application may receive time-correlated analyte data or time-correlated data characteristic of a subject's analyte values. The data may be received from a server, the cloud, or the sensor control device 102. In step 2214, the system or application may determine a first subset of the time-correlated data based on filtering criteria. In some embodiments, the filtering criteria may be the activation of at least one alarm. The system may also receive time-correlated dosage data regarding glucose-regulating drug doses or dosage values received by the subject over a period of time. The filtering criteria may include a concordance of glucose-regulating drug doses. In some embodiments, the concordance of drug doses includes recommended doses, missed doses, under-bolus doses, over-bolus doses, late mealtime doses, or more mealtime doses than required.

[0193] In step 2216, the system may determine a second subset of time-correlated analyte data based on the filtering criteria. In some embodiments, the second subset of data may include data that does not meet the filtering criteria. For example, if the filtering criterion is whether at least one alarm is enabled, the first subset of time-correlated analyte data may be data during periods when at least one alarm was enabled. The second subset of time-correlated analyte data may be data during periods when at least one alarm was not enabled (or at least one alarm was disabled).

[0194] In step 2218, the system or method may display a first analyte profile based on a first subset of the time-correlated analyte data based on the filtering criteria, and a second analyte profile based on a second subset of the time-correlated analyte data.

[0195] It should be understood that the reports and GUIs described herein may include any combination of the described graphs or profiles. Any combination or subset of these graphs (e.g., only two of the three graphs) may also be displayed in a GUI or report. For example, a GUI or report may include a glucose profile with at least one alarm enabled and a glucose profile with at least one alarm disabled, and may not include a glucose profile that includes all data regardless of alarm status.

[0196] By displaying glucose data separately based on whether or not an alarm is active, users and caregivers can directly see the impact on glucose values. The ability to visualize glucose profiles when alarms are enabled can be particularly useful for individuals undergoing treatments that may cause hypoglycemia. Comparing the profile with the alarm enabled to the profile without the alarm enabled can show the user how enabling and acting on the hypoglycemia alarm can mitigate instances of hypoglycemia compared to turning the hypoglycemia alarm off.

[0197] In some embodiments, an indication of an alarm occurrence may be added to any of the glucose profiles within the associated time windows. The alarm occurrence may be indicated by including an icon, such as a bell or alarm clock, on the glucose profile. The alarm occurrence may include the time the alarm condition was met, regardless of whether the alarm was enabled or disabled. For example, including the alarm occurrence on the glucose profile for data where the alarm was not enabled may indicate the frequency of alarms by time of day and how alarms were missed because the user had turned off or disabled the alarm, thereby leading to poor glucose control.

[0198] In some embodiments, comparative glucose profiles may be presented showing alarms enabled at different thresholds, for example, a glucose profile in which a low glucose alarm threshold is enabled at 70 mg / dL may be presented against a glucose profile in which a low glucose alarm threshold is enabled at 90 mg / dL.

[0199] In some embodiments, for any of the various filtering criteria described herein, a user may select additional filtering criteria to further customize the graphs or metrics displayed. For example, a user may select a first-level filter to display data or metrics when a low glucose alarm is activated. The user may then select an additional filter, a second-level filter, related to medication concordance. For example, a user may select to display data or metrics when the user takes a medication. Such a display may indicate that the user's current medication is causing hypoglycemia and should be reduced. The administration information may be collected from an integrated device (e.g., an integrated pen or pump) or from user input. In another example, a user may further select to add an indication of the alarm occurrence (or the time the alarm condition was met) to the display to highlight an opportunity to adjust medication dosage.

[0200] As shown in FIG. 29C , in exemplary method 2220, starting at step 2222, a system or application may receive time-correlated analyte data or time-correlated data characteristic of a subject's analyte values. The data may be received from a server, the cloud, or the sensor control device 102. In step 2224, the system or application may determine a first subset of the time-correlated data based on a first filtering criterion. In step 2226, the system or method may determine a second subset of the time-correlated data based on a second filtering criterion. In any step, the filtering criterion may be enabling at least one alarm. Different filtering criteria may be different types of alarms or alarms with different thresholds. The system may also receive time-correlated dosage data regarding glucose-regulating drug dosages received by the subject over a period of time. The filtering criteria may include concordance of glucose-regulating drug dosages. In some embodiments, the concordance of medication administration includes recommended dose administration, missed doses, under-bolus administration, over-bolus administration, late mealtime administration, or more mealtime administrations than necessary. In step 2228, the system or method may display a first analyte profile based on a first subset of the time-correlated analyte data based on the filtering criteria, and a second analyte profile based on a second subset of the time-correlated analyte data.

[0201] 29D , in an exemplary method 3220, beginning at step 3202, a system or application may receive time-correlated data for an analyte and an additional analyte, or time-correlated data characteristic of an analyte value and an additional analyte value for a subject. In some embodiments, the analyte may be glucose. In some embodiments, the additional analyte may be ketones, ketone bodies, beta-hydroxybutyrate, or lactate.

[0202] In step 3224, the system or application may determine a subset of the time-correlation data based on a first filtering criterion associated with at least one determined value of the additional analyte. In some embodiments, the first filtering criterion may be based on the at least one determined analyte value of the additional analyte being above a threshold. In some embodiments, if the additional analyte is a ketone, ketone body, or β-hydroxybutyrate, the threshold may be at least 1 mmol / L, e.g., between about 1 mmol / L and 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, when the additional test substance 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.

[0203] In step 3226, the system or method may display a first analyte profile based on the time-correlated data and a second analyte profile based on the subset determined based on the filtering criteria. In some embodiments, the analyte displayed in the first analyte profile and the second analyte profile is the same analyte, e.g., glucose.

[0204] In some embodiments, the method may optionally include determining whether the activity level of the person, user, or subject is below a high activity threshold before displaying the second test substance profile.

[0205] For example, a user may select a first level filter to display data or metrics when a high glucose alarm is activated. The user may then select an additional filter, a second level filter, related to concordance of medication administration. When presented along with the distribution of alarm occurrence times, this chart can highlight opportunities to increase prandial insulin administration.

[0206] In some embodiments, various filtering criteria may be selected from a drop-down menu or list of options. In some embodiments, various filtering criteria may be used for any of the reports described herein depicting different glucose data. Furthermore, various filtering criteria may be used for any of the glucose reports, insulin reports, or meal / exercise reports, or a combination thereof.

[0207] In the case of an alarm filter, the filter may be used in connection with any report of remotely sensed data in which an alarm is associated with any of the remotely sensed data. In other embodiments, data associated with the alarm is included in the report. In some embodiments, data associated with the alarm is not included in the report. For example, an insulin administration report may be filtered according to whether glucose alarms are enabled or disabled. The display may also include an indication of insulin administration (and optionally its amount) time-aligned with the glucose alarm occurrence (or instance when an alarm condition was met).

[0208] In some embodiments, any analyte metric calculation and / or status display may be filtered based on filtering criteria. For example, reports incorporating A1c lab measurements may be filtered. In some embodiments, a user may choose to analyze only data from a specific period (e.g., one month) prior to an A1c value being greater than a certain threshold (e.g., 6.5%, 7%, 7.5%, or 8%). Similarly, data may be filtered according to when the user viewed the detected analyte value, for example, by accessing a GUI on a mobile application or reading device that displays the most recent analyte value. The user may choose to review the data for a period (e.g., about 2 hours, about 3 hours, about 4 hours, between about 1 and 5 hours, between about 2 and 5 hours, or between about 2 and 4 hours) after the user viewed the detected analyte value.

[0209] As shown in FIG. 30A , in exemplary method 2230, starting at step 2232, a system or application may receive time-correlated analyte data or time-correlated data characteristic of a subject's analyte values. The data may be received from a server, the cloud, or the sensor control device 102. In step 2234, the system or application may determine a subset of the time-correlated data based on filtering criteria. In some embodiments, the filtering criteria may be the activation of at least one alarm. The system may also receive dosage data regarding glucose-regulating drug doses received by the subject over a period of time. The filtering criteria may include a concordance of glucose-regulating drug doses. In some embodiments, the concordance of drug doses includes recommended doses, missed doses, under-bolus doses, over-bolus doses, late mealtime doses, or more mealtime doses than required. In step 2236, the system or method may display a first analyte metric based on the time-correlated data and a second analyte metric based on the subset determined based on the filtering criteria.

[0210] In an alternative method, as shown in FIG. 30B , in exemplary method 2240, starting at step 2242, a system or application may receive time-correlated analyte data or time-correlated data characteristic of a subject's analyte values. The data may be received from a server, the cloud, or the sensor control device 102. In step 2244, the system or application may determine a first subset of the time-correlated data based on filtering criteria. In some embodiments, the filtering criteria may be the activation of at least one alarm. The system may also receive dosage data regarding glucose-regulating drug doses received by the subject over a period of time. The filtering criteria may include a concordance of glucose-regulating drug doses. In some embodiments, the concordance of drug doses includes recommended doses, missed doses, undersized boluses, oversized boluses, late mealtime doses, or more mealtime doses than required.

[0211] In step 2246, the system may determine a second subset of time-correlated analyte data based on the filtering criteria. In some embodiments, the second subset of data may include data that does not meet the filtering criteria. For example, if the filtering criterion is whether at least one alarm is enabled, the first subset of time-correlated analyte data may be data during periods when at least one alarm was enabled. The second subset of time-correlated analyte data may be data during periods when at least one alarm was not enabled (or at least one alarm was disabled).

[0212] In step 2248, the system or method may display a first analyte metric based on a first subset of the time-correlated analyte data based on the filtering criteria, and a second analyte metric based on a second subset of the time-correlated analyte data.

[0213] As shown in FIG. 30C , in example method 2250, starting at step 2252, a system or application may receive time-correlated analyte data or time-correlated data characteristic of a subject's analyte values. The data may be received from a server, a cloud, or the sensor control device 102. In step 2254, the system or application may determine a first subset of the time-correlated data based on a first filtering criterion. In step 2256, the system or method may determine a second subset of the time-correlated data based on a second filtering criterion. In any step, the filtering criterion may be enabling at least one alarm. Different filtering criteria may be different types of alarms or alarms with different thresholds. The system may also receive dosage data regarding glucose-regulating drug dosages received by the subject over a period of time. The filtering criteria may include concordance of glucose-regulating drug dosages. In some embodiments, the concordance of medication administration includes recommended dose administration, missed doses, under-bolus administration, over-bolus administration, late mealtime administration, or more mealtime administrations than necessary. In step 2258, the system or method may display a first analyte metric based on a first subset of the time-correlated analyte data based on the filtering criteria, and a second analyte metric based on a second subset of the time-correlated analyte data.

[0214] Analyte metric calculations that may be filtered may include a time-in-range metric. The time-in-range metric may include multiple ranges. As described elsewhere, the time-in-range metric may be displayed in a graph, such as a bar graph, histogram, pie chart, or other known graph. In some embodiments, the time-in-range GUI portion 954 may include a single bar made up of up to five rectangular segments. The five rectangles include (from top to bottom): a first rectangle indicating a portion of the predefined length of time when the user's glucose range is "very high" (i.e., above 250 mg / dL); a second rectangle indicating a portion of the predefined length of time when the user's glucose range is "high" (i.e., between 180 and 250 mg / dL); a third rectangle indicating a portion of the predefined length of time when the user's glucose range is within the "target range" (i.e., between 70 and 180 mg / dL); a fourth rectangle indicating a portion of the predefined length of time when the user's glucose range is "low" (i.e., between 54 and 69 mg / dL); and a fifth rectangle indicating a portion of the predefined length of time when the user's glucose range is "very low" (i.e., below 54 mg / dL). The time within range GUI 954 may display text next to each rectangular portion indicating the actual length of time, for example, in hours and / or minutes.

