Systems and methods for diabetes management - Patents.com
Patent Information
- Application Number
- JP2023563223
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-08-25
- Filing Date
- 2022-04-20
- Publication Date
- 2025-04-28
AI Technical Summary
Existing diabetes management systems face challenges in accurately correlating glucose monitoring data with insulin dosing data, leading to inconsistent drug administration and poor blood sugar control due to manual logging inaccuracies and the complexity of managing multiple drug types and administration routes, which results in high cognitive load and missed doses.
An integrated diabetes management system that includes an analyte monitoring device, drug delivery device, reading device, and reporting software, allowing seamless data transfer and generating reports that correlate glucose data with insulin administration metrics to identify concordance issues and improve blood sugar control.
The system enhances diabetes management by providing real-time insights into insulin administration concordance, reducing missed doses, and improving blood sugar control through automated data logging and reporting, thereby facilitating better clinical decision-making.
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Abstract
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 177,706, filed April 21, 2021, and U.S. Provisional Patent Application No. 63 / 236,910, filed August 25, 2021, the entire contents of both applications being expressly incorporated by reference herein for any purpose. [Technical field]
[0002] 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]
[0003] Detecting and / or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc., can be critical to the health of individuals with diabetes. Patients with diabetes mellitus may experience loss of consciousness and other complications, such as cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetic patients generally need to monitor their glucose levels to ensure that they are maintained within a clinically safe range, and may also use this information to determine if and when they need to lower their glucose levels with insulin or when they need to raise their glucose levels with additional glucose.
[0004] And there is growing clinical data showing 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.
[0005] For patients who rely on medication (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 dosing data to provide more actionable insights for both patients, caregivers, and healthcare professionals (HCPs). Manually logging insulin dosing is time consuming and often results in inaccurate dosing logs. Furthermore, sharing such manual logs with healthcare professionals is very cumbersome for patients and creates workflow challenges.
[0006] Diabetes care management often requires the use of multiple medications with different delivery frequencies (i.e., daily, weekly, etc.) and routes of administration (oral vs. injection). However, managing the combination of medications, delivery frequencies, and routes of administration is difficult and places a high cognitive load on users, which often leads to poor concordance of the medication regimen. Studies have shown that insulin-dependent type 1 diabetes patients miss up to 24% of mealtime bolus doses of rapid-acting insulin and 36% of once-daily basal doses of long-acting insulin, which leads 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 the willingness of users 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, makes it possible to automatically log dosing in a companion application on the mobile phone without user interaction. However, while this method is useful for daily management, it has two notable shortcomings: (1) it does not directly correlate with blood glucose progression, and (2) insulin dosing is often displayed in a tabular format that is difficult to understand and interpret over long timescales. Summary of the Invention [Problem to be solved by the invention]
[0007] For the above reasons and others, there is a need for improved systems, methods, and devices relating to integrated systems for diabetes management. [Means for solving the problem]
[0008] Exemplary embodiments of systems, devices, and methods related to diabetes management are provided herein. The embodiments include an integrated management system (IMS) that includes an analyte monitoring device, a drug 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 the drug delivery device (e.g., an insulin pen) are communicatively coupled to the reading device to facilitate transfer of information such as analyte data and administration logs to a computing device that includes 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 drug delivery device to the monitoring software (e.g., on the reading device) and transfer information such as administration logs from the drug delivery device. The integrated system also includes reporting software that may generate multiple reports incorporating data regarding analyte values and metrics and administered drug amounts and metrics.
[0009] The method addresses both of these concerns by utilizing glucose data as an indicator of poor drug concordance and presenting the data in a manner that allows a skilled medical professional to quickly identify poor drug concordance conditions that may lead to glycemic compromise. In some embodiments, glucose data may be the only indicator of poor drug concordance.
[0010] 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, all of which are intended to be included herein, be within the scope of the subject matter described herein, and be protected by the accompanying claims. Features of the exemplary embodiments are not to be construed as limiting the scope of the appended claims, unless expressly recited in the appended claims.
[0011] Details of the subject matter described herein, both in structure and operation, will become apparent from a study of the accompanying drawings, in which like reference numerals refer to like parts throughout the drawings. Additionally, the drawings do not necessarily illustrate components to scale, with emphasis instead being placed upon illustrating the principles of the subject matter. Additionally, the drawings are intended to convey concepts, and detailed attributes such as relative size and shape may be shown diagrammatically and not precisely. [Brief description of the drawings]
[0012] [Figure 1A] Block diagram of an exemplary embodiment of an integrated management system [Figure 1B] 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] FIG. 1 is a schematic diagram illustrating an exemplary embodiment of a drug delivery device. [Figure 3B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a drug delivery device. [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. [Diagram 5] FIG. 1 is a block diagram illustrating an exemplary embodiment of a user interface device. [Figure 6] 1 is a flow diagram illustrating a user experience of an exemplary embodiment of an integrated management system; [Figure 7] Flow diagram showing the user experience of adding a medication delivery device to the integrated management system [Figure 8A] FIG. 1 is a block diagram illustrating an example embodiment of a "snapshot" report. [Figure 8B] FIG. 1 illustrates an example embodiment of a "snapshot" report. [Figure 8C] FIG. 1 illustrates an example embodiment of a "snapshot" report. [Figure 9A] A block diagram illustrating an example embodiment of a "Weekly Summary" report. [Figure 9B] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9C] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9D] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9E] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9F] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 9G] FIG. 13 illustrates an example embodiment of a "Weekly Summary" report. [Figure 10A] A block diagram illustrating an example embodiment of a "Daily Log" report. [Figure 10B] FIG. 13 illustrates an example embodiment of a "Daily Log" report. [Figure 10C] FIG. 13 illustrates an example embodiment of a "Daily Log" report. [Figure 11A] A block diagram illustrating an example embodiment of an Intraday Pattern report. [Figure 11B] FIG. 13 illustrates an example embodiment of a "Day Pattern" report. [Figure 11C]FIG. 13 illustrates an example embodiment of a "Day Pattern" report. [Figure 11D] FIG. 1 illustrates an exemplary embodiment of an "Intraday Pattern" report GUI that may be displayed on a display device. [Figure 11E] FIG. 1 illustrates an exemplary embodiment of an "Intraday Pattern" report GUI that may be displayed on a display device. [Figure 12A] A block diagram illustrating an example embodiment of a "Mealtime Patterns" report. [Figure 12B] FIG. 1 illustrates an example embodiment of a "Mealtime Patterns" report. [Figure 12C] FIG. 1 illustrates an example embodiment of a "Mealtime Patterns" report. [Figure 13A] A block diagram illustrating an example embodiment of a "Device Details" report. [Figure 13B] FIG. 1 illustrates an example embodiment of a "Device Details" report. [Figure 14] Block diagram illustrating an exemplary embodiment of an AGP report [Figure 15A] FIG. 1 is a block diagram illustrating an example embodiment of a patient dashboard GUI. [Figure 15B] FIG. 1 illustrates an example embodiment of a patient dashboard GUI. [Figure 16A] FIG. 1 is a block diagram illustrating an example embodiment of a GUI associated with a data source modal for associated pens. [Figure 16B] FIG. 1 illustrates an example embodiment of a GUI associated with a data source modal for associated pens. [Figure 17A] FIG. 1 is a block diagram illustrating an example embodiment of alerts related to an associated insulin pen. [Figure 17B] FIG. 1 illustrates an example embodiment of alerts related to a linked insulin pen. [Figure 18A] A block diagram illustrating an exemplary embodiment of an "AGP Comparison" report. [Figure 18B] A block diagram illustrating an exemplary embodiment of an "AGP Comparison" report. [Figure 18C] Figure 1 shows an example AGP showing all data [Figure 18D] Figure 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] FIG. 1 illustrates an exemplary embodiment of a GUI for use in managing a user's associated medication delivery devices and monitoring applications. [Figure 20F] FIG. 1 illustrates an exemplary embodiment of a GUI for use in managing a user's associated medication delivery devices and monitoring applications. [Figure 21A] FIG. 1 illustrates an exemplary embodiment of a GUI for use in downloading and viewing administration records. [Figure 21B] FIG. 1 illustrates an exemplary embodiment of a GUI for use in downloading and viewing administration records. [Figure 21C] FIG. 1 illustrates an exemplary embodiment of a GUI for use in editing a drug dose. [Figure 21D] FIG. 1 illustrates an exemplary embodiment of a GUI used to prompt a user to learn about drug delivery device integration. [Figure 22] FIG. 1 illustrates an exemplary embodiment of a GUI for use in customizing the name of a medication delivery device. [Figure 23A] FIG. 1 illustrates an exemplary embodiment of a GUI for use in a transfer data error application. [Figure 23B] FIG. 1 illustrates an exemplary embodiment of a GUI for use in a transfer data error application. [Figure 23C] FIG. 1 illustrates an exemplary embodiment of a GUI for use in a transfer data error application. [Figure 24A] FIG. 13 illustrates an example embodiment of an “Insulin Summary” report GUI. [Figure 24B] FIG. 13 illustrates an example embodiment of an “Insulin Summary” report GUI. [Figure 24C] FIG. 13 illustrates an example embodiment of an “Insulin Summary” report GUI. [Diagram 25] FIG. 1 illustrates an exemplary method for displaying a missed meal dose alert or message. [Figure 26] FIG. 1 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. 13 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28B] FIG. 13 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28C] FIG. 13 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28D] FIG. 13 illustrates an example embodiment of a "Daily View" report GUI. [Figure 28E] FIG. 13 illustrates an example embodiment of a "Daily View" report GUI. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] 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, and 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.
[0014] In general, 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 smart insulin pen, associated with the glucose sensor, software for receiving and processing data from the glucose sensor and the smart delivery system, and a viewing platform for identifying and visualizing dosing profiles. The integrated management system can also include reports that include insights into the effectiveness of various insulin doses and treatment advice, including recommended dosing information.
[0015] The integrated diabetes management may 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 may be owned by a user or a medical practitioner, who may interact with the computing device via a user interface. According to some embodiments, the computing device may be a server or trusted computer system accessible over a network, and the integrated management software may be presented to the user in the form of an interactive web page. In such a case, the presentation of the interactive web page may be via a browser running on a local display device (having a user interface) in communication with the server or trusted computer system over a network. In embodiments such as those described above, the integrated management software may be executed across multiple devices, or may 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 of an integrated management system performing an action, one of ordinary skill in the art will understand that such action is performed in accordance with 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 not via instructions stored in memory, but rather by hardware (e.g., dedicated circuitry) that is hardwired to effect the action.
[0016] Further, in this specification, a system in which the integrated management system is implemented can be referred to as an integrated management system. The integrated management system can be configured for the sole purpose of providing integrated management, or can be a multi-function system having only one aspect of providing integrated management. For example, in some embodiments, the integrated management system can further have the function of monitoring a user's test substance values. In some embodiments, the integrated management system can further have the function of delivering a drug to a user, such as by using an injection device or an infusion device. In some embodiments, the integrated management system can have both the function of monitoring a test substance and the function of delivering a drug.
[0017] 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 the embodiments of the present disclosure are described in further detail below.
[0018] 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.
[0019] Exemplary embodiments of the 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 test substances, calculate and display analytical results, and provide treatment recommendations. This multi-functional example illustrates the high level of interconnectivity and performance provided by the system 100.
[0020] In this example, the 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.
[0021] The system 100 is configured to allow highly interconnected and highly flexible communication between the devices. The three devices 102, 120, 152 can communicate directly with each other (without any electronic device in between) or indirectly with each other (through the cloud network 190 or through other devices and the network 190, in that order). In FIG. 1A, the bidirectional communication capabilities between the devices and between the devices and the network 190 are shown with bidirectional arrows. However, those skilled in the art will understand that any one of the one or more devices (e.g., sensor control devices) can also perform unidirectional communication, such as broadcast, multicast, or advertisement communication. Whether bidirectional or unidirectional, in either case, the communication can be wired or wireless. Also, the protocols governing the communication of each path can be the same or different, proprietary or standard. For example, wireless communications between devices 102, 120, 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, etc. 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 any 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 mobile telephony). It is noted that an embodiment of system 100 need not necessarily have communication capabilities that cover all of the paths shown in FIG. 1A.
[0022] 1A shows one each of the display device 120, the sensor control device 102, and the drug delivery device 152, those skilled in the art will appreciate that the system 100 may include a plurality of any of these devices. For example, and by way of example only, the system 100 may include a single sensor control device 102 in communication with multiple (e.g., two, three, four, etc.) display devices 120 and / or multiple drug delivery devices 152. Alternatively, the system 100 may include multiple sensor control devices 102 in communication with a single display device 120 and / or single drug delivery device 152. Furthermore, when multiple devices are included, the types of each device 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, smart watches, etc., and each display device 120 may be capable of communicating with either or both of the sensor control device 102 and the drug delivery device 152, as well as between the display devices 120.
[0023] The test substance data may be transferred between devices in the system 100 autonomously (e.g., automatically according to a schedule) or in response to a request for the test substance data (e.g., a first device sends a request for the test substance data to a second device, which then sends the test substance data to the first device). Other data communication techniques may also be employed to accommodate more complex systems, such as a cloud network 190.
[0024] 1B is a block diagram showing another exemplary embodiment of the integrated management system 100. In this example, the system 100 includes a sensor control device 102, a drug 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 by a cloud network 190. The sensor control device 102 and the drug delivery device 152 are configured to communicate with each other and with the display device 120-1, which can function as a communication hub for aggregating information from the sensor control device 102 and the drug delivery device 152, processing the aggregated information, displaying the aggregated information at 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 drug delivery device 152, or both. The computer system 170 may be a suitable data processing device such as a personal computer, a server terminal, a notebook computer, or a tablet terminal. The computer system 170 may include or present software for data management, data analysis, and data communication with components in 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. Although FIG. 1B shows one sensor control device 102, one drug delivery device 152, and two display devices 120-1 and 120-2, a person skilled in the art will understand that the system 100 may include a plurality of any of these devices, and when a plurality of devices are included, the types of each device may be the same or different among the plurality of devices.
[0025] 1B, according to some embodiments, the trusted computer system 180 may be located under the ownership of a manufacturer or distributor of the components of the system 100, either physically or virtually through a secured connection. The trusted computer system 180 may be utilized to authenticate the devices of the system 100 (e.g., devices 102, 120-n, 152) to securely store user data, and may also be used as a server to provide data analysis programs (e.g., accessible via a web browser) to perform analysis of the user's analyte measurement data and medical history. Furthermore, the trusted computer system 180 may also function as a data hub for data routing and data exchange between all devices that communicate with the system 180 via the cloud network 190. In other words, all devices of the system 100 that are configured to communicate with the 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 the system 100 that are configured to communicate with the cloud network 190.
[0026] In the figure, the display device 120-2 is shown in communication with the cloud network 190. In this example, the device 120-2 may be owned by another user authorized to access the analyte and medication data of the wearer of the sensor control device 102. For example, the owner of the display device 120-2 may be, in one example, a parent of a child wearing the sensor control device 102, or, in another example, a caregiver of an elderly patient wearing the sensor control device 102. The system 100 may be configured to communicate the analyte and medication data about the wearer via the cloud network 190 (e.g., communicating via the trusted computer system 180) to other users authorized to access the data.
[0027] 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 a user's analyte data. Exemplary embodiments of such devices and methods of use are described in WO 2018 / 152241 and U.S. Patent Application Publication No. 2011 / 0213225, the entire contents of which are incorporated herein by reference for any purpose.
[0028] Analyte monitoring can occur 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 from a sensor control device to a display device (e.g., automatically, according to a schedule) with or without prompting. Another example is a "Flash Analyte Monitoring" device (e.g., a "Flash Glucose Monitoring" device, or simply "Flash" device), which can transfer data from the sensor control 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.
[0029] Analyte monitoring devices that utilize sensors configured to be placed 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 such that at least a portion of the sensor is in contact with bodily fluid (e.g., interstitial fluid ("ISF"), such as dermal fluid in 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, optical). Some systems that utilize in vivo analyte sensors may operate without the need for finger-prick calibration.
[0030] 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 accurately, "ex vivo"). Typically, an in vitro system includes a port for receiving an analyte test strip carrying 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 non-invasively, 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 include in vitro capabilities (e.g., an in vivo display device that also includes a test strip port).
[0031] The subject matter will be described below through a description of a sensor configured to measure glucose concentration, however, the detection and measurement of other analyte concentrations are within the scope of the present disclosure. These other analytes may include, for example, ketones, lactate, oxygen, hemoglobin A1C, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormone, hormones, peroxides, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, troponin, and the like. Drug concentrations may also be monitored, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), 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.
[0032] 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 mentioned above.
[0033] 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 the 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 in the user's body together 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 in 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 is placed outside the body, such as on the body. In other embodiments, the sensor control device 102 may be configured to be located outside the body and to non-invasively measure the analyte value of the user. Depending on the actual implementation or embodiment, the sensor control device may 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, to name just a few examples.
[0034] In some embodiments, the sensor control device 102 includes a user interface (e.g., a touch panel) and is 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 directly in the sensor control device 102, in whole or in part. However, in many embodiments, it may be desirable to have a display device interconnected to the sensor control device that allows a user to ascertain the analyte values, either to minimize the physical form factor of the sensor control device 102 (e.g., to minimize the portion of the sensor control device that is visible on the user's body) or because the sensor control device may not be accessible to the user (e.g., the entire device may be implanted).
[0035] FIG. 2A is a side view of an exemplary embodiment of a sensor control device 102. The sensor control device 102 may include a housing (mount) 103 for the sensor electronics (FIG. 2B), which may be electrically coupled to the analyte sensor 101, which in this example is configured as an electrochemical sensor. According to some embodiments, the sensor 101 may be configured to be placed partially inside the 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 to measure analyte-related data of the user in conjunction with the sensor electronics. The housing 103 may be secured to the user's skin using an attachment structure 105, such as an adhesive patch. The sensor 101 may extend through the attachment structure 105 and protrude outside the housing 103. Those skilled in the art will appreciate that other forms of attachment to the body and / or housing 103 may be used in addition to or instead of adhesive, and all such other attachment forms are within the scope of the present disclosure.
[0036] 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 place all or part of the analyte sensor 101 through the outer surface of the user's skin and into contact with the user's bodily fluids. The insertion device can also place the sensor control device 102 on the skin in a similar manner. In other embodiments, the insertion device can first place the sensor 101, and then the associated electronics (e.g., wireless transmission circuitry, data processing circuitry, etc.) can be coupled to the sensor 101 (e.g., inserted into a mount). Such coupling of electronics can be done 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 by reference herein for any purpose.
[0037] 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 may be implemented on one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), a processor or controller, memory, 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 clocks to each component of the sensor control device 102), and communication circuitry 116. The AFE 110 is configured to provide an analog interface with the sensor 101 and convert the signal from analog to digital (e.g., with an A / D converter), digital to analog, or both. The power source 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.
[0038] 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.
[0039] 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 many different chips (and portions thereof). The processing circuitry 112 may include on-board memory. The processing circuitry 112 may interconnect with the communication circuitry 116 to perform functions such as analog-to-digital conversion, encoding and decoding processes, digital signal processing, and the like that aid in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature). The processing circuitry 112 may also interconnect with the communication 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.
[0040] 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 final analyte values. 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 predefined time window, a calculated rate of change of the analyte value within a predefined time window, and a determination of whether the calculated analyte metric exceeds a predefined threshold condition. The instructions may also cause the processing circuitry 112 to read and process received transmissions, adjust the timing of the timing circuitry 115, process data or information received from other devices (e.g., calibration, encryption, or authentication information received from the display device 120), perform tasks to establish and maintain communications with the display device 120, recognize voice commands from a user, and transmit using the communications circuitry 116. In embodiments in which the sensor control device 102 includes a user interface, the instructions may also cause the 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. It should be noted that while the above functionality is described as being coded into the instructions, such functionality may instead be implemented in the sensor control device 102 using hardware or firmware designs that are capable of providing functionality without relying on the execution of stored software instructions.
[0041] The memory 114 may be shared by one or more of the various functional units present in the sensor control device 102, or distributed among two or more of them (e.g., as separate memories present in different chips). The memory 114 may also be a separate chip in itself. The memory 114 is a non-transitory memory and may be a volatile memory (e.g., RAM, etc.) and / or a non-volatile memory (e.g., ROM, Flash memory, F-RAM, etc.).
[0042] The communications circuitry 116 may be implemented as one or more components (e.g., communications circuitry such as transmitters, receivers, transceivers, passive circuits, encoders, decoders, 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.
[0043] The power source 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 source 111, boost power, convert DC, etc.
[0044] Additionally, a temperature sensor (optional) (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 a temperature measurement 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 measurement before being output to the user.