[0215] In some embodiments, different filtered glucose profiles or metrics may be displayed on the same graph, while in other embodiments, different filtered glucose profiles or metrics may be displayed on different graphs displayed on a single GUI or within a single report.

[0216] Meals can be recognized or logged by the subject, with meal start times manually specified. Alternatively, meal start times can be estimated in a number of ways. Exemplary methods are described in U.S. Patent Application Nos. 16 / 944,736 and 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," J Diabetes Sci Techol., March 2014, 8(2), 307-320, the disclosures of all of which are expressly incorporated herein by reference for all purposes. A delayed prandial administration can be determined to have occurred if it is determined that the administration occurred a certain time after the meal start time, for example, about 30 minutes, about 45 minutes, about 60 minutes, or about 90 minutes after the estimated meal start time. In other embodiments, a meal can be determined to have occurred if the glucose level obtained from the CGM device is greater than 70 mg / dL and if there has been a glucose rise of more than 70 mg / dL within the past two hours. In such cases, a delayed prandial bolus can be defined as occurring when the glucose level obtained from the CGM device rises by more than 50 mg / dL from the pre-insulin baseline. A missed prandial bolus can also be defined as occurring if no insulin administration has occurred within the two hours prior to the onset of the glucose rise. In some embodiments, a missed prandial administration can be defined as occurring if there has been a glucose rise of 80 mg / dL for two hours or less and no insulin administration has occurred within the previous hour.

[0217] In some embodiments, the GUI or report may also include at least some analyte metrics associated with each of the multiple glucose profiles, including, but not limited to, the mean or median analyte values for the time period, the standard deviation (SD), the CV ([(SD of glucose values) / (mean glucose value)] x 100), an indication of "time in range" for the time period, a GMI index for the time period, the number and duration of upward excursions above a high threshold and / or the number and duration of downward excursions below a low threshold, the number and duration of extreme upward excursions above a very high threshold and / or the number and duration of extreme downward excursions below a very low threshold, and multiple administration indices corresponding to administered medications. In some embodiments, the data from which the glucose profiles are analyzed for patterns may be included or excluded. For example, a "low" pattern may be identified by including time periods associated with medication administration but excluding time periods not associated with medication delivery. Dosage guidance and / or delivery of medication can be based on these patterns determined from the time window associated with medication administration. In some embodiments, recommendations can be provided based on the type of pattern determined (detected). Further details on pattern analysis are provided in WO 2021 / 026004, the entire disclosure of which is expressly incorporated herein by reference for all purposes.

[0218] The methods described herein are not limited to displaying metrics or plots, but may also be used in processes such as automated insulin (or other medication) delivery processes, insulin (or other medication) dosing guidance systems, and therapy guidance systems. In some embodiments, the data used as input or feedback data in these systems may include or exclude various glucose (or analyte) readings associated with missed medication doses, as described herein. For example, in the case of a therapy guidance system, recommendations for therapy changes may be provided based on glucose data excluding glucose data associated with missed medication doses. In other embodiments, an automated insulin delivery system may employ adaptive models and perform adaptive processing based on glucose data excluding glucose data for missed medication doses.

[0219] In other embodiments, a profile "comparison" report may present multiple graphs. By utilizing drug administration data from an associated drug delivery device and / or analyte data from a continuous analyte monitor as input, many embodiments can generate a GUI or report that includes multiple analyte profiles over a selected time period. As seen in FIGS. 18A and 18B, in some embodiments, the GUI or report can include multiple versions of the analyte profile over the selected time period. The number of versions can be two, or more than two, or three, or four, or five, or six, or more than six. Analytes include, but are 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, hormones, ketones, ketone bodies, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, and troponin. The analyte profile can be any of the various graph types described in the discussion of other embodiments, such as a glucose profile.

[0220] In some embodiments, the multiple graphs can include at least two graphs, or at least three graphs, or at least four graphs, or at least five graphs, or at least six graphs, or at least seven graphs, or at least eight graphs. Each of the multiple graphs can display a different data set. In some embodiments where a person is administering multiple medications at once, one graph can display all data for a certain period of time, or two graphs can be displayed for each type of medication being administered. For each medication, a first graph can include analyte measurements taken during a time range after or associated with administration of the medication, and a second graph can include analyte measurements taken during a time range after or associated with a missed medication. Thus, for a person administering n medications, multiple graphs can be presented, including (2n+1) graphs. As noted above in the description of other embodiments, the time range after or associated with administration of the medication can be determined by the duration of action of the medication being administered.

[0221] Detecting whether medication is administered or not Determining whether a medication has been delivered to a patient can be easily accomplished using an associated medication delivery device. For non-associated medication delivery devices (e.g., syringes), the system can use other means to determine whether a medication has been delivered. The system can provide a UI that allows a patient to log each medication administration. Additionally, the system can predefine a typical time period during which a patient administers medication, and if a medication administration log is not recorded during this time period, the system can prompt the patient to confirm whether the medication has been administered. For oral medications, an associated pill case or other device can be used to determine whether the medication has been administered. The system can also use both an associated device and a UI means. In this case, if an administration notification is not received from an associated device, the system can prompt the patient to confirm that the medication has not been administered (or has been administered).

[0222] If a medication is administered later than the standard (prescribed) time window, glucose data associated with that time window can be excluded. Similarly, glucose data associated with the later time window during which the medication was administered can also be excluded. The glucose data associated with these time windows (time windows) can then be included in some form of data analysis, such as an analysis to show the impact of delayed medication administration on a glucose metric. In this case, the calculation of this metric can include only glucose values for the time window associated with the delayed medication administration, and this metric can be compared to a metric calculated using glucose data only for time windows during which the medication was administered on time.

[0223] Feedback mechanisms on drug delivery devices Feedback related to recommended dosage In some embodiments, the dosing calculation module in the DSS system may be linked to an interface or display of the medication delivery device 152. As described elsewhere, the medication delivery device 152 may be a smart pen, pen cap, or pump that delivers a glucose level-regulating medication, such as insulin. The DSS system may receive a recommended medication dose from the medication dosing calculation module of the DSS system. The recommended dose may be communicated to the medication delivery device 152. When a dose is entered or selected by the user on the medication delivery device 152, the medication delivery device 152 may provide feedback to the user as to whether the dose entered on the medication delivery device 152 is the same as, less than, or more than the recommended dose from the medication dosing calculation module.

[0224] In some embodiments, the feedback provided may be visual. For example, if the medication delivery device 152 is an integrated insulin pen 2152, as shown in FIGS. 33A-33D , the dose may be entered by the user using a rotatable dial or knob 2154. The dose entered using the dial or knob 2154 may be displayed on the displays 2156 and / or 2158 to indicate the amount selected for manual injection. The background color of the displays 2156 and / or 2158 may be a different color depending on the dose entered. For example, if the entered amount is the same as the recommended dose, the background color may be a first color, e.g., green. If the entered amount is greater than the recommended dose, the background color may be a second color, e.g., red. If the entered amount is less than the recommended dose, the background color may be a third color, e.g., gray.

[0225] In some embodiments, the medication delivery device 152 may be a smart button configured to fit over an actuator of a delivery pen, or may be a pen cap configured to attach to the pen (e.g., attached to the needle end, body, or dose selector (e.g., dial)). As shown in FIGS. 34A-34D , a medication pen 2180, which may be a single-use medication delivery pen, may include a display 2186 and a dose selector such as a rotatable dial 2184 for selecting a dose. The pen cap or smart button 2190 may fit over the dose selector 2184 or other portion of the pen (e.g., the needle end or body) and may snap onto the pen 2180. After the pen cap or smart button 2190 is paired with a reading device, the pen cap or smart button 2190 may track dosing, store dosing data, and transmit the dosing data to the reading device. Medication may be delivered by pressing the pen cap or smart button 2190 straight down to inject the dose. The pen cap or smart button 2190 may include a display 2196 that can display the recommended dose and / or the dose to be administered. The background color of the display 2196 may be a different color depending on the dose entered. For example, if the amount entered is the same as the recommended dose, the background color may be a first color, e.g., green. If the amount entered is greater than the recommended dose, the background color may be a second color, e.g., red. If the amount entered is less than the recommended dose, the background color may be a third color, e.g., gray.

[0226] 35 , if the medication delivery device 152 is an insulin pump 2172, the pump may include at least one button or keypad 2174 used to enter a dose. The entered dose may be shown on a display 2176. Similar to the integrated pen example, the display 2176 may have a first background color, e.g., green, if the entered dose is the same as the recommended dose. The display may have a different color, e.g., a red background, if the entered dose is more than the recommended dose. The display may be yet another different color, e.g., gray, if the entered dose is less than the recommended dose.

[0227] In some embodiments, the feedback provided may be auditory. For example, if the entered dose is the same as the recommended dose, the drug delivery device 152 may emit a first sound, such as a single short beep or chirp. If the entered dose is higher than the recommended dose, the drug delivery device 152 may emit a second sound, such as a long beep. If the entered dose is lower than the recommended dose, the drug delivery device 152 may emit a third sound, such as a series of short beeps.

[0228] In some embodiments, the feedback provided may be tactile feedback. For example, if the input dose is the same as the recommended dose, the drug delivery device 152 may not vibrate. If the input dose is greater than the recommended dose, the drug delivery device 152 may vibrate for a first period of time. If the input dose is less than the recommended dose, the drug delivery device 152 may vibrate for a second period of time that is different from the first period of time. In some embodiments, if the input dose is the same as the recommended dose, the drug delivery device 152 may vibrate for a third period of time that is different from the first and second periods of time. Alternatively, the drug delivery device 152 may emit different vibration patterns depending on the relationship between the input dose and the recommended dose.

[0229] In some embodiments, the medication dosage calculation module may determine a recommended dosage range having an upper and lower limit. Alternatively, the medication dosage calculation module may recommend a nominal value within the recommended dosage range. The visual, auditory, and tactile feedback mechanisms described above may be used to compare the entered dosage with the recommended dosage range to determine whether the entered dosage is within the recommended dosage range, greater than the upper limit of the recommended dosage range, or less than the lower limit of the recommended dosage range.

[0230] 31A , in exemplary method 2270, starting at steps 2272 and 2274, one or more processors of the medication delivery device 152 may receive a recommended dose (step 2272) and a dose entered by a user (step 2274). In step 2276, the one or more processors may compare the entered dose with the recommended dose. In step 2278, the one or more processors may provide feedback on the delivery device based on the comparison.

[0231] As explained elsewhere, the comparison can be whether the entered dose is the same as the recommended dose, greater than the recommended dose, or less than the recommended dose. 31B , in exemplary method 2280, starting at steps 2282 and 2284, one or more processors of the drug delivery device 152 may receive a recommended dose (step 2282) and a dose entered by a user (step 2284). In step (2286), the one or more processors may determine whether the entered dose is the same as the recommended dose. If the entered dose is the same as the recommended dose, in step 2288, a first type of feedback may be provided on the drug delivery device 152. In different embodiments, the feedback may be visual, auditory, or tactile, as described in connection with other embodiments.

[0232] If the entered dose is not the same as or equal to the recommended dose, then in step 2290, the one or more processors may determine whether the entered dose is greater than the recommended dose. If the entered dose is greater than the recommended dose, then in step 2292, a second type of feedback may be provided on the drug delivery device 152. In different embodiments, the feedback may be visual, auditory, or tactile, as described in connection with other embodiments. Alternatively, in step 2290, the one or more processors may determine whether the entered dose is less than the recommended dose.

[0233] If the entered dose is not more than the recommended dose (i.e., less than the recommended dose), a third type of feedback may be provided on the drug delivery device 152 in step 2294. In different embodiments, the feedback may be visual, auditory, or tactile, as described in connection with other embodiments.

[0234] Steps in any of the methods described herein are optional and may be omitted from the method or performed in a different order than that shown in the figures. For example, the method may only determine whether the input dose is the same as the recommended dose. If the input dose is the same as the recommended dose, the one or more processors may provide feedback on the delivery device. If the input dose is different from the recommended dose (i.e., less or more), in some embodiments, the one or more processors may not provide feedback on the delivery device. In another example, the method may only determine whether the input dose is different from the recommended dose (e.g., more), but may not determine whether the input dose is equal to the recommended dose.

[0235] As discussed above, the feedback can be visual (e.g., a different color background), auditory (e.g., a different sound), or tactile (e.g., a different vibration). The feedback provided based on a comparison of the entered dose to the recommended dose can differ depending on whether the entered dose is the same as, greater than, or less than the recommended dose.

[0236] Safety precautions for higher than recommended doses Haptic feedback in drug delivery devices In another embodiment, as a safety measure to prevent administering more or less than the recommended dose, the medication delivery device 152 may include tactile feedback if the user is entering a dose more or less than the recommended dose. For example, in the case of an integrated insulin pen, if the user enters a dose more than the recommended dose using the rotatable dial or knob 2154, as shown in FIGS. 33A-33B , the dial or knob 2154 may be configured to default to the recommended dose or nominally recommended value within the recommended dosage range. Alternatively, or additionally, the dial or knob 2154 may be configured to increase resistance to rotation when the entered dose exceeds the recommended dose, compared to rotating or dialing the knob 2154 to the recommended dose. Alternatively, the dial or knob 2154 may be configured to spring back to the recommended dose when dialing a dose above the recommended dose. For example, the dial or knob 2154 may be resiliently biased to the recommended dose.

[0237] In another example, the medication delivery device 152 may be an insulin pump that includes at least one button for inputting a dose to be administered. The at least one button may be configured to increase resistance to downward movement (e.g., become harder to press or select) if a dose above or below the recommended dose is entered. For example, as shown in FIG. 35 , an insulin pump 2172 may include “+” and “−” buttons or a numeric keypad 2174 that allows a user to input a dose to be delivered. The buttons or keypad may be configured to increase resistance to downward movement if the dose entered is out of range.

[0238] 32A , in exemplary method 3000, starting at step 3002, one or more processors of the drug delivery device 152 may receive a recommended dose. In step 3004, the one or more processors may also determine an input dose using a dose selector of the drug delivery device 152. In step (3006), the one or more processors may determine whether the input dose differs from the recommended dose, i.e., whether the input dose is above or below the recommended dose. In step 3008, if the input dose differs from the recommended dose, the one or more processors may provide tactile feedback to the drug delivery device 152.

[0239] As described elsewhere, the tactile feedback can be increased resistance, bounce, rebound, and other known tactile feedback mechanisms. Lockout if a dose higher than the recommended dose is entered In another embodiment, as another safety measure to prevent dosing more or less than the recommended dose, the drug delivery device 152 may be configured to mechanically lock the drug delivery device 152 to prevent any drug from being delivered to the user. In some embodiments, the drug delivery device 152 may only be locked if the difference between the entered dose and the recommended dose is greater than a predetermined number of units. The predetermined number of units may be about 1 unit, or about 2 units, or about 3 units, or about 4 units.

[0240] In some embodiments, the medication delivery device 152 may be locked by mechanically locking the dose selector. For example, if the medication delivery device 152 is an associated pen 2152, the rotatable dial 2154 may be mechanically locked so that it can no longer be rotated. Alternatively, the medication delivery device 152 may be locked by mechanically locking or disengaging the injector.

[0241] In some embodiments, the entered dose may be communicated to a reading device, and one or more processors of the reading device may display a notification or alert regarding the entered higher dose and request the user to confirm the higher dose on the GUI of the DSS module.

[0242] 32B , in the exemplary method 3020, starting at step 3022, one or more processors of the drug delivery device 152 may receive a recommended dose. In step 3024, the one or more processors of the drug delivery device 152 may also determine a dose to be entered using a dose selector of the drug delivery device 152. In step (3026), the one or more processors may determine whether the entered dose differs from the recommended dose, i.e., whether the entered dose is above or below the recommended dose. In step 3028, if the entered dose differs from the recommended dose, the one or more processors may lock the drug delivery device 152 to prevent delivery of the drug.

[0243] Alert adjustment if more than the recommended dose is administered In some embodiments, if a user sets and / or delivers an insulin dose that differs from the recommended dose or outside the recommended range, the DSS system may adjust alert parameters. For example, if the dose delivered by or entered into the drug delivery device 152 is a first predetermined amount greater than the recommended dose or a second predetermined amount less than the recommended dose, the DSS system may adjust the urgency or characteristics of a low glucose alert and / or a high glucose alert for a period of time after delivery of the insulin dose. Examples of adjusting the urgency of an alert include increasing the low glucose threshold, decreasing the high glucose threshold, or increasing the prediction range (the period over which predicted glucose values are determined) of an impending low or high glucose alert. Examples of adjusting the characteristics of an alert include shortening the snooze period for the alert, increasing the volume of the alert, prolonging the audible alert, or requiring additional confirmation to dismiss the alert.

[0244] 32C , in an exemplary method 3040, one or more processors of the reading device may determine a recommended dose in step 3042. The one or more processors may also receive a dose delivered by or entered into the drug delivery device 152 in step 3044. The one or more processors may then determine whether the delivered dose differs from the recommended dose in step 3046. If the delivered dose or entered dose differs from the recommended dose in step 3048, the one or more processors may adjust alert parameters.

[0245] In some embodiments, the low glucose threshold may be increased to a higher concentration. Alternatively, or additionally, the high glucose threshold may be decreased to a lower concentration. Alternatively, or additionally, the period during which an alert is predicted may be increased, for example, by 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. In some embodiments, the snooze period is shortened to a shorter period. For example, the snooze period may be shortened by at least 3 minutes. For example, the snooze period may be shortened by about 15 minutes, or about 10 minutes, or about 5 minutes, or about 3 minutes. In some embodiments, the volume of the audible alert may be increased. In some embodiments, the DSS may allow the user to request that the alert be acknowledged.

[0246] Safety precautions for delayed administration Time-out feature of medication delivery device The DSS may also include safeguards against delayed administration (e.g., administration after the start of a meal). In some embodiments, the drug delivery device 152 may include a timeout feature that may disable the drug delivery device 152 from administering a drug after a predetermined time has elapsed since the recommended dose was determined. For example, the dose selector of the drug delivery device 152 may be set to zero dose and / or locked. The drug delivery device 152 may also be unable to deliver any drug until a new recommended dose has been determined and communicated to the drug delivery device 152.

[0247] 32D , in an exemplary method 3060, in step 3062, one or more processors of the drug delivery device 152 may receive a recommended dose at a first time T1 from the drug dosing calculation module. In step 3064, one or more processors of the drug delivery device 152 may receive dose data regarding a dose entered into the drug delivery device 152 at a second time T2. In step 3066, one or more processors of the drug delivery device 152 may determine whether the difference between T2 and T1 is greater than a predetermined time, e.g., 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 time, in step 3068, one or more processors may change a configuration of the drug delivery device. For example, a dose selector of the drug delivery device 152 may be changed to a locked configuration. Alternatively, or additionally, if the medication delivery device 152 is an insulin pump, the dose selector may be set to zero dose.

[0248] 32E , in an exemplary method 3070, in step 3072, one or more processors of the drug delivery device 152 may receive a recommended dose at time T1 from a drug dose calculation module. In step 3074, the one or more processors of the drug delivery device 152 may determine whether a dose has been administered within a predetermined time period since the recommended dose was determined at time T1. If no dose has been administered, in step 3076, the one or more processors of the drug delivery device 152 may change the configuration of the drug delivery device 152. For example, the dose selector of the drug delivery device 152 may be changed to a locked configuration. Alternatively, or additionally, the dose selector may be set to a zero dose.

[0249] Updates to medication delivery device displays An additional safeguard for delayed administration may include the administration calculation module taking into account a wait time or time delay of the current administration relative to the recommended administration time. The administration calculation module may calculate a new recommended dose. This new recommended dose may then be communicated to the drug delivery device 152 and displayed on the delivery device.

[0250] 32F , in exemplary method 3080, in step 3082, one or more processors of the reading device may determine a recommended dose at a first time T1. In some embodiments, a dosing calculation module may determine the recommended dose. In step 3084, one or more processors of the reading device may determine whether a dose has been administered within a predetermined time period since the recommended dose was determined at the first time T1. If no dose has been administered, in step 3086, one or more processors of the reading device may determine a new recommended dose. In step 3088, the new recommended dose may be communicated to the drug delivery device 152. In some embodiments, the drug delivery device 152 may display the new recommended dose. In some embodiments, the reading device may display the new recommended dose.

[0251] 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.

[0252] In another embodiment, the new recommended dose is a function that is periodically updated based on the initial recommended dose at a fixed time interval since the previous recommendation. As shown in FIG. 32G, in exemplary method 3090, in step 3092, one or more processors of the reading device may determine a first recommended dose. In some embodiments, a dosing calculation module may determine the recommended dose. In step 3095, one or more processors may determine whether the recommended dose is below a threshold. If the first recommended dose is below a threshold, such as zero units, in some embodiments, the process stops providing the recommended dose (step 3093). Otherwise, in step 3095, one or more processors may wait for a first period of time (e.g., 20 minutes) to elapse (step 3091). Thereafter, in step 3094, one or more processors of the reading device may determine whether a dose has been delivered. If so, the process stops providing the recommended dose (step 3093). Otherwise, in step 3096, the process determines a new recommended dose by considering factors including the time elapsed since the previous period. In step 3098, if the recommended dose is below the threshold, the process stops providing the recommended dose (step 3093). Otherwise, the one or more processors wait for a second period (e.g., 5 minutes) to elapse (step 3099). Then, in step 3097, the one or more processors of the reading device may determine whether the dose has been delivered. If so, the process stops providing the recommended dose (step 3093). Otherwise, the process returns to step 3096. In some embodiments, an additional timeout may be provided such that the process stops providing the recommended dose if the time elapsed since the first recommended dose exceeds a third period (e.g., 5 hours).

[0253] Other Safety Features Lockout if zero doses are allowed The DSS may include other safety features. In some embodiments, if the recommended dose is determined to be zero (0), the drug delivery device 152 may lock the drug delivery device 152 so that no drug can be delivered until further action is taken or a non-zero recommended dose is received. The drug dosing calculation module may determine that the recommended dose should be zero based on several factors, including the remaining insulin in the body and / or the risk of hypoglycemia above a threshold. Exemplary methods for determining the risk of hypoglycemia are described in U.S. Patent Application Publication Nos. 2014 / 0088392, 2014 / 0187887, 2014 / 0188400, and 2014 / 0350369, the entire disclosures of which are expressly incorporated herein by reference for any purpose.

[0254] 32H, in the exemplary method 3100, the medication delivery device 152 may receive a recommended dose from a reading device in step 3102. One or more processors of the medication delivery device 152 may determine whether the recommended dose is equal to a zero (0) dose in step 3104. In step 3106, the one or more processors of the medication delivery device 152 may lock the medication delivery device 152, thereby preventing delivery of any medication from the device until further operation is performed or until a non-zero recommended dose is received.