[0045] Exemplary embodiments of a drug delivery device The medication delivery function of the integrated management system 100 can be realized by including one or more medication delivery devices (MDDs) 152. The medication delivery device 152 can be any device configured to deliver a particular medication. The medication delivery device 152 can 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 can be configured as a portable injection device (PID) that can deliver a single dose, such as a bolus dose, in one injection. A portable injection device is basically a manually operated syringe, where the medication must be pre-loaded or drawn into the syringe from a container before injection. However, in many embodiments, the portable injection device includes electronics for interacting with the user to deliver the medication. The portable injection device is often referred to as a medication pen, but does not necessarily have to look like a pen. Portable injection devices that have user interface electronics are also often referred to as smart pens. Portable injection devices can be used for a single administration and then disposed of, or can be durable enough to be reused for multiple administrations over the course of a day, week, or month. Portable injection devices are popular among users of multiple daily injection (MDI) therapy.
[0046] 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 in 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 is left implanted for 2-3 days or longer. The pump device includes electronic components for interacting with the user to control the slow infusion of the drug. In both the portable injection device and the pump, the drug may be stored in a drug reservoir.
[0047] The drug delivery device 152 may function as part of a closed loop system (e.g., an artificial pancreas system that may operate without user intervention), a semi-closed loop system (e.g., an insulin loop system that may operate with little to no user intervention, such as confirming dosage changes), or an open loop system. For example, the sensor control device 102 may automatically monitor analyte levels in a diabetic patient on a repetitive basis and transmit that information to an application for incorporation into various analyses and reports.
[0048] In many embodiments, the integrated management system can include data on 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 mixed insulin), and the drugs 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 preparations. There are also premixed formulations of insulin. However, the integrated management embodiments and drug delivery functions of the drug delivery device 152 described herein can be applied to other drugs besides 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 therapy, including, but not limited to, insulin and glucagon-like peptide 1 receptor agonists (GLP-1RAs) and insulin and pramlintide.
[0049] For ease of describing the integrated management embodiments, the drug 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 drug delivery device 152 may alternatively be configured as a pen cap, a pump, or any other type of drug delivery device.
[0050] In some embodiments, the integrated management system can include an associated pen cap, which, when attached to an insulin pen, pairs with the display device, and after pairing, can automatically transmit administration data from the associated pen cap to the display device, for example via "BLUETOOTH", every time insulin is administered.
[0051] FIG. 3A is a schematic diagram illustrating an exemplary embodiment of a drug delivery device 152 configured as a portable injection device, specifically a smart pen. The drug delivery device 152 may include a housing 154 for electronics, an injection motor, and a drug reservoir (see FIG. 3B) from which a drug may be delivered through a needle 156. The housing 154 may include a removable cap or cover 157 that protects the needle 156 when not in use and can be removed for subsequent injections. The drug delivery device 152 may also include a user interface 158. The user interface 158 may be implemented as a single component (e.g., a touch panel for outputting information to a user and receiving input from the user) or multiple components (e.g., a combination of a touch panel or display and one or more buttons, switches, etc.). The drug delivery device 152 may also include an actuator 159. Actuator 159 can be moved, depressed, touched, or otherwise actuated to initiate delivery of the drug from the on-board reservoir through needle 156 and into the recipient's body. In some embodiments, cap 157 and actuator 159 can also include one or more safety mechanisms to prevent removal or actuation to reduce the risk of health hazards from drug 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 any purpose.
[0052] FIG. 3B is a block diagram illustrating an exemplary embodiment of a drug delivery device 152 having an electronic component 160. In the figure, the electronic component 160 is coupled to a power source 161 and a motorized injection motor 162, which is coupled to the power source 161 and a drug reservoir 163. Although the needle 156 is shown in fluid communication with the reservoir 163, there may be a valve (not shown) between the reservoir 163 and the needle 156. The 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 drug. The electronic component 160 may be implemented on one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), a processor or controller, a memory, a programmable gate array, etc.). In the embodiment of FIG. 3B, the electronic component 160 may comprise multiple higher-order 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 drug delivery device 152 (e.g., the display device 120) in a wired, wireless, or both manner.
[0053] The drug delivery device 152 can be implemented with a high degree of interconnectivity, i.e., a power source 161 is coupled to each component shown in Fig. 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) can be communicatively coupled to every other component responsible for such functionality, e.g., via one or more communication connections (i.e., bus) 169.
[0054] 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 many different chips (and portions thereof). The processing circuitry 164 may include on-board memory. The processing circuitry 164 may interconnect with the communication circuitry 166 to perform functions such as analog-to-digital conversion, encoding and decoding processes, digital signal processing, and the like that aid in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature). The processing circuitry 164 may also interconnect with the communication circuitry 166 to perform functions in the opposite direction, i.e., functions necessary to receive wireless transmissions and convert them into digital data or information.
[0055] The processing circuitry 164 may execute software instructions stored in the memory 165. These instructions may cause the processing circuitry 164 to receive a selection or designation of a designated dose from a user (e.g., input via the user interface 158 or received from another device), process commands (e.g., signals from the actuator 159) to deliver the designated dose, and control the 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 the display device 120), perform tasks to establish and maintain communication with the display device 120, recognize voice commands from the user, and transmit using the communication circuitry 166. In embodiments in which the drug 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 drug dose to be administered or input to accept a recommended dose), display information on the user interface, format data for display, etc. Although the above functionality has been 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.
[0056] The memory 165 may be shared by one or more of the various functional units present in the drug delivery device 152, or distributed among two or more of them (e.g., as separate memories present in different chips). The memory 165 may also be a separate chip in itself. The memory 165 is a non-transitory memory and may be a volatile memory (e.g., RAM, etc.) and / or a non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).
[0057] 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.) for each communications path or link that performs a function for communication over that 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.
[0058] The power source 161 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 source 161, boost power, convert DC, and so on.
[0059] 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.
[0060] Exemplary embodiments of a display device The display device 120 can be configured to display information regarding the system 100 to a user and to accept or receive input from the user regarding the system 100. The display device 120 can display recent test substance measurements to the user in any number of formats. The display device can display the user's past test substance values and other metrics representative of the user's test substance 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, date and time of dosing, etc. The display device 120 can display notifications, such as alarms or alerts, regarding the test substance values and drug delivery.
[0061] The display device 120 may be a dedicated device for the system 100 (e.g., an electronic device designed and manufactured primarily to interface with analyte sensors and / or drug delivery devices), or may be a multi-function general-purpose computing device. Examples of such multi-function general-purpose computing devices include handheld or portable mobile communication devices (e.g., smartphones or tablet terminals), or computing devices such as laptops, personal computers, etc. The display device 120 may 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.
[0062] 4A is a schematic diagram illustrating an exemplary embodiment of a display device 120. In this example, the display device 120 includes a user interface 121 and a housing 124 that holds the display device electronics 130 (FIG. 4B). The user interface 121 may 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, the user interface 121 includes a touch panel display 122 (configured to display information and / or graphical images and to receive user input via touch) and input buttons 123, both of which are coupled to the housing 124.
[0063] The display device 120 may store thereon (e.g., by a manufacturer or by a user in the form of a software package, such as one or more "apps"), software that interfaces with the sensor control device 102, the drug delivery device 152, and / or a user. 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.
[0064] FIG. 4B is a block diagram illustrating an exemplary embodiment of a display device 120 including display device electronics 130. In this example, the 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 each component of the display device 120). The 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.). The communication circuitry 126 is configured for one-way or two-way communication with one or more other devices external to the display device 120. Each of these components may be implemented as one or more devices individually, or may be combined into a multi-function device (e.g., the processing circuitry 131, memory 125, and communication circuitry 126 integrated on a single semiconductor chip). Display device 120 may be implemented with a high degree of interconnectivity, 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, communication circuitry 126, timing circuitry 128) may be communicatively coupled to every other component responsible for such functionality, for example, via one or more communication connections (i.e., bus) 129. It should be noted that FIG. 4B is a simplified diagram of typical hardware and functionality present in a display device, and one of ordinary skill in the art will readily recognize that other hardware and functionality (e.g., codecs, drivers, glue logic) may also be present.
[0065] The 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 many different chips (and portions thereof). The processing circuitry 131 may include on-board memory. The processing circuitry 131 may be interconnected with the communication circuitry 126 to perform functions such as analog-to-digital conversion, encoding and decoding processes, digital signal processing, and the like that aid in converting data signals into a form suitable for wireless or wired transmission (e.g., in-phase or quadrature). The processing circuitry 131 may also be interconnected with the communication circuitry 126 to perform functions in the opposite direction, i.e., functions necessary to receive wireless transmissions and convert them into digital data or information.
[0066] The processing circuitry 131 may execute software instructions stored in memory 125. The instructions may cause the processing circuitry 131 to process raw analyte data (i.e., unprocessed analyte data) to derive corresponding analyte values suitable for display to a user. The instructions may also cause the processing circuitry 131 to read, process, store, and communicate administration instructions from a user to drug delivery device 152. The instructions may also cause the 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 the user (e.g., information regarding food consumed, activities performed, medications administered, etc.), and presenting notifications and alarms to a user. The instructions may also cause the processing circuitry 131 to transmit using the communications circuitry 126, read and process received transmissions, read input from the user interface 121 (e.g., entering a drug dose to be administered or approving a recommended dosage), display information on the user interface 121, adjust the timing of the timing circuitry 128, process data or information received from other devices (e.g., analyte data, calibration information, encryption information, or authentication information received from the sensor control device 102), perform tasks to establish and maintain communications with the sensor control device 102, recognize voice commands from a user, etc. It should be noted that while the above functionality is described as being coded and included in the instructions, such functionality may instead be implemented in the display device 120 using a hardware or firmware design that is capable of realizing the functionality without relying on the execution of stored software instructions.
[0067] Memory 125 may be shared by one or more of the various functional units present in display device 120, or distributed among two or more of them (e.g., as separate memories present in different chips). Memory 125 may also be a separate 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.).
[0068] The communications circuitry 126 may be implemented as one or more components (e.g., communications circuitry such as transmitters, receivers, transceivers, passive circuits, encoders, decoders, 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.
[0069] The power source 127 may include one or more batteries, which may be rechargeable or disposable, and may include power management circuitry to control battery charging, monitor the usage of the power source 127, boost power, convert DC, etc.
[0070] Additionally, the display device 120 may further include one or more data communication ports (not shown) for wired data communication with external devices, such as the computer system 170, the sensor control device 102, or the drug delivery device 152. The 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 making in-vitro measurements of blood glucose.
[0071] 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 alarms 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 any purpose.
[0072] 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 executing on display device 120.
[0073] Thus, there are many different embodiments regarding the number and type of electronic devices used to store, execute, and present the integrated management system or portions thereof to a user. In regard to presentation to a user, a device configured to implement the presentation to a user is 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 input or receive information from the 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 an input component 206 (e.g., a button, an actuator, a touch-sensitive switch, a capacitive switch, a pressure-sensitive switch, a jog wheel, a microphone, a touch pad, soft keys, a keyboard, etc.).
[0074] Many of the devices described herein can be implemented as a user interface device 200. For example, in many embodiments, the display device 120 is utilized as the user interface device 200. In some embodiments, the drug delivery device 152 can also be implemented as a user interface device 200. Also, in embodiments in which the sensor control device 102 comprises a user interface, the sensor control device 102 can be implemented as a user interface device 200. Additionally, the computer system 170 can also be implemented as a user interface device 200.
[0075] Exemplary embodiments of integrated management system user experience As seen in FIG. 6, in the exemplary user experience method 300, in step 302, a user can check an analyte value, such as a glucose value. As described above, the user can 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. In step 304, the user administers a medication (e.g., insulin) from an associated medication delivery device 152, which can be an associated smart insulin pen, an associated pen cap, or an automated insulin delivery (AID) device in a closed loop system, as previously described. Then, in step 306, the user transfers the administration information from the medication delivery device 152 to the display device 120. This transfer can be done in any manner known in the art. For example, the display device 120 (e.g., a smartphone) can scan the associated medication delivery device 152 and transfer the information via NFC. Alternatively, the administration information can be transferred automatically without further interaction from the user. For example, the 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 that the transfer of the administration information can be expressed, and can be expressed by other similar terms such as scan, transfer, download, upload, export, import, connect, sync, pair, etc. 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 time of delivery. Next, in step 308, the user or others (e.g., caregivers, medical personnel) view a comprehensive history (which may include analyte values and medication doses) in various displays and reports for visualization and assistance of the user's diabetes care.
[0076] Before data can be transferred from the drug delivery device 152 to the integrated management system, the drug delivery device 152 must first be added to the integrated management system. FIG. 7 illustrates an exemplary method 310 for adding a drug delivery device 152 to the integrated management system and managing the associated drug delivery device 152. In the 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 drug delivery device 152 communicating with the display device 120 and can list various tasks or functions that the integrated management system performs after connecting the drug delivery device 152 to the integrated management system. Such listings can include connecting a compatible smart pen to record insulin doses, reviewing and tracking past doses, sharing reports with the user's medical team, and the like. Selecting "Let's get started" can open insulin pen settings, as seen in GUI 324 of FIG. 20A, and prompt the user to select the drug delivery device 152 they want to associate with, at step 312. The drug delivery devices 152, e.g., insulin pens, may be listed by their respective brand names. Then, once the user selects the appropriate drug delivery device and selects "Next," a graphical image or animation may be presented showing how to scan the drug delivery device 152 (e.g., insulin pen) with the display device 120 (e.g., smartphone), as seen in GUI 326 of FIG. 20B. In addition, GUI 326 may include text instructing the user to hold the insulin pen display straight up against the back of the smartphone to scan. Additionally, GUI 326 may post text indicating that the user may need to slowly move the insulin pen until the correct position is found to affect the connection / communication between the insulin pen and the smartphone.A link to the insulin pen user manual may also be provided that contains further information on how to link the insulin pen to a smartphone. If the linking is successful, a GUI 328 may appear, as seen in FIG. 20B, indicating that a new drug delivery device 152 has been added to the integrated management system. The name of the newly added drug delivery device may also be displayed in the GUI 328. If the user selects "Next", the user may be prompted to select a pen color for the newly linked drug delivery device 152 in step 314. As seen in FIG. 20C, the GUI 330 may display various color options 332. Then, if the user selects "Next" in the GUI 334 of FIG. 20C, the user may be prompted to select a type of drug that is packaged in the newly linked drug delivery device 152. If the drug 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., ultrafast-acting insulin, long-acting insulin, etc.) in a 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 the selected type of insulin 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 drug delivery device 152 is complete. The GUI 342 may also include a reminder to scan the associated drug delivery device 152 to transfer the insulin dose to the integrated management system software. The GUI 342 may also include an animation showing how to scan the drug delivery device 152 (e.g., an insulin pen) with the display device 120 (e.g., a smartphone).Additionally, the GUI can include text instructing the user to hold the insulin pen display directly towards the back of the smartphone to scan, and can also post text indicating that the user may need to slowly move the insulin pen until the correct position is found to affect the connection / communication between the insulin pen and the smartphone.
[0077] Additional drug delivery devices may be associated in a similar manner as above. The additional drug delivery devices may be assigned a different color or other identifying feature or name than the previously associated drug delivery device. For example, the drug delivery device 152 that delivers fast acting insulin may be assigned a pen color of blue, while the drug delivery device 152 that delivers long acting insulin may be assigned a color other than blue, such as red, silver, or black. The additional drug delivery device may be added under the insulin pen menu by selecting an option to add another drug delivery device (e.g., a plus sign labeled "Add insulin pen") (see reference numeral 356 in FIG. 20E).
[0078] The user may select the option "Manage your insulin pen associations" under the insulin pen menu. The user may then be presented with a window such as GUI 350 and GUI 368 in FIG. 20E. The window includes a representation of the associated medication delivery device 152 along with a description 358 indicating the type and / or brand of insulin the medication delivery device 152 delivers, and details 360 of the last scan (such as the time the scan was taken and the amount of medication delivered). As mentioned above in the description of GUI 326, the user may select the information icon "i" to display GUIs 364a, 364b as shown in FIG. 20F, which include information on how to transfer insulin logs and administration information. GUIs 364a, 364b may include an animation showing how to scan the medication delivery device 152 with a smartphone. The GUIs displayed to instruct how to scan may 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 towards the back of the smartphone to scan, and may also post text in GUI 364a, 364b indicating that the user may need to slowly move the insulin pen until the correct position is found that results in connection / communication between the insulin pen and the smartphone.
[0079] In some embodiments, the drug delivery device 152 may be a pen cap such as Dialoq® that can wirelessly transfer dosage data via “BLUETOOTH”. In that case, it may be necessary to pair the drug delivery device 152 with the monitoring application using “BLUETOOTH” rather than NFC. The monitoring application may remind 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 drug delivery device 152. The GUI may also include a picture, diagram, or animation showing where the code is located on the drug 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 drug 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 pairing. A window may be displayed on the display device 120 indicating that the drug delivery device 152 is seeking to be paired with the display device 120. Alternatively, the pairing may be completed only after the user selects "pair". Once the drug delivery device is paired with the display device 120, a GUI may be displayed displaying a confirmation of the pairing and / or setup completion.
[0080] Once the drug delivery device 152 has been associated with the monitoring software on the display device 120, the administration information is transferred from the drug delivery device 152 to the software, such as by download (e.g., via NFC or "BLUETOOTH"). As seen in Figs. 21A-21C, in the GUI 390, the monitoring software may indicate that it is ready to receive a download from the associated drug delivery device 152 (e.g., a banner or other message may be displayed indicating that the monitoring software is "ready to scan"). When the user scans the drug delivery device 152 in step 306, a window 394 may be opened indicating that a new administration has appeared in the logbook. For example, the window 394 in the GUI 390 may indicate that three administrations have been transferred from the drug delivery device to the monitoring software. The window 394 may also indicate the scanned drug delivery device 396 and the type of insulin administered 398. Additionally, after the initial scan of the drug delivery device 152, the GUI 400 as seen in Fig. 21A may be displayed. The GUI 400 allows the user to select a default insulin type that will become the default selected the next time the user scans the insulin pen.
[0081] As seen in FIG. 21B, the home screen 410 may include a button or link 412 for selecting to scan the drug delivery device 152. The home screen 410 may also include a display showing the test substance profile, a "time in range" statistic, previous test substance readings, test substance averages, a test substance readings graph over a period of time (e.g., the current day), and a display showing the current sensor life. Additionally, the home screen 410 may provide icons (e.g., a syringe icon) 414 along the test substance readings graph to indicate when various medications were administered. The location of the icon 414 along the test substance readings graph corresponds to the time the medication was administered. In some embodiments, the user may view or edit the insulin notes by tapping the syringe icon 414 on the home screen 410. The user may tap the syringe icon to view the dosage and may also tap the pencil icon to edit the entry if desired. 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, a blank syringe icon may indicate that the dose was automatically transferred from an associated drug delivery device 152. Additionally, icons indicating meals (e.g., an apple icon), exercise (e.g., a runner icon), or comments (e.g., a notepad icon) may also be displayed along or above the test substance reading graph. The icons are positioned along the time axis (x-axis) according to when meals were consumed or notes were added.
[0082] 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., in units (u)). Note that priming of the medication delivery device 152 may also be listed in the logbook. A priming dose / prime refers to the amount of medication (e.g., insulin) administered to deflate the tip of the needle. Priming may also be referred to by other similar terms, such as an airshot, flow check, or squirt. The logbook may also include notes added manually.
[0083] The monitoring application may also allow the user to edit the notes associated with a particular drug administration event. A user wishing to edit the details of an insulin administration may tap on the corresponding entry line in the logbook GUI 416. Each entry line links to a "logbook details" GUI 430, as seen in FIG. 21C. The analyte graph on the "logbook details" GUI 430 may include highlighting, such as a vertical line, representing the administration currently being viewed. If the user wishes to edit the details of a selected insulin administration, the user may tap on the edit (pencil) icon 444. This icon 444 links to an "edit notes" GUI 450, where the user may 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 priming amount) 452, insulin brand, number of units, name of delivery device, 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 the insulin brand. The user can also change the type of this dose from a therapeutic dose to a flow check (i.e., priming) amount by tapping the drop-down caret icon and selecting the "Priming (Flow Check)" option. In some embodiments, once the user indicates that this dose is a priming amount, a banner at the top of the "Edit Note" screen will indicate that this dose is a priming amount, as seen in GUI 460 in FIG. 21C.
[0084] In the event of an error, the monitoring application may prompt the user to review details of the administration that was administered. The details may include the amount administered, the type of drug, 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 details of 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 amount missed 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 the administration entry that has 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.
[0085] As seen in GUI 470 of Figure 21D, the monitoring application may also prompt the user to learn more about new features of the monitoring application via a pop-up window 472. This prompt may provide the user with information about new features that may be 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 dosage. A similar window may also pop up if the monitoring application has an update available.
[0086] The monitoring application may also allow the user to define a name for the associated medication delivery device 152. As seen in FIG. 22, the user can navigate to the insulin "Settings" GUI 480 and tap or select the "Name" field 484 to open the "Name" GUI window 486. The user can tap or select the "New Name" field 488 and type the 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.
[0087] Insights and Alerts Hints for forgetting to take a mealtime dose If a missed dose is believed to have occurred, the monitoring application may display an alert, hint, or prompt. In some embodiments, the dose data is automatically forwarded to the monitoring application via "BLUETOOTH". For example, if no dose is logged within a certain time (e.g., 1 hour, or 2 hours, or 3 hours) after the 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 rising and that the last logged dose was X hours ago. The alert may also suggest that the user sync the drug delivery device 152 to update the dose data. The alert may further suggest that the user follow the advice of a healthcare professional if a dose is missed. In some embodiments, if the alert is related to a particular meal, the alert may ask if the user missed a [breakfast / lunch / dinner] dose and may further indicate that the user typically takes this mealtime dose by X:XX (e.g., the user typically takes a lunchtime dose by 1:30 p.m.).
[0088] The user can minimize the number of alerts that pop up on his / her device by setting conditions for issuing alerts or hints that warn (suggest) that a mealtime administration is forgotten. For each of breakfast administration, lunch administration, dinner administration, and sustained-release administration, the user can specify that hints suggesting a missed administration are displayed only after a certain time. For example, the user can set that if an administration is not detected within a certain time before 10:00 a.m., a hint suggesting a breakfast administration is displayed after 10:00 a.m., if an administration is not detected within a certain time before 1:30 p.m., a hint suggesting a lunch administration is displayed after 1:30 p.m., and if an administration is not detected within a certain time before 8:00 p.m., a hint suggesting a dinner administration is displayed after 8:00 p.m.
[0089] As seen in FIG. 25, the exemplary method 1900 can begin at step 1902, where the system or application receives analyte data from the sensor control device 102. Then, at step 1904, the system can receive insulin data for the subject (e.g., from the drug delivery device 152). For example, the system or application can automatically receive insulin data wirelessly (e.g., via "BLUETOOTH") from the drug delivery device 152, such as an associated pen or an associated pen cap, without requesting insulin data. In other embodiments, the system or application can also check for the latest insulin administration data from various sources (including, but not limited to, the drug delivery device 152, a drug delivery device-related application, or an interface that stores the latest insulin delivery information (e.g., a web server of the drug delivery device application)) or by checking the latest insulin delivery information in the memory of various applications.
[0090] At step 1906, the system or application may determine whether a meal has been ingested. This may be done 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 described in U.S. Patent Application Publication No. 2021 / 0030323, U.S. Patent Application Publication No. 2021 / 0050085, and U.S. Patent Application No. 17 / 591229, the entire disclosures of which are expressly incorporated herein by reference for any purpose. 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 a meal has not been consumed, the system returns to step 1902 to receive more analyte data.
[0091] On the other hand, if the system or application determines that a meal was consumed, then in step 1908, the system may analyze the received insulin administration data to determine whether insulin administration was recorded or received during a period of time. The period of time may be about 1 hour, or about 2 hours, or about 3 hours. Optionally, the period of time may be user-configurable rather than being a system-set default period of time. If insulin administration was recorded during the period of time, then the system determines that no doses were missed and returns to step 1904 to receive further insulin administration data.
[0092] In some embodiments, the period can be set for each meal by the user by setting the appropriate time for each meal to be administered. The system can also check whether an insulin dose was recorded or received before the meal-specific time. For example, if no breakfast dose was recorded or received by 10:30 AM, the system can determine that the user missed a breakfast dose. Similarly, if the user normally administers a lunch dose by 2:30 PM, the lunch dose can be set to 2:30 PM. And if the user normally administers 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 each individual's eating habits.
[0093] 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 the missed meal dose in step 1910. In some embodiments, the text of the alert interface may be made customizable by the user.
[0094] Hints for corrective dosing The monitoring application can display an alert, hint, or prompt to the user to consider a correction dose if a certain period of time has passed since the last insulin dose and glucose levels remain high. In some embodiments, the dose data is automatically transferred to the monitoring application via "BLUETOOTH". The user can set conditions for the alert or hint to warn of a correction dose, thereby minimizing the number of alerts that pop up on their device. The user can set the alert to appear only if the glucose level is above a high threshold (e.g., about 250 mg / dL) and the period of time since the last insulin dose is above a minimum time threshold (e.g., about 2 hours).
[0095] The message displayed in the hint can also be customized by the user. For example, the message could indicate that the dose taken X hours ago (e.g. 2 hours ago) did not lower glucose levels enough and it is time to take X units of additional insulin or go for a walk in the park. The default setting could be a message encouraging the user to seek medical advice for treatment or exercise to get out of the high glucose situation.
[0096] As seen in FIG. 26, the exemplary method 1920 may begin at step 1922, where the system or application receives analyte data from the sensor control device 102. Then, at step 1924, the system or application may receive insulin data for the subject (e.g., from the drug delivery device 152). For example, the system or application may automatically receive insulin data wirelessly (e.g., via "BLUETOOTH") from the drug delivery device 152, such as an associated pen or associated pen cap, without requesting insulin data. In other embodiments, the system or application may also check the latest insulin dosing data. Such data checks may be performed by requesting delivery information from various sources (including, but not limited to, the drug delivery device 152, a drug delivery device-related application, or an interface that stores the latest insulin delivery information (e.g., a web server of the drug delivery device application), or by checking the latest insulin delivery information in the memory of various applications.
[0097] In step 1926, the system or application may determine whether the received analyte value is above an upper threshold value. The upper threshold value may be a threshold value that indicates that the user's glucose value is outside the target range. 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 more analyte data.
[0098] 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 period of time has passed since an insulin administration was recorded or received. The period of time may be about 2 hours, or about 2.5 hours, or about 3 hours. Optionally, the period of time may be user configurable rather than being a system default time. If the period of time has not passed since the last recorded insulin administration, the system returns to step 1924 to receive more insulin administration data.
[0099] 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 made customizable by the user.
[0100] 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 that may have helped the user reach their target range.
[0101] 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 be less than 180 mg / dL and the time to return to the target range after administration to be 2 hours.
[0102] As seen in FIG. 27, the exemplary method 1940 may begin at step 1942, where the system or application receives analyte data from the sensor control device 102. Then, at step 1944, the system may receive insulin data for the subject (e.g., from the drug delivery device 152). For example, the system may automatically receive insulin data wirelessly (e.g., via "BLUETOOTH") from the drug delivery device 152, such as an associated pen or associated pen cap, without requesting insulin data. In other embodiments, the system or application may also check the latest insulin dosing data. Such data checks may be performed by requesting delivery information from various sources (including, but not limited to, the drug delivery device 152, a drug delivery device-related application, or an interface that stores the latest insulin delivery information (e.g., a web server of the drug delivery device application), or by checking the latest insulin delivery information in the memory of various applications.
[0103] At step 1946, the system or application may determine whether the received analyte value is below an upper threshold value. The upper threshold value may be a threshold value 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 value, the system or application returns to step 1942 to receive more analyte data.
[0104] 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 period of time has passed since an insulin administration was recorded or received. The period of time may be about 2 hours, or about 2.5 hours, or about 3 hours. Optionally, the period of time may be user configurable rather than being a default time set by the system. If the period of time has not yet passed since the last recorded insulin administration, the system returns to step 1944 to receive more insulin administration data.
[0105] 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 a target range, at step 1950. In some embodiments, the text of the alert interface may also be made customizable by the user.
[0106] Reports The monitoring application can transfer data, including analyte values from the sensor control device 102 and dosing data / logs from the drug delivery device 152, to a reporting application. The reporting application can generate reports highlighting various aspects of the analyte and drug 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 are executed by one or more processors to generate and display reports including the insulin data in the monitoring application.
[0107] 8A-8C are diagrams illustrating an exemplary embodiment of an insulin dosage interface 502, in which the insulin dosage interface 502 is 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 period of time 504 (e.g., 14 days) and includes multiple report sections on a single report GUI. Such 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.
[0108] The AGP graph 511 may display percentiles of hourly glucose readings for a "typical" day based on all days within a selected time frame. Percentiles of glucose readings may be presented as 5th, 25th, 50th (median), 75th, and 95th percentiles. The AGP graph 511 may also include two horizontal lines that indicate the upper and lower limits of the target ranges defined in the "Glucose Statistics and Goals" and "Time in Range" sections. The report 500 may also include a section 517 that provides metrics, statistics, or both for the average glucose readings. The metrics section 517 may list the average glucose readings, 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 events graph 513 may include a graph of events in which the subject's glucose readings fell below a low threshold (e.g., 72 mg / dL). The low glucose event graph may show a graph of glucose concentration (mg / dL) versus time to show at a glance when low glucose event episodes occurred. And, 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 provide the number of low glucose events and the average duration of the low glucose events.
[0109] The sensor usage frequency interface 506 may include a sensor active time percentage graph 521 and a metric section 523. The metric section 523 may include a percentage of time the sensor was active and an average scans / views metric (e.g., showing an 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., from midnight to midnight). Note that the sensor active time percentage graph 521 may be aligned with one of the coordinate axes of one or more other graphs (e.g., the average glucose value trend graph 511 and the low glucose events graph 513). This allows a user to visually grasp the correlation between data for multiple graphs in two or more columns in the report GUI by the common units (e.g., time) on the aligned axes.
[0110] 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.
[0111] The "Insulin Administered" section 502 may include a list of drug 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 there are multiple insulin pens associated, the drug 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 indicated by a light green icon 516, and a long acting insulin pen may be indicated by a dark green icon 518.
[0112] 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 associated drug delivery device 152. The insulin dose may be entered into a monitoring or reporting application. If the insulin dose was entered manually, 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 of each insulin type, and the total daily average insulin (units / day). The rapid acting insulin dose 516 may be listed as the total dose administered (units / day), or may be broken down into mealtime doses, corrections, user overrides, and / or manual entries.
[0113] The comments interface 514 may provide spoken information about the user's test substance and dosing patterns. For example, the comments section 514 may include an indication of a trend in the number of tests per day compared to the previous reporting period, any variability detected during the reporting period, and the insulin correction amount as a percentage of the average daily dose.
[0114] The report 500 may also include a list of sources 522 of the listings. The sources 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 of the medication delivery devices and may also include the name of the first associated insulin pen and a number of other medical devices (but not the specific names of the other insulin pens).
[0115] 9A-9G illustrate an exemplary embodiment of a report GUI 600 for another analyte monitoring system that includes information regarding administered insulin amounts. According to one aspect of this embodiment, the GUI 600 is a "weekly summary" report for a time period 613, including multiple report sections separated by days of the week. The 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 the time period 613, and health information interfaces 606, 608, 610, 612. The 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.
[0116] In some embodiments, the glucose trend graphs 601a-601bb can include a sensor usage indicator to indicate that a scan, 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 use color to highlight portions of the graph that are outside of the target range by painting the area under the curve a particular color or changing the color of the portion of the graph that is outside of the target range to a particular color. The area under the curve above the target range 603 can be painted, for example, yellow or orange, and the area under the curve below the target range 605 can be painted, for example, red.
[0117] The "Low" events 612a-612bb column may list 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 coloring the area under the curve during the low event in a darker color (e.g., red).
[0118] Similarly, the health information interface 604 may also include total carbohydrate intake 608a-608bb for each day. The carbohydrate entries may be displayed in a different color, e.g., orange, and may include a different icon, e.g., an apple icon, to distinguish them from the insulin dose entries. If no carbohydrate value is available, the total carbohydrate entries 608a-608bb may be blank or may include one or more dashes. Additionally, the glucose trend graphs 601a-601bb may include carbohydrate intake. As with insulin doses, the carbohydrate amounts of various meals and snacks may be included in orange boxes and noted at or near the time of the meal or snack. If insulin is administered at or around the time of the meal (carbohydrate intake), the insulin amount may also be displayed below the carbohydrate intake on the glucose trend graph.
[0119] The insulin doses 610a-610bb column interface may include the total amount of insulin administered that day for each type of insulin. The total insulin doses for each type of insulin may be differentiated by different colors. For example, the total amount of fast acting insulin administered may be shown in a light green rectangle, and the total amount of long acting insulin administered may be shown in a dark green rectangle. If a value for the amount of insulin administered is not available, the entry for the amount of insulin administered may be displayed with one or more dashes. Individual doses of various insulins may also be listed on the glucose trend graphs 601a-601bb. For example, a dose rectangle may be displayed on the glucose trend graph at or near the time the administration occurred. The rectangle may also be color coded similar to the total amount of insulin to allow the user to quickly determine which insulin was administered. For example, the dose of fast acting insulin administered may be placed in a light green rectangle, and the dose of long acting insulin administered may be placed 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 dose was administered simultaneously with, before or after a long acting dose, the long acting dose may be displayed on the glucose trend graph below the rapid acting dose entry box. The brand name of each type of insulin administered may also be displayed in the legend 630 at the foot of the "Weekly Summary" report 600.
[0120] In some embodiments, the dosage information may be a manual amount entered by the user, rather than transferred directly from the associated drug delivery device 152. The insulin dosage may be entered into a monitoring or reporting application. If the insulin dosage was manually entered, the report 600 may include the amount of fast acting insulin delivered, but may not include the brand name of the insulin in the legend 630, and may include an icon in the legend 630 corresponding to the particular insulin type administered. In some embodiments, the dosage information may be automatically transferred from the associated delivery device. The data source field 632 may include the name of the device that provided 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 for each insulin type, and the daily total insulin average (units / day). If the insulin administration is close in time to the carbohydrate recording, 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 can include the brand name of the insulin, for example in the legend 630 .
[0121] The report may also list the data source 632, including the name of the device that provided the analyte data values and the name of the primary drug 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 (a numerical value).
[0122] 10A-10C illustrate an exemplary embodiment of a report GUI 700 of another analyte monitoring system that includes information regarding multiple types of insulin administered as a "Daily Log" report. According to one aspect of this embodiment, the 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 a 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 of report 700, including graphs and information for the first three days of the 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 marks to indicate that a scan, view, or both occurred at a particular time during the 24-hour period. In some embodiments, the glucose values scanned or viewed 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 marks, such as carbohydrate intake log marks and insulin dose log marks, and glucose event marks, such as a low glucose event mark. Additionally, report 700 may include multiple rows containing additional information below the glucose trend graphs 702a-702c, such as rows 704a-704c corresponding to "Scan / View," rows 706a-706c corresponding to "Carbohydrates," rows 708a-708c corresponding to "Insulin Administered," and rows 710a-710c corresponding to "Notes."In the "Scan / View" rows 704a-704c, notable glucose values can be noted in a location that corresponds to the time the glucose value was logged. For example, if a glucose bout occurs that exceeds the target range, the peak glucose value can be color coded in a first color, such as orange, and if a hypoglycemic bout occurs, the low glucose value can be color coded in a second color, such as red. In the "Carbs" rows 706a-706c, the amount of carbohydrates can be noted in a location that corresponds to the time the carbohydrates were logged.
[0123] Regarding the "Insulin Administered" rows 708a-708c, the amount of insulin injected can be displayed in hourly blocks in the rows below each glucose trend graph 702. A separate row can be displayed for each drug delivery device. For example, as shown in FIG. 10C, the insulin dose from the fast acting insulin pen can be displayed in a first row, and the insulin dose from the insulin pen containing the long acting insulin can be displayed in a separate row. The row for the long acting insulin dose can then be displayed below the row for the fast acting insulin dose. The fast acting insulin dose can be displayed as a white rectangle surrounded by a black border. User corrections or changes can be displayed before the dose. Meanwhile, the long acting insulin dose can be displayed as a dark green rectangle. The data source field 754 can include the name of the device providing the test substance data value, the name of the first linked insulin pen, and the number of other glucose measuring devices integrated into the data.
[0124] In some embodiments, the insulin doses may not be transferred directly from the linked drug delivery device 152, but may instead be entered manually by the user or calculated using a dose calculator. The insulin doses may be entered into a monitoring or reporting application. If the insulin doses were entered manually, the Daily Log report may include the rapid and long acting insulin 618 doses, but may not include the brand name of the insulin next to each icon. In some embodiments, the dose information may be transferred automatically from the linked delivery device. The data source field 754 may include the name of the device that provided 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. A row for a particular type of insulin may only be displayed if data for that type of insulin was entered on that day. If there is no data for a type of insulin on that day, the row for that type of insulin may not be displayed below the glucose trend graph 702. A color-coded icon and insulin brand or type may also be displayed next to the insulin dose rows beside the glucose trend graphs 702a-702c. As with other report embodiments, different icons and colors may be used between fast acting and long acting insulin pens. For example, fast acting insulin may be represented by a light green filled syringe icon, whereas long acting insulin may be represented by a dark green filled syringe icon. A row may be displayed on a particular day only if there is insulin administration data for that day. Also, if a user switches insulin brands for linked pens, a note to that effect may be included in the "Daily Log" report 700 for the day the switch was made. The note displayed when the insulin brand is changed may include the insulin brand name before and after the change.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.
[0125] "Notes" rows 710a-710c may also be included in the "Daily Log" report 700. The notes may contain text that adds information about the event. The text may appear in the "Notes" row at the location that corresponds to the time the note was logged.
[0126] 11A-11D are diagrams illustrating an exemplary embodiment of a "Daily Pattern" report GUI 770. The "Daily Pattern" report 770 includes an ambulatory glucose profile 772 of the user, 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 day or 24 hour period, with glucose measurements organized by time, for example, over a multi-day period 771, such as a 14 day period (see FIG. 11B), a 28 day period (see FIG. 11C), etc. The glucose measurements can be displayed as individual points or can be averaged and displayed in 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, as well as 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 have a display of daily average glucose values 785. Above the ambulatory glucose profile 772 may be a line 773 listing average glucose values by time period. The time periods may be about 2 hours, or about 3 hours, or about 4 hours in duration. Also, notable glucose values (e.g., the highest average glucose values) may be highlighted in different colors to help the user easily see which time periods had the highest glucose values.
[0127] In addition to glucose measurements, the "Daily Pattern" report 770 may 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 amount of carbohydrate (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 carbohydrate consumed 794 during a particular time period 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).
[0128] The Insulin Dosage by Insulin Type section 778a, 778b of the Daily Pattern report 770 may include one row for each type of insulin administered via the associated drug delivery device 152, for example, an upper row 778a for ultra rapid acting insulin and a lower row 778b for long acting insulin. The Insulin rows 778a, 778b may include, for each type of insulin (ultra rapid or fast-acting 802 (including "other insulin") and long acting 804), an icon representing the type of insulin, average daily dose 803, 805, average dose for each time period, and number of entries for that time period (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 represent an insulin pen filled with fast acting insulin and a dark green syringe icon may be used to represent 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.
[0129] In some embodiments where only one insulin pen is associated, 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 associated, the data source field 812 may include only the name of the device that provided the analyte data value and the name of the associated insulin pen, and no numbers to indicate association with any other devices.
[0130] In some embodiments, the insulin dosages can be entered into a monitoring or reporting application. If the insulin dosages were entered manually, the Daily Pattern report 770 can include the rapid and long acting insulin dosages, but without the brand name of the insulin near each icon. In some embodiments, the dosage information can be automatically transferred from the associated delivery device. The data source field 812 can include the name of the device that provided the analyte data values and the number of other glucose measuring devices integrated into the data, but can not include the name of the individual insulin pen. The number of units per day of each insulin type and the average total insulin amount per day (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.
[0131] 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-d that may be selected to be displayed instead of the time period. The ambulatory glucose profile 772 is as described in detail in the other embodiments and reports. The ambulatory glucose profile 772 may also indicate how many days of the time period 771 were available for glucose data. The ambulatory glucose profile 772 may also include a syringe above or below the graph to indicate the time the dose was administered. Alternatively, the dose may be graphed along the median line of the ambulatory glucose profile to indicate what time the dose was administered. The insulin summary section 1778 may include a graph showing the amount of insulin administered during the time period 771. In some embodiments, the graph may be a bar graph of the average number of insulin units administered versus time (x-axis). The graph may include both fast acting insulin doses and basal doses. The insulin summary section may also show how many days of the time period 771 were available for administration data. The x-axis (time) of the insulin summary section 1778 graph may be aligned with the x-axis (time) of the ambulatory glucose profile 772, and the graph may show the average doses and basal doses per meal at the respective average administration times. Each average administration time is the average over the time period 771 of the times the administrations were administered. Thus, the user may easily see the correlation between the insulin doses and the glucose profile for the associated time period for each insulin administration.The GUI 1700 may also include tabs 1774a-d with various time periods that a user may select for which to display the "Intra-Day Pattern" report. For example, the time period tabs 1774a-d may be 1 day, 7 days, 14 days, 30 days, or 90 days.
[0132] Alternatively, the user may select a time period in a drop down menu 1775, as seen in GUI 1720 of FIG. 11D. In such a case, GUI 1700 may include a date range 1775, and the user may scroll forward or backward in time by tapping on the forward or backward caret icons. In some embodiments, if the user selects "1 day" as the time period, an intraday graph may be displayed showing glucose and insulin data for the individual day selected. The intraday graph may display the glucose profile for that day instead of the ambulatory glucose profile, while simultaneously highlighting the user's goal range. The glucose profile graph may also include a syringe icon above or below the graph showing the time when insulin was administered. Alternatively, the doses may be graphed along the median line of the glucose profile, showing what time they were administered. The insulin summary section may display a graph showing the amount of insulin administered for that day (rather than the average doses over a multi-day period). In some embodiments, the graph may be a bar graph of the number of insulin units administered versus time (x-axis). The graph can include both fast 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, and the graph can show meal doses and basal doses at their respective time of administration. Thus, each bar in the bar graph and the syringe icon in the glucose profile graph would be aligned at the same time.