[0255] Actions for pen trigger GUI on reading device In some embodiments, a series of actions on the medication delivery device 152 may trigger an application module on the reading device to display a specific user interface or dialogue menu. For example, the series of actions may include a user entering a dose that is higher by multiple increments within a first predetermined time period. Alternatively, the series of actions may include a user entering a dose (suggested dose) that is higher or lower than the recommended dose within a second predetermined time period. In response to the series of actions, a user interface, such as a dialogue menu, may be displayed on the reading device that may present possible dosing guidance options (e.g., additional dosing guidance). In some embodiments, a dialogue menu for mealtime dosing advice or post-meal correction dosing may be presented depending on the user's time period and previous pattern. In some embodiments, basal dosing guidance may not be displayed if the user's pattern and the specific time period are not within a certain period (e.g., one hour) of the previous basal dose taken by the user.

[0256] As shown in FIG. 32I , in exemplary method 3120, in step 3122, one or more processors of the reading device may determine a recommended dose. In step 3124, the reading device may receive dose data regarding a dose entered using a dose selector on the medication delivery device 152. In step 3126, the one or more processors of the reading device may determine whether the entered dose differs from the recommended dose. For example, the entered dose may be a few units more or less than the recommended dose. In step 3128, the one or more processors of the reading device may cause a GUI related to the recommended dose to be displayed. For example, the GUI may include a suggested dose guidance option or may include an under- or over-dosing alert. In some embodiments, the dose guidance may be a suggested prandial dose based on the time of day the dose is entered. In some embodiments, the dose guidance may be a suggested correction dose based on the time of day the dose is entered. In some embodiments, the dose guidance may be a suggested basal dose based on the time of day the dose is entered.

[0257] Shortcuts on medication delivery devices In some embodiments, the drug delivery device 152 may include a single shortcut button or multiple shortcut buttons 2158a-e in Figures 33A-33B, multiple shortcut buttons 2188a-e in Figure 34C, and multiple shortcut buttons 2178a-e in Figure 35 for a particular recommended dose. For example, the drug delivery device 152 may include shortcut buttons for each of a breakfast dose, a lunch dose, a dinner dose, a basal dose, a snack dose, and / or a correction dose. When a button is pressed or selected, one or more processors of the drug delivery device 152 may retrieve the corresponding recommended drug dose determined by the drug dose calculation module, and the recommended dose may be displayed.

[0258] 32J , in the exemplary method 3140, in step 3142, the drug delivery device 152 may receive a recommended dose for at least one meal type. In step 3144, one or more processors of the drug delivery device 152 may assign the recommended dose for the at least one meal type to one of a plurality of buttons on the drug delivery device 152. In response to a user selecting one of the plurality of buttons (step 3146), the drug delivery device 152 may display the recommended dose (step 3148). More specifically, in response to a user selecting the button corresponding to the recommended dose (step 3146), the drug delivery device 152 may display the recommended dose (step 3148). In an optional step, the drug delivery device 152 may also set the dosage to the recommended dose displayed by and associated with the selected button.

[0259] Alternatively, the drug delivery device 152 may receive multiple recommended doses for different meal types. One or more processors of the drug delivery device 152 may assign each of the recommended doses for the different meal types to a different button on the drug delivery device 152. In response to a user selecting one of the multiple buttons, the drug delivery device 152 may display the recommended dose for the corresponding meal type. In an optional step, the drug delivery device 152 may also set the dosage to the recommended dose displayed by and associated with the selected button.

[0260] Steps in any of the methods described herein are optional and may be omitted from the method or performed in a different order than that shown in the figures. Systems, devices, and methods are provided for incorporating medication delivery devices into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose management device, an integrated insulin pen, and software. The integrated management system may generate multiple reports that may include data related to analyte values (e.g., glucose values) and medications delivered (e.g., insulin delivered). The medication delivery device may also provide feedback to the user.

[0261] Several embodiments have been described above, and various aspects of the present subject matter are presented below as a summary and / or supplement to the above. It should be noted that emphasis is placed on the interrelationship and interchangeability of the following embodiments. In other words, emphasis is placed on the fact that each feature of the multiple embodiments can be combined with any other feature unless otherwise explicitly stated or without logical justification. Although no explicit reference is made to the drawings below, the following paragraphs are a reprint and development of the embodiments described in this specification.

[0262] In many embodiments, an analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device including a display, a dosing selector, a first wireless communication circuit configured to receive a recommended dose from a reading device, and a first one or more processors coupled to a first memory; and a reading device including a display, a second wireless communication circuit configured to receive time-correlated data characteristic of the subject's analyte values and time-correlated dosage data of medication received by the subject over a period of time, and a second one or more processors coupled to a second memory. and a reading device having one or more processors, wherein the second memory stores instructions that, when executed by the second one or more processors, cause the second one or more processors to determine a recommended dose of a medication based on at least calculated test substance values based on time correlation data characteristic of the subject's test substance values and communicate the recommended dose of the medication to a medication delivery device, and 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 recommended dose and a dose entered using the administration selector.

[0263] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the administration received by the subject over a period of time. The dosage data regarding the dosage of the drug received by the subject may be simply referred to as the dosage of the drug received by the subject throughout this specification. The comparison between the recommended dose and the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0264] In some embodiments, the feedback comprises visual feedback. In some embodiments, the feedback comprises tactile feedback. In some embodiments, the feedback comprises tactile feedback.

[0265] In some embodiments, the medication delivery device is a pen. In some embodiments, the medication delivery device further comprises a pen cap. In some embodiments, the display is present on the pen cap.

[0266] In some embodiments, the medication delivery device further comprises a smart button. In some embodiments, the display is present on the smart button. In some embodiments, the dose selector is a rotatable knob.

[0267] In some embodiments, the drug delivery device is a pump.In some embodiments, the dose selector is at least one button. In some embodiments, the display of the medication delivery device has a background color, and if the dose entered using the dose selector equals the recommended dose of the medication, the feedback includes the background color of the display of the medication delivery device being a first color, hi some embodiments, the first color is green.

[0268] In some embodiments, if the dose entered using the dose selector is greater than the recommended dose of the medication, the feedback includes the background color of the display of the medication delivery device being a second color, hi some embodiments, the second color is red.

[0269] In some embodiments, if the dose entered using the dose selector is less than the recommended dose of the medication, the feedback includes the background color of the display of the medication delivery device being a third color, hi some embodiments, the third color is gray.

[0270] In some embodiments, if the dose entered using the dose selector is equal to the recommended dose of the medication, the feedback comprises a first pattern; if the dose entered using the dose selector is greater than the recommended dose of the medication, the feedback comprises a second pattern; and if the dose entered using the dose selector is less than the recommended dose of 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 light pattern.

[0271] In some embodiments, the recommended dose is a single dose. In some embodiments, the recommended dose includes a recommended dose range including an upper and lower limit, and if the dose entered using the dose selector is within the upper and lower limits of the recommended dose range or equals either the upper or lower limit, the feedback includes the background color of the display of the medication delivery device being a first color. In some embodiments, if the dose entered using the dose selector is greater than the recommended dose of the medication, the feedback includes the background color of the display of the medication delivery device being a second color. In some embodiments, if the dose entered using the dose selector is less than the recommended dose of the medication, the feedback includes the background color of the display of the medication delivery device being a third color.

[0272] In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0273] In many embodiments, the method includes the steps of: one or more processors of the drug delivery device receiving a recommended dose; one or more processors of the drug delivery device receiving dosage data regarding an entered dose on the drug delivery device; comparing the entered dose with the recommended dose; and providing feedback on the drug delivery device based on the comparison.

[0274] In some embodiments, the comparing step includes determining whether the entered dose is equal to the recommended dose. In some embodiments, in response to determining that the entered dose is equal to the recommended dose, a first feedback is provided on the medication delivery device, hi some embodiments, the first feedback is a first color background of a display of the medication delivery device.

[0275] In some embodiments, the comparing step includes determining whether the entered dose is greater than the recommended dose. In some embodiments, in response to determining that the entered dose is greater than the recommended dose, second feedback is provided on the medication delivery device, the second feedback being different from the first feedback.

[0276] In some embodiments, the comparing step includes determining whether the entered dose is greater than the recommended dose. In some embodiments, in response to determining that the entered dose is greater than the recommended dose, second feedback is provided on the medication delivery device, the second feedback being different from the first feedback.

[0277] In some embodiments, the comparing step includes determining whether the entered dose is less than the recommended dose. In some embodiments, in response to determining that the entered dose is less than the recommended dose, a third feedback is provided on the medication delivery device.

[0278] In some embodiments, the feedback is visual, auditory, or tactile. In many embodiments, a analyte monitoring system includes a drug delivery device configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: a display; a dosage selector; a first wireless communication circuit configured to receive a recommended dose from a reading device; and a first one or more processors coupled to a first memory; a reading device comprising: a display; a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte values and drug doses received by the subject over a period of time; and a second one or more processors coupled to the second memory; wherein the second memory stores 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 on at least the calculated analyte value based on the time correlation data characteristic of the subject's analyte; and the instructions stored in the first memory, when executed, cause the first one or more processors to provide tactile feedback through the dosage selector based on a comparison between the recommended dose and a dose entered using the dosage selector.

[0279] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. The dosage data regarding the drug dosage received by the subject may simply be referred to as the drug dosage received by the subject throughout this specification. The comparison between the recommended dose and the dose entered using the dosage selector may include comparing the value of the recommended dose with the value of the dose entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dose entered using the dosage selector. The first memory and 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 reading device.

[0280] In some embodiments, the tactile feedback comprises increasing resistance when the dose selector is set to a dose higher than the recommended dose. In some embodiments, the tactile feedback comprises increasing resistance when the dose selector is set to a dose less than the recommended dose.

[0281] In some embodiments, the dose selector is a rotatable knob configured to rotate in a first direction to increase the dose, and the tactile feedback includes a biasing means for rotating in a second direction opposite the first direction when the dose selector is rotated to a dose greater than, or optionally, less than, the recommended dose.

[0282] In some embodiments, the drug delivery device is a pen. In some embodiments, the drug delivery device is a pump. In some embodiments, the dose selector is at least one button, and optionally, the at least one button is configured to increase resistance to downward movement if a dose higher than the recommended dose is selected.

[0283] In some embodiments, the system also includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0284] In many embodiments, the method includes the steps of: one or more processors of the drug delivery device receiving a recommended dose; one or more processors of the drug delivery device receiving an input dose on the drug delivery device; comparing the input dose with the recommended dose; and providing tactile feedback on the drug delivery device if the input dose differs from the recommended dose.

[0285] In some embodiments, the tactile feedback comprises an increased resistance of the dose selector. In some embodiments, the entered dose is entered using a dose selector, which is configured to default to the recommended dose.

[0286] In some embodiments, the input dose is input using a dose selector. In some embodiments, the dose selector is a rotatable dial. In some embodiments, the rotatable dial is configured to bounce back to the recommended dose setting. For example, the rotatable dial may be resiliently biased to the recommended dose setting. In some embodiments, the rotatable dial is configured to apply resistance when rotated an amount above the recommended dose.

[0287] In many embodiments, a analyte monitoring system includes a drug delivery device configured to deliver a quantity of a drug to a subject, the drug delivery device comprising: a display; a dosage selector; a first wireless communication circuit configured to receive a recommended dose from a reading device; and a first one or more processors coupled to a first memory; a reading device comprising: a display; a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte values and dosage data related to drug doses received by the subject over a period of time; and a second one or more processors coupled to the second memory; wherein the second memory stores 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 on at least the calculated analyte value based on the time correlation data characteristic of the subject's analyte; and 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 if the dosage selector is set to a dose different from the recommended dose.

[0288] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0289] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the dose selector if the dose selector is set to a dose different from the recommended dose.

[0290] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the medication delivery device if the dose selector is set to a dose that is a predetermined number of units more than the recommended dose.

[0291] In some embodiments, the predetermined number of units is about 2 units. In some embodiments, the second instructions further cause the one or more processors of the reading device to display a GUI including a notification of the dose being a predetermined number of units more than the recommended dose.