[0133] If the user requests more information (e.g., by tapping the "i" icon), window 1800 may be displayed, as shown in FIG. 11E. Window 1800 includes a description 1806 that the "Diurnal Pattern" report shows the user's glucose and insulin patterns over a period of time. Window 1800 may also include a target range (e.g., 70-180 mg / dL). The user may also select the type of insulin data they wish to view (either rapid acting 1802 or long acting 1804).
[0134] 28A-28D illustrate an exemplary embodiment of a report GUI 2000 of another analyte monitoring system that includes information regarding 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 amount of rapid acting insulin administered items 2014a-2014g, total amount of long acting insulin administered items 2016a-2016g, and total amount of carbohydrates ingested items 2018a-2018g for each day in a period of time 2002. The period of time 2002 can be a week or a number of 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 7 days of the period. The "Daily View" report GUI 2000 can also list the times 2020 the sensors were 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 sources 2026 of the data used in report 2000.
[0135] The glucose profiles 2010a-g may include the user's glucose values over a 24-hour period. In some embodiments, the glucose profiles 2010a-g may also optionally include a sensor usage indicator (e.g., a circle) 2066 to indicate that a scan, a view, or both occurred at a particular time during the 24-hour period. In some embodiments, the glucose value scanned or viewed may be noted 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 a 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. The portions of the graph that are outside the target range 2056 may be color coded to further highlight readings (analyte values) that are outside the target range 2056. The color coding may correspond to colors used in other reports to represent "time in range" graphs. For example, the portions of the graph that are above the target range 2056 and have "high" levels (e.g., 181-250 mg / dL) may be color coded yellow. Meanwhile, the portions of the graph that are below the target range 2056 and have "low" levels (e.g., 54-69 mg / dL) may be color coded red. Additionally, the portions of the graph that are below the target range 2056 and have "very low" levels (e.g., <54 mg / dL) may be color coded dark red or maroon. The color coding may 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) with a particular color or by changing the relevant portion of the graph to a particular color.
[0136] Optionally, the glucose profiles 2010a-2010g may also include event log marks, such as an exercise event record 2064, a carbohydrate intake log mark, an insulin dose log mark, and glucose event marks, such as a low glucose event mark, etc. The event log marks may be written above or below the glucose graph at the time the event was logged.
[0137] As seen in FIGS. 28B-E, in some embodiments, instead of including numbers in the glucose profiles 2010a-g, the report 2000 may include multiple rows of additional information below the glucose profiles 2010a-g, such as rows 2038a-e corresponding to "Carbohydrates Consumed," rows 2034a-e corresponding to "Super Rapid Acting Insulin Received," and rows 2036a-e 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 "Super Rapid Acting" row 2034 may include the amount of super rapid acting insulin administered 2060 below the time it was administered. Similarly, the "Long Acting Insulin" row 2036 may include the amount of long acting insulin administered 2062 below the time it was administered. In some embodiments where the administration data comes from an associated pen or an associated pen cap, the 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.
[0138] Additionally or alternatively, in some embodiments, the report 2000 may include lines indicating "Scan / View" and "Notes." In the "Scan / View" line, notable glucose values may be noted at a location 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.
[0139] Additionally or alternatively, in some embodiments where basal insulin was administered using an insulin pump, as seen in FIG. 28D, instead of the "long acting insulin" row 2036 showing individual doses, the report can include an insulin delivery graph 2042 above or below the glucose profile 2010 showing when and how much insulin was delivered. 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 the basal administration information is from an insulin pump, the total amount of long acting insulin administered section 2016 can include the name of the pump system and the percentage of time the pump was on. Note that FIG. 28D shows the entries for one day in the daily view report 2000.
[0140] 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, and a time interval 2046 when the pump was operating in automatic delivery mode, 2048 when it was operating in maximum delivery mode, or 2050 when it was operating in automatic pause mode, or a time interval 2054 when insulin was delivered manually. If basal administration information is obtained from an insulin pump, the total amount of long acting insulin administered section 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.
[0141] The "Time in Range" metric 2012a-2012g may be the percentage of time that was within the goal range 2056 for that day.
[0142] The total amount of super fast acting insulin administered for each day fields 2014a-2014g can be determined from data automatically transferred from an associated drug delivery device 152, such as an associated pen, an associated pen cap, or an insulin pump. Alternatively, in some embodiments, the total amount of super fast acting insulin administered for each day fields 2014a-2014g can be determined from insulin doses manually logged by the user.
[0143] The total amount of long acting insulin administered for each day 2016a-g can be determined from data automatically transferred from an associated drug 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-g can be determined from insulin doses manually logged by the user.
[0144] The total carbohydrate ingested fields 2018a-2018g may be derived from carbohydrates manually logged by the user, or alternatively, the total carbohydrate ingested fields 2018a-2018g may be derived from logged meals and snacks by programmatically estimating the carbohydrate content of the meals and snacks.
[0145] 12A-12C illustrate an exemplary embodiment of a "Mealtime Patterns" report GUI 850. The "Mealtime Patterns" report 850 can include graphical and numerical representations of glucose level information for specific time periods that can be associated with meals: morning (breakfast, e.g., 6AM-10AM), midday (lunch, e.g., 10AM-4PM), afternoon (dinner, e.g., 4PM-10PM), and evening (late-night snack, e.g., 10PM-6AM). Vertical lines separating the hours before (pre-meal) 852 and after (post-meal) 854 each meal can also be displayed. Further, such glucose level information may include numerical representations 858a-858d of glucose levels before a particular meal and 860a-860d of glucose levels after a particular meal for each day within mealtime pattern period 856, along with average pre-meal glucose values 859a-859d and average post-meal glucose values 861a-861d for each time period above the table. In addition, the report may also include representations 864a-864d of the amount of carbohydrate 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.
[0146] 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 during the mealtime pattern period 862a-862d, with the average insulin dose for that time period 863a-863d displayed in the upper column of the table. An icon corresponding to the type of insulin administered (e.g., a light green syringe icon for rapid acting insulin) can also be displayed to indicate the type of insulin administered.
[0147] The data source 874 may also be displayed to include the name of the device that provided the analyte data values, and may also display the name of the primary drug delivery device if the drug 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.
[0148] In some embodiments, the insulin dose may be manually entered by a user or calculated by a dose calculator, rather than transferred directly from an associated drug delivery device 152. The insulin dose may be entered into a monitoring or reporting application. If the insulin dose was manually entered, the "Mealtime Patterns" report 850 may include the dose of rapid acting insulin 872, but may not include the brand name in the report. In some embodiments, the dose information may be transferred automatically from an associated delivery device. The data source field 874 may include the name of the device that provided 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 that may be placed at the foot of the "Mealtime Patterns" report 850 may not include the brand name of the insulin type administered. In that case, the legend 876 may not include the brand name of the insulin, but may include, for example, "rapid acting." In other embodiments, the Mealtime Patterns report 850 may also include the brand name of the insulin, for example in the legend 876 .
[0149] The "Meal Time Pattern" report 850 may also include multiple glucose value graphs 868a-d 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-d may include a vertical line indicating the start of the meal and may be plotted over a time frame from about 1 hour before the start of the meal to about 3 hours after the start of the meal. The graphs may further include multiple data points on the vertical line indicating multiple glucose values (listed in columns 858a-d) 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-d) 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 showing post-meal glucose values, e.g., glucose values at least about two hours after the start of a meal (as listed in columns 860a-860d). Each graph may also highlight the post-meal glucose value, e.g., the average of multiple glucose values at least about two hours after the start of a meal (as listed at the top of columns 860a-860d). Graphs 858a-858d may also highlight the pre-meal target range, e.g., about 70 mg / dL to about 130 mg / dL, and the post-meal target range, e.g., about 100 mg / dL to about 180 mg / dL, to enable a user to see at a glance whether the recorded glucose value is within or outside the target range.
[0150] 13A and 13B are diagrams illustrating an example embodiment of a “Device Details” report GUI 900. The “Device Details” report 900 may include glucose settings 910 of a primary glucose measuring device, insulin settings of a first associated insulin pen 930, and insulin settings of a second (or additional) associated insulin pen 940. The glucose settings 910 may 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 includes low and high thresholds and may be set from a monitoring application or a reader. Optionally, the glucose settings 910 may also include calculator settings and notifications. The “Device Details” report 900 may 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, the model of the smartphone running the associated application, etc. If the sensor control device 102 is used in combination with a reader or metering device, the device details 916 may include the serial number of the reader or metering device.
[0151] The Device Details report 900 can also include detailed information about any associated medication delivery devices 152 (e.g., associated insulin pens). The associated medication delivery devices 152 can be listed under the main glucose measurement device. If more than one medication delivery device is associated, each device can be displayed. The insulin pen settings 930, 940 can include the type of insulin, the last scan (e.g., date and timestamp of the last insulin value), and the pen color for each associated 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.
[0152] 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 shows various statistics and graphs for a multi-day period 960 (e.g., 14 or 28 days). Additionally, the information source 962 may include the name (e.g., brand name) of the primary glucose measuring device, the name (e.g., brand name) of the primary pen associated with it, and the number of other devices.
[0153] The "Glucose Statistics and Goals" (or "Glucose Metrics") section 952 may include one or more metrics, which may include any one or more of the following: a reporting period for the statistics over multiple days, 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 low 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 high threshold (e.g., above 180 mg / dL), and the length of time above a higher threshold (e.g., above 250 mg / dL).
[0154] The "Time-in-Ranges" section 954 may include multiple "Time-in-Ranges" (Time-in-Range, Time-in-Target) GUIs. Each "Time-in-Range" GUI may include multiple bars or multiple rectangles that make up a bar, each of which correlates to a predefined analyte range and indicates the amount of time that the user's analyte value is within that analyte range. In some embodiments, for example, the amount of time that is within the analyte range may be expressed as a percentage of the predefined amount of time. The "Time-in-Range" GUI section 954 may include a bar made up of up to five rectangles. The rectangular portions include (from top to bottom): a first rectangular portion 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 rectangular portion 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 rectangular portion 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 rectangular portion 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 rectangular portion 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" GUI 954 may display text next to each rectangular portion indicating the actual length of time (eg, in hours and / or minutes).
[0155] According to one aspect of the embodiment shown in FIG. 14, the squares in the "Time in Range" GUI 954 may be different colors. In some embodiments, the squares may be separated by dashed or dotted lines, a numerical scale may be added, or both to indicate the ranges between adjacent squares. In some embodiments, the "Time in Range" of the squares may be further expressed as a percentage, an actual amount 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 square may vary depending on the user's test substance data. In some embodiments of the "Time in Range" GUI 954, the target range may be set by the user. In other embodiments, the target range of the "Time in Range" GUI 954 may not be altered by the user.
[0156] The AGP report 950 may also include an AGP column 956 similar to the AGP graph 511. The AGP graph may display percentiles of glucose readings for each hour of a "typical" day based on all days within the selected time frame. The percentiles of glucose readings may be presented as 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 ranges defined in the "Glucose Statistics and Goals" column 952 and / or the "Time in Range" column 954. 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 rectangle in the "Time in Range" column 954. Additionally, the data or graph intervals within each concentration range of the AGP can be color-coded to correspond to the same color as each of the squares in the "Time in Range" column (954). For example, AGP data points or graph intervals within the target range can be colored green, AGP data points or graph intervals within the high concentration range can be colored orange, AGP data points or graph intervals within the low concentration range can be colored red, and AGP data points or graph intervals within the very low concentration range can be colored dark red or maroon. In this way, the AGP graph can clearly show the length of time within the target range (or the number of readings that fell within the target range).
[0157] The AGP report 950 may also include a "Daily Glucose Profile" section 958. The "Daily Glucose Profile" section 958 displays a number of daily profiles 958-1 through 958-14, one for each day in the time period 960. Each daily profile may represent the time from midnight to midnight of the date displayed in the same frame as the profile. In addition to the date, each profile may also display the day of the week. Each profile may also include an indication of the target glucose range (e.g., a shaded area or lines indicating the upper and lower limits of the target area) to indicate which portions of each daily profile were within the target range. Readings (analyte values) that are outside the target range may be color-coded to more clearly indicate the readings that are outside the target range. The color coding may correspond to the colors used in the "Time in Range" field 954. For example, the 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, the portion of the graph with "low" levels (e.g., 54-69 mg / dL) that are below the target range can be color coded red. Additionally, the portion 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.
[0158] FIG. 19 illustrates an exemplary embodiment of a “Comparison” report GUI 1020. The “Comparison” report 1020 may include two sections: a section 1022a that displays metrics for a first time period 1024a, and a section 1022b that displays 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 metrics for 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 shows various statistics and graphs for the two time periods (e.g., 14 days each). In some embodiments, a banner may be displayed, for example in the header, to inform viewers when an adjustment to the glucose threshold has been made.
[0159] The "Compare" report GUI 1020 can include multi-day report aggregation periods 1024a, 1024b for various metrics, as well as the amount of time the sensors were active (listed in the report as percentages) 1034a, 1034b.
[0160] The "Glucose Metrics" sections 1026a, 1026b may include, for example, average glucose values, glucose management index (GMI), and glucose value variability.
[0161] The "Time-in-Range" sections 1028a, 1028b may include multiple graphical representations of time-in-ranges, time-in-range, and time-in-target. Each graphical representation of time-in-range may include multiple bars or multiple rectangular segments that make up a bar, each of which correlates with a predefined analyte range and indicates the amount of time that the user's analyte value was in that analyte range. In some embodiments, for example, the amount of time in the analyte range may be expressed as a percentage of the predefined amount of time. Each of the graphs 1028a, 1028b representing time-in-range may include a bar that is made up of multiple rectangular segments stacked one on top of the other. In some embodiments, the graph may 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 graphs 1028a, 1028b representing time in range may also display text next to each rectangular portion indicating the actual amount of time (e.g., in hours and / or minutes). In some embodiments, the "time in range" represented by the rectangular portion may be further expressed as a percentage, an actual amount of time (e.g., 4 hours and 19 minutes), or both.Furthermore, one of ordinary skill in the art will recognize that the percentage of time associated with each rectangle may vary depending on the user's analyte data.
[0162] According to one aspect of the embodiment shown in FIG. 19, the squares in the graphs 1028a, 1028b representing times within ranges can be different colors. In some embodiments, the ranges between adjacent squares can be indicated by dashed or dotted lines separating the squares, 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 followed 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 events graph. In some embodiments of the "Time in Range" graphs 1028a, 1028b, the target ranges may be set by the user. In other embodiments, the target ranges in the "Time in Range" GUIs 1028a, 1028b may not be changed by the user.
[0163] Sections 1022a, 1022b of the "Compare" report 1020 may also include AGP columns 1030a, 1030b similar to the AGP graph 511 shown in FIGS. 8A-8C. The AGP graph may display hourly glucose percentiles for a "typical" day based on all days within the selected time frame. Percentiles of glucose readings are provided: 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 ranges defined in the "Glucose Statistics and Goals" 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 squares indicating the target ranges in the "Time in Range" columns 1028a, 1028b. The same color coding as the "Time in Range" GUIs 1028a, 1028b may be employed for the AGP graph, with glucose values in the "Very High" range (e.g., over 250 mg / dL) in orange, glucose values in the "High" range (e.g., between 180 mg / dL and 250 mg / dL) in yellow, glucose values in the "Target Range" (e.g., between 70 mg / dL and 180 mg / dL) in green, glucose values in the "Low" range (e.g., between 54 mg / dL and 70 mg / dL) in red, and glucose values in the "Very Low" range (e.g., below 54 mg / dL) in dark red or maroon. In this way, the AGP graph may easily indicate the amount of time spent in the target range (or the number of readings that fall within the target range) for each time period 1024a, 1024b.
[0164] 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 below a very low threshold (e.g., 54 mg / dL). Each graph may also include a line 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 allow a user to see at a glance when low glucose events occurred. As described above, the same color coding as in the "Time in Range" GUI 1028a, 1028b may be employed for the glucose value graph in the "Low Glucose Events" section 1032a, 1032b, with glucose values between the low and very low thresholds (e.g., 54 mg / dL to 70 mg / dL) in red and glucose values below the very low threshold (e.g., below 54 mg / dL) in dark red or maroon. Color coding may include highlighting the range of interest with a corresponding color, such as by painting the area under the curve with a particular color or by changing that portion of the graph to a particular color. The "Low Glucose Events" section 1032a, 1032b may also include metrics, statistics, or both related to the low glucose events. In some embodiments, the low glucose event metrics section 1032a, 1032b may include the number of low glucose events and, optionally, the average duration of the low glucose events.
[0165] 15A and 15B are diagrams illustrating 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 can be displayed on the patient dashboard include average glucose value (mmol / L), average duration of low glucose events sensed by the sensor (min), % below target, % in target range, % above target, low glucose events, standard deviation (mmol / L), estimated A1c (%), and estimated A1c (mmol / mol).
[0166] 16A and 16B are diagrams illustrating an example 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 show all linked pens that contributed data during the collection period. In the modal 980, each linked pen can be displayed by device. The linked devices can be displayed in order according to the date of last upload 986, which is the date of the timestamp of the last insulin. The device (insulin pen) field can include the brand name of the insulin pen, the serial number of the insulin pen, and an image of the insulin pen. The image of the pen can be placed 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 the device, the estimated device time 988 can be left blank. Insulin data acquisition 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 which data sources to include in any of the reports described herein.
[0167] 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 be a timed box that appears in a portion of the screen, e.g., the bottom right corner, to avoid obtrusiveness. 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 includes glucose measurement devices and no linked insulin delivery devices. The alert 1002 may indicate that the data in the report may not include data for all devices. The report may also include only insulin data for linked pens.
[0168] 24A-C illustrate an exemplary embodiment of an "Insulin Summary" report GUI 1840. The "Insulin Summary" report GUI 1840 may also include tabs 1842a-d with various time periods that the user may select for the time period over which to display the "Daily Pattern" report. For example, the time period tabs 1842a-d 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 dosage 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 dosages and long acting dosages. 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 fast and ultra fast acting insulin administered on that day. In some embodiments, the user may tap to select a day's entry, causing a window to appear showing details about that day (e.g., the total units of fast and ultra fast acting insulin administered on that day).
[0169] In some embodiments, a user can access a "Daily Insulin" report GUI 1850 for a day by tapping on the "Details" window for that day or by selecting 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 a graphical representation 1858 with "1 Day" 1842a selected as the display 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 shown at the time it was administered. The graphical representation can include both rapid and long acting doses. The GUI 1850 can include the total amount of each insulin type injected for that day 1854 under the symbol or color indicating rapid or long acting insulin in the legend 1856.
[0170] FIG. 24C illustrates an example embodiment of an “Insulin Usage” report GUI 1870 that summarizes 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 the date range 1872.
[0171] 18A-18D illustrate an exemplary embodiment of a "Profile Comparison" report GUI. Utilizing administration data from an associated drug delivery device and / or 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, or more than two, or three, or more than three.
[0172] In some embodiments, each glucose profile 1010, 1012, 1014 may be an ambulatory glucose profile (AGP) graph or part of an AGP. As mentioned in the description of the exemplary diagram of FIG. 14, the AGP may display the percentiles of hourly glucose readings for a "typical" 24-hour day based on all days in a selected time frame. The percentiles of glucose readings may be the 5th, 25th, 50th (median), 75th, and 95th percentiles. Alternatively, the AGP may display the percentiles of hourly glucose readings for a "typical" 24-hour day based on all days in a selected time frame: the 10th, 25th, 50th (median), 75th, and 90th percentiles. The AGP graph may 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) as the target range rectangle in the "Time in Range" column 954. In this way, the AGP graph can clearly show the amount of time spent in the target range (or the number of readings that fall within the target range). Other exemplary AGP graphs can be found in U.S. Patent Application Publication No. 2018 / 0235524, U.S. Patent Application Publication No. 2014 / 0188400, U.S. Patent Application Publication No. 2014 / 0350369, and U.S. Patent Application Publication No. 2018 / 0226150. The disclosures of all of the above patents are expressly incorporated herein by reference for all purposes.
[0173] In other embodiments, the glucose profile can be a single graph or chart plotting the daily trajectory for multiple days. In some embodiments, the glucose profile can be a single graph or chart plotting the daily trajectory for multiple days 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, time series plots, etc. The graphs can also present or be based on other time-based analyte data associated with the patient, data derived from other time-based data such as insulin administration events, insulin delivery data, or meal event data. It is noted that while graphs based on glucose data are described as exemplary graphs, any patient data can be represented in these exemplary formats.
[0174] 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 7 days, or the last 2 weeks, or the last month, or the last 2 months, or the last 3 months, or the last 6 months, or the last 9 months, or the last year.
[0175] 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 adjusting drug, measurements taken after a missed dose of a glucose level adjusting drug, and measurements taken after a program or application did not receive administration information.
[0176] A second profile 1012 of the multiple glucose profiles may display only specific data associated with the glucose value lowering drug for a selected period of time. See, for example, FIG. 18D. The specific data may include only glucose measurements taken in a certain time range after (or associated with) administration of the glucose value adjusting drug. The specific data associated with administration of the glucose value adjusting drug may include glucose data (glucose measurements) taken within a time range specified by defining a fixed time. If administration of the glucose value adjusting drug is associated with a certain time range, glucose data for that time range may be included. The time range associated with an administration action may not be a time range immediately after the administration action is performed. In some embodiments, the time range may be the duration of a fixed time. For example, glucose values for a fixed time range may be included only if administration of ultrafast-acting insulin was performed in the fixed time range (e.g., from approximately 7:00 a.m. to approximately 12:00 a.m.). 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 administration of basal or long acting insulin may be 24 hours and the fixed time window for rapid acting insulin may be 5 hours. In other embodiments, the time window may be a variable time window. In this case, the variable time window may be a time window starting from the glucose value obtained at the most recent time after the administration timestamp or the logged administration time and extending by the therapeutic time window of the administered drug. For example, the therapeutic time window may be about 5 hours for rapid acting insulin and about 24 hours for long acting insulin. The administration of the glucose level adjusting drug may be performed by a linked drug delivery device. In other embodiments, the drug delivery device may not be linked and the dosage may be logged by the user. The drug administration record may be obtained by the linked drug delivery device or by other means such as manual entry of drug administration events.The particular data for the second glucose profile 1012 may not include glucose measurements in the time range after the missed dose or in the time range not associated with the drug administration. A tranche of glucose measurements after the missed dose may be cut from a data set including all glucose measurements for a selected period, e.g., glucose measurements in the time range after the missed dose or measurements in the time range not associated with the drug administration, and the remaining glucose measurements may 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 may reflect the blood glucose level of the user when the user does not forget to administer the dose. As can be seen by comparing FIG. 18D with FIG. 18C, the spread (variability) of data in the AGP graph of the profile with insulin administration (FIG. 18D) is much smaller than the spread (variability) of data in the AGP of the profile including all data (including data after the missed dose).
[0177] The third profile 1014 of the plurality of glucose profiles may display only certain data for a selected period of time where a glucose level adjusting drug was not administered (e.g., by the user or a caregiver). The certain data may be displayed in the third profile 1014 of the plurality of glucose profiles and may include only glucose readings taken in a time range after a missed dose of the drug. The third profile 1014 of the plurality of glucose profiles may include data that was cut from the entire data set when the second profile of the plurality of glucose profiles was generated. The length of the glucose readings after the missed dose (tranche) may vary depending on the type and characteristics of the glucose level adjusting drug. The glucose readings displayed in the third profile 1014 may be higher (e.g., higher median), more variable, or both, compared to the second profile and the first profile, since the glucose readings are measured when the drug that helps control glucose levels is not present in the user's body. Thus, the glucose readings associated with a missed dose may be high glucose readings. 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., 1012) that display only data from the time period after administration of a glucose-lowering drug more directly reveal the effect of the administered drug on blood glucose levels, which may be useful for trained medical personnel to adjust the current drug regimen. Profiles (e.g., 1014) that reveal glucose values in the event of a missed dose may more directly reveal the impact of poor concordance of the drug administration on the subject's blood glucose levels.
[0178] Thus, the first profile 1010, which displays glucose values without removing data, and the third profile 1014, which displays glucose values measured after a missed dose, are expected to show higher glucose measurements (e.g., a higher median), greater variability, or both, compared to the second profile 1012, which displays glucose values measured after administration of a glucose-lowering medication.
[0179] In some embodiments, multiple glucose profiles can be presented in a side-by-side display. The 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 the practitioner to easily and quickly identify differences between the graph trajectories. In some embodiments, a glucose profile can be displayed with other glucose profiles overlaid as transparent layers in a single figure. In other embodiments, problem areas in the glucose profile can be highlighted to better indicate how poor concordance of medication administration is or how the current dosing regimen is affecting the glucose value results. It should be noted that multiple profiles can be presented in any order or spatial arrangement.
[0180] The data of the associated drug delivery device may also include a dosing timestamp. If the data of the associated drug delivery device does not provide a dose to the program creating the glucose profile, the program may infer that the user did not administer a regularly scheduled dose, i.e., missed a dose. In the event of a missed dose, a predefined portion (tranche) of glucose data may be removed from the data set containing all glucose measurements (which may be used to create the first glucose profile 1010), leaving only glucose data that may be associated with the administered drug dose (which may be used to create the second glucose profile 1012). The removed portion (tranche) may then be used to create a third glucose profile 1014.
[0181] The length of each tranche of glucose data (or the length of the time range from which the data is cut) may vary depending on the pharmacokinetic and pharmacodynamic profile of the user's medication. For example, if a once-daily basal insulin injection is taken on Monday but forgotten on Tuesday, the data from the linked drug delivery device would show the administration timestamp for Monday but not for Tuesday. Thus, the glucose data for Monday can be included in the data generating the second glucose profile 1012, and the glucose data for Tuesday can be excluded from the data displayed in the second glucose profile. However, the data for Tuesday can be used in generating the third glucose profile 1014. In this example, the pharmacodynamic glucose lowering duration of action of long-acting basal insulin is approximately 24 hours, so a day's worth of glucose data can be excluded. On the other hand, if a mealtime dose of ultra-rapid acting insulin is forgotten, a smaller portion of glucose data (tranche) can be cut from the data generating the second glucose profile and used to generate the third glucose profile. This is because the pharmacodynamic glucose lowering duration of action of ultrarapid acting insulin is approximately 6 hours.
[0182] 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, 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 a basal insulin dose(s) or in a time range associated with a basal insulin dose(s), a third graph may include glucose measurements taken after missed administration of a basal insulin dose(s) or in a time range associated with a missed administration of a basal insulin dose(s), a fourth graph may include glucose measurements taken after administration of a bolus insulin dose(s) or in a time range associated with a bolus insulin dose(s), and a fifth graph may include glucose measurements taken after missed administration of a bolus insulin dose(s) or in a time range associated with a missed administration of a bolus insulin dose(s).
[0183] The glucose level adjusting drug may be a glucose level lowering drug or a glucose level increasing drug. Although the embodiments described herein relate to glucose level lowering drugs such as insulin, it is believed that the framework can be generalized to glucose level increasing drugs such as glucagon. The glucose level lowering drug may be a type of insulin. The types of insulin include ultrafast acting insulin, short acting insulin, intermediate acting insulin (such as NPH insulin), mixed insulin (such as premixed insulin), long acting insulin, and ultra long acting insulin. Although examples are given herein for insulin administration, the methodology can be generalized to any glucose level adjusting drug delivered from an associated drug delivery device and with a known glucose lowering time. Such glucose level adjusting 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.
[0184] 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 hours to about 28 hours, or about 22 hours to about 40 hours, or about 20 hours to about 38 hours, or about 20 hours to about 36 hours.
[0185] The length of the data portion (tranche) or time range that can be cut from the data after a missed administration of ultrafast-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 from the administration of the glucose lowering drug. In some embodiments, the length of the data portion (tranche) or time range that can be cut from the data can be defined or determined by the drug, for example, by the insulin action time of the insulin at mealtime. In some embodiments, the length of the data portion (tranche) or time range that can be cut 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 cut from the data can be manually entered.
[0186] 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 hours to about 16 hours, or about 10 hours to about 14 hours.
[0187] The length of the data portion (tranche) or time period that can be cut from the data after a missed dose of ultra-long acting insulin can be from about 36 hours to about 42 hours, or from about 32 hours to about 44 hours.
[0188] 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 different types of non-adherence. The specific data that can be selected to be displayed by the filter can include specific data for glucose level adjusting drug administered at the recommended dose, specific data for glucose level adjusting drug administered at an under-dosage bolus, and specific data for glucose level adjusting drug administered at an over-dosage bolus for a selected time period. A graph showing specific data for glucose level adjusting drug administered at an under-dosage bolus (i.e., glucose level adjusting drug administered at a dose less than the recommended dose) for a selected time period, a graph showing specific data for glucose level adjusting drug administered at an over-dosage bolus (i.e., glucose level adjusting drug administered at a dose more than the recommended dose) for a selected time period, or both, can be displayed in comparison with a graph showing specific data for glucose level adjusting drug administered at the recommended dose for a selected time period to assist a healthcare professional in persuading a patient not to change the dosage according to the recommended dosing regimen.
[0189] In some embodiments, the specific data that can be selected for display using a filter can include specific data for a selected time period where a delayed prandial administration occurred (i.e., administration occurred a certain period of time after the start of a meal). In some embodiments, the specific data that can be selected for display using a filter can include specific data for a selected time period where an excessive number of prandial administrations occurred (i.e., additional administrations occurred during a meal). By displaying a graph showing specific data for a selected time period where a glucose level adjusting drug was administered a certain period of time after the start of a meal, a graph showing specific data for a selected time period where an additional glucose level adjusting drug was administered during a meal, or both, the healthcare professional can be helped to reduce the patient's anxiety about hypoglycemic episodes.
[0190] In addition to other methods described herein, non-adherence can also be determined to occur when the dose is administered outside of a preset time period. For example, non-adherence to basal administration can be determined to occur when a basal dose is missed or administered at a time outside the time range of the prescribed administration time. In some embodiments, the time range can be about 30 minutes, about 1 hour, or about 90 minutes after the prescribed administration time. In the case of bolus administration, a time range can be associated with each meal. For example, the time range associated with breakfast can be from about 6:00 am to about 11:00 am, the time range associated with lunch can be from about 11:00 am to about 4:00 pm, and the time range associated with dinner can be from about 4:00 pm to about 10:00 pm. The time range associated with nighttime can be from 10:00 pm to about 6:00 am. If the recommended dose is administered within these time ranges, it can be determined that the dose has been administered correctly. If the dose is not administered within these time ranges, it can be determined that a missed dose has occurred. If an additional dose is administered in addition to the one administered 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 is poor adherence. In addition, missed doses and administration of more doses than necessary can also be determined as poor adherence.
[0191] Meals can be recognized or logged by the subject, and meal start times can be 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 any purpose. A delayed prandial administration may be determined to have occurred when 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 may be determined to have occurred when the glucose value obtained from the CGM device is greater than 70 mg / dL and when there has been a glucose rise of more than 70 mg / dL within the past two hours. In such a case, a delayed prandial bolus may be defined to have occurred when the glucose value obtained from the CGM device rises by more than 50 mg / dL from the baseline before insulin administration. Also, a no prandial bolus may be defined to have occurred when no insulin administration has occurred within the two hours prior to the start of the glucose rise. In some embodiments, a no prandial administration may be defined to have occurred when there has been a glucose rise of 80 mg / dL for 2 hours or less and no insulin administration has occurred within the previous hour.
[0192] 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), CV ([(SD of glucose value) / (mean glucose value)]×100), an indication of “time in range” for the time period, a GMI index for the time period, the number or duration of upward deviations above a high threshold and / or the number or duration of downward deviations below a low threshold, the number or duration of extreme upward deviations above a very high threshold and / or the number or duration of extreme downward deviations below a very low threshold, and multiple dosing indices corresponding to drug administrations administered. In some embodiments, the data from which the glucose profile patterns are analyzed may include or exclude various data. For example, a “low” pattern may be identified by including time ranges associated with drug administration but excluding time ranges not associated with drug delivery. Dosage guidance or delivery of the drug can be based on these patterns determined from the time range associated with drug administration. In some embodiments, recommendations can be provided based on the type of pattern determined (detected). Further details on pattern analysis are described in WO 2021 / 026004, the entire disclosure of which is expressly incorporated herein by reference for any purpose.
[0193] 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 that excludes 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 that excludes glucose data that did not result in a missed medication dose.
[0194] In other embodiments, multiple graphs may be presented in a profile "compare" report. Utilizing drug administration data from associated drug delivery devices and / or analyte data from continuous analyte monitors as inputs, in many embodiments, a GUI or report may be generated that includes multiple analyte profiles over a selected time period. As seen in Figures 18A and 18B, in some embodiments, the GUI or report may include multiple versions of the analyte profile over a selected time period. The number of versions may 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 types of graphs discussed in the discussion of other embodiments, such as a glucose profile.
[0195] In some embodiments, the multiple graphs may 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 may display a different data set. In some embodiments where a person is administering multiple medications at once, one graph may display (present) all data for a period of time, or two graphs may be displayed for each type of medication administered. For each medication, a first graph may include analyte measurements measured in a time range after administration of the medication or a time range associated with administration of the medication, and a second graph may include analyte measurements measured in a time range after a missed medication or a time range associated with a missed medication. Thus, for a person administering n types of medication, multiple graphs including (2n+1) graphs may be presented. As described above in the description of other embodiments, the time range after administration of the medication or the time range associated with administration of the medication may be determined by the duration of action of the medication administered.
[0196] Detecting whether medication has been administered The determination of whether the medication has been delivered to the patient can be easily performed using the associated medication delivery device. For non-associated medication delivery devices (such as a syringe), the system can use other means to determine whether the medication has been delivered. The system can provide a UI that allows the patient to log each time the medication is administered. Additionally, the system can predefine a typical time range for the patient to administer medication, and if the medication log is not recorded during this time range, 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 that case, if the associated device does not provide a notification that the medication has been administered, the system can prompt the patient to confirm that the medication has not been administered (or has been administered).
[0197] If the drug is administered later than the standard (prescribed) time window, glucose data associated with that time window may be excluded. Similarly, glucose data associated with the later time window during which the drug was administered may also be excluded. The glucose data associated with the time window may then be included in some form of data analysis, for example, to show the impact of delayed drug administration on a glucose metric. In this case, the calculation of the metric may include only glucose values for the time window associated with delayed drug administration, and this metric may be compared to a metric calculated using glucose data only for time windows during which the drug was administered on time.
[0198] As a summary and / or supplement to the above described several embodiments, various aspects of the present subject matter are presented below. Note that what is emphasized here is the mutual relationship 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 expressly described or without logical validity. Note that although no explicit reference is made below to the drawings, the description in each of the following paragraphs is a reprint and development of each embodiment described in this specification.
[0199] In many embodiments, an analyte monitoring system includes a sensor control device including an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of a subject, a drug delivery device configured to deliver an amount of drug to the subject and log the amount delivered, and a reading device. The reading device includes a display, wireless communication circuitry configured to receive current sensor readings from the sensor control device and to receive the log from the drug delivery device, and one or more processors coupled to a memory storing instructions. When executed by the one or more processors, the instructions cause the one or more processors to output an interface on the display prompting the subject to interface with the drug delivery device, output an interface on the display prompting the subject to select a type of drug delivery device, output an interface on the display prompting the subject to select a type of drug to be delivered by the drug delivery device, and output an interface on the display prompting the subject to select a brand of drug to be delivered by the drug delivery device.
[0200] In some embodiments, the medication delivery device is an insulin pen.
[0201] In some embodiments, the type of medication delivery device is a brand of insulin pen.
[0202] In some embodiments, the type of drug delivered is a type of insulin, hi some embodiments, the type of insulin is ultrafast-acting or long-acting.
[0203] In some embodiments, the instructions further cause the one or more processors to output on the display an animation showing how to hold the medication delivery device relative to the reading device and transfer the log to the reading device.
[0204] In some embodiments, the instructions further cause the one or more processors to output an interface on the display prompting the subject to select a color for a medication delivery device.
[0205] In many embodiments, an analyte monitoring system includes a sensor control device including an analyte sensor, at least a portion of the analyte sensor configured to be in fluid contact with a bodily fluid of a subject, a drug delivery device configured to deliver an amount of drug to the subject and log the delivered amount, and a reading device. The reading device includes a display, wireless communication circuitry configured to receive current sensor readings from the sensor control device and to receive the log from the drug delivery device, and one or more processors coupled to a memory storing instructions. The instructions, when executed by the one or more processors, cause the one or more processors to output a logbook interface to the display, the logbook interface comprising a plurality of entries including at least two of a drug dosage, a comment, an alarm, and a drug delivery device priming amount.
[0206] In some embodiments, the plurality of entries is ordered chronologically.
[0207] In some embodiments, the agent is insulin.
[0208] In many embodiments, a system for displaying metrics related to a subject includes a drug delivery device, a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analyte and drug administration received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a first graph with time on the x-axis and glucose concentration on the y-axis, the first graph including a plot of median average glucose concentration for the period of time; display a second graph with time on the x-axis and glucose concentration on the y-axis, the second graph including a plot of low glucose events having glucose values below a threshold; display an average daily carbohydrate intake for the period of time; and display an average daily delivery of at least one drug for the period of time.
[0209] In some embodiments, the memory further retains instructions to execute the step of displaying a third graph having time on the x-axis and the relative length of time that the sensor is active on the y-axis, the third graph including a plot of the average time that the sensor was active during the period.
[0210] In some embodiments, the instructions further cause the one or more processors to display an average total daily delivery of the at least one medication.
[0211] In some embodiments, the at least one agent delivered comprises an ultrafast acting insulin and a long acting insulin.
[0212] In many embodiments, a system for displaying metrics related to a subject includes a medication delivery device, a wireless communication circuit configured to receive measured analyte data and medication administration data, the wireless communication circuit automatically receiving the medication administration data from the medication delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the administration of analytes and medication received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a plurality of intra-day graphs corresponding to each day of the period, each graph of the plurality of intra-day graphs having time on the x-axis and glucose concentration on the y-axis, including a plot of glucose concentration over a 24-hour period and a plurality of administration indices, each of the plurality of administration indices indicating an amount of medication administered; and display a plurality of total administration indices indicating an amount of at least one medication delivered in the 24-hour period.
[0213] In some embodiments, the plurality of total administration indices includes numerical values highlighted in a first color corresponding to a first medication. In some embodiments, the plurality of total administration indices includes numerical values highlighted in a second color corresponding to a second medication. In some embodiments, the plurality of administration indices includes numerical values corresponding to the first medication correspondingly highlighted in the first color. In some embodiments, the plurality of administration indices includes numerical values corresponding to the first medication highlighted in the first color and numerical values corresponding to the second medication highlighted in the second color.
[0214] In some embodiments, the instructions further cause the one or more processors to display a plurality of average glucose values for at least some of the days of the time period.
[0215] In some embodiments, the instructions further cause the one or more processors to display a plurality of total carbohydrate intake values for at least some of the days of the time period.
[0216] In some embodiments, the instructions further cause the one or more processors to display a number of events in which the subject's glucose level fell below a threshold.
[0217] In some embodiments, each graph of the plurality of intra-day graphs includes a target range, and the area under the curve of the plot portion that falls outside the target range is colored. In some embodiments, the area under the curve of the plot portion that falls outside the target range is colored red if the plot portion falls below the target range. In some embodiments, the area under the curve of the plot portion that falls outside the target range is colored yellow if the plot portion falls above the target range.
[0218] In some embodiments, each graph of the plurality of intra-day graphs includes a target range, and plot portions that fall outside the target range are colored. In some embodiments, the plot portions that fall outside the target range are colored red if the plot portions fall below the target range. In some embodiments, the plot portions that fall outside the target range are colored yellow if the plot portions fall above the target range.
[0219] In many embodiments, a system for displaying metrics associated with a subject includes a drug delivery device, wireless communication circuitry configured to receive measured analyte data and drug administration data, the wireless communication circuitry automatically receiving the drug administration data from the drug delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data characteristic of the subject's analytes and drug administrations received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a plurality of intra-day graphs corresponding to each day of the time period, each graph of the plurality of intra-day graphs including a plot of glucose concentration over a 24-hour period with time on the x-axis and glucose concentration on the y-axis; display a plurality of carbohydrate indicators corresponding to a plurality of amounts of carbohydrate ingested during the 24-hour period, each of the plurality of carbohydrate indicators being located in a time period during which the carbohydrate was ingested; and display a plurality of dosage indicators corresponding to a plurality of administrations of at least one medication, each of the plurality of dosage indicators indicating an amount of medication administered, and each of the plurality of dosage indicators being located in a time period during which the medication was administered.
[0220] In some embodiments, the plurality of dosing indicators correspond to dosing of a first medication and a second medication, and the instructions further cause the one or more processors to display the plurality of dosing indicators for the first medication in a first row and the plurality of dosing indicators for the second medication in a second row, hi some embodiments, the plurality of dosing indicators for the first medication in a first color and the plurality of dosing indicators for the second medication in a second color.
[0221] In some embodiments, the plurality of dosage indicators includes a total dose administered. In some embodiments, the instructions further cause the one or more processors to display a plurality of components for at least some of the plurality of dosage indicators. In some embodiments, the plurality of components includes an amendment or modification.
[0222] In some embodiments, the at least one agent is insulin.
[0223] In many embodiments, a system for displaying metrics related to a subject includes a drug delivery device, a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analyte and drug administration received over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a plot of glucose readings over a 24-hour period, the plot showing a trajectory of the median glucose value over the period and a plurality of trajectories of glucose readings for different percentiles; display a plot of carbohydrate indicators corresponding to amounts of carbohydrate ingested during the 24-hour period, each of the carbohydrate indicators being located in a time period during the period when the carbohydrate was ingested; and display a plurality of average doses corresponding to at least one drug administration administered during a time period during the 24-hour period.