[0292] In some embodiments, the second instructions further cause the second one or more processors of the reading device to request confirmation from the subject regarding the dose being a predetermined number of units more than the recommended dose.

[0293] In some embodiments, the medication delivery device is a pen and the dose selector is a rotatable knob. In some embodiments, the drug delivery device is a pump and the dose selector is at least one button.

[0294] In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0295] In many embodiments, the method includes the steps of: one or more processors of the drug delivery device receiving a recommended dose; one or more processors of the drug delivery device receiving an input dose on the drug delivery device; comparing the input dose with the recommended dose; and locking the drug delivery device to prevent delivery of the drug if the input dose exceeds the recommended dose.

[0296] In some embodiments, the step of locking the medication delivery device comprises locking a dose selector. In some embodiments, the medication delivery device locks when the dose selector is set to a dose that is a predetermined number of units above the recommended dose, hi some embodiments, the predetermined number of units is about 2 units.

[0297] In some embodiments, the medication delivery device is a pen and the dose selector is a rotatable knob. In some embodiments, the drug delivery device is a pump and the dose selector is at least one button.

[0298] In many embodiments, an analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device including a display, a dosage selector, a first wireless communication circuit configured to receive a recommended dosage from a reading device, and a first one or more processors coupled to a first memory; a reading device including a display, a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte values and dosage data related to dosages of medication received by the subject over a period of time, and a second one or more processors coupled to a second memory. and a reading device comprising a processor, wherein the second memory stores instructions that, when executed by the second one or more processors, cause the second one or more processors to determine a recommended dose of medication based on at least the calculated analyte value based on time correlation data characteristic of the subject's analyte value and dosages of the medication received by the subject over a period of time, and communicate the recommended dose to a medication delivery device, and 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 if the recommended dose is equal to zero.

[0299] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0300] In some embodiments, the instructions stored in the first memory, when executed, cause the first one or more processors to lock the dose selector if the recommended dose is equal to zero.

[0301] In some embodiments, the recommended dose is determined to be zero based on an insulin-on-board determination. In some embodiments, the recommended dose is determined to be zero based on at least calculated test substance values based on time correlation data characteristic of the subject's test substance values and a determination of hypoglycemia risk based on medication doses received by the subject over a period of time.

[0302] In some embodiments, the medication delivery device is a pen, and optionally the dose 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 disengaged from the plunger when the recommended dose is zero.

[0303] In some embodiments, the drug delivery device is a pump and the dose selector is at least one button. In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0304] In many embodiments, the method includes receiving a recommended dose by one or more processors of the medication delivery device, determining whether the recommended dose is equal to zero, and locking the medication delivery device to prevent delivery of the medication if the recommended dose is determined to be a zero dosage. Locking the medication delivery device may include disconnecting portions of the medication delivery device necessary for delivery of the medication from the medication delivery device.

[0305] In some embodiments, the step of locking the medication delivery device comprises locking a dose selector. In some embodiments, the recommended dose is determined to be zero based on an on-board insulin determination.

[0306] In some embodiments, the recommended dose is determined to be zero based on a determination of hypoglycemia risk based at least on the calculated analyte value and dosages of medication received by the subject over a period of time. The calculated analyte value may also be based on time-correlated data characteristic of the analyte in the subject.

[0307] In some embodiments, the medication delivery device is a pen and / or the dose selector is a rotatable knob. In some embodiments, the pen further comprises a delivery button and a plunger mechanically coupled to the delivery button, and locking the medication delivery device comprises decoupling the delivery button from the plunger.

[0308] In many embodiments, an analyte monitoring system includes a drug delivery device configured to deliver an amount of drug to a subject, the drug delivery device including a display, a dose selector, and a first wireless communication circuit configured to receive a recommended dose from a reading device and communicate a dose of the drug received by the subject; a reading device including a display, a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte value and dosage data related to the dose of the drug received by the subject from the drug delivery device; and one or more processors coupled to a memory, wherein the memory stores instructions that, when executed by the one or more processors, cause the one or more processors to: determine a recommended dose of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the subject's analyte value; compare the recommended dose of the drug with a corresponding amount of the drug delivered by the drug delivery device; and adjust an alert parameter if the corresponding amount of the drug delivered differs from the recommended dose. The corresponding amount of the drug delivered may be a value of a dose of the drug delivered at a time that is the same as or similar to a time corresponding to the recommended dose.

[0309] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0310] In some embodiments, the alert parameter is a low glucose threshold, which is increased to a higher concentration when the amount of drug being delivered is greater than the recommended dose.

[0311] In some embodiments, the alert parameter is a high glucose threshold, which is reduced to a lower concentration when the amount of drug delivered is less than the recommended dose.

[0312] In some embodiments, the alert parameter is a time period during which an alert is predicted, and the time period during which an alert is predicted is increased if the corresponding amount of drug delivered differs from the recommended dose, hi some embodiments, the time period during which an alert is predicted is increased by at least about 20 minutes if the corresponding amount of drug delivered differs from the recommended dose.

[0313] In some embodiments, the alert parameter is a snooze period, which is reduced to a shorter period if the corresponding amount of drug delivered differs from the recommended dose.

[0314] In some embodiments, the alert parameter is the volume of the audible alert, and the volume is increased if the corresponding amount of medication delivered differs from the recommended dose. In some embodiments, the alert parameter is the duration of the audible alert, which is increased if the corresponding amount of drug delivered differs from the recommended dose.

[0315] In some embodiments, the alert parameter is a request for confirmation of the alert, and the request for confirmation of the alert is enabled if the corresponding amount of the drug delivered differs from the recommended dose.

[0316] In some embodiments, the instructions, when executed, further cause the one or more processors to display additional information regarding the amount of medication delivered. In some embodiments, the alert parameter is a tactile parameter, and the alert parameter is adjusted to vibrate the reading device if the corresponding amount of medication delivered is more than the recommended dose. In some embodiments, the alert parameter is a tactile parameter, and the alert parameter is adjusted to vibrate the reading device if the corresponding amount of medication delivered is less than the recommended dose.

[0317] In some embodiments, the alert parameter is an audible parameter, and the alert parameter is adjusted to cause the reading device to emit a sound if the corresponding amount of medication delivered is more than the recommended dose. In some embodiments, the alert parameter is an audible parameter, and the alert parameter is adjusted to cause the reading device to emit a sound if the corresponding amount of medication delivered is less than the recommended dose.

[0318] In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0319] In many embodiments, the method includes the steps of one or more processors of the reading device determining a recommended dose; one or more processors of the reading device receiving dosage data regarding a dose entered or delivered by a drug delivery device; comparing the entered or delivered dose with the recommended dose; and one or more processors of the reading device adjusting alert parameters if the entered or delivered dose differs from the recommended dose.

[0320] In some embodiments, the alert parameter is a low glucose threshold, which is increased to a higher concentration when the amount of drug being delivered is greater than the recommended dose.

[0321] In some embodiments, the alert parameter is a high glucose threshold, which is reduced to a lower concentration when the amount of drug delivered is less than the recommended dose.

[0322] In some embodiments, the alert parameter is a time period during which an alert is predicted, and the time period during which an alert is predicted is increased if the corresponding amount of drug delivered differs from the recommended dose, hi some embodiments, the time period during which an alert is predicted is increased by at least about 20 minutes if the corresponding amount of drug delivered differs from the recommended dose.

[0323] In some embodiments, the alert parameter is a snooze period, and the snooze period is reduced to a shorter period if the corresponding amount of drug delivered differs from the recommended dose. For example, the snooze period can be reduced by at least 5 minutes if the corresponding amount of drug delivered differs from the recommended dose.

[0324] In some embodiments, the alert parameter is the volume of the audible alert, and the volume is increased if the corresponding amount of medication delivered differs from the recommended dose. In some embodiments, the alert parameter is the duration of the audible alert, which is increased if the corresponding amount of drug delivered differs from the recommended dose.

[0325] In some embodiments, the alert parameter is a request for confirmation of the alert, and the request for confirmation of the alert is enabled if the corresponding amount of the drug delivered differs from the recommended dose.

[0326] In some embodiments, the method further comprises displaying additional information regarding the amount of medication delivered. In some embodiments, the alert parameter is a tactile parameter, and the alert parameter is adjusted to vibrate the reading device if the corresponding amount of medication delivered is higher than the recommended dose.

[0327] In some embodiments, the alert parameter is an audible parameter, and the alert parameter is adjusted to cause the reading device to emit a sound if the corresponding amount of medication delivered is greater than the recommended dose.

[0328] In many embodiments, the analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device including a display, a dosage selector, and a first wireless communication circuit configured to communicate a suggested dosage of the medication entered using the dosage selector from the medication delivery device prior to delivery of the entered dosage of the medication; and a reading device including a display and a second wireless communication circuit configured to receive time-correlated data characteristic of the subject's analyte value and the suggested and communicated dosage of the medication entered using the dosage selector from the medication delivery device prior to delivery of the entered dosage of the medication. The reading device includes a communication circuit 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 recommended dose of a drug based on at least calculated test substance values based on time correlation data characteristic of the test substance values of the subject, compare the recommended dose of the drug with a suggested dose of the drug entered using a dose selector, and display a graphical user interface on a display, the graphical user interface comprising additional dose guidance if the suggested dose of the drug differs from the recommended dose of the drug.

[0329] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0330] In some embodiments, the proposed dosage of the agent is higher than the recommended dose. In some embodiments, the suggested dosage of the agent is less than the recommended dose. In some embodiments, if a suggested dosage of the medication is entered within a predetermined time from determining the recommended dosage, a graphical user interface is displayed.

[0331] In some embodiments, a graphical user interface is displayed when a suggested dosage of a drug is entered a predetermined time after the determination of the recommended dosage. In some embodiments, the additional dosing guidance relates to the time of day during which the suggested dosage of the medication is entered.

[0332] In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0333] In many embodiments, the method includes the steps of: one or more processors of the reading device determining a recommended dose (i.e., a recommended dose); one or more processors of the reading device receiving an input dose on the medication delivery device; comparing the input dose with the recommended dose; and, if the input dose differs from the recommended dose, displaying a user interface related to the recommended dose. The recommended dose may be a recommendation regarding the value and / or timing of a dose of the medication. The recommended dose may be referred to throughout this specification as a recommended dose.

[0334] In some embodiments, if the dose is entered within a predetermined time from determining the recommended dose, a user interface is displayed. In some embodiments, the user interface is displayed if the dose is entered a predetermined time after the recommended dose is determined.

[0335] In some embodiments, the user interface includes additional dosing guidance related to the time period corresponding to the dose entered on the medication delivery device. In many embodiments, an analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device comprising a display, at least one button, a first wireless communication circuit configured to receive a recommended dosage from a reading device, and a first one or more processors coupled to a first memory; a reading device comprising a display, a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte values and dosage data related to dosages of medication received by the subject over a period of time from the medication delivery device, and a second one or more processors coupled to a second memory; The memory stores 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 for at least one meal type based on at least the calculated test substance values, the at least the calculated test substance values being based on time correlation data characteristic of the test substance values of the subject, and communicate the recommended dose of the drug for the at least one meal type to a drug delivery device; and the instructions stored in the first memory, when executed, cause the first one or more processors of the drug delivery device to display the recommended dose of the drug for the at least one meal type on a display of the drug delivery device when at least one button is selected.

[0336] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0337] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a recommended dose for each of a plurality of meal types, the at least one button comprising a plurality of buttons, each meal type corresponding to a respective button of the plurality of buttons, and the first memory of the medication delivery device causes the first one or more processors of the medication delivery device to display a recommended dose for one of the plurality of meal types in response to selection of a respective button of the plurality of buttons. Each meal type may correspond to, e.g., be assigned to, a corresponding button. A recommended dose for one meal type may be displayed in response to selection of the corresponding button. In some embodiments, the plurality of meal types include breakfast, lunch, dinner, and snacks.