[0224] In some embodiments, the instructions further cause the one or more processors to display an average daily amount of carbohydrate ingested during the time period. In some embodiments, the instructions further cause the one or more processors to display an average amount of carbohydrate ingested during each of a plurality of time periods in the 24 hour period.
[0225] In some embodiments, the at least one medication includes a first medication and a second medication, and the instructions further cause the one or more processors to display a plurality of average dosages corresponding to administration of the first medication in a first row and a plurality of average dosages corresponding to administration of the second medication in a second row.
[0226] In some embodiments, the instructions further cause the one or more processors to display an average daily amount of at least one medication taken during the time period.
[0227] In some embodiments, the at least one agent is insulin.
[0228] In many embodiments, a system for displaying metrics associated with a subject includes a medication delivery device, a wireless communication circuit configured to receive measured analyte data and medication administration data, the wireless communication circuit automatically receiving the medication administration data from the medication delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analyte and medication administration received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a plurality of plots of glucose readings for different time periods, each plot displaying glucose readings for the period of time and a target range; and display a plurality of tables for the different time periods, each table including pre-meal and post-meal glucose readings for at least some days of the period and at least one medication dose delivered for at least some days of the period.
[0229] In some embodiments, the instructions further cause the one or more processors to perform the step of displaying an average for each period of the delivered dose of the at least one pharmaceutical agent.
[0230] In some embodiments, the instructions further cause the one or more processors to display an average of each period of pre-meal and post-meal measured glucose values.
[0231] In some embodiments, each table of the plurality of tables further comprises an amount of carbohydrate ingested for at least some days of the time period. In some embodiments, the instructions further cause the one or more processors to display an average of the amount of carbohydrate ingested for each time period.
[0232] In some embodiments, the at least one agent is insulin.
[0233] In many embodiments, a system for displaying metrics associated with a subject includes a medication delivery device, wireless communication circuitry configured to receive measured analyte data and medication administration data, the wireless communication circuitry automatically receiving the medication administration data from the medication delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analyte and medication administration received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: display a plurality of settings associated with analyte values; and display a plurality of settings associated with at least one medication delivery device.
[0234] In some embodiments, the analyte value related settings include a target analyte range.
[0235] In some embodiments, the analyte value related settings include alarm settings that include a low analyte value threshold and an high analyte value threshold.
[0236] In some embodiments, the analyte value related settings include an alarm setting related to a loss of signal from a sensor control device configured to measure the analyte value.
[0237] In some embodiments, the plurality of settings associated with the at least one medication delivery device includes a medication type and information related to a last dose data transfer from the medication delivery device. In some embodiments, the information related to the last dose data transfer includes a date and time of the last dose data transfer. In some embodiments, the plurality of settings associated with the at least one medication delivery device further includes a color of the medication delivery device.
[0238] In some embodiments, the analyte data is glucose data.
[0239] In some embodiments, the at least one drug delivery device is at least one insulin delivery device.
[0240] In some embodiments, the at least one drug delivery device is a first drug delivery device and a second drug delivery device.
[0241] In some embodiments, the instructions further cause the one or more processors to display information associated with a sensor control device configured to measure an analyte value, hi some embodiments, the information associated with the sensor control device includes a name of the sensor control device and a software version on the sensor control device.
[0242] In some embodiments, the instructions further cause the one or more processors to perform the step of displaying information associated with the at least one medication delivery device. In some embodiments, the information associated with the at least one medication delivery device includes a brand name of the at least one medication delivery device. In some embodiments, the information associated with the at least one medication delivery device includes a serial number of the at least one medication delivery device.
[0243] In many embodiments, a system for providing an alert to a subject includes a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device, a display configured to present an alert, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine whether a meal has been consumed based on a rise in the analyte value above a high threshold, determine whether an insulin dose has not been recorded within a period of time since the last insulin administration, and display an alert interface related to a missed mealtime in response to determining that a meal has been consumed and that an insulin dose has not been recorded within the period of time since the last insulin administration.
[0244] In some embodiments, the high threshold is about 175 mg / dL.
[0245] In some embodiments, the period of time since the last insulin administration is about 3 hours.
[0246] In some embodiments, the one or more processors are further configured to display the alert interface for a meal at a predetermined time selected by a user.
[0247] In some embodiments, at least a portion of the text of the alert interface is customizable by a user.
[0248] In many embodiments, a system for providing an alert to a subject includes wireless communication circuitry configured to receive measured analyte data and drug administration data, the wireless communication circuitry automatically receiving the drug administration data from the drug delivery device, a display configured to present an alert, and one or more processors coupled to a memory storing the wireless communication circuitry, the display, and instructions that, when executed by the one or more processors, cause the one or more processors to: determine whether an analyte value is above an upper threshold value a predetermined time after a last insulin administration, and, in response to determining that the analyte value is above the upper threshold value the predetermined time after the last insulin administration, display an alert interface related to a correction administration.
[0249] In some embodiments, at least a portion of the text of the alert interface is customizable by a user.
[0250] In some embodiments, the predetermined period of time is at least about 2 hours.
[0251] In some embodiments, the high threshold is about 250 mg / dL.
[0252] In some embodiments, the upper threshold is set by a user.
[0253] In many embodiments, a system for providing an alert to a subject includes wireless communication circuitry configured to receive measured analyte data and drug administration data, the wireless communication circuitry automatically receiving the drug administration data from the drug delivery device, a display configured to present an alert, and one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions that, when executed by the one or more processors, cause the one or more processors to: determine whether an analyte value is below an upper threshold value a predetermined time after a last insulin administration, and, in response to determining that the analyte value is below the upper threshold value the predetermined time after the last insulin administration, display a message interface related to the analyte value being within a target range.
[0254] In some embodiments, at least a portion of the text in the message interface is customizable by a user.
[0255] In some embodiments, the predetermined period of time is at least about 2 hours.
[0256] In some embodiments, the upper threshold is set by a user.
[0257] In some embodiments, the instructions further cause the one or more processors to display a prompt prompting a user to enter a note related to the analyte value being within the target range.
[0258] In many embodiments, a system for displaying metrics associated with a subject includes a drug delivery device, wireless communication circuitry configured to receive measured analyte data and drug administration data, the wireless communication circuitry automatically receiving the drug administration data from the drug delivery device, a display configured to visually present information, and one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data characteristic of the subject's analytes and drug administrations received by the subject over a period of time. When executed by the one or more processors, the instructions cause the system to: display a plurality of intra-day graphs corresponding to each day of the period, each graph of the plurality of intra-day graphs including a plot of glucose concentration over a 24 hour period with time on the x-axis and glucose concentration on the y-axis; displaying a "time in range" metric for each day of the period; displaying a total amount of fast acting insulin and a total amount of long acting insulin received by the user for each day of the period; and displaying a plurality of administration indicators corresponding to a plurality of administrations of at least one of fast acting insulin and long acting insulin, each of the plurality of administration indicators indicating the amount of at least one of fast acting insulin and long acting insulin administered, each of the plurality of administration indicators being located in a time period in which the administration was administered.
[0259] In some embodiments, the instructions further cause the one or more processors to display the plurality of dosing indicators for the super fast acting insulin in a first row and the plurality of dosing indicators for the long acting insulin in a second row, hi some embodiments, the plurality of dosing indicators for the super fast acting insulin are displayed in a first color and the plurality of dosing indicators for the long acting insulin are displayed in a second color.
[0260] In some embodiments, the plurality of dosage indicators comprises a total dose administered.
[0261] In some embodiments, the instructions further cause the one or more processors to display a plurality of carbohydrate indicators corresponding to a plurality of amounts of carbohydrate ingested during the 24 hour period, each of the plurality of carbohydrate indicators located in a time period during which the carbohydrate was ingested.
[0262] In some embodiments, the medication delivery device is an associated pen or an associated pen cap.
[0263] In some embodiments, the drug delivery device is an insulin pump.
[0264] In some embodiments, the instructions further cause the one or more processors to display a graph of the received long acting insulin.
[0265] In some embodiments, the instructions further cause the one or more processors to display a graphical representation representative of operating states of the insulin pump, hi some embodiments, the operating states include an automatic delivery state, a maximum delivery state, and an automatic pause state.
[0266] In many embodiments, a system for displaying metrics associated with a subject includes a wireless communication circuit configured to receive time correlation data characteristic of a subject's analytes and administration of a drug received by the subject over a period of time, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analytes and administration of a glucose level modulating drug received by the subject over a period of time, the instructions, when executed by the one or more processors, cause the system to: identify a subset of time correlation data based on filtering criteria selected by the subject; and display, on a single graphical subject interface, a first glucose profile displaying glucose values associated with the time correlation data over a first period of time and a second glucose profile displaying the subset of the time correlation data over the first period of time.
[0267] In some embodiments, the medication is a glucose level regulating drug, hi some embodiments, the glucose level regulating drug is insulin.
[0268] In some embodiments, the filtering criteria is one of recommended dose administration, missed doses, underdosing, overdosing, late prandial administration, or more prandial administrations than necessary. In some embodiments, the filtering criteria is recommended dose administration, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received in a dosing time range, the amount of the at least one drug administration received being equal to the recommended dose of the drug. In some embodiments, the filtering criteria is missed doses, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration not received in a dosing time range. In some embodiments, the dosing time range for breakfast is from about 6:00 am to about 11:00 am. In some embodiments, the dosing time range for lunch is from about 11:00 am to about 4:00 pm. In some embodiments, the dosing time range for dinner is from about 4:00 pm to about 10:00 pm. In some embodiments, the dosing time range for basal administration is about one hour from the prescribed basal administration time. In some embodiments, the filtering criterion is an under-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being less than a recommended dose of the drug. In some embodiments, the filtering criterion is an over-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug. In some embodiments, the filtering criterion is a delayed prandial dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received after a predetermined period of time from the start of a meal.In some embodiments, the filtering criterion is more than necessary meal-time administrations, and the subset of time-correlated data based on the filtering criterion includes test substance data associated with at least one additional administration of the drug after a first administration of the drug in the administration time window.
[0269] In some embodiments, the instructions, when executed by the one or more processors, further cause the system to identify an additional subset of time-correlated data based on second filtering criteria selected by the subject, and display a third glucose profile displaying the additional subset of the time-correlated data over the first time period. In some embodiments, the second filtering criteria is one of: a recommended dose administered, a missed dose, a bolus dose that is too small, a bolus dose that is too large, a late meal dose, or more meal doses than necessary.
[0270] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0271] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0272] In some embodiments, the first period of time is selected by the subject.
[0273] In some embodiments, the first period of time is set automatically.
[0274] In some embodiments, the filtering criteria is selected using a drop-down menu.
[0275] In many embodiments, a method for displaying a glucose profile comparison includes receiving time correlation data characteristic of a subject's test substance and administration of medication received by the subject over a period of time, identifying a subset of the time correlation data based on filtering criteria selected by the subject, and displaying on a single graphical user interface a first glucose profile displaying glucose values associated with the time correlation data over a first period of time and a second glucose profile displaying the subset of the time correlation data over the first period of time.
[0276] In some embodiments, the medication is a glucose level regulating drug, hi some embodiments, the glucose level regulating drug is insulin.
[0277] In some embodiments, the filtering criteria is one of recommended dose administration, missed doses, underdosing, overdosing, late prandial administration, or more prandial administrations than necessary. In some embodiments, the filtering criteria is recommended dose administration, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received in a dosing time range, the amount of the at least one drug administration received being equal to the recommended dose of the drug. In some embodiments, the filtering criteria is missed doses, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration not received in a dosing time range. In some embodiments, the dosing time range for breakfast is from about 6:00 am to about 11:00 am. In some embodiments, the dosing time range for lunch is from about 11:00 am to about 4:00 pm. In some embodiments, the dosing time range for dinner is from about 4:00 pm to about 10:00 pm. In some embodiments, the dosing time range for basal administration is about one hour from the prescribed basal administration time. In some embodiments, the filtering criterion is an under-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being less than a recommended dose of the drug. In some embodiments, the filtering criterion is an over-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug. In some embodiments, the filtering criterion is a delayed prandial dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received after a predetermined period of time from the start of a meal.In some embodiments, the filtering criterion is more than necessary meal-time administrations, and the subset of time-correlated data based on the filtering criterion includes test substance data associated with at least one additional administration of the drug after a first administration of the drug in the administration time window.
[0278] In some embodiments, the method further includes identifying an additional subset of time-correlated data based on a second filtering criterion selected by the subject, and displaying a third glucose profile on the one graphical user interface displaying the additional subset of the time-correlated data over the first time period. In some embodiments, the second filtering criterion is one of: a recommended dose, a missed dose, a bolus dose that is too small, a bolus dose that is too large, a late meal dose, or more meal doses than necessary.
[0279] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0280] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0281] In some embodiments, the first period of time is selected by the subject.
[0282] In some embodiments, the first period of time is set automatically.
[0283] In some embodiments, the filtering criteria is selected using a drop-down menu.
[0284] In many embodiments, a system for displaying metrics associated with a subject includes a wireless communication circuit configured to receive time correlation data characteristic of a subject's analytes and administration of a drug received by the subject over a period of time, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analytes and administration of a glucose level modulating drug received by the subject over a period of time. The instructions, when executed by the one or more processors, cause the system to: identify a first subset of time correlation data based on first filtering criteria selected by the subject, identify a second subset of time correlation data based on second filtering criteria selected by the subject, and display on a single graphical user interface a first glucose profile displaying the first subset of the time correlation data over a first period of time and a second glucose profile displaying the second subset of the time correlation data over the first period of time.
[0285] In some embodiments, the medication is a glucose level regulating drug, hi some embodiments, the glucose level regulating drug is insulin.
[0286] In some embodiments, the filtering criteria is one of recommended dose administration, missed doses, underdosing, overdosing, late prandial administration, or more prandial administrations than necessary. In some embodiments, the filtering criteria is recommended dose administration, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received in a dosing time range, the amount of the at least one drug administration received being equal to the recommended dose of the drug. In some embodiments, the filtering criteria is missed doses, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration not received in a dosing time range. In some embodiments, the dosing time range for breakfast is from about 6:00 am to about 11:00 am. In some embodiments, the dosing time range for lunch is from about 11:00 am to about 4:00 pm. In some embodiments, the dosing time range for dinner is from about 4:00 pm to about 10:00 pm. In some embodiments, the dosing time range for basal administration is about one hour from the prescribed basal administration time. In some embodiments, the filtering criterion is an under-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being less than a recommended dose of the drug. In some embodiments, the filtering criterion is an over-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug. In some embodiments, the filtering criterion is a delayed prandial dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received after a predetermined period of time from the start of a meal.In some embodiments, the filtering criterion is more than necessary meal-time administrations, and the subset of time-correlated data based on the filtering criterion includes test substance data associated with at least one additional administration of the drug after a first administration of the drug in the administration time window.
[0287] In some embodiments, the instructions, when executed by the one or more processors, further cause the system to identify a third subset of time-correlated data based on a third filtering criterion selected by the subject, and display a third glucose profile displaying the third subset of the time-correlated data over the first time period, In some embodiments, the third filtering criterion is one of: a recommended dose administered, a missed dose, a bolus dose that is too small, a bolus dose that is too large, a late meal dose, or more meal doses than necessary.
[0288] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0289] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0290] In some embodiments, the first period of time is selected by the subject.
[0291] In some embodiments, the first period of time is set automatically.
[0292] In some embodiments, the first and second filtering criteria are selected using drop-down menus.
[0293] In many embodiments, a method for displaying a glucose profile comparison includes receiving time correlation data characteristic of a subject's test substance and administration of a drug received by the subject over a period of time; identifying a first subset of the time correlation data based on first filtering criteria selected by the subject and identifying a second subset of the time correlation data based on second filtering criteria selected by the subject; and displaying on a single graphical user interface a first glucose profile displaying the first subset of the time correlation data over the first period of time and a second glucose profile displaying the second subset of the time correlation data over the first period of time.
[0294] In some embodiments, the medication is a glucose level regulating drug, hi some embodiments, the glucose level regulating drug is insulin.
[0295] In some embodiments, the filtering criteria is one of recommended dose administration, missed doses, underdosing, overdosing, late prandial administration, or more prandial administrations than necessary. In some embodiments, the filtering criteria is recommended dose administration, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received in a dosing time range, the amount of the at least one drug administration received being equal to the recommended dose of the drug. In some embodiments, the filtering criteria is missed doses, and the subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration not received in a dosing time range. In some embodiments, the dosing time range for breakfast is from about 6:00 am to about 11:00 am. In some embodiments, the dosing time range for lunch is from about 11:00 am to about 4:00 pm. In some embodiments, the dosing time range for dinner is from about 4:00 pm to about 10:00 pm. In some embodiments, the dosing time range for basal administration is about one hour from the prescribed basal administration time. In some embodiments, the filtering criterion is an under-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being less than a recommended dose of the drug. In some embodiments, the filtering criterion is an over-bolus dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug. In some embodiments, the filtering criterion is a delayed prandial dose, and the subset of time-correlated data based on the filtering criterion includes analyte data associated with at least one drug administration received after a predetermined period of time from the start of a meal.In some embodiments, the filtering criterion is more than necessary meal-time administrations, and the subset of time-correlated data based on the filtering criterion includes test substance data associated with at least one additional administration of the drug after a first administration of the drug in the administration time window.
[0296] In some embodiments, the method further includes identifying a third subset of time-correlated data based on a third filtering criterion selected by the subject, and displaying a third glucose profile on the one graphical user interface displaying the third subset of the time-correlated data over the first time period. In some embodiments, the method further includes displaying a third glucose profile on the one graphical user interface displaying glucose values associated with the time-correlated data over the first time period.
[0297] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0298] In some embodiments, the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement.
[0299] In some embodiments, the first period of time is selected by the subject.
[0300] In some embodiments, the first period of time is set automatically.
[0301] In some embodiments, the first and second filtering criteria are selected using drop-down menus.
[0302] In many embodiments, a system for displaying metrics associated with a subject comprises a wireless communication circuit configured to receive measured drug administration data and analyte data, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analyte and glucose level adjusting drug administrations received by the subject over a period of time, the time correlation data including at least one portion of analyte data associated with at least one received administration of the glucose level adjusting drug and at least one portion of analyte data associated with at least one missed administration of the glucose level adjusting drug. When the instructions are executed by the one or more processors, the instructions cause the one or more processors to: identify the at least one portion of analyte data associated with the at least one received administration of the glucose level adjusting drug, identify the at least one portion of analyte data associated with the at least one missed administration of the glucose level adjusting drug, and display a plurality of glucose profiles.Among the plurality of glucose profiles, a first glucose profile displays glucose values determined from test substance data including at least one portion of test substance data associated with the at least one administered administration of the glucose value regulating drug and at least one portion of test substance data associated with the at least one not administered administration of the glucose value regulating drug; a second glucose profile displays glucose values determined from test substance data including at least one portion of test substance data associated with the at least one administered administration of the glucose value regulating drug but not including the at least one portion of test substance data associated with the at least one not administered administration of the glucose value regulating drug; and a third glucose profile displays glucose values determined from test substance data including at least one portion of test substance data associated with the at least one not administered administration of the glucose value regulating drug but not including the at least one portion of test substance data associated with the at least one not administered administration of the glucose value regulating drug.
[0303] In some embodiments, each of the first glucose profile, the second glucose profile, and the third glucose profile includes a plot of glucose values determined from the test substance data over the time period, the plot displaying a median glucose trajectory and multiple trajectories of glucose values at different percentiles.
[0304] In some embodiments, the period is about one month.
[0305] In some embodiments, the glucose level regulating drug is a glucose level lowering drug. In some embodiments, the glucose level regulating drug is insulin. In some embodiments, the glucose level regulating drug is a fast acting insulin. In some embodiments, the glucose level regulating drug is a long acting insulin. In some embodiments, the glucose level regulating drug is an SGLT inhibitor. In some embodiments, the glucose level regulating drug is a GLP1 receptor antagonist. In some embodiments, the glucose level regulating drug is selected from the group consisting of insulin, SGLT2 inhibitors, GLP1 receptor agonists, biguanides (e.g., metformin), α-glucosidase inhibitors, thiazolidinediones, DPP4 inhibitors, and combinations thereof.
[0306] In some embodiments, a length of the at least one portion of test substance data associated with the at least one received dose of the glucose level regulating drug varies depending on the type of the glucose level regulating drug.
[0307] In some embodiments, the length of the at least one portion of test substance data associated with the at least one administered dose of the glucose level regulating drug is a fixed time range related to a therapeutic time range of the glucose level regulating drug.
[0308] In some embodiments, the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level adjusting drug is a variable time range, and a start point of the variable time range is a time associated with administration of the glucose level adjusting drug. In some embodiments, the time associated with administration of the glucose level adjusting drug is derived from a timestamp of an associated delivery device. In some embodiments, the time associated with administration of the glucose level adjusting drug is derived from a logged administration.