[0338] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a recommended dose for basal administration, the at least one button comprises a plurality of buttons, the recommended dose for basal administration corresponds to an individual button of the plurality of buttons, and the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the recommended dose for basal administration in response to selection of an individual button of the plurality of buttons.

[0339] In some embodiments, the second instructions, when executed, cause the second one or more processors to determine a recommended dose for the correction administration, the at least one button comprises a plurality of buttons, the recommended dose for the correction administration corresponds to an individual button of the plurality of buttons, and the first memory of the medication delivery device causes the first one or more processors of the medication delivery device to display the recommended dose for the correction administration in response to selection of an individual button of the plurality of buttons.

[0340] In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0341] In many embodiments, the method includes the steps of: one or more processors of the drug delivery device receiving a recommended dose for at least one meal type; one or more processors of the drug delivery device assigning the recommended dose for the at least one meal type to one of a plurality of buttons on the drug delivery device; and displaying the recommended dose on the drug delivery device in response to selection of one of the plurality of buttons on the drug delivery device.

[0342] In some embodiments, the method further comprises the step of one or more processors of the medication delivery device setting a dose selector of the medication delivery device to the recommended dose. In some embodiments, the receiving step includes one or more processors of the medication delivery device receiving a recommended dosage for each of a plurality of meal types, hi some embodiments, the plurality of meal types includes at least two of breakfast, lunch, dinner, and a snack.

[0343] In some embodiments, the method further includes the steps of one or more processors of the drug delivery device receiving a recommended dose for basal administration, and the one or more processors of the drug delivery device assigning the recommended dose for basal administration to one of a plurality of buttons on the drug delivery device.

[0344] In some embodiments, the method further includes the steps of one or more processors of the drug delivery device receiving a recommended dose for the correction dose, and the one or more processors of the drug delivery device assigning the recommended dose for the correction dose to one of a plurality of buttons on the drug delivery device.

[0345] In many embodiments, an analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device including a display, a dosage selector, a first wireless communication circuit configured to receive a recommended dosage from a reading device, and a first one or more processors coupled to a first memory; and a reading device including a display, a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte values and dosage data related to dosages of medication received by the subject over a period of time, and a second one or more processors coupled to a second memory. and a reading device comprising a 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 a medication based on at least the calculated analyte value based on time correlation data characteristic of the subject's analyte value and dosages of the medication received by the subject over a period of time, and the instructions in the first memory, when executed, cause the first one or more processors to alter a configuration of the medication delivery device to prevent the medication delivery device from delivering the medication when a predetermined time has elapsed since the recommended dose of the medication was determined.

[0346] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0347] In some embodiments, the dose selector changes to a locked configuration after a predetermined time has elapsed, and in the locked configuration the dose selector cannot be adjusted to a different dose by the user.

[0348] In some embodiments, the dose selector changes to a zero dose after a predetermined time has elapsed. In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0349] In many embodiments, the method includes the steps of one or more processors of the drug delivery device receiving dosage data relating to a recommended dose at a first time, one or more processors of the drug delivery device receiving dosage data relating to a dose entered on the drug delivery device at a second time, one or more processors of the drug delivery device determining whether a difference between the second time and the first time is greater than a predetermined time, and if the difference between the second time and the first time is greater than the predetermined time, one or more processors of the drug delivery device altering a configuration of the drug delivery device.

[0350] In some embodiments, the dose selector of the medication delivery device is changed to a locked configuration after a predetermined time has elapsed. In some embodiments, the dose selector of the medication delivery device is changed to zero after a predetermined time has elapsed.

[0351] In many embodiments, an analyte monitoring system includes a medication delivery device configured to deliver a quantity of medication to a subject, the medication delivery device comprising: a display; a dose selector; a first wireless communication circuit configured to receive a recommended dose from a reading device at a first time T1; and a first processor or processors coupled to a first memory, the first memory storing instructions that, when executed by the first processor or processors, cause the first processor or processors to determine whether a dose has been delivered within a predetermined time period from the first time T1; and a reading device having a display and time-correlated data characteristic of the subject's analyte values and dosages of medication received by the subject over a period of time. and a reading device comprising a second wireless communication circuit configured to receive dosage data relating to the subject's test substance value and a second one or more processors coupled to a second memory, wherein the second memory stores instructions that, when executed by the second one or more processors, cause the second one or more processors to determine a recommended dosage of a drug based on at least calculated test substance values based on time correlation data characteristic of the subject's test substance values and dosages of the drug received by the subject over a period of time, and the instructions stored in the first memory, when executed, cause the first one or more processors to modify a 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 within a predetermined period of time from a first time T1.

[0352] In some embodiments, the dose selector is changed to the locked configuration after a predetermined period of time has elapsed from the first time T1. In some embodiments, the dose selector is changed to a dose of zero after a predetermined period of time has elapsed from the first time T1.

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

[0354] In many embodiments, the method includes the steps of one or more processors of the drug delivery device receiving dosage data relating to a recommended dose at a first time, the one or more processors of the drug delivery device determining whether the dose has been delivered within a predetermined period of time from the first time T1, and altering a configuration of the drug delivery device if it is determined that the dose has not been delivered within the predetermined period of time from the first time T1.

[0355] In some embodiments, the step of changing the configuration of the medication delivery device comprises changing a dose selector of the medication delivery device to a locked configuration. In some embodiments, the step of changing the configuration of the medication delivery device comprises changing a dose selector of the medication delivery device to a dose of zero.

[0356] 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, a dosage selector, and wireless communication circuitry configured to receive a recommended dose from a reading device and communicate the dosage to the reading device; a reading device including a display and wireless communication circuitry configured to receive time correlation data characteristic of the subject's analyte values and dosage data from the drug delivery device regarding dosages of the drug received by the subject 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 recommended dosage of the drug based on at least a calculated analyte value based on the time correlation data characteristic of the subject's analyte value at a first time; determine whether the administration occurred within a predetermined period of time since the recommended dosage was determined at the first time; determine a new recommended dosage of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the subject's analyte value at a second time; and communicate the new recommended dosage to the drug delivery device.

[0357] The dosage selector referred to throughout this application may also be referred to as a dosage selector. The dosage selector is configured to receive an input indicating a dosage of the drug to be administered. The dosage of the drug entered via the dosage selector may be entered and / or selected by a user. The time-correlated data representative of the subject's analyte characteristic may be data representing / reflecting the subject's analyte concentration over time. The dosage data may be the dosage and timing of the drug received by the subject over a period of time. Dosage data regarding the dosage of the drug received by the subject may simply be referred to as the dosage of the drug received by the subject throughout this specification. Comparing the recommended dose to the dosage entered using the dosage selector may include comparing the value of the recommended dose with the value of the dosage entered using the dosage selector. The recommended dose may correspond to a time similar to or the same as the time of the dosage entered using the dosage selector. The first memory and 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 reading device.

[0358] In some embodiments, the drug delivery device further comprises one or more processors coupled to additional memory, the additional memory storing instructions that, when executed by the one or more processors, cause the recommended dose to be displayed on a display of the drug delivery device.

[0359] In some embodiments, the new recommended dose is less than the recommended dose. In some embodiments, the system further includes a sensor control device comprising an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of the subject.

[0360] In many embodiments, the method includes the steps of one or more processors of the readi...

Claims

1. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device; the medication delivery device comprising a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time-correlated data characteristic of the subject's analyte levels and time-correlated dosage data of medication received by the subject over a period of time; and the reading device comprising: 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 dosage of a drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; transmitting the recommended dose of medication to the medication delivery device; 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 recommended dose and a dose entered using the administration selector.

2. 1. A method comprising: receiving, by one or more processors of the medication delivery device, the recommended dose; receiving, by the one or more processors of the medication delivery device, dosage data relating to a dose entered on the medication delivery device; comparing the input dose with the recommended dose; and providing feedback on the medication delivery device based on the comparison.

3. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device; a medication delivery device comprising: a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte levels and dosage data relating to medication dosages received by the subject over a period of time; a reading device comprising: 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 on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; A test substance monitoring system, wherein the instructions stored in the first memory, when executed, cause the first one or more processors to provide tactile feedback through the dosage selector based on a comparison between the recommended dose and a dose entered using the dosage selector.

4. 1. A method comprising: receiving, by one or more processors of the medication delivery device, the recommended dose; receiving a dose input on the medication delivery device by the one or more processors of the medication delivery device; comparing the input dose with the recommended dose; and providing tactile feedback on the medication delivery device if the entered dose differs from the recommended dose.

5. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device; a medication delivery device comprising: a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte levels and dosage data relating to medication dosages received by the subject over a period of time; a reading device comprising: 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 on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; A test substance monitoring system, 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 drug if the administration selector is set to a dose different from the recommended dose.

6. 1. A method comprising: receiving, by one or more processors of the medication delivery device, the recommended dose; receiving a dose input on the medication delivery device by the one or more processors of the medication delivery device; comparing the input dose with the recommended dose; and locking the medication delivery device to prevent delivery of medication if the entered dose exceeds the recommended dose.

7. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device; a medication delivery device comprising: a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte levels and dosage data relating to medication dosages received by the subject over a period of time; a reading device comprising: 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 dosage of a drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject and the dosage of the drug received by the subject over a period of time; communicating the recommended dose to the medication delivery device; A test substance monitoring system, 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 drug if the recommended dose is equal to zero.

8. 1. A method comprising: receiving, by one or more processors of the medication delivery device, the recommended dose; determining whether the recommended dose is equal to zero; and locking the medication delivery device to prevent delivery of medication if the recommended dose is determined to be a zero dose.

9. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a medication delivery device including a first wireless communication circuit configured to receive the recommended dosage from the reading device and to communicate the dosage of medication received by the subject; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of an analyte value of the subject and dosage data relating to a dosage of a drug received by the subject from the drug delivery device; a reading device comprising 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: determining a recommended dosage of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; comparing the recommended dose of drug with the corresponding amount of drug delivered by the drug delivery device; The analyte monitoring system causes an alert parameter to be adjusted if the corresponding amount of delivered drug differs from the recommended dose.

10. 10. The system of claim 9, wherein the alert parameter is a low glucose threshold, and the low glucose threshold is increased to a higher concentration if the amount of drug delivered is greater than the recommended dose.

11. 10. The system of claim 9, wherein the alert parameter is a high glucose threshold, and the high glucose threshold is reduced to a lower concentration when the amount of drug delivered is less than the recommended dose.

12. 10. The system of claim 9, wherein the alert parameter is a period of time during which an alert is predicted, and the period of time during which an alert is predicted is increased if the corresponding amount of medication delivered differs from the recommended dose.

13. 13. The system of claim 12, wherein the period during which an alert is predicted is increased by at least about 20 minutes if the corresponding amount of medication delivered differs from the recommended dose.

14. 10. The system of claim 9, wherein the alert parameter is a snooze period, and the snooze period is reduced to a shorter period if the corresponding amount of medication delivered differs from the recommended dose.

15. 10. The system of claim 9, wherein the alert parameter is a volume of an audible alert, the volume being increased if the corresponding amount of medication delivered differs from the recommended dose.

16. 10. The system of claim 9, wherein the alert parameter is a duration of an audible alert, the duration being increased if the corresponding amount of medication delivered differs from the recommended dose.

17. 10. The system of claim 9, wherein the alert parameter is a request for confirmation of an alert, and the request for confirmation of the alert is enabled if the corresponding amount of medication delivered differs from the recommended dose.