[0309] In some embodiments, the glucose level regulating drug is a long-acting insulin and the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug is about one day.
[0310] In some embodiments, the glucose level regulating drug is an ultrafast-acting insulin and the length of the at least one portion of test substance data associated with the received dose of the glucose level regulating drug is between about 4 hours and about 8 hours.
[0311] In some embodiments, the instructions further cause the one or more processors to display the plurality of glucose profiles in a side-by-side arrangement.
[0312] In some embodiments, the instructions further cause the one or more processors to display the plurality of glucose profiles in a vertical arrangement.
[0313] In some embodiments, the instructions further cause the one or more processors to display a “Time in Range” interface for each of the plurality of glucose profiles, the “Time in Range” interface including a bar having a plurality of rectangular portions, each rectangular portion of the plurality of rectangular portions indicating an amount of time that a user's analyte value is within a predefined analyte range associated with that rectangular portion, the plurality of rectangular portions based on data indicative of analyte values, and the plurality of rectangular portions based on the analyte data for each of the plurality of glucose profiles.
[0314] In some embodiments, the instructions further cause the one or more processors to display a GMI metric for each of the plurality of glucose profiles, hi some embodiments, the GMI metric is a percentage GMI and / or a GMI value in mmol / mol.
[0315] In some embodiments, the instructions further cause the one or more processors to display a glucose statistic for each of the plurality of glucose profiles. In some embodiments, the glucose statistic is a mean glucose value or a median glucose value. In some embodiments, the glucose statistic is a CV.
[0316] In some embodiments, the instructions further cause the one or more processors to display a plurality of dosing indicators corresponding to the administration of a plurality of doses of the glucose level adjusting drug in the first glucose profile and the second glucose profile.
[0317] In many embodiments, a method for displaying glucose profile comparisons includes receiving time correlated data characteristic of a subject's test substance and administrations of glucose level regulating drug taken by the subject over a period of time; identifying at least a portion of the time correlated data associated with at least one administered administration of the glucose level regulating drug; identifying at least a portion of the time correlated data associated with at least one missed administration of the glucose level regulating drug; and displaying a plurality of glucose profiles, wherein a first glucose profile of the plurality of glucose profiles comprises at least one portion of test substance data associated with the at least one administered administration of the glucose level regulating drug and at least a portion of the time correlated data associated with the at least one missed administration of the glucose level regulating drug. a first glucose profile displaying glucose values determined from test substance data including the at least one portion of test substance data associated with the at least one administered administration of the glucose level regulating drug, but not including the at least one portion of test substance data associated with the at least one not administered administration of the glucose level regulating drug; and a third glucose profile displaying glucose values determined from test substance data including the at least one portion of test substance data associated with the at least one not administered administration of the glucose level regulating drug, but not including the at least one portion of test substance data associated with the at least one administered administration of the glucose level regulating drug.
[0318] In some embodiments, each of the first glucose profile, the second glucose profile, and the third glucose profile includes a plot of glucose values determined from the test substance data over the time period, the plot displaying a median glucose trajectory and multiple trajectories of glucose values at different percentiles.
[0319] In some embodiments, the period is about one month.
[0320] In some embodiments, the glucose level regulating drug is a glucose level lowering drug. In some embodiments, the glucose level regulating drug is insulin. In some embodiments, the glucose level regulating drug is a fast acting insulin. In some embodiments, the glucose level regulating drug is a long acting insulin.
[0321] In some embodiments, the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug varies depending on the type of the glucose level regulating drug. In some embodiments, the glucose level regulating drug is a long-acting insulin, and the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug is about 1 day. In some embodiments, the glucose level regulating drug is a rapid-acting insulin, and the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug is about 4 hours to about 8 hours. In some embodiments, the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug is a fixed time range related to a therapeutic time range of the glucose level regulating drug. In some embodiments, the length of the at least one portion of test substance data associated with the at least one received administration of the glucose level regulating drug is a variable time range, and a start point of the variable time range is a time associated with the administration of the glucose level regulating drug. In some embodiments, the time associated with administration of the glucose level modulating drug is derived from a timestamp of an associated delivery device, hi some embodiments, the time associated with administration of the glucose level modulating drug is derived from a logged administration.
[0322] In some embodiments, the multiple glucose profiles are displayed in a side-by-side arrangement.
[0323] In some embodiments, the multiple glucose profiles are displayed in a vertical arrangement.
[0324] In some embodiments, the method further includes displaying a “Time in Range” interface for each of the plurality of glucose profiles, wherein the “Time in Range” interface for each of the plurality of glucose profiles includes a bar having a plurality of rectangular portions, each rectangular portion indicating an amount of time that a user's test substance value is within a predefined test substance range associated with that rectangular portion, and wherein the plurality of rectangular portions are based on the test substance data for each of the plurality of glucose profiles.
[0325] In some embodiments, the method further comprises displaying a GMI metric for each of the plurality of glucose profiles, hi some embodiments, the GMI metric is a percentage GMI and / or a GMI value in mmol / mol.
[0326] In some embodiments, the method further comprises displaying a glucose statistic for each of the plurality of glucose profiles, hi some embodiments, the glucose statistic is a mean glucose value or a median glucose value.
[0327] In some embodiments, the method further comprises displaying a plurality of dosing indicators corresponding to the administration of a plurality of doses of the glucose level modulating drug in the first glucose profile and the second glucose profile.
[0328] In many embodiments, a system for displaying metrics associated with a subject includes wireless communication circuitry configured to receive measured drug administration data and analyte data, a display configured to visually present information, and one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data, the time correlation data characteristic of the subject's analytes and drug administrations received by the subject over a period of time, the time correlation data including at least one portion of analyte data associated with at least one received administration of the drug and at least one portion of analyte data associated with at least one missed administration of the drug. The instructions, when executed by the one or more processors, cause the system to: identify the at least one portion of analyte data associated with the at least one received administration of the drug, identify the at least one portion of analyte data associated with the at least one missed administration of the drug, and display a plurality of analyte profiles.a first test substance profile among the plurality of test substance profiles displays a test substance value determined from test substance data including the at least one portion of test substance data associated with the at least one administered administration of the drug and the at least one portion of test substance data associated with the at least one not administered administration of the drug; a second test substance profile displays a test substance value determined from test substance data including the at least one portion of test substance data associated with the at least one administered administration of the drug but not including the at least one portion of test substance data associated with the at least one not administered administration of the drug; and a third test substance profile displays a test substance value determined from test substance data including the at least one portion of test substance data associated with the at least one not administered administration of the drug but not including the at least one portion of test substance data associated with the at least one not administered administration of the drug.
[0329] In some embodiments, each of the first test substance profile, the second test substance profile, and the third test substance profile includes a plot of test substance values determined from the test substance data over the time period, the plot displaying a trajectory of the median test substance value and multiple trajectories of test substance values at different percentiles.
[0330] In some embodiments, the period is about one month.
[0331] In some embodiments, the test substance is glucose and the drug is a glucose-lowering drug. In some embodiments, the glucose-lowering drug is insulin. In some embodiments, the glucose-lowering drug is at least one of ultrarapid-acting insulin, long-acting insulin, and intermediate-acting insulin. In some embodiments, the glucose-lowering drug is an SGLT inhibitor or a GLP1 receptor antagonist.
[0332] In some embodiments, the length of the at least one portion of analyte data after the at least one administration of the drug varies depending on the type of drug. In some embodiments, the length of the at least one portion of analyte data associated with the at least one administration of the drug is a fixed time range related to a therapeutic time range of the drug. In some embodiments, the length of the at least one portion of analyte data associated with the at least one administration of the drug is a variable time range, the beginning of the variable time range being a time associated with administration of the drug. In some embodiments, the time associated with administration of the drug is derived from a timestamp of an associated delivery device. In some embodiments, the time associated with administration of the drug is derived from a logged administration.
[0333] In some embodiments, the instructions further cause the one or more processors to display the multiple analyte profiles in a side-by-side arrangement.
[0334] In some embodiments, the instructions further cause the one or more processors to display the multiple analyte profiles in a vertical arrangement.
[0335] In some embodiments, the instructions further cause the one or more processors to display an analyte metric for each of the plurality of analyte profiles.
[0336] In some embodiments, the instructions further cause the one or more processors to display an analyte statistic for each of the plurality of analyte profiles, hi some embodiments, the analyte statistic is a mean analyte value or a median analyte value.
[0337] In some embodiments, the instructions further cause the one or more processors to display a plurality of administration indicators corresponding to administration of a plurality of administrations of the drug in the first test substance profile and the second test substance profile.
[0338] In some embodiments, the time-correlated data further includes at least one portion of analyte data after at least one administration of the second drug and at least one portion of analyte data after at least one absence of the second drug, and the instructions, when executed by the one or more processors, further cause the system to: identify the at least one portion of analyte data after at least one administration of the second drug; identify the at least one portion of analyte data after the at least one absence of the second drug; and display a plurality of analyte profiles, wherein a first analyte profile of the plurality of analyte profiles includes at least one portion of analyte data after at least one administration of the second drug and at least one portion of analyte data after at least one absence of the second drug. a fourth analyte profile displaying analyte values determined from analyte data including the at least one portion of analyte data after the at least one administration of the second drug, the at least one portion of analyte data after the at least one administration of the second drug, and the at least one portion of analyte data after the at least one administration of the second drug, a fourth analyte profile displaying analyte values determined from analyte data including the at least one portion of analyte data after the at least one administration of the second drug but not including the at least one portion of analyte data after the at least one administration of the second drug, and a fifth analyte profile displaying analyte values determined from analyte data including the at least one portion of analyte data after the at least one administration of the second drug but not including the at least one portion of analyte data after the at least one administration of the second drug. In some embodiments, the first analyte is a long acting insulin and the second analyte is a rapid acting insulin.
[0339] In some embodiments, the test substance is at least one of glucose, a glucose derivative, a ketone, a ketone body, or lactate.
[0340] In some embodiments, the test substance is at least one of oxygen, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, DNA, fructosamine, glutamine, growth hormone, hormone, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.
[0341] In many embodiments, a method for displaying comparative test substance profiles includes receiving time correlation data characteristic of a subject's test substance and administration of a drug to the subject over a period of time; identifying at least a portion of the time correlation data after at least one administration of the drug; identifying at least a portion of the time correlation data after at least one absence of the drug; and displaying a plurality of test substance profiles, wherein a first of the plurality of test substance profiles comprises the at least one portion of the test substance data after the at least one administration of the drug and the at least one portion of the time correlation data after the at least one absence of the drug. a second analyte profile displaying analyte values determined from analyte data including the at least one portion of analyte data after the at least one administration of the drug but not including the at least one portion of analyte data after the at least one absence of the drug; and a third analyte profile displaying analyte values determined from analyte data including the at least one portion of analyte data after the at least one absence of the drug but not including the at least one portion of analyte data after the at least one administration of the drug.
[0342] In some embodiments, each of the first test substance profile, the second test substance profile, and the third test substance profile includes a plot of test substance values determined from the test substance data over the time period, the plot displaying a trajectory of the median test substance value and multiple trajectories of test substance values at different percentiles.
[0343] In some embodiments, the period is about one month.
[0344] In some embodiments, the test substance is glucose and the drug is a glucose-lowering drug. In some embodiments, the glucose-lowering drug is insulin. In some embodiments, the glucose-lowering drug is at least one of ultrarapid-acting insulin, long-acting insulin, and intermediate-acting insulin. In some embodiments, the glucose-lowering drug is an SGLT inhibitor or a GLP1 receptor antagonist.
[0345] In some embodiments, the length of the at least one portion of analyte data after the at least one administration of the drug varies depending on the type of drug. In some embodiments, the length of the at least one portion of analyte data associated with the at least one administration of the drug is a fixed time range related to a therapeutic time range of the drug. In some embodiments, the length of the at least one portion of analyte data associated with the at least one administration of the drug is a variable time range, the beginning of the variable time range being a time associated with administration of the drug. In some embodiments, the time associated with administration of the drug is derived from a timestamp of an associated delivery device. In some embodiments, the time associated with administration of the drug is derived from a logged administration.
[0346] In some embodiments, the method further comprises displaying the multiple analyte profiles in a side-by-side arrangement.
[0347] In some embodiments, the method further comprises displaying the multiple test substance profiles in a vertical arrangement.
[0348] In some embodiments, the method further comprises displaying an analyte metric for each of the plurality of analyte profiles.
[0349] In some embodiments, the method further comprises displaying an analyte statistic for each of the plurality of analyte profiles, hi some embodiments, the analyte statistic is a mean analyte value or a median analyte value.
[0350] In some embodiments, the method further includes displaying a plurality of dosing indicators corresponding to administration of a plurality of doses of the agent in the first test substance profile and the second test substance profile.
[0351] In some embodiments, the time-correlated data further comprises at least one portion of test substance data after at least one administration of the second drug and at least one portion of test substance data after not receiving at least one administration of the second drug, and the method further comprises identifying the at least one portion of test substance data after at least one administration of the second drug, identifying the at least one portion of test substance data after not receiving the at least one administration of the second drug, and displaying a plurality of test substance profiles, the plurality of test substance profiles further comprising a fourth test substance profile and a fifth test substance profile, the first test substance profile comprising the at least one portion of test substance data after receiving the at least one administration of the drug, and the at least one portion of test substance data after not receiving the at least one administration of the second drug, the fourth test substance profile displays test substance values identified from test substance data including the at least one portion of the test substance data after the at least one administration of the second drug and the at least one portion of the test substance data after the at least one administration of the second drug; the fourth test substance profile displays test substance values identified from test substance data including the at least one portion of the test substance data after the at least one administration of the second drug but not including the at least one portion of the test substance data after the at least one administration of the second drug; and the fifth test substance profile displays test substance values identified from test substance data including the at least one portion of the test substance data after the at least one administration of the second drug but not including the at least one portion of the test substance data after the at least one administration of the second drug.
[0352] In some embodiments, the first agent is a long-acting insulin and the second agent is an ultra-rapid acting insulin.
[0353] In some embodiments, the test substance is at least one of glucose, a glucose derivative, a ketone, a ketone body, or lactate.
[0354] In some embodiments, the test substance is at least one of oxygen, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, DNA, fructosamine, glutamine, growth hormone, hormone, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.
[0355] In many embodiments, a system for displaying a metric associated with a subject includes a wireless communication circuit configured to receive measured analyte data, a display configured to visually present information, and one or more processors coupled to the wireless communication circuit, the display, and a memory storing instructions and time correlation data, the time correlation data being representative of an analyte characteristic of the subject over a period of time, the instructions, when executed by the one or more processors, causing the one or more processors to: display a first "time in range" graphical representation for a first period of time and a second "time in range" graphical representation for a second period of time, each of the first "time in range" graphical representation and the second "time in range" graphical representation including a predetermined number of portions corresponding to a plurality of concentration ranges, each of the predetermined number of portions including a predetermined number of different colors equal in number to the predetermined number of portions; The method includes the steps of: displaying a first ambulatory glucose profile for the first time period and a second ambulatory glucose profile for the second time period, wherein the first glucose metric section includes a glucose control indicator and an average glucose value for the first time period and the second glucose metric section includes a glucose control indicator and an average glucose value for the second time period; displaying a first ambulatory glucose profile for the first time period and a second ambulatory glucose profile for the second time period; and displaying a first low glucose event section including a graph of glucose values below a low threshold during the first time period and a second low glucose event section including a graph of glucose values below the low threshold during the second time period.
[0356] In some embodiments, each of the first ambulatory glucose profile and the second ambulatory glucose profile includes the predetermined number of portions corresponding to a plurality of concentration ranges, and the glucose values displayed in each of the predetermined number of portions include the predetermined number of different colors.
[0357] In some embodiments, the first low glucose event section further includes a total number of low glucose events in the first time period, and the second low glucose event section further includes a total number of low glucose events in the second time period.
[0358] In some embodiments, the predetermined number of portions includes an ultra-low concentration range, a low concentration range, a target concentration range, a high concentration range, and an ultra-high concentration range.
[0359] In some embodiments, the first glucose metric section further includes a variability metric for glucose values during the first time period, and the second glucose metric section further includes a variability metric for glucose values during the second time period.
[0360] In some embodiments, the first 'times within range' graphical representation and the second 'times within range' graphical representation further comprise a percentage value corresponding to each of the predetermined number portions.
[0361] In some embodiments, the instructions, when executed by the one or more processors, further cause the system to display a first sensor metric for the first time period and a second sensor metric for the second time period. In some embodiments, the first sensor metric includes a length of time a sensor was active during the first time period and the second sensor metric includes a length of time a sensor was active during the second time period. In some embodiments, the first sensor metric includes an average number of views of glucose values by a user during the first time period and the second sensor metric includes an average number of views of glucose values by a user during the second time period. In some embodiments, the first sensor metric includes an average number of scans of a sensor by a user during the first time period and the second sensor metric includes an average number of scans of a sensor by a user during the second time period.
[0362] In some embodiments, the first 'time within range' graphical representation and the second 'time within range' graphical representation are each bar graphs.
[0363] In some embodiments, the predetermined number of portions are arranged in a tandem.
[0364] In some embodiments, the plurality of concentration ranges consists of five concentration ranges.
[0365] In some embodiments, the predetermined number of portions consists of up to five portions.
[0366] In many embodiments, a method for displaying a glucose profile comparison includes receiving time correlation data representative of a user's analyte characteristic over a period of time; displaying on a single graphical user interface a first "time in range" graphical representation for a first period of time and a second "time in range" graphical representation for a second period of time, each of the first "time in range" graphical representation and the second "time in range" graphical representation including a predetermined number of portions corresponding to a plurality of concentration ranges, each of the predetermined number of portions including a predetermined number of different colors equal in number to the predetermined number of portions; and displaying on the single graphical user interface a first glucose metric section for the first period of time and a second glucose metric section for the second period of time. the first glucose metric section including a glucose control indicator and an average glucose value for the first time period and the second glucose metric section including a glucose control indicator and an average glucose value for the second time period; displaying a first ambulatory glucose profile for the first time period and a second ambulatory glucose profile for the second time period on the single graphical user interface; and displaying a first low glucose event section including a graph of glucose values below a low threshold during the first time period and a second low glucose event section including a graph of glucose values below the low threshold during the second time period on the single graphical user interface.
[0367] In some embodiments, each of the first ambulatory glucose profile and the second ambulatory glucose profile includes at least five portions corresponding to the five concentration ranges, and the glucose values displayed in each of the five portions include five different colors.
[0368] In some embodiments, the first low glucose event section further includes a total number of low glucose events in the first time period, and the second low glucose event section further includes a total number of low glucose events in the second time period.
[0369] In some embodiments, the predetermined number of portions includes an ultra-low concentration range, a low concentration range, a target concentration range, a high concentration range, and an ultra-high concentration range.
[0370] In some embodiments, the first glucose metric section further includes a variability metric for glucose values during the first time period, and the second glucose metric section further includes a variability metric for glucose values during the second time period.
[0371] In some embodiments, the first 'times within range' graphical representation and the second 'times within range' graphical representation further comprise a percentage value corresponding to each of the predetermined number portions.
[0372] In some embodiments, the method further includes displaying a first sensor metric for the first time period and a second sensor metric for the second time period. In some embodiments, the first sensor metric includes a length of time a sensor was active during the first time period and the second sensor metric includes a length of time a sensor was active during the second time period. In some embodiments, the first sensor metric includes an average number of views of glucose values by a user during the first time period and the second sensor metric includes an average number of views of glucose values by a user during the second time period. In some embodiments, the first sensor metric includes an average number of scans of a sensor by a user during the first time period and the second sensor metric includes an average number of scans of a sensor by a user during the second time period.
[0373] In some embodiments, the first 'time within range' graphical representation and the second 'time within range' graphical representation are each bar graphs.
[0374] In some embodiments, the predetermined number of portions are arranged in a tandem.
[0375] In some embodiments, the plurality of concentration ranges consists of five concentration ranges.
[0376] In some embodiments, the predetermined number of portions consists of up to five portions.
[0377] The present disclosure provides systems, devices and methods for integrating medication delivery devices into an integrated management system, which may be an integrated diabetes management system and may include a glucose monitor, an associated insulin pen, and software. The integrated management system may generate reports, which may include data related to analyte values (e.g., glucose values) and medication delivered (e.g., insulin delivered).
[0378] The GUI improvements in various aspects described herein and in the claims provide at least the technical effect of assisting a user of the device to operate the device more accurately, efficiently and safely. It will be appreciated that the information provided to the user on the GUI, the order in which the information is provided, and the clarity of the organization of the information can have a significant impact on the user's interaction with the system and the way the system is operated. Thus, the GUI guides the user to perform technical tasks related to the operation of the system and to enable the user to read the required measurements and obtain the required information accurately and efficiently.