18. 10. 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 medication delivered.

19. 10. The system of claim 9, wherein the alert parameter is a tactile parameter, and the alert parameter is adjusted to vibrate the reading device when the corresponding amount of medication delivered is greater than the recommended dose.

20. 10. The system of claim 9, wherein the alert parameter is an audible parameter, and the alert parameter is adjusted to cause the reading device to emit a sound when the corresponding amount of the delivered medication is greater than the recommended dose.

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

22. 1. A method comprising: one or more processors of the reading device determining a recommended dosage; receiving, by the one or more processors of the reading device, dosage data relating to a dose entered or delivered by a medication delivery device; comparing the input or delivered dose with the recommended dose; and if the entered or delivered dose differs from the recommended dose, the one or more processors of the reading device adjust an alert parameter.

23. 23. The method of claim 22, wherein the alert parameter is a low glucose threshold, and the low glucose threshold is increased to a higher concentration if the amount of drug delivered is greater than the recommended dose.

24. 23. The method of claim 22, wherein the alert parameter is a high glucose threshold, and the high glucose threshold is reduced to a lower concentration when the amount of drug delivered is less than the recommended dose.

25. 23. The method of claim 22, wherein the alert parameter is a period of time during which an alert is predicted, and the period of time during which an alert is predicted is increased if the corresponding amount of medication delivered differs from the recommended dose.

26. 26. The method of claim 25, wherein the period during which an alert is predicted is increased by at least about 20 minutes if the corresponding amount of medication delivered differs from the recommended dose.

27. 23. The method of claim 22, wherein the alert parameter is a snooze period, and the snooze period is reduced to a shorter period if the corresponding amount of medication delivered differs from the recommended dose.

28. 23. The method of claim 22, wherein the alert parameter is a volume of an audible alert, the volume being increased if the corresponding amount of medication delivered differs from the recommended dose.

29. 23. The method of claim 22, wherein the alert parameter is a duration of an audible alert, the duration being increased if the corresponding amount of medication delivered differs from the recommended dose.

30. 23. The method of claim 22, wherein the alert parameter is a request for confirmation of an alert, and the request for confirmation of an alert is enabled if the corresponding amount of medication delivered differs from the recommended dose.

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

32. 23. The method of claim 22, wherein the alert parameter is a tactile parameter, and the alert parameter is adjusted to vibrate the reading device if the corresponding amount of medication delivered is greater than the recommended dose.

33. 23. The method of claim 22, wherein the alert parameter is an audible parameter, and the alert parameter is adjusted to cause the reading device to emit a sound when the corresponding amount of medication delivered is greater than the recommended dose.

34. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; the medication delivery device including a first wireless communication circuit configured to communicate a suggested dose of the medication entered using the dose selector from the medication delivery device prior to delivery of the entered dose of the medication; A reading device, The display and a second wireless communication circuit configured to receive, prior to delivery of the entered dose of medication, time-correlated data characteristic of the subject's analyte value and a communicated suggested dose of the medication entered using the dose selector from the medication delivery device; a reading device comprising 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: determining a recommended dosage of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; comparing the recommended dose of a drug with a suggested dose of the drug entered using the dose selector; and displaying on the display a graphic user interface including additional administration guidance if the suggested dosage of the medication differs from the recommended dosage of the medication.

35. 1. A method comprising: one or more processors of the reading device determining a recommended dosage; receiving a dose entered on a medication delivery device by the one or more processors of the reading device; comparing the input dose with the recommended dose; If the entered dose differs from the recommended dose, displaying a user interface related to the recommended dose.

36. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and At least one button a first wireless communication circuit configured to receive a recommended dosage from the reading device; a medication delivery device comprising: a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte value and dosage data relating to dosages of medication received by the subject over a period of time from the medication delivery device; a reading device comprising: 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 dosage of a drug for at least one type of meal based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject; transmitting the recommended dose of medication for at least one meal type to the medication delivery device; The system, wherein the instructions stored in the first memory, when executed, cause the first one or more processors of the medication delivery device to display the recommended dosage of medication for the at least one meal type on the display of the medication delivery device when the at least one button is selected.

37. 37. The system of claim 36, wherein the second instructions, when executed, cause the second one or more processors to determine a recommended dose for each of a plurality of meal types, the at least one button comprising a plurality of buttons, each meal type corresponding to a respective button of the plurality of buttons, and the first memory of the medication delivery device causes the first one or more processors of the medication delivery device to display a recommended dose for one of the plurality of meal types in response to selection of a respective button of the plurality of buttons.

38. 38. The system of claim 37, wherein the plurality of meal types includes breakfast, lunch, dinner, and snacks.

39. 37. The system of claim 36, wherein the second instructions, when executed, cause the second one or more processors to determine a recommended dose for a basal administration, the at least one button comprising a plurality of buttons, the recommended dose for the basal administration corresponding to an individual button of the plurality of buttons, and the first memory of the drug delivery device causes the first one or more processors of the drug delivery device to display the recommended dose for the basal administration in response to selection of an individual button of the plurality of buttons.

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

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

42. 1. A method comprising: receiving, by one or more processors of the medication delivery device, a recommended dosage for at least one meal type; the one or more processors of the medication delivery device assigning the recommended dose for the at least one meal type to one of a plurality of buttons on the medication delivery device; and displaying the recommended dose on the medication delivery device in response to selection of one of the plurality of buttons on the medication delivery device.

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

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

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

46. receiving, by the one or more processors of the medication delivery device, a recommended dose for a basal administration; 43. The method of claim 42, further comprising the step of: the one or more processors of the medication delivery device assigning the recommended dose for basal administration to one of a plurality of buttons on the medication delivery device.

47. receiving, by the one or more processors of the medication delivery device, a recommended dose for a correction dose; 43. The method of claim 42, further comprising the step of: the one or more processors of the medication delivery device assigning the recommended dose for the correction dose to one of a plurality of buttons on the medication delivery device.

48. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device; a medication delivery device comprising: a first one or more processors coupled to a first memory; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte levels and dosage data relating to medication dosages received by the subject over a period of time; a reading device comprising: 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 dosage of a drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject and the dosage of the drug received by the subject over a period of time; A test substance monitoring system, wherein the instructions 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 when a predetermined time has elapsed since the recommended dose of the drug was determined.

49. 1. A method comprising: receiving, by one or more processors of the medication delivery device, dosage data relating to a recommended dose at a first time; receiving, by the one or more processors of the medication delivery device, dosage data relating to a dose entered on the medication delivery device at a second time; the one or more processors of the medication delivery device determining whether a difference between the second time and the first time is greater than a predetermined time; and if the difference between the second time and the first time is greater than a predetermined time, the one or more processors of the medication delivery device change a configuration of the medication delivery device.

50. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; a first wireless communication circuit configured to receive a recommended dosage from the reading device at a first time T1; 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 within a predetermined time period from the first time T1; A reading device, The display and a second wireless communication circuit configured to receive time correlation data characteristic of the subject's analyte levels and dosage data relating to medication dosages received by the subject over a period of time; a reading device comprising: 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 dosage of a drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject and the dosage of the drug received by the subject over a period of time; A test substance monitoring system, wherein 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 drug if it is determined that a dose has not been delivered within the predetermined period from the first time T1.

51. 1. A method comprising: receiving, by one or more processors of the medication delivery device, dosage data relating to a recommended dose at a first time; the one or more processors of the medication delivery device determining whether a dose has been delivered within a predetermined time period from a first time T1; and changing a configuration of the medication delivery device if it is determined that a dose has not been delivered within the predetermined period of time from the first time T1.

52. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; the medication delivery device comprising a wireless communication circuit configured to receive a recommended dosage from a reading device and to communicate the dosage to the reading device; A reading device, The display and a wireless communication circuit configured to receive time correlation data characteristic of an analyte value of a subject and dosage data relating to dosages of a drug received by the subject over a period of time from the drug delivery device; a reading device comprising 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: determining a recommended dose of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject at a first time; determining whether the recommended dose was administered within a predetermined period of time after the recommended dose was determined at the first time; determining a new recommended dose of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value for the subject at a second time; The analyte monitoring system causes the new recommended dose to be communicated to the drug delivery device.

53. 1. A method comprising: one or more processors of the reading device determining a recommended dose at a first time T1; one or more processors of the reading device determining whether a dose has been delivered within a predetermined period of time from said first time T1; determining a new recommended dose if the one or more processors of the reading device determine that a dose has not been delivered within a predetermined period of time from time T1; and communicating the new recommended dose to a medication delivery device.

54. 1. A analyte monitoring system, comprising:

1. A medication delivery device configured to deliver an amount of medication to a subject, comprising: The display and a dose selector; the medication delivery device comprising a wireless communication circuit configured to receive a recommended dosage from a reading device and to communicate the dosage to the reading device; A reading device, The display and a wireless communication circuit configured to receive time-correlated data characteristic of an analyte value in a subject and to receive dosage data from the medication delivery device relating to medication dosages received by the subject over a period of time; a reading device comprising 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: determining a first recommended dose of the drug based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value 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 a threshold, determining whether the administration was performed within a predetermined period from the first time; If it is determined that administration has not occurred within the specified period, a test substance monitoring system determines a second recommended dose of the drug at a second time based on at least the calculated test substance value based on the time correlation data characteristic of the subject's test substance value.

55. 1. A method comprising: determining, by one or more processors of the reading device, a first recommended dose of the medication based on at least the calculated analyte value based on the time correlation data characteristic of the analyte value of the subject at the first time; the one or more processors of the reading device determining whether the first recommended dose is below a threshold; if it is determined that the first recommended dose is not below a threshold, the one or more processors of the reading device determine whether administration occurred within a predetermined time period from the first time; If it is determined that administration has not occurred within the specified period, the one or more processors of the reading device determine a second recommended dose of the drug at a second time based on at least the calculated test substance value based on the time correlation data characteristic of the subject's test substance value.

56. 1. A system for displaying metrics related to a subject, comprising: a wireless communication circuit configured to receive time-correlated data characteristic of an analyte value 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, the memory storing instructions and time-correlated data characteristic of analyte values of a subject, the instructions, when executed by the one or more processors, causing the system to: determining a subset of the time-correlated data based on filtering criteria selected by the subject, the filtering criteria including activation of at least one alarm; The system causes a first glucose profile and a second glucose profile to be displayed on a single graphical subject interface, the first glucose profile displaying glucose values associated with the time-correlated data over a first period of time and the second glucose profile displaying a subset of the time-correlated data over the first period of time.

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

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

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

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

61. The instructions, when executed by the one or more processors, cause the system to:

57. The system of claim 56, further configured to display the at least one alarm occurrence during the first time period in at least one of the first glucose profile and the second glucose profile.

62. the wireless communication circuitry is further configured to receive dosage data regarding dosages of medication received by the subject over a period of time, the memory further storing dosages of glucose level adjusting medication received by the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to:

57. The system of claim 56, further configured to display in at least one of the first and second glucose profiles an instance of a dosage of a medication received during the first time period.

63. The instructions, when executed by the one or more processors, cause the system to: determining a second subset of time correlation data based on the filtering criteria selected by the subject, the second subset of time correlation data including time correlation data when the at least one alarm is disabled; and displaying a third glucose profile on the single graphical subject interface, the third glucose profile displaying a second subset of the time-correlated data over the first period of time.

64. The instructions, when executed by the one or more processors, cause the system to:

64. The system of claim 63, further configured to display the occurrence of the at least one alarm during the first time period in at least one of the first, second, and third glucose profiles.

65. the wireless communication circuitry is further configured to receive dosage data regarding dosages of medication received by the subject over a period of time, the memory further storing dosages of glucose level adjusting medication received by the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to:

65. The system of claim 64, further configured to display instances of medication doses received during the first time period in at least one of the first, second, and third glucose profiles.

66. 66. The system of claim 65, wherein instances of medication doses received during the first time period are displayed in the second glucose profile.

67. 57. The system of claim 56, wherein the wireless communication circuitry is further configured to receive medication doses taken by the subject over a period of time, the memory further storing glucose level adjusting drug doses taken by the subject over a period of time, the instructions causing the one or more processors to determine at least one recommended dose, and the filtering criteria further include concordance of glucose adjusting drug doses.

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

69. 68. The system of claim 67, wherein the concordance of medication administration includes missed doses, under-bolus administration with reference to the at least one recommended dose, over-bolus administration with reference to the at least one recommended dose, delayed mealtime administration, or more mealtime administrations than necessary.

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

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

72. 72. The system of claim 71, wherein the first glucose profile and the second glucose profile each further include a second upper trajectory of the hourly 75th percentile of glucose values and a second lower trajectory of the hourly 25th percentile of glucose values.

73. 71. The system of claim 70, wherein the first glucose profile and the second glucose profile each further include data representing the 75th percentile of hourly glucose values and a second sub-trajectory of the 15th percentile of hourly glucose values.

74. 57. The system of claim 56, wherein the first glucose profile and the second glucose profile each include a plurality of trajectories, one trajectory of the plurality of trajectories corresponding to a day of the first period, and the plurality of trajectories are displayed in an overlay pattern.

75. The instructions, when executed by the one or more processors, cause the system to: determining a first analyte metric based on the time correlation data for the first time period, and determining a second analyte metric based on a subset of the time correlation data for the first time period; 57. The system of claim 56, further causing the first analyte metric and the second analyte metric to be displayed on the single graphical subject interface.

76. The instructions, when executed by the one or more processors, cause the system to: determining at least one first analyte statistical value based on the time correlation data for the first time period, and determining at least one second analyte statistical value based on a subset of the time correlation data for the first time period; 57. The system of claim 56, further comprising: displaying the at least one first analyte statistical value and the at least one second analyte statistical value on the single graphical subject interface.

77. 77. The system of claim 76, wherein the at least one first test substance statistical value comprises a first glucose control index, a first mean glucose value, a first standard deviation, or a combination thereof, and / or the at least one second test substance statistical value comprises a second glucose control index, a second mean glucose value, a second standard deviation, or a combination thereof.

78. The instructions, when executed by the one or more processors, cause the system to: determining a first hypoglycemic risk based on the time-correlated data for the first time period, and determining a second hypoglycemic risk based on a subset of the time-correlated data for the first time period; 57. The system of claim 56, wherein the system is configured to display the first hypoglycemic risk and the second hypoglycemic risk on the single graphical subject interface.

79. 1. A method for displaying metrics related to a subject, comprising: receiving time-correlated data characteristic of an analyte value of the subject; determining a subset of the time-correlated data based on filtering criteria selected by the subject, the filtering criteria including activation of at least one alarm; and displaying a first glucose profile and a second glucose profile on a single graphical subject interface, wherein the first glucose profile displays glucose values associated with the time-correlated data over a first period of time and the second glucose profile displays a subset of the time-correlated data over the first period of time.

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

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

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

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

84. 80. The method of claim 79, further comprising displaying the at least one alarm occurrence in the first time period in at least one of the first glucose profile and the second glucose profile.

85. receiving dosage data regarding dosages of medication received by a subject over a period of time; storing dosage data relating to the dosage of glucose level-modifying medication received by the subject over a period of time; and displaying instances of dosages of medication received during the first time period in at least one of the first and second glucose profiles.

86. determining a second subset of the time correlation data based on the filtering criteria selected by the subject, the second subset of time correlation data including time correlation data when the at least one alarm is disabled; 80. The method of claim 79, further comprising displaying a third glucose profile on the single graphical subject interface, the third glucose profile displaying a second subset of the time-correlated data over the first period of time.

87. 87. The method of claim 86, further comprising displaying the at least one alarm occurrence in the first time period in at least one of the first, second, and third glucose profiles.

88. receiving dosage data regarding dosages of medication received by a subject over a period of time; storing dosage data relating to the dosage of glucose level-modifying medication received by the subject over a period of time; 88. The method of claim 87, further comprising displaying an instance of a dosage of a medication received during the first time period in at least one of the first, second, and third glucose profiles.

89. 89. The method of claim 88, wherein instances of dosages received by the subject during the first time period are displayed on the second glucose profile.

90. 80. The method of claim 79, wherein the wireless communication circuitry is further configured to receive dosage data regarding medication dosages received by the subject over a period of time, and the memory further stores glucose level adjusting medication dosages received by the subject over a period of time, and the filtering criteria further include concordance of medication dosages.

91. 91. The method of claim 90, wherein the concordance of medication administration includes recommended dose administration, missed doses, under-bolus administration, over-bolus administration, delayed mealtime administration, or more mealtime administrations than necessary.

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

93. 93. The method of claim 92, wherein the first glucose profile and the second glucose profile each further comprise an upper trajectory of the hourly 95th percentile of glucose values and a lower trajectory of the hourly 5th percentile of glucose values.

94. 95. The method of claim 94, wherein the first glucose profile and the second glucose profile each further comprise a second upper trajectory of the hourly 75th percentile of glucose values and a second lower trajectory of the hourly 25th percentile of glucose values.

95. 93. The method of claim 92, wherein the first glucose profile and the second glucose profile further comprise data representing the 75th hourly percentile of glucose values and a second sub-trajectory of the 15th hourly percentile of glucose values, respectively.

96. 80. The method of claim 79, wherein the first glucose profile and the second glucose profile each include a plurality of trajectories, one trajectory of the plurality of trajectories corresponding to a day of the first period, and the plurality of trajectories are displayed in an overlay pattern.

97. determining a first analyte metric based on the time correlation data for the first time period and determining a second analyte metric based on a subset of the time correlation data for the first time period; and displaying the first analyte metric and the second analyte metric on the single graphical subject interface.

98. determining at least one first analyte statistical value based on the time correlation data for the first time period and determining at least one second analyte statistical value based on a subset of the time correlation data for the first time period; 80. The method of claim 79, further comprising the step of: displaying the at least one first analyte statistical value and the at least one second analyte statistical value on the single graphical subject interface.

99. 99. The method of claim 98, wherein the at least one first test substance statistical value comprises a first glucose control index, a first mean glucose value, a first standard deviation, or a combination thereof, and / or the at least one second test substance statistical value comprises a second glucose control index, a second mean glucose value, a second standard deviation, or a combination thereof.

100. determining a first hypoglycemic risk based on the time-correlated data for the first time period and determining a second hypoglycemic risk based on a subset of the time-correlated data for the first time period; 80. The method of claim 79, further comprising displaying the first hypoglycemic risk and the second hypoglycemic risk on the single graphical subject interface.

101. 1. A system for displaying metrics related to a subject, comprising: a wireless communication circuit configured to receive time-correlated data characteristic of an analyte value 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, the memory storing instructions and time-correlated data characteristic of analyte values of a subject, the instructions, when executed by the one or more processors, causing the system to: determining a subset of the time-correlated data based on filtering criteria selected by the subject; determining a first analyte metric based on the time-correlated data for a first time period; determining a second analyte metric based on a subset of the time-correlated data for the first time period; and displaying the first analyte metric and the second analyte metric on a single graphical subject interface.

102. 1. A method for displaying metrics related to a subject, comprising: receiving time-correlated data characteristic of an analyte value of the subject; determining a subset of the time correlation data based on filtering criteria selected by the subject; determining a first analyte metric based on the time correlation data for a first time period and determining a second analyte metric based on a subset of the time correlation data for the first time period; and displaying the first analyte metric and the second analyte metric on a single graphical subject interface.

103. 1. A system for displaying metrics related to a subject, comprising: a wireless communication circuit configured to receive time-correlated data characteristic of glucose in the subject and time-correlated data characteristic of an additional analyte in 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 and time-correlated data characteristic of analyte values of a subject, the instructions, when executed by the one or more processors, cause the system to: determining a subset of time-correlated data characteristic of glucose based at least on a first filtering criterion associated with the at least one determined value of the additional analyte; The system causes a first glucose profile and a second glucose profile to be displayed on a single graphical subject interface, wherein the first glucose profile displays glucose values associated with the time-correlated data over a first period of time, and the second glucose profile displays a subset of the time-correlated data representing glucose characteristics based at least on the first filtering criteria over the first period of time.

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

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

106. 105. The system of claim 104, wherein the additional test substance is beta-hydroxybutyric acid.

107. 105. The system of claim 104, wherein the additional test substance is lactate.

108. 108. The system of claim 107, wherein the wireless communication circuitry is further configured to receive data characteristic of the subject's activity, and the first filtering criterion further comprises the subject's determined activity level being below a high activity threshold.

109. 1. A method for displaying metrics related to a subject, comprising: receiving time-correlated data characteristic of an analyte value of the subject; determining a subset of time-correlated data characteristic of glucose based at least on a first filtering criterion associated with the at least one determined value of the additional analyte; and displaying a first glucose profile and a second glucose profile on a single graphical subject interface, wherein the first glucose profile displays glucose values associated with the time-correlated data over a first period of time, and the second glucose profile displays a subset of the time-correlated data representing glucose characteristics based at least on the first filtering criteria over the first period of time.

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

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

112. 111. The method of claim 110, wherein the additional test substance is beta-hydroxybutyric acid.

113. 111. The method of claim 110, wherein the additional test substance is lactic acid.

114. 114. The method of claim 113, wherein the wireless communication circuitry is further configured to receive data representative of activity characteristics of the subject, and wherein the first filtering criterion further comprises the subject's determined activity level being below a high activity threshold.

115. 1. A system for displaying metrics related to a subject, comprising: a wireless communication circuit configured to receive time-correlated data representative of a glucose characteristic 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, the memory storing instructions and time-correlated data characteristic of analyte values of a subject, the instructions, when executed by the one or more processors, causing the system to: determining a subset of the time-correlated data characteristic of glucose based on at least a first filtering criterion; The system causes a first glucose profile and a second glucose profile to be displayed on a single graphical subject interface, wherein the first glucose profile displays glucose values associated with the time-correlated data over a period of time, and the second glucose profile displays a subset of the time-correlated data representing glucose characteristics based at least on the first filtering criteria over the period of time.

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

117. 117. The system of claim 116, wherein the day type is a weekday.

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

119. The system of claim 116, wherein the day type is a work day of the subject.

120. The system of claim 116, wherein the day type is a vacation day for the subject.

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

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

123. The system of claim 116, wherein the day type is a day on which the subject forgets to administer basal insulin.

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

125. The system of claim 116, wherein the day type is a day on which the subject misses at least one bolus insulin dose.

126. 116. The system of claim 115, wherein the wireless communication circuitry is further configured to receive data characteristic of the subject's activity.

127. 1. A method for displaying metrics related to a subject, comprising: receiving time-correlated data characteristic of an analyte value of the subject; determining a subset of time-correlated data representative of glucose characteristics based on at least a first filtering criterion; and displaying a first glucose profile and a second glucose profile on a single graphical subject interface, wherein the first glucose profile displays glucose values associated with the time-correlated data over a period of time, and the second glucose profile displays a subset of the time-correlated data representing glucose characteristics based at least on the first filtering criteria over the period of time.

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

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

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

131. 129. The method of claim 128, wherein the day type is a work day of the subject.

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

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

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

135. The method of claim 128, wherein the day type is a day on which the subject forgets to administer basal insulin.

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

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

138. 138. The method of claim 137, wherein the wireless communication circuitry is further configured to receive data representative of a characteristic of the subject's activity.

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