[0379] It should be noted that all features, elements, components, functions, and steps described in the description of any embodiment described herein are intended to be freely combinable and interchangeable with features, elements, components, functions, and steps of any other embodiment. Also, if a particular feature, element, component, function, or step is described only in the description of one embodiment, it should be understood that the feature, element, component, function, or step can also be used in all other embodiments described herein, unless expressly stated otherwise. Therefore, even if the following description does not expressly state as a specific example that features, elements, components, functions, and steps can be combined between different embodiments, or that features, elements, components, functions, and steps can be interchanged between embodiments, this paragraph serves as a preceding and supporting description that allows claims with such combinations or substitutions to be added at any time. It is clearly recognized that it would be an undue burden to explicitly state all possible combinations and substitutions, especially considering that a person skilled in the art can easily recognize the acceptability of all such combinations and substitutions.
[0380] To the extent that the embodiments disclosed herein include or operate in conjunction with memory, storage, and / or computer-readable medium, the memory, storage, and / or computer-readable medium are non-transitory, and thus only to the extent that one or more claims regarding the memory, storage, and / or computer-readable medium are encompassed by the memory, storage, and / or computer-readable medium.
[0381] In this specification, an entity is often described as being coupled to a different entity. In this specification, the terms "coupled" and "connected" (or any variation thereof) are used interchangeably and should be understood as generic terms that refer to a direct coupling of two entities (without significant (e.g., parasitic) intervening entities) and an indirect coupling of two entities (with one or more intervening entities that are significant). When entities are shown as being directly coupled to each other, or when entities are described as being coupled to each other without any intervening entities, it should be understood that the entities can also be indirectly coupled, unless the context clearly indicates otherwise.
[0382] The subject matter described in this specification and the accompanying drawings has been described with sufficient detail and clarity to permit means-plus-function claims to be included within the scope of the claims set forth in 35 U.S.C. 112(f), but the means-plus-function format should be construed only as being limited to claims that expressly recite the phrase "means for."
[0383] In this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include references to the corresponding plural forms unless the context clearly indicates otherwise.
[0384] The publications referenced herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure of such publication. Further, the publication dates provided herein may be different from the actual publication dates, which may need to be independently confirmed.
[0385] Although the embodiments can be modified in various ways, specific examples thereof are shown in the drawings and described in detail herein. These embodiments are not limited to the specific forms disclosed, but on the contrary, these embodiments are intended to embrace all modifications, equivalents, and alternatives that do not depart from the spirit of the present invention. Furthermore, any feature, function, step, or element of the embodiments can be described or included in the claims, and the claims can be defined by negative limitations of features, functions, steps, or elements not included in the claims.
[0386] Itemized Description Exemplary embodiments are described below in numbered sections.
[0387] Section 1 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 a subject; and a medication delivery device configured to deliver an amount of medication to the subject and log the amount delivered; display, a wireless communication circuit configured to receive current sensor readings from the sensor control device and to receive the log from the medication delivery device; and one or more processors coupled to a memory storing instructions; A reading device comprising: A test substance monitoring system comprising: The instructions, when executed by the one or more processors, cause the one or more processors to: outputting an interface on the display prompting the subject to cooperate with the medication delivery device; outputting an interface on the display prompting the subject to select a type of medication delivery device; outputting an interface on the display prompting the subject to select a type of medication to be delivered by the medication delivery device; outputting an interface on the display prompting the subject to select a brand of medication to be delivered by the medication delivery device; A test substance monitoring system that performs the above steps.
[0388] Section 2 2. The system of claim 1, wherein the medication delivery device is an insulin pen.
[0389] Section 3 2. The system of claim 1, wherein the type of medication delivery device is an insulin pen brand.
[0390] Section 4 2. The system described in paragraph 1, wherein the type of drug delivered is insulin type.
[0391] Section 5 5. The system described in paragraph 4, wherein the type of insulin is ultrafast-acting or long-acting.
[0392] Section 6 The instructions cause the one or more processors to: outputting an animation on the display showing how to hold the medication delivery device relative to the reading device to transfer the log to the reading device. The system according to claim 1, further comprising:
[0393] Section 7 The instructions cause the one or more processors to: outputting an interface on the display prompting the subject to select a color of a medication delivery device. The system according to claim 1, further comprising:
[0394] Section 8 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 a subject; and a medication delivery device configured to deliver an amount of medication to the subject and log the amount delivered; display, a wireless communication circuit configured to receive current sensor readings from the sensor control device and to receive the log from the medication delivery device; and One or more processors coupled to a memory that stores instructions A reading device comprising: A test substance monitoring system comprising: The instructions, when executed by the one or more processors, cause the one or more processors to: outputting a logbook interface on said display; Run the command, The logbook interface comprises a plurality of entries including at least two of a drug dosage, a comment, an alarm, and a drug delivery device priming amount.
[0395] Section 9 9. The system of claim 8, wherein the plurality of entries are arranged in chronological order.
[0396] Section 10 9. The system of claim 8, wherein the drug is insulin.
[0397] Section 11 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a first graph with time on the x-axis and glucose concentration on the y-axis, the first graph including a plot of the median average glucose concentration over said time period; displaying a second graph with time on the x-axis and glucose concentration on the y-axis, the second graph including a plot of low glucose events having glucose values below a threshold; displaying an average daily carbohydrate intake for said period; displaying an average daily delivery amount of at least one drug for said time period; A system that executes the above.
[0398] Section 12 The memory comprises: displaying a third graph having time on the x-axis and the relative length of time that the sensor is active on the y-axis, the graph including a plot of the average amount of time that the sensor was active during said period. 12. The system of claim 11, further comprising instructions to execute:
[0399] Section 13 The instructions cause the one or more processors to: displaying the average total daily delivery of said at least one drug. 12. The system according to claim 11, further comprising:
[0400] Section 14 12. The system of claim 11, wherein the at least one delivered agent comprises an ultrafast-acting insulin and a long-acting insulin.
[0401] Section 15 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a plurality of intra-day graphs corresponding to each day of the time period, each graph of the plurality of intra-day graphs including a plot of glucose concentration over a 24 hour period with time on the x-axis and glucose concentration on the y-axis, and a plurality of dosage indices, each of the plurality of dosage indices indicating an amount of medication administered; displaying a plurality of total administration indicators indicative of the amount of at least one medication delivered during said 24 hour day; A system that executes the above.
[0402] Section 16 16. The system of claim 15, wherein the plurality of total administration indicators include a numerical value highlighted in a first color corresponding to a first medication.
[0403] Section 17 17. The system of claim 16, wherein the plurality of total administration indicators include numbers highlighted in a second color corresponding to a second medication.
[0404] Section 18 17. The system of claim 16, wherein the plurality of dosing indicators include numerical values corresponding to the first medication and correspondingly highlighted in the first color.
[0405] Section 19 20. The system of claim 17, wherein the plurality of dosing indicators include a number highlighted in the first color corresponding to the first medication and a number highlighted in the second color corresponding to the second medication.
[0406] Section 20 The instructions cause the one or more processors to: Displaying a plurality of average glucose values for at least some of the days of said period. 16. The system of claim 15, further comprising:
[0407] Section 21 The instructions cause the one or more processors to: displaying a plurality of total carbohydrate intake values for at least some days of said time period. 16. The system of claim 15, further comprising:
[0408] Section 22 The instructions cause the one or more processors to: Displaying the number of events in which the subject's glucose level fell below a threshold. 16. The system of claim 15, further comprising:
[0409] Section 23 Each of the plurality of intraday graphs includes a target range; 16. The system of claim 15, wherein the area under the curve of the plot portion that falls outside the target range is colored.
[0410] Section 24 24. The system of claim 23, wherein the area under the curve of the plot portion that deviates from the target range is colored red if the deviating plot portion is below the target range.
[0411] Section 25 24. The system of claim 23, wherein the area under the curve of the plot portion that is outside the target range is colored yellow if the outside plot portion is above the target range.
[0412] Section 26 Each of the plurality of intraday graphs includes a target range; 16. The system of claim 15, wherein plot portions that fall outside the target range are colored.
[0413] Section 27 27. The system of claim 26, wherein the plot portion that is outlying from the target range is colored red if the outlying plot portion is below the target range.
[0414] Section 28 27. The system of claim 26, wherein the plot portion that is out of the target range is colored yellow if the outlying plot portion is above the target range.
[0415] Section 29 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a plurality of intra-day graphs corresponding to respective days of the time period, each graph of the plurality of intra-day graphs including a plot of glucose concentration over a 24 hour period with time on the x-axis and glucose concentration on the y-axis; displaying a plurality of carbohydrate indicators corresponding to a plurality of amounts of carbohydrate ingested during said 24 hour period, each of said plurality of carbohydrate indicators being located in a time period during which said carbohydrate was ingested; displaying a plurality of dosage indicators corresponding to a plurality of administrations of at least one medication, each of the plurality of dosage indicators indicating an amount of medication administered, each of the plurality of dosage indicators being located at a time period during which the medication was administered; A system that executes the above.
[0416] Section 30 the plurality of administration indices correspond to administration of a first agent and a second agent; The instructions cause the one or more processors to: Displaying the plurality of dosage indicators for the first medication in a first row and displaying the plurality of dosage indicators for the second medication in a second row. 30. The system of claim 29, further comprising:
[0417] Section 31 31. The system of claim 30, wherein the plurality of dosage indicators for the first medication are displayed in a first color and the plurality of dosage indicators for the second medication are displayed in a second color.
[0418] Section 32 30. The system of claim 29, wherein the plurality of administration indicators comprises a total administered dose.
[0419] Section 33 The instructions cause the one or more processors to: displaying a plurality of components for at least some of said plurality of dosage indicia; 33. The system of claim 32, further comprising:
[0420] Section 34 34. The system of claim 33, wherein the plurality of components includes a correction or modification.
[0421] Section 35 30. The system of clause 29, wherein the at least one medication is insulin.
[0422] Section 36 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a plot of glucose readings over a 24 hour period, the plot showing a trajectory of the median glucose reading over said period and a plurality of trajectories of glucose readings for different percentiles; displaying a plot of carbohydrate indicators corresponding to the amount of carbohydrate ingested during said 24 hour period, each of said carbohydrate indicators being located at a time during said period during which that carbohydrate was ingested; displaying a plurality of average doses corresponding to administration of at least one drug during a period of the 24 hour period; A system that executes the above.
[0423] Section 37 The instructions cause the one or more processors to: Displaying the average daily amount of carbohydrates consumed during said period. 37. The system of claim 36, further comprising:
[0424] Section 38 The instructions cause the one or more processors to: displaying an average amount of carbohydrates ingested during each of a plurality of time periods during said 24 hour period; 38. The system of claim 37, further comprising:
[0425] Section 39 the at least one agent comprises a first agent and a second agent; The instructions cause the one or more processors to: Displaying a plurality of average doses corresponding to administration of the first drug in a first row and displaying a plurality of average doses corresponding to administration of the second drug in a second row. 37. The system of claim 36, further comprising:
[0426] Section 40 The instructions cause the one or more processors to: displaying the average daily amount of at least one medication taken during said period. 37. The system of claim 36, further comprising:
[0427] Section 41 37. The system of clause 36, wherein the at least one medication is insulin.
[0428] Section 42 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a plurality of plots of glucose readings for different time periods, each plot showing the glucose readings for said time periods and a target range; displaying a plurality of tables for the different time periods, each table including pre-meal and post-meal glucose values for at least some days of the period and a dose of at least one drug delivered for at least some days of the period; A system that executes the above.
[0429] Section 43 The instructions cause the one or more processors to: displaying an average of each period of the dose of the at least one drug delivered. 43. The system of claim 42, further comprising:
[0430] Section 44 The instructions cause the one or more processors to: Displaying the average of the glucose values measured before and after the meal for each period. 43. The system of claim 42, further comprising:
[0431] Section 45 43. The system of claim 42, wherein each table of the plurality of tables further includes an amount of carbohydrates ingested on at least some of the days of the period.
[0432] Section 46 The instructions cause the one or more processors to: Step to display the average amount of carbohydrate intake for each period 46. The system of claim 45, further comprising:
[0433] Section 47 43. The system of claim 42, wherein the at least one medication is insulin.
[0434] Section 48 A drug delivery device; a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and time correlation data; A system comprising: the time-correlated data characterizing administration of a test substance to the subject and a drug administered to the subject over a period of time; The instructions, when executed by the one or more processors, cause the system to: displaying a number of settings associated with the analyte values; displaying a plurality of settings associated with at least one medication delivery device; A system that executes the above.
[0435] Section 49 49. The system of claim 48, wherein the analyte value related settings include a target analyte range.
[0436] Section 50 49. The system of clause 48, wherein the analyte value related settings include alarm settings including a low analyte value threshold and an high analyte value threshold.
[0437] Section 51 49. The system of clause 48, wherein the settings related to the test substance value include an alarm setting related to loss of signal from a sensor control device configured to measure the test substance value.
[0438] Section 52 49. The system of claim 48, wherein the plurality of settings associated with the at least one medication delivery device include information related to type of medication and the last administration data transfer from the medication delivery device.
[0439] Section 53 53. The system of claim 52, wherein the information relating to the last administration data transfer includes a date and time of the last administration data transfer.
[0440] Section 54 53. The system of claim 52, wherein the plurality of settings associated with the at least one medication delivery device further includes a color of the medication delivery device.
[0441] Section 55 49. The system of clause 48, wherein the test substance data is glucose data.
[0442] Section 56 49. The system of clause 48, wherein the at least one drug delivery device is at least one insulin delivery device.
[0443] Section 57 49. The system of clause 48, wherein the at least one drug delivery device is a first drug delivery device and a second drug delivery device.
[0444] Section 58 The instructions cause the one or more processors to: Displaying information related to a sensor control device configured to measure an analyte value. 49. The system of claim 48, further comprising:
[0445] Section 59 59. The system of clause 58, wherein the information related to the sensor control device includes a name of the sensor control device and a software version on the sensor control device.
[0446] Section 60 The instructions cause the one or more processors to: Displaying information relating to said at least one medication delivery device. 49. The system of claim 48, further comprising:
[0447] Section 61 61. The system of claim 60, wherein the information related to the at least one medication delivery device includes a brand name of the at least one medication delivery device.
[0448] Section 62 61. The system of claim 60, wherein the information relating to the at least one medication delivery device includes a serial number of the at least one medication delivery device.
[0449] Section 63 a wireless communication circuit configured to receive measured analyte data and drug administration data, the wireless communication circuit automatically receiving the drug administration data from the drug delivery device;...
Claims
1. A wireless communication circuit configured to receive time-correlated data representative of a test substance of a subject and a drug administration received by the subject over a period of time; a display configured to visually present information; one or more processors coupled to the wireless communication circuitry, the display, and a memory storing instructions and the time correlation data; 1. A system for displaying metrics related to a subject, comprising: The instructions, when executed by the one or more processors, cause the system to: identifying a first subset of the time correlation data based on filtering criteria selected by the subject; displaying a first glucose profile and a second glucose profile on a 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 the first subset of the time-correlated data over the first period of time; A system that executes the above.
2. When the instructions are executed by the one or more processors, the instructions cause the system to: further identifying a second subset of the time correlation data based on second filtering criteria selected by the subject; Run the command, the first glucose profile displays the first subset of the time correlation data over the first time period rather than the glucose values associated with the time correlation data over the first time period, and the second glucose profile displays the second subset of the time correlation data over the first time period rather than the first subset of the time correlation data over the first time period. The system of claim 1 .
3. When the instructions are executed by the one or more processors, the instructions further identifying a third subset of the time correlation data based on a third filtering criterion selected by the subject; and displaying a third glucose profile, the third glucose profile displaying the third subset of the time-correlated data over the first period of time. The system of claim 2 , further comprising:
4. The system of claim 3, wherein the third filtering criterion is one of recommended dose administration, missed dose, underdose bolus administration, overdose bolus administration, delayed mealtime administration, or more mealtime administrations than necessary.
5. The system described in claim 1 or 2, wherein the drug is a glucose level regulating drug.
6. The system described in claim 5, wherein the glucose level regulating drug is insulin.
7. The filtering criteria: recommended dose administration, wherein the first subset of the time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being equal to a recommended dose of the drug; a missed dose, wherein the first subset of the time-correlated data based on the filtering criteria includes analyte data associated with at least one medication dose that was not taken during a dose window; an under-bolus dose, wherein the first subset of time-correlated data based on the filtering criteria includes analyte data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being less than a recommended dose of the drug; an overdose bolus administration, wherein the first subset of time-correlated data based on the filtering criteria includes analyte data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug; delayed meal dosing, and the first subset of the time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration taken after a predetermined period of time from the start of a meal; or more than necessary prandial dosing, and the first subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one additional dose of the drug taken after a first dose of the drug taken in a dosing time window; The system according to claim 1 or 2, wherein the
8. The system of claim 7, wherein the administration time range is at least one of a breakfast administration time range of 6:00 a.m. to 11:00 a.m., a lunch administration time range of 11:00 a.m. to 4:00 p.m., a dinner administration time range of 4:00 p.m. to 10:00 p.m., or a basal administration time range of one hour from the prescribed basal administration time.
9. When the instructions are executed by the one or more processors, the instructions further identifying an additional subset of the time-correlated data based on a second filtering criterion selected by the subject; displaying a third glucose profile, the third glucose profile displaying the additional subset of the time-correlated data over the first period of time; The system of claim 1 , 10. The system of claim 9, wherein the second filtering criterion is one of recommended dose administration, missed dose, underdose bolus administration, overdose bolus administration, delayed mealtime administration, or more mealtime administrations than necessary.
11. A system as described in claim 1 or 2, wherein the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement, the first glucose profile and the second glucose profile are displayed in a vertical arrangement, the first time period is selected by input by the subject, the first time period is set automatically, or the filtering criteria are selected using a drop-down menu.
12. The method of claim 1, further comprising: receiving time-correlated data characteristic of a subject's test substance and administration of a drug received by the subject over a period of time; identifying a first subset of time correlation data based on filtering criteria selected by the subject; displaying a first glucose profile and a second glucose profile on a 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 the first subset of the time-correlated data over the first period of time; A method comprising:
13. The method of claim 12, further comprising identifying a second subset of the time correlation data based on a second filtering criterion selected by the subject; 13. The method of claim 12, wherein the first glucose profile displays the first subset of the time correlation data over the first period of time rather than a glucose value associated with the time correlation data over the first period of time, and the second glucose profile displays the second subset of the time correlation data over the first period of time rather than the first subset of the time correlation data over the first period of time.
14. The method described in claim 12 or 13, wherein the drug is a glucose level adjusting drug.
15. The method of claim 14, wherein the glucose level regulating drug is insulin.
16. The filtering criteria: recommended dose administration, wherein the first subset of the time-correlated data based on the filtering criteria includes test substance data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being equal to a recommended dose of the drug; a missed dose, wherein the first subset of the time-correlated data based on the filtering criteria includes analyte data associated with at least one medication dose that was not taken during a dose window; an under-bolus dose, wherein the first subset of time-correlated data based on the filtering criteria includes analyte data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being less than a recommended dose of the drug; an overdose bolus administration, wherein the first subset of time-correlated data based on the filtering criteria includes analyte data associated with at least one drug administration received during a dose time window, the amount of the at least one drug administration received being greater than a recommended dose of the drug; delayed meal dosing, wherein the first subset of the time-correlated data based on the filtering criteria includes test substance data associated with at least one medication dose taken after a predetermined period of time from meal start; more than necessary prandial dosing, and the first subset of time-correlated data based on the filtering criteria includes test substance data associated with at least one additional dose of the drug taken after a first dose of the drug taken in a dosing time window; The method according to claim 12 or 13, wherein the 17. The method of claim 16, wherein the administration time range is at least one of a breakfast administration time range of 6:00 AM to 11:00 AM, a lunch administration time range of 11:00 AM to 4:00 PM, a dinner administration time range of 4:00 PM to 10:00 PM, or a basal administration time range of one hour from the prescribed basal administration time. identifying an additional subset of the time-correlated data based on a second filtering criterion selected by the subject; displaying a third glucose profile in the one graphical subject interface, the third glucose profile displaying the additional subset of the time-correlated data over the first time period. The method of claim 12 further comprising:
19. The system of claim 16, wherein the second filtering criterion is one of recommended dose administration, missed dose, underdose bolus administration, overdose bolus administration, delayed mealtime administration, or more mealtime administrations than necessary.
20. The method of claim 12, wherein the first glucose profile and the second glucose profile are displayed in a side-by-side arrangement, the first glucose profile and the second glucose profile are displayed in a vertical arrangement, the first time period is selected by input by the subject, the first time period is set automatically, or the filtering criteria are selected using a drop-down menu.
21. The glucose level adjusting drug is insulin, the filtering criterion is a recommended dose administration, and the first subset of the time correlation data based on the filtering criterion includes test substance data associated with at least one drug administration received during a dosing time window, the amount of the at least one drug administration received being equal to a recommended dose of the drug, The method further comprises: identifying a third subset of the time correlation data based on a third filtering criterion selected by the subject; displaying a third glucose profile on the one graphical subject interface, the third glucose profile displaying the third subset of the time-correlated data over the first time period or glucose values associated with the time-correlated data over the first time period; 15. The method of claim 14, comprising: