Systems, devices and methods for monitoring health status using physiological sensors

Abstract

A system and method for monitoring glucose variability of a subject is described. Data indicative of a glucose value of the subject is received from a sensor control device. A first glucose variability metric of the subject during a first time period is identified. The first glucose variability metric is compared to a threshold value. A first indication is displayed if the first glucose variability metric does not exceed the threshold value, and a second indication is displayed if the first glucose variability metric exceeds the threshold value. Further glucose variability metrics for subsequent time periods may also be identified according to a moving window, and real-time or reported displays of the metrics may be provided. The glucose variability metric may be a range of variation relative to a baseline, a difference between a maximum and minimum glucose value, or a time in or out of a target range.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 337,442, filed May 2, 2022, and U.S. Provisional Patent Application No. 63 / 295,284, filed December 30, 2021, the entire disclosures of which are expressly incorporated by reference herein for any purpose. [Technical field]

[0002] FIELD OF THE DISCLOSURE The subject matter described herein relates generally to digital and user interfaces for analyte monitoring systems, and related systems, methods, and devices. [Background technology]

[0003] Detecting, monitoring, or detecting and monitoring analyte levels, such as glucose, ketones, ketone bodies (e.g., beta-hydroxybutyrate), lactate, oxygen, hemoglobin A1C, and the like, can be critical to the overall health of a person, particularly an individual with diabetes. Patients with diabetes mellitus may experience complications such as loss of consciousness, 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 while there is growing clinical data showing a strong correlation between frequency of glucose monitoring and glycemic control, despite this correlation, many people 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] To improve patient adherence to a schedule of frequent glucose monitoring, an in vivo analyte monitoring system can be used to attach a sensor-controlled device to an individual who requires analyte monitoring. The sensor-controlled device has a small form factor for increased comfort and convenience for the wearer, and can be attached by the individual using a sensor applicator. The attachment procedure includes inserting at least a portion of the sensor, which senses analyte values ​​in bodily fluids within a layer of the user's body, using an applicator such that the sensor contacts the bodily fluid. The analyte monitoring system can also be configured to transmit analyte data, alarms, or both to another device where a caregiver, such as a parent, spouse, or health care provider (HCP), can view the analyte data and make treatment decisions. Moreover, not only diabetic patients can benefit from analyte monitoring systems. For example, analyte monitoring systems can provide useful information and insights to individuals interested in improving their health and wellness. In one example, an athlete can wear a sensor-controlled device on his or her body and use it to collect data on one or more analytes (e.g., glucose, lactate, or both) in order to improve their sports performance. Additionally, analyte monitoring systems can be used in other non-medical applications, as described in more detail below.

[0006] However, despite the benefits of using substance monitoring systems, some people were reluctant to use them for a variety of reasons, including the complexity and volume of data presented, the learning curve involved in mastering the substance monitoring system software and user interface, and the overall lack of immediately actionable information presented.

[0007] Nevertheless, as sensor-controlled devices become more convenient and comfortable for users and more affordable, non-medical applications are becoming feasible. For example, high-performance athletes are interested in optimizing the levels of analytes that affect their performance (e.g., blood glucose) before and during training and competitions. However, the user interfaces of some existing sensor-controlled devices are designed for medical use by patients under the supervision of a doctor, and not for non-medical use, such as athletic training and competition. As a result, the data collected by the sensor-controlled devices and the way in which this data is presented to the user may not be suitable for non-medical use. In addition, sensor-controlled devices for non-medical use (health and fitness) may be mistaken for similar devices for medical use, leading to problems in interpreting and using the data.

[0008] Various applications use sensor data to perform various functions, including health maintenance functions. However, when trying to use sensor data with software, each piece of software is considered a programmed medical device (SaMD) and may be subject to regulatory standards or require approval by a regulatory agency. Therefore, when building use cases for physiological data obtained from sensors in new applications, there is a possibility that they will face regulatory obstacles from the Food and Drug Administration. Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, there is a need to provide a framework that can communicate with physiological sensors to receive analyte data for use in a variety of applications, including third party applications, while avoiding the need to obtain regulatory approval for every use case of the received analyte data. Additionally, there is a need for digital and graphical user interfaces for analyte monitoring systems for medical, non-medical, or medical and non-medical applications, and related systems, methods, and devices that are robust, user friendly, and capable of providing timely, actionable responses. [Means for solving the problem]

[0010] Objects and advantages of the disclosed subject matter will be set forth in the description which follows. Such objects and advantages will be in part obvious from the description, or may be learned by the practice of the disclosed subject matter. Further advantages of the disclosed subject matter which are realized and attained by the methods and systems will be particularly pointed out in the description, claims, and accompanying drawings.

[0011] To achieve the above and other advantages and in accordance with the objectives of the presently disclosed subject matter, as illustrated and outlined in the embodiments, the presently disclosed subject matter relates to a software library used by an application to acquire sensor data. The software library may include a sensor control module and a remote management module, and may include software logic for communicating with a plurality of physiological sensors and an application. The sensor control module may authenticate a receiving device to allow the receiving device to receive the sensor data (e.g., enable communication between the receiving device and the plurality of physiological sensors to allow the receiving device to receive sensor data including data indicative of a sensor-specific physiological signal). Additionally, the sensor control module may store the sensor data in a memory of the computing device. The sensor control module may obtain an output indicative of the sensor-specific physiological signal from the sensor data of each of the plurality of physiological sensors. Additionally, the sensor control module may provide an output of the sensor-specific physiological signal obtained from the physiological sensors to an authenticated third-party application running on the computing device.

[0012] In accordance with the subject matter of the present disclosure, a physiological sensor can include an analyte sensor configured to detect an analyte value in a bodily fluid of a user. The analyte value can also be included in a variety of different physiological signal outputs. The output can further include a notification of a physiological condition. The output can also indicate information regarding the delivery of a medication to the user.

[0013] In accordance with the subject matter of this disclosure, communication sessions within the computing device and between the computing device and the physiological sensor may use any suitable wireless communication protocol known in the art, such as Near Field Communication (NFC), Bluetooth® Low Energy (BLE), or the like.

[0014] The software library may further include a remote data management module that includes instructions for transmitting the sensor data over a network to a remote server. The remote management module may be configured to communicate with the remote server to authenticate applications, such as the sensor control module or third party applications, using a uniform user interface regardless of the application accessing the software library.

[0015] In accordance with the subject matter of this disclosure, the physiological sensors and software library are subject to regulatory approval, such as being approved as a programmed medical device, and outputs indicative of physiological signals from the physiological sensors are also subject to regulatory approval, but third party applications executing on the computing device are not subject to regulatory approval.

[0016] The software library can be configured to be implemented as a component of certified third-party applications. Its modular architecture and common functionality allows it to receive, interpret, and display sensor data from multiple physiological sensors substantially simultaneously.

[0017] In accordance with the subject matter of the present disclosure, a method of monitoring glucose excursion is described that includes a system receiving data indicative of a glucose value of a subject from a sensor control device. The method may determine a first glucose excursion metric for the subject over a first time period. The first glucose excursion metric may then be compared to a threshold. A first indication may then be displayed if the first glucose excursion metric does not exceed the threshold, and a second indication may be displayed if the first glucose excursion metric exceeds the threshold.

[0018] The glucose excursion metric can be a measure such as the range of excursion from a moving baseline, the difference between maximum and minimum glucose values, the amount of time within or outside the target range during a period of interest, or a combination thereof.

[0019] In accordance with the subject matter of the present disclosure, a method of monitoring glucose excursion is described that includes a system receiving data indicative of a subject's glucose levels from a sensor control device. The method may identify a maximum glucose value and a minimum glucose value over a period of time. A difference between the maximum glucose value and the minimum glucose value over the period of time may then be calculated. The difference may be compared to a threshold. A first indication may then be displayed if the difference does not exceed the threshold, and a second indication may be displayed if the difference exceeds the threshold.

[0020] In accordance with the subject matter of the present disclosure, a system for displaying metrics associated with a subject is described, the system comprising one or more processors and a memory having instructions stored thereon, which, when executed by the one or more processors, cause the system to: determine a glucose status of the subject based on glucose data received during a moving window; display an indication of the glucose status of the subject in a graphical user interface (GUI), the indication including a text description and a graphic having a first color; and display a graph in the GUI, the graph including a glucose profile including a first portion and a second portion, the first portion and the second portion being different colors, and the second portion being the first color.

[0021] In accordance with the subject matter of the present disclosure, a system for displaying metrics related to a subject is described, the system comprising one or more processors and a memory storing instructions. The instructions, when executed by the one or more processors, cause the system to determine multiple glucose states of the subject based on the glucose data received for multiple moving windows, each of the moving windows including a logged activity; displaying a first graph including a first glucose profile for a first moving window and a description of the first logged activity, wherein the first glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a second color; and displaying a second graph including a second glucose profile for a second moving window and a description of the second logged activity, wherein the second glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a third color. [Brief description of the drawings]

[0022] 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. [Figure 1] Overall view of the system including the software library, the receiving device, and the sensor assembly [Diagram 2] 1 is a block diagram illustrating an exemplary embodiment of a receiving device; [Diagram 3] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor assembly; [Figure 4] FIG. 1 is a block diagram showing a software library with a sensor control module and a remote management module as an example of a software library for communicating with an application; [Diagram 5] 1 is a block diagram illustrating an exemplary embodiment of a sensor control module; [Figure 6] 1 is a block diagram illustrating an exemplary embodiment of a remote management module; [Figure 7A] Exemplary embodiments of applications utilizing the architecture of the present invention [Figure 7B] Exemplary embodiments of applications utilizing the architecture of the present invention [Figure 7C] Exemplary embodiments of applications utilizing the architecture of the present invention [Figure 8] FIG. 1 illustrates an example method for communicating sensor data from a sensor to an application or a third-party application utilizing the subject matter of this disclosure. [Figure 9] FIG. 1 illustrates an example method for communicating sensor data from a sensor to an application or a third-party application utilizing the subject matter of this disclosure. [Figure 10A] FIG. 1 illustrates an exemplary embodiment of a GUI associated with a biosensor banner. [Figure 10B] [Figure 10C] FIG. 1 illustrates an exemplary embodiment of a GUI associated with a biosensor banner. [Figure 10D] FIG. 1 illustrates an exemplary embodiment of a GUI associated with a biosensor banner. [Figure 10E] FIG. 1 illustrates an exemplary embodiment of a GUI associated with a biosensor banner. [Figure 11A] FIG. 1 illustrates an exemplary embodiment of a GUI for biosensor module details. [Figure 11B] FIG. 1 illustrates an exemplary embodiment of a GUI for biosensor module details. [Figure 12A] FIG. 1 illustrates an exemplary embodiment of a GUI for system messages related to a biosensor. [Figure 12B] FIG. 1 illustrates an exemplary embodiment of a GUI for system messages related to a biosensor. [Figure 13A] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI associated with pairing a biosensor with a reading device. [Figure 13B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI associated with pairing a biosensor with a reading device. [Figure 13C] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI associated with pairing a biosensor with a reading device. [Figure 13D] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI associated with pairing a biosensor with a reading device. [Figure 14] A system diagram of a analyte monitoring system including a sensor applicator, a sensor control device, a reading device, a network, a trusted computer system, and a local computer system. [Figure 15A] FIG. 1 is a block diagram illustrating an exemplary embodiment of a reading device. [Figure 15B] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 15C] FIG. 1 is a block diagram illustrating an exemplary embodiment of a sensor control device. [Figure 16A] FIG. 1 is a block diagram illustrating an example embodiment of a GUI associated with a live home screen. [Figure 16B] FIG. 1 is a block diagram illustrating an example embodiment of a GUI associated with a live home screen. [Figure 17A] FIG. 13 is a block diagram illustrating an example embodiment of a GUI associated with a "Learn More" screen with further details. [Figure 17B] FIG. 13 is a block diagram illustrating an example embodiment of a GUI associated with a "Learn More" screen with further details. [Figure 18] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI related to sharing a user's progress. [Figure 19] FIG. 1 is a block diagram illustrating an example embodiment of a GUI associated with tracking various activities. [Figure 20] FIG. 1 is a block diagram illustrating an exemplary embodiment of a GUI related to learning and inquiry. [Figure 21A] FIG. 1 illustrates an exemplary method for determining glucose excursion. [Figure 21B] FIG. 1 illustrates an exemplary method for determining glucose excursion. [Figure 21C] FIG. 1 illustrates an exemplary method for determining glucose excursion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Reference will now be made in detail to various exemplary embodiments of the presently disclosed subject matter, which are illustrated in the accompanying drawings.

[0024] The system may include a device that receives the analyte data measured by the analyte monitoring device and the drug delivery data recorded by the delivery device and processes the data, displays the data to a user in any number of forms, or both. Such devices and variations thereof may be referred to as "receiving devices," "reader devices" (or simply "readers"), "handheld electronics" (or simply "handheld"), "portable data processing" devices or units, "data receivers," "receiver" devices or units (or simply "receivers"), or "remote" devices or units, as just a few examples of how such devices may be referred to. The device may be a smartphone, a smartwatch, or a display device.

[0025] The system may further include an in-vivo analyte monitoring sensor assembly, which may include various types of monitoring devices. For example, a "Continuous Analyte Monitoring" system (or "Continuous Glucose Monitoring" system) may transmit data from the sensor device to the reading device continuously (e.g., automatically according to a schedule) rather than prompting. Another example may be a "Flash Analyte Monitoring" system (or "Flash Glucose Monitoring" system, or simply "Flash" system). A flash analyte monitoring system may transmit data from the sensor device in response to a data scan or request by the reading device, such as using a "Bluetooth" Low-Energy (BLE) Near Field Communication (NFC) protocol or a Radio Frequency Identification (RFID) protocol. The in-vivo analyte sensor assembly may also operate without the need for finger-prick calibration.

[0026] An in vivo monitoring sensor assembly may include a sensor. When placed in a living body, the sensor contacts the user's bodily fluid and generates analyte data indicative of the analyte value in the bodily fluid. The sensor assembly is a device that is placed on the user's body and contains the electronics and power source responsible for achieving and controlling the analyte sensing. Sensor assemblies and variations thereof may also be referred to as "on-body electronics" devices or units, "on-body" devices or units, "sensor data communication" devices or units, analyte sensors, sensor devices, in vivo analyte monitor sensor assemblies, sensors, and the like, which are just a few examples of alternative names for sensor assemblies.

[0027] Additionally, the system may include external devices for use with the analyte sensors. For example, but not limited to, the external devices may include a delivery device that utilizes information from the analyte sensors to determine and deliver a beneficial agent, such as a medication, to the user. Additionally or alternatively, the external devices may include other sensors, such as other analyte sensors, accelerometers, pressure sensors, and external computing devices. Such external computing devices may include, for example, a medical server or a smartphone application configured to utilize the analyte sensor information to provide further insights to the user, such as medical or non-medical insights or analyses, such as, but not limited to, insights regarding a medical condition, well-being, fitness, or appetite.

[0028] Generally, and as described in more detail below, the subject matter of the disclosure presented herein includes a software library in a receiving device that communicates with the analyte sensor to allow a third party application to access the sensor data for use in a medically necessary or user well-being related application. Thus, the system further comprises a software library that can be implemented independent of the sensor and integrated into the third party application to allow the third party application to access the sensor data. Additionally, the sensor control module can communicate with multiple sensor assemblies in a manner that allows the sensor control module to receive data from the multiple sensor assemblies simultaneously or substantially simultaneously. Still further, the system also allows sensor information to be transferred from the sensor control module to a remote management module.

[0029] The embodiments described herein may be utilized to monitor and / or process information regarding any number of different analytes, including, but 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 (e.g., β-hydroxybutyrate), lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. Additionally, concentrations of drugs may be monitored, including, for example, antibiotics (e.g., gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline, warfarin, and the like. In embodiments where more than one analyte is monitored, the analytes may be monitored simultaneously or at staggered times.

[0030] FIG. 1 is a schematic diagram illustrating an exemplary embodiment of a system 100 comprising a modular connectivity framework utilizing a software library 400 , various applications 420 , a sensor assembly 300 , and a receiving device 200 .

[0031] In accordance with the subject matter of the present disclosure, a non-transitory computer readable storage medium includes a software library that is utilized by an application 420 on the receiving device 200 or a standalone device (e.g., pump, insulin pen, etc.) to acquire sensor data. The software library may include a sensor control module and a remote management module, and may include software logic for communicating with a plurality of sensors and applications. The sensor control module authenticates the receiving device to allow the receiving device to receive the sensor data (e.g., by enabling the receiving device to communicate with the plurality of sensors to allow the receiving device to receive sensor data including data indicative of a sensor-specific signal). The sensor control module may also store the sensor data in a memory of the computing device. The sensor control module may obtain an output indicative of a sensor-specific signal from the sensor data for each of the plurality of sensors. The sensor control module may also provide an output of the sensor-specific signal obtained from the sensors to an authenticated third-party application running on the computing device.

[0032] The system 100 includes a software library 400 that operates in a modular architecture. The modular architecture allows the sensor control module 500 to communicate with and reside within various applications 420 on the receiving device 200. Furthermore, the applications 420 can interface with the sensor assembly 300 via the sensor control module 500, in particular by issuing a request to the communication control module 540 (shown in FIG. 5) to interface directly with the sensor assembly 300. The sensor assembly 300 can be a device with multiple sensors 302 or a sensor 302 configured to detect more than one analyte.

[0033] The receiving device 200 includes one or more applications 420, with each application instance embedding a software library 400. The receiving device 200 employs a modular connectivity framework for the applications 420. In particular, each application 420 includes a software library 400, which includes a remote management module 600 and a sensor control module 500 for communicating with one or more sensor assemblies 300. The software library 400 can also be run as a service that executes simultaneously with the underlying application, such that the sensor control module 500 or the remote management module 600 can also be a service that executes in parallel with one or more applications.

[0034] Additionally, the sensor control module 500 may interface with sensor data. Various modules in the software library 400 implemented in the application 420 may send and receive communications to and from the sensor assembly 300 via the communication link 102.

[0035] Although the sensor control module 500 is present in the application 420 of the receiving device 200, the basic components of the sensor control module 500 can be placed in a second receiving device, such as a wearable device, such as a smart watch or a mobile device. Although such a device, such as a smart watch or a wearable device, may not provide the user interface experience that a smartphone, a tablet terminal, or a computer provides, by incorporating the sensor control module 500 in such a device, it is possible to communicate with the sensor assembly 300 directly from the sensor control module 500 on the smart watch or mobile wearable device. This makes it possible to use the sensor data from an application specialized for the wearable device. Each wearable device can be independently synchronized with the receiving device 200, and most of the user login function, initial setting function, authentication function, and consent function required to execute or start receiving sensor data can be executed using the receiving device 200.

[0036] The communication links 102 may be wireless protocols such as Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), etc. Each communication link 102 may use the same or different wireless protocols. The system 100 may also be configured to communicate via other wireless data communication links, including, but not limited to, any type of suitable wireless communication connection (and which may be unidirectional or bidirectional) connecting two or more electronic devices, such as an RF communication link or an infrared communication link. Alternatively, the data communication link may include a wired cable connection, including, but not limited to, an RS232 connection, a USB connection, a FireWire connection, a Lightning connection, or a serial cable connection.

[0037] For example, as shown in the embodiments herein, the communication link 102 can be configured to use a “Bluetooth” protocol such as BLE, or the communication link 102 can be configured to use an NFC protocol. Additionally or alternatively, there may be another communication link (not shown) with the second sensor assembly, which may be configured to use BLE or a combination of NFC and BLE. The communication links may be configured to perform different operations. For example, the communication link 102 may be configured to only be responsible for activating the sensor assembly. Furthermore, the communication link may be configured differently depending on the overall system configuration or depending on which components of the system are activated or in use at a given time. For example, as shown in the embodiments herein, the communication link 102 may have a first communication setting when the receiving device 200 is active in the system and a second communication setting when the receiving device is not active or is not included in the system.

[0038] In a first communication setting, the communication link 102 can be configured to only activate the sensor using the NFC radio protocol. In another setting, the BLE functionality between the sensor assembly 300 and the application 420 (if provided) can remain off. The application 420 can utilize the NFC radio protocol to activate the sensor assembly 300 and obtain sensor context information. The sensor context information can include authentication information for authenticating a communication session with the sensor assembly 300, encryption information for enabling encrypted data communication over the communication link, and a BLE communication address for initiating a BLE connection with the sensor assembly 300. The software library 400 can also obtain sensor context information from the sensor assembly 300 via BLE. Using the sensor context information, the software library 400 is provided with the ability to switch sessions from an application 420 on one receiving device 200, such as a smartphone, to another application 420 on another receiving device 200, such as a smartwatch. The transmission of sensor context information can occur within these applications 420.

[0039] In accordance with the subject matter of the present disclosure, a sensor assembly 300 as shown may include multiple sensor elements for detecting different analytes within the same sensor assembly. System 100 may also include multiple sensor assemblies 300 as shown connected via a communication link having communication capabilities similar to communication link 102 described herein. Two or more sensor assemblies 300 may be used in combination to provide multiple sensor elements working together to produce an analyte reading or multiple sensor elements may independently produce readings for a variety of different analytes. While any number of sensor assemblies may be used together to measure any number of different analyte readings, two sensor assemblies are shown in the present disclosure for purposes of illustration and not limitation.

[0040] In some embodiments, the application 420 can be configured to access the software library 400 from a remote cloud 700 infrastructure via a wireless communication link 710. In certain embodiments, the communication link 710 includes a wireless communication portion configured for two-way radio frequency (RF) communication with other devices to transmit and receive data to and from the system 100. Additionally, the communication link 710 can be configured to include a physical port or interface, such as one or more of any suitable electrical connection port that allows data communication between the system 100 and the receiving device 200, such as a USB port, an RS-232 port, a serial port, an IEEE 1394 (Firewire) port, or an Ethernet port. The receiving device 200 may also include a personal computer, a laptop computer, a notebook computer, an iPad, a tablet computing device, a mobile phone, a smart phone, a personal data assistant, a workstation, a server, a mainframe computer, a cloud computing system, an external medical device (e.g., a device including an infusion device, an analyte monitoring device, or an insulin delivery device), or other device configured for similar complementary data communication. In certain embodiments, the communication link 710 may include a cellular or Wi-Fi (IEEE 802.1x) communication protocol, or an equivalent wireless communication protocol that allows multiple units to communicate securely wirelessly (e.g., in accordance with HIPPA requirements) while avoiding potential data collisions or interference.

[0041] In other embodiments, wireless communication 710 is any suitable wireless communication mechanism that allows receiving device 200 to communicate with other devices, such as infrared, Bluetooth, wireless USB, ZigBee, cellular, Wi-Fi (IEEE802.1Ix), or RFID (passive or active RFID) communication, including infusion devices, analyte monitoring devices, computer terminals, servers, personal computers, laptop computers, iPads, tablet computers, mobile phones, smartphones, workstations, mainframe computers, cloud computing systems, mobile phone-enabled mobile phones, personal digital assistants, or other communication devices that may be used in conjunction with a patient or device user to manage the treatment of a health condition, such as diabetes.

[0042] The system 100 can be configured to operate as an open loop system, a closed loop system, or a hybrid closed loop system. An open loop system requires manual input from a user to control certain functions of the sensor assembly 300. A closed loop system uses data from the sensor assembly 300 and algorithms to control the software library 400 without user input. A hybrid system may also require user input to control the application 420 and initiate the software library 400. A hybrid closed loop system may be used in conjunction with or instead of a closed loop system. As disclosed herein, regulatory approval may be limited to the software library 400 regardless of the type of system configuration employed by the system 100.

[0043] Receiving Device FIG. 2 is a block diagram illustrating an exemplary embodiment of a receiving device 200. The software library 400 can be provided to a third party to be incorporated into an application 420 for a multi-purpose receiving device 200, such as a mobile phone, tablet, personal receiving device, or other similar receiving device. The receiving device 200, which is responsible for implementing and executing the device application software, can also be referred to as a computing device or a multi-purpose device. The receiving device 200 refers to a suitably configured hardware device that executes an application 420 incorporating the software library 400 having a sensor control module 500 configured to communicate with the sensor assembly 300. Here, the receiving device 200 can include a display 202, an input component 204, and a processor 206 coupled to a memory 208. It can also include a communication circuit 210 coupled to an antenna 212, and a power source 214. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to form a functional device. As shown in the embodiment herein, the memory 208 can include an application and a sensor control module 500 for the sensor assembly 300. The application 420 may also import a software library 400 that includes a sensor control module 500. The software library 400 and the sensor control module 500 may be developed by the provider of the sensor assembly 300.

[0044] The receiving device may be responsible for most of the processing power of the system 100 to render the final result data suitable for display to a user. The receiving device 200 may be a smartphone or a smartwatch.

[0045] The receiving device 200 can receive analyte data, such as glucose data, calculate low and high analyte values, and generate corresponding alarms and messages. The receiving device 200 can also mirror alert notifications generated by other devices, such as the sensor assembly 300. The receiving device 200 can process the analyte data in the processor 206 to render information about the analyte as values, trends, graphs on the display 202, and provide additional messages and notifications based on the received analyte values.

[0046] Sensor Assembly 3 is a block diagram illustrating an exemplary embodiment of a sensor assembly 300 including a glucose sensor 302 and sensor electronics 304 (including analyte monitoring circuitry). The glucose sensor 302 may be an in-vivo analyte sensor with a duration of about 13-30 days. Additionally, the sensor assembly 300 may be configured without wide area network communication capabilities.

[0047] The glucose sensor 302 generates a raw data signal for measuring the glucose level of the patient. The sensor electronics 304 is operatively coupled to the glucose sensor 302 and includes a memory 316 that stores one or more predetermined characteristics 322 associated with the sensor electronics 304. The memory 316 may be a so-called "one-time programmable" (OTP) memory and may be configured to define the number of writes, such as by including a support architecture that defines the number of times that a particular address or area of ​​the memory may be written to. This number may be one or more writes, and once the defined number of writes is reached, the memory may be marked as unavailable or otherwise unavailable for programming. The subject matter disclosed herein relates to systems and methods for updating such OTP memory with new information.

[0048] As shown, the sensor electronics 304 may comprise a single semiconductor chip, which may be a custom application specific integrated circuit (ASIC 306). Inside the ASIC 306, several higher level functional units are provided, such as an analog front end (AFE 308), a power management (control) circuit 310, a processor 312, and a communication circuit 314 (which may be implemented as a transmitter, a receiver, a transceiver, a passive circuit, etc., according to a communication protocol). For example, but not limited to, an exemplary communication circuit 314 may include a "Bluetooth" Low Energy ("BLE") chipset, a Near Field Communication ("NFC") chipset, or other chipset for use with similar short-range communication methods (e.g., personal area networks according to IEEE 802.15 protocol, IEEE 802.11 protocol, infrared communication according to IrDA (Infrared Data Association) standard, etc.). The communication circuit 314 may communicate with a communication module of similar functionality to send and receive data and commands. Certain communication chipsets may be embedded in the ASIC 306 (eg, an NFC antenna).

[0049] The sensor assembly 300 may utilize application layer encryption using one or more block ciphers to establish mutual authentication and encryption with other devices in the system 100. There are several advantages to adopting a non-standard encryption design implemented at the application layer. One advantage of this approach is that in certain embodiments, a user may complete pairing of the sensor assembly 300 with other devices with minimal interaction, such as using an NFC scan, without requiring additional input from the user, such as entering a security pin or approving the pairing. The sensor assembly 300 may be configured to dynamically generate authentication and encryption keys. Alternatively, the sensor assembly 300 may be pre-programmed with a valid set of authentication and encryption keys for use with a particular class of device. Additionally, the ASIC 306 may be configured to use received data to perform authentication procedures (e.g., handshakes, mutual authentication, etc.) with other devices and apply the generated keys to sensitive data before transmitting the sensitive data.

[0050] While this embodiment utilizes both the AFE 308 and the processor 312 as analyte monitoring circuitry, in other embodiments, either circuitry may perform the analyte monitoring function. The processor 312 may comprise one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or may be distributed across several different chips (and portions thereof).

[0051] Also included within the ASIC 306 is a memory 316. The memory 316 may be shared among various functional units present within the ASIC 306 or may be distributed among two or more of such functional units. The memory 316 may be a separate chip. The memory 316 may be a volatile memory and / or a non-volatile memory. In this embodiment, the ASIC 306 is coupled to a power source 318, which may be a coin cell battery or the like. The AFE 308 interfaces with the glucose sensor 302 to receive measurement data from the glucose sensor 302 and outputs the data in digital form to the processor 312. The data is then provided to the communication circuitry 314 for transmission to the software library 400 via the antenna 320.

[0052] Alternatively, the glucose sensor 302 can monitor other analytes, such as acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glutamine, growth hormone, hormones, ketones, ketone bodies (e.g., β-hydroxybutyrate), lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.

[0053] The sensor assembly 300 includes a sensor assembly embedded library (not shown) configured to provide sensor assembly data to the software library 400 based on information received from the sensor assembly 300. The sensor assembly data can include glucose readings, data types, ranges, real-time and historical glucose values ​​and trends, sensor operation information, and sensor system information.

[0054] Software Library 4 is a block diagram illustrating an example of a software library 400 for communicating with applications 420 (illustrated as applications 422, 424, 426, and third-party application 428). Note that when referring to application 420, it refers to one or more of applications 422, 424, 426, and third-party application 428. Software library 400 includes a sensor control module 500 and a remote management module 600, each of which has the capability of independently communicating with applications 422, 424, 426, or third-party application 428. In accordance with the subject matter of the present disclosure, each of sensor control module 500 and remote management module 600 can provide a single unified interface as an interface for communicating with applications 422, 424, 426, or third-party application 428.

[0055] The software library 400 may have a modular architecture and may be commonly used by multiple applications 420 through a software development kit. The software library 400 may include two modules, each of which may be provided for independent use by other applications 420. The first of these modules may be a sensor control module 500. The sensor control module may communicate with the sensor assembly 300 and receive a result of a particular value from the sensor assembly 300. The sensor control module 500 may also communicate with the applications 422, 424, 426 or a third-party application 428 through a sensor control module interface (SCMI) 520.

[0056] The software library 400 may further include a remote management module 600, which is described further below. The remote management module 600 communicates with the applications 422, 424, 426 or third party applications 428 using a remote management module interface (RMMI) 620.

[0057] Additionally, the remote management module 600 can receive sensor data from the sensor control module 500 via the inter-module interface 450, and can also be utilized to store the received data in a remote server 640 (shown in FIG. 6) for remote storage, such as cloud storage. For application developers, the remote management module 600 can be utilized to provide a consistent user interface for user account management across a variety of different third-party applications, such as the third-party application 428. Additionally, data confidentiality protection can be incorporated into the remote management module 600 for account management purposes.

[0058] The sensor control module 500 may receive a request to activate the sensor assembly 300. The sensor control module 500 may include logic to identify the specific type of receiving device 200 making the request and may perform authentication of the receiving device 200. The authentication may use a three-pass design using multiple different keys. The keys may be associated with different roles (manufacturer, application developer, etc.). In addition, sensitive commands that may leak security information may trigger authenticated encryption using an additional set of authenticated keys. The sensor data provided to the sensor control module 500 and transmitted to the application 422, 424, 426 or a third party application is very sensitive data and there is an advantage to protecting it. At least some of the medical data about a patient is sensitive data because it can be used for various purposes such as monitoring health status and determining medication administration. As shown in the embodiments herein, the various modules and applications 422, 424, 426, and third party applications 428 can be configured to comply with security interfaces designed to protect the confidentiality, integrity, and availability ("CIA") of this communication data and associated data. To address the CIA concerns, the communication connection between the sensor assembly 300 and the sensor control module 500 can be mutually authenticated before any sensitive data is transmitted to enhance data confidentiality. The same applies to the communication between the sensor control module 500 and the applications 422, 424, 426, and third party applications 428. The communication connection can be encrypted using a unique encryption key per device or unique encryption key per session. As shown in the embodiments herein, the encryption parameters can be configured to change for each data block of the communication.

[0059] As shown in the embodiments herein, if an encrypted communication occurs between two components (e.g., between the sensor control module 500 and the sensor assembly 300) to ensure data integrity, the communication can be verified with a transmission integrity check built into the communication. As shown in the embodiments herein, the communication can be encrypted using session key information, which can be exchanged between the two devices after authentication of the two devices is completed. The encrypted communication between the sensor assembly 300 and the dedicated sensor control module 500 can be verified using an error detection or correction code. Such an error detection or correction code can include, but is not limited to, any suitable method for detecting the presence or absence of errors in a digital message, such as a non-secure error detection code, minimum distance coding, repetition code, parity bit, checksum, cyclic redundancy check, cryptographic hash function, error correction code, etc.

[0060] Additionally, the sensor control module 500 may generate state information for the receiving device 200 to remain active for as long as the receiving device 200 desires to acquire sensor data.

[0061] The sensor control module 500 may include a user interface 510. The user interface 510 may enable data sharing with an application, including providing necessary permissions to enable data sharing with the application. The user interface 510 of the sensor control module 500 may also display sensor data received from the sensor assembly 300.

[0062] The software library user interface 510 is disclosed herein as a modular user interface 510 that allows for sharing and displaying different analytes that may be measured by different sensor assemblies 300. In particular, as disclosed herein, the software library 400 and the sensor control module 500 may be utilized to develop a shared user interface for displaying sensor data from multiple sensor assemblies 300. When the user interface 510 is shared, the user interface 510 may be capable of switching between sensor data for the various sensor assemblies 300, displaying the sensor data on a single screen, and displaying the sensor data in different combinations.

[0063] Communication between the sensor control module 500 and the applications 422, 424, 426 or third party applications 428 occurs through the sensor control module interface 520. Communication between the remote management module 600 and the applications 422, 424, 426 or third party applications 428 occurs through the remote management module interface 620. Additionally, some communication may occur through an event notification or callback process. For example, when the sensor control module 500 receives a request for sensor data from a third party application 428, the request may be communicated through the sensor control module interface 520 and an event may be generated in the user interface 510 of the sensor control module 500 that initiates an authentication.

[0064] For another example, when the sensor control module 500 receives sensor data via the communication link 102, it may generate an event that notifies other modules or components in the software architecture that the sensor data is ready to be displayed on the user interface 510 of the sensor control module 500.

[0065] The system is modular in architecture utilizing software libraries 400 and sensor control module 500 to interface with applications 422, 424, 426 and third party applications 428, allowing communication with a variety of different sensor assemblies 300, including multiple sensor assemblies 300. In particular, the communication control module 540 can have specialized functionality for each sensor assembly 300 in the system and can simultaneously access, communicate with, and receive sensor data from the various sensor assemblies 300.

[0066] Alternatively, for example, a developer of the third-party application 428 may select a particular module from the software library 400 to be used to support a function within the third-party application 428. For example, a particular third-party application 428 may use sensor data as health maintenance data. Generally, health maintenance data may include any type of data related to a person's health, such as weight, heart rate, blood pressure, blood glucose level, etc. The sensor data provided by the sensor assembly may include such health maintenance data. The third-party application may access each module from the software library 400 to use the desired sensor data within the scope of the sensor data use desired by the third-party application. The software library 400 eliminates the need for the third-party application 428 to directly interface with the sensor assembly 300 to receive the sensor data. The software library 400 includes a sensor control module 500, which may receive the sensor data and provide it to each third-party application 428. It should be understood that the term "third party" may correspond to an entity other than the manufacturer of the sensor assembly 300 or the software library 400. The third party application 428 may access certain authorized data on a database 530 accessible via the sensor control module interface 520. Alternatively, the third party application 428 may have its own database (not shown) for storing sensor data received via the sensor control module 500.

[0067] In certain applications, software that operates in conjunction with a medical device, such as a sensor assembly that senses data from user interaction or health information of the user, may be regulated as medical device software. Standards related to the regulation of medical device software include ISO13485:2016 "Medical devices - Quality management systems - Requirements for regulatory purposes", ISO14971:2012 "Medical devices - Application of risk management to medical devices", and IEC62304, Ed1.1:2015 "Medical device software - Software life cycle processes" with reference to the above. Specifically, the regulations require that software that functions as a medical device (commonly referred to as a "programmed medical device") is subject to regulation by regulatory authorities such as the U.S. Food and Drug Administration. At a minimum, the regulations require the submission of an application for regulatory approval.

[0068] In the present disclosure, as the subject matter of the present disclosure, the regulated portion of the programmed medical device may be contained within the software library 400 and the sensor assembly 300. This allows the applications 422, 424, 426 or the third-party application 428 to utilize the sensor data without the need for regulatory approval or clearance. In particular, a third-party developer may develop one or more third-party health applications without being required to submit an application for clearance under the definition of a "programmed medical device" because all of the regulated functionality is contained within the software library 400. This may benefit users by allowing them to develop other uses of the sensor data that may not have been originally contemplated by the original manufacturer of the sensor assembly 300, such as developing new and different health tracking applications.

[0069] The applications 422, 424, 426 or third party applications 428 communicate with the sensor control module 500 using the sensor control module interface 520. By using the sensor control module interface 520, the applications 422, 424, 426 or third party applications 428 can receive data via the sensor control module 500.

[0070] Optionally, the sensor control module 500 may also include an alarm module (not shown) for managing alarms and notifications triggered by the sensor data. In accordance with the subject matter of the present disclosure, the alarm module may include logic for generating alarms for each type of sensor data measured by the sensor assembly 300. In particular, an alarm may be triggered when a problem occurs with the device hardware of the sensor assembly 300. Additionally, an alarm may be triggered when a user being monitored by the sensor assembly 300 exhibits a particular condition. The modular framework allows the alarm logic of the alarm module to be kept separate within the sensor control module 500.

[0071] For purposes of illustration, the alarm module is described herein as operating in conjunction with an application 422, 424, 426 or a third party application 428 and a sensor control module 500. The sensor control module 500 receives sensor data representing analyte values ​​from the sensor assembly 300. One such value may be a glucose reading. The sensor control module 500 and alarm module include threshold detection logic that can identify an alarm trigger condition based on a particular analyte value, such as a glucose reading.

[0072] During initialization, the third party application 428 or the applications 422, 424, 426 may provide as a callback function the conditions under which an alarm should be triggered. The triggers may include logic that takes into account the value and temporal relationship of the sensor data. For example, if the sensor assembly provides glucose data, a trigger value that will trigger an alarm may be set along with a temporal relationship, such as if the trigger value increases by a certain amount over a certain period of time, or if the trigger value remains above a certain value for a certain period of time. These trigger conditions may also include a rate of change as a mechanism for triggering an alarm. Incorporating an alarm module into the sensor control module 500 may further reduce the need to submit the applications 422, 424, 426 or third party application 428 for regulatory approval, since alarm conditions that require regulatory review and approval may be built into the sensor control module 500.

[0073] Sensor Control Module FIG. 5 is a block diagram illustrating an example embodiment of a sensor control module 500 within the software library 400.

[0074] In a particular embodiment, the sensor control module 500 includes a communication control module 540. The communication control module 540 includes logic for communicating with the sensor assembly 300 via the communication link 102. The communication control module 540 further includes logic for receiving sensor data and displaying the sensor data on the user interface 510. In particular, each sensor assembly 300 includes control logic for performing operations related to sensor communication, in particular proprietary operations related to sensor communication. For example, the sensor assembly 300 includes logic for receiving sensor measurements and performing complex algorithms such as data decoding and glucose calculations on the measurements, as logic provided by the manufacturer of the sensor control device. In this regard, the communication control module 540 only needs to receive the processed calculation results with data accuracy and data integrity that can protect the complex proprietary algorithms occurring in the closed sensor assembly 300. The sensor assembly 300 further includes logic for performing authentication, as logic provided by the manufacturer of the sensor control device. This allows the sensor assembly 300 to be capable of providing sensor data, which is data obtained from sensor measurements of various sensors, to the communication control module 540. By utilizing a modular framework, the communications control module 540 is provided with logic to receive data from multiple sensor assemblies 300, thereby allowing for communication from multiple sensor assemblies 300 substantially simultaneously, thereby allowing a certified third party to develop a mobile app without bearing significant responsibility to provide the same level of performance or accuracy on their own.

[0075] This further enables various third-party companies with various use cases different from those currently supported by the manufacturer to develop their own mobile applications that interface with the manufacturer's sensor assembly 300 via the software library 400 and the sensor control module 500. By utilizing the modular architecture, the third parties can implement a limited number of interface calls by simply referencing each modular component of the software library 400.

[0076] Communication with the various components within the sensor control module 500 occurs via the sensor control module's messaging channel 104. Once sensor data is received via the sensor control module's messaging channel 104, a user interface 510 can be used to display the sensor data.

[0077] The applications 422, 424, 426 or third-party applications 428 have logic to communicate with the communication control module 540 via the sensor control module interface 520. This logic operates within the framework and allows for the reception of sensor data. The applications 422, 424, 426 or third-party applications 428 request the sensor control module 500 to perform an enabling function by first starting the sensor control module 500 and then sending a request to obtain sensor data. The sensor control module 500 has a sensor control module interface 520 to ensure consistency of overlapping functionality required by the various applications 422, 424, 426 or third-party applications 428. The sensor control module interface 520 is implemented as an application program interface (API) of the underlying applications 422, 424, 426 or third-party applications 428. The sensor control module 500 also has a standard interface for common functionality, which allows the sensor control module 500 to be used to receive sensor data from multiple sensors substantially simultaneously. The software library contains logic for managing the enablement of the various applications 422, 424, 426 or third party applications 428 that are authorized to receive sensor data. The sensor control module 500 may also include logic for controlling and managing the state of the various applications 422, 424, 426 or third party applications 428 via the sensor control module interface 520.

[0078] The sensor control module 500 in the software library 400, together with the sensor assembly 300, is positioned as a programmed medical device that requires regulatory approval. By containing components that cause programmed medical device regulatory issues in the software library that communicates with the sensor assembly, there is no need to submit additional third party applications 428 for regulatory approval. This allows other application developers to build other use cases without submitting the use case of the application for regulatory review, thereby allowing sensor data to be utilized in non-regulated applications. This advantage is achieved by employing the modular logic described in the description of the software library 400.

[0079] The user interface 510 provides a unified interface for the applications 422, 424, 426 or third-party applications 428 to display received sensor data. The user interface 510 can provide consent and onboarding functionality for the applications 422, 424, 426 or third-party applications 428. Onboarding includes obtaining all consents required for a new user of the applications 422, 424, 426 or third-party applications 428 to access sensor data. The user interface 510 can also provide a readiness check functionality to determine whether the various sensor assemblies 300 are functioning properly through the communication control module 540. The user interface 510 can provide a display functionality for displaying the sensor data. The user interface 510 can be utilized in a common format between the applications 422, 424, 426 or third-party applications 428 as a user interface for any number of common functions, such as user account creation, consent for data privacy and sharing, and other similar functions. According to embodiments of the present disclosure, the sensor control module 500 can present a particular customized user interface 510 when running an application 422, 424, 426 developed by the manufacturer of the sensor assembly 300, and a completely different user interface 510 when running a third-party application 428 whose developer is different from that of the manufacturer of the sensor assembly 300. Thus, the look and feel of the user interface 510 is automatically adjusted depending on whether the application 422, 424, 426 or the third-party application 428 is requesting sensor data. Note that as disclosed herein, the sensor control module 500 can be implemented without a user interface 510 component.In this configuration, the sensor control module interface 520 functions to provide information directly to the display of the underlying application 422 , 424 , 426 or third party application 428 .

[0080] Optionally, the sensor control module 500 can include account integrity and initialization checks to allow connection to sensors and access to sensor data. Upon launch of an application 422, 424, 426 or third-party application 428, the application 422, 424, 426 or third-party application 428 requests initialization of the sensor control module 500 by providing the sensor control module 500 with identification information and authentication information that the sensor control module 500 can use to authenticate. If the integrity check cannot be passed, the sensor control module 500 does not allow the application 422, 424, 426 or third-party application 428 to operate. In the case of a third-party application 428, the remote management module 600 can be utilized to revoke or remove authorization of the third-party application 428 to the sensor control module 500 based on the manufacturer's current authorization and purpose as determined by the connectivity of the remote management module 600 and the remote server 640. The remote management module 600 may also initiate the process of revoking authorization of the third party application 428 from the sensor control module 500 to prevent further operation of the third party application 428. Upon successful initialization, the sensor control module 500 initializes the remote management module 600 by providing the remote management module 600 with the necessary identification and authentication information for authentication.

[0081] The sensor control module 500 may include protection features that verify that requests for sensor data are being made by authorized and proper applications 422, 424, 426 or third party applications 428.

[0082] The communication control module 540 can communicate with the sensor assembly 300 via the communication link 102. The sensor data received from the sensor assembly 300 is provided to other components of the sensor control module 500 using the message transmission / reception channel 104 of the sensor control module. The sensor data can also be communicated to the remote management module 600 via another inter-module interface 450 between the sensor control module 500 and the remote management module 600. The sensor data is also stored in a database 530 managed by a database manager 532.

[0083] The modular architecture of the software library 400 allows the communications control module 540 to receive data from any of the various types of sensors represented by the sensor assembly 300. This allows the system to receive sensor data substantially simultaneously. Because support for multiple different types of sensors is provided at a modular system level, in the future, as new sensors are built to track additional data, the system can be expanded by incorporating the necessary modules within the software library 400 and sensor control module 500.

[0084] The functionality of the user interface 510 is limited to displaying sensor data such as glucose values, and by maintaining this format, it is possible to uniformly display sensor data across multiple sensor readings using the user interface 510. Processing calculations are performed in the sensor assembly 300, and the communication control module 540 receives the results of the sensor data as values.

[0085] After receiving the sensor data, the communication control module 540 generates an event notification to notify each application 422, 424, 426 that the sensor data is available and accessible through the sensor control module interface 520, so that the event can be posted. The sensor data is stored in a database 530 and can be accessed directly through the sensor control module interface 520. By utilizing the sensor control module interface 520 and the user interface 510, the sensor control module 500 presents a unified interface for the various applications 422, 424, 426 or third party applications 428 to activate the sensor data and receive the sensor data results. In addition, the unified interface 510 also includes software logic to identify and register the various applications 422, 424, 426 or third party applications 428 to receive specific types of sensor data via callbacks. For example, when glucose sensor data is available, the unified interface software logic invokes a callback via the sensor control module interface 520 in an application 422, 424, 426 or third party application 428 that is authorized to receive the glucose sensor data.

[0086] The unified interface logic can use a unique identifier to identify the sensor assembly 300 for which sensor data is being requested. Although not shown, according to one aspect of an embodiment, as a first step, a unique identifier object can be created if one does not already exist. In some embodiments, for example, the unique identifier object can be a user-specific identifier object (e.g., a username, a user profile, or a user account ID). Such a user-specific identifier object can be input, generated, or aided by a software application, module, or routine within the software library 400 executing on the application 420. In other embodiments, the unique identifier object can be associated with a physical device, e.g., a particular sensor assembly 300, and can include, for example, a serial number, a media access control (MAC) address, a public key, a private key, or a similar string.

[0087] According to another aspect of the embodiment, each of the applications 422, 424, 426 or third party application 428 has parameters that can be passed to the sensor control module 500 with each call. These various structures and data types can be made available to the sensor control module 500 to assist the sensor control module 500 in accessing the sensor assembly 300 and receiving sensor data.

[0088] According to another aspect of the embodiment, the sensor control module 500 may store metadata and status information associated with the sensor assembly 300 or the application 422, 424, 426 or the third party application 428. Additionally, the sensor control module 500 may store this data in an encrypted format. Such encryption may be performed using any information useful for establishing or maintaining a connection with the sensor assembly 300, application 422, 424, 426 or the third party application 428, such as, for example, an identifier or status information related to the receiving device 200 or the sensor assembly 300. This database is an active (but not normally accessible) component within the application 422, 424, 426 or the third party application 428, and may be a separate database from the database accessible by the application 422, 424, 426 or the third party application 428. Additionally, the application 422, 424, 426 or the third party application 428 may be disabled or have its access rights removed from the sensor data.

[0089] The sensor control module 500 illustrated in the embodiments herein can identify the application 422, 424, 426 or the third party application 428 based on the tag information. The tagging information corresponding to the application 422, 424, 426 or the third party application 428 can be preloaded into the sensor control module 500 so that if a particular application of the application 422, 424, 426 or the third party application 428 requests access to the sensor data, the sensor control module 500 can identify the application.

[0090] The current framework and system may also be compatible with previous applications developed by the manufacturer of the sensor assembly 300. In particular, logic for converting sensor readings into usable data may be provided within the sensor assembly 300 or within each application 422, 424, 426. In this manner, the system may take advantage of a framework that allows previously developed applications to be integrated into the system's framework.

[0091] The sensor control module 500 also includes logic to identify whether a request for sensor data is from one of the applications 422, 424, 426 or a third party application 428. The sensor control module can also communicate information regarding the request for sensor data to the remote management module 600.

[0092] The sensor control module 500 may also have logic to receive information regarding a hardware problem with the sensor component of the sensor assembly 300. The sensor control module 500 may send a communication to the application 422, 424, 426 or the third-party application 428 to display a status message regarding the problem with the sensor assembly 300. Such a status message may alert a user via the application 422, 424, 426 or the third-party application 428 that a problem has occurred that prevents the sensor assembly 300 from providing sensor data regarding the analyte being monitored, such as a sensor that is about to expire or that has a hardware failure. The sensor control module 500 may send a communication to the operating system of the receiving device 200 while the application 422, 424, 426 or the third-party application 428 is in the background to display a notification identifying a problem with the sensor assembly 300. Such a problem may include a sensor that is about to expire or that has a hardware failure that prevents the sensor assembly 300 from providing sensor data regarding the analyte being monitored.

[0093] Applications 422, 424, 426 or third party application 428 may have a user interface (further illustrated in FIGS. 7A-7C below) that includes touch input or voice command input and serves as an interface for accepting commands from a user. These commands or inputs may include any number of different actions that may be taken on the display of sensor data, such as a user requesting a sensor reading, a user tapping on a display to obtain sensor data, acknowledging an alarm, etc.

[0094] The sensor control module 500 can be coded in a modular manner that allows the software library 400 to be upgraded to add functionality to communicate with newly developed sensor assemblies. By using variables instead of hard-coded values, the sensor control module 500 can be modified to communicate with newly developed sensor assemblies, allowing the applications 422, 424, 426 or third-party applications 428 to obtain sensor data from the newly developed sensor assemblies without submitting new or modified applications of the underlying applications for regulatory review and approval.

[0095] Remote Management Module FIG. 6 is a block diagram illustrating an exemplary embodiment of a remote management module 600.

[0096] The user interface 610 of the remote management module 600 provides a consistent interface to certain common features of the applications 422, 424, 426 or third party applications 428. As illustrated in the embodiments herein, these common features and functions may include data confidentiality, user consent, third party consent, application authentication, and other actions. The user interface 610 of the remote management module 600 provides a consistent interface to allow the various applications 422, 424, 426 or third party applications 428 to access these common features. Communication with the various software logic within the remote management module 600 may be accomplished using the remote management module's messaging channel 106. The user interface 610 also provides a consistent account management capability, allowing a user to create accounts, set passwords, and configure profile related information.

[0097] The remote management module 600 further comprises a remote control module 630 enabling communication with a remote server 640. The communication with the remote server 640 is performed wirelessly using any available communication means such as BLE or NFC communication.

[0098] In one embodiment of the system, the remote management module 600 may also provide a transport function to allow a user to back up data stored in the various applications 422, 424, 426 or third party applications 428 if the user upgrades the smartphone or receiving device 200. The remote management module 600 may also communicate with the applications 422, 424, 426 or third party applications 428 via a remote management module interface 620.

[0099] The software library 400, including the sensor control module 500 and the remote management module 600, can include multiple secure coding layers that help prevent cyber threats such as hacking, remote access, etc. For example, defenses against such threats include the use of digital certificates and profile provisioning.

[0100] The sensor control module 500 can further identify whether the request for sensor data was generated by the application 422, 424, 426 or the third-party application 428. As illustrated in the embodiment herein, the sensor control module can pass this identification information to the remote management module 600 via the inter-module interface 450, which can utilize the remote infrastructure to further customize the user interface 610 for the application 422, 424, 426 or the third-party application 428. As part of this customized user interface, a custom user authentication interface can be presented to the user of the application 422, 424, 426 or the third-party application 428. Additionally, the remote management module 600 further includes logic to revoke authentication of the application 422, 424, 426 or the third-party application 428. Specifically, removing authentication for the third-party application 428 allows the remote management module 600 to disable access by the third-party application 428, thereby improving monitoring and control over applications 422, 424, 426 or third-party application 428 accessing sensor data.

[0101] set up Biosensor setup can begin by displaying a series of GUIs to assist the user in placing the biosensor on the skin surface and pairing the biosensor with an application. In some embodiments, the setup GUI can be launched simply by selecting a banner. In other embodiments, the setup GUI can be opened by a setup button or a settings link or button.

[0102] The application can present a number of GUIs that explain how to apply the biosensor. It can also display a GUI showing what is inside the box, with an image and a description that the box contains a biosensor pack and a biosensor applicator. It can also display a GUI that instructs the user to select a site on the back of the upper arm away from scars, moles, stretch marks, and lumps. This GUI can be accompanied by an image that prominently displays the appropriate site on the upper arm for the biosensor. It can also display a GUI that instructs the user to wash the selected site with regular soap, wipe with alcohol, and dry it.

[0103] The application can present a GUI that explains how to prepare the biosensor pack and applicator. The GUI can include an image showing how to open the pack as well as text instructing the user to completely peel the lid off the biosensor pack and twist the cap off the biosensor applicator. The application can then display a GUI with an image of a person loading a biosensor into the applicator with instructions to align the dark markings on the biosensor applicator with the dark markings on the biosensor pack and press the biosensor applicator firmly down onto a hard, flat surface until it stops. The application can then display a GUI instructing the user to lift the biosensor applicator off the biosensor pack and informing the user that the biosensor applicator is ready to accept a biosensor. The GUI can include a warning that the biosensor applicator in this state contains a needle and the user should not touch the inside of the biosensor applicator or place it back into the biosensor pack.

[0104] The application can then display a GUI that explains how to place the biosensor on the user's body. As shown in GUI 3200 in FIG. 13A, the introductory GUI 3200 can include a graphic 3202 of a biosensor with introductory text 3204 that guides the user to begin the setup for pairing the biosensor. The user can then begin the setup process by tapping or selecting a start setup button 3206.

[0105] As shown in GUI 3210 of FIG. 13B, the "Set Up Biosensor" GUI 3210 can include a graphic or image 3212 showing a person placing an applicator on the body (e.g., the back of the upper arm). The GUI 3210 can also include text 3214 that describes how to apply the biosensor. The text 3214 can instruct the user to place the biosensor applicator on the site and press firmly until the biosensor is applied. The text 3214 can then instruct the user to gently pull the biosensor applicator away from the body. The text 3214 can also remind the user not to press down on the biosensor applicator until it is against the application site to prevent unexpected results or injury. Once the biosensor is applied, the user can tap the arrow button to proceed to GUI 3220.

[0106] The application may also present a GUI that instructs the user to make sure the biosensor is securely attached by trying to press down on the adhesive.

[0107] As shown in GUI 3220 of FIG. 13C, the next "Set Up Biosensor" GUI 3220 may show a graphic or image 3222 of a person pairing the biosensor to a reading device (e.g., a smartphone) by holding the device in close proximity to the worn biosensor. Text 3224 may instruct the user to tap a start pairing button 3226 to pair the biosensor. A pop-up window may also be displayed instructing the user to hold the reading device (e.g., a mobile phone) in close proximity to the biosensor. The phone may also vibrate upon a successful scan of the biosensor.

[0108] Once the biosensor pairing is complete, a GUI 3230 may be displayed that indicates the time remaining until the biosensor is ready, as shown in FIG. 13D. The GUI 3230 may include a graphic 3232 that highlights the time remaining until the biosensor is active. The graphic 3232 may include a circle of dots that radiate outward, which may be animated. Alternatively, the graphic 3232 may include a progress indicator. The progress indicator may be a bar with colored segments or a circle with colored segments that extend around the circumference, where the colored segments are proportional to the amount of time remaining until the sensor is active. For example, the circumference of the circle may be 60 minutes, and the colored segments may be proportional to the amount of time remaining until the sensor is active (less than an hour). Alternatively, the graphic 3232 may be animated, changing color around the circumference as the remaining time decreases. The GUI 3230 may also include an indication 3236 of the number of minutes remaining until the biosensor is activated (e.g., "55:10" if 55 minutes and 10 seconds remain until the sensor is ready or activated). Alternatively, in some embodiments, the message "Getting Ready...Time Left: 55 minutes" may be displayed inside the circle or below the graphic 3236, and the colored circumference may be animated to change color periodically as the time remaining until the biosensor is activated decreases. The GUI may also include multiple selectable links that the user may select to display additional information to the user, such as instructions for replacing the biosensor, support, application details, ordering a biosensor, etc., as described elsewhere herein.

[0109] The GUI 3230 may also include a legend or message 3234 informing the user that the biosensor is currently acquiring user information and that real-time analyte values ​​will be available within the time indicated by the display 3236. In some embodiments, each element of the GUI 3230 may be provided by the biosensor module. For example, the graphic 3232 including the progress indicator and the display 3236 of the time remaining until the biosensor is active may be provided by the biosensor module. When the user clicks "OK", the GUI 3230 collapses and the home screen with the banner is visible to the user. As shown in FIG. 10A, the banner 1002 may display an icon 1008 indicating the status of the biosensor along with information 1010 regarding the status of the biosensor. In some embodiments, the icon 1008 may also include a progress indicator indicating the time remaining until the biosensor is ready, similar to the progress indicator described in the description of the graphic 3232. The icon 1008 may also include a graphic highlighting the time remaining until the biosensor is active. The graphic may include a circle of radiating dots, which may be animated. Alternatively, the icon 1008 may include a progress indicator. The progress indicator may be a bar with colored segments or a circle with colored segments extending around the circumference, where the colored segments are proportional to the amount of time remaining until the sensor is activated. For example, the circumference of the circle may be 60 minutes, and the colored segments may be proportional to the amount of time remaining until the sensor is activated (less than an hour). The information 1010 may include text indicating that the biosensor is "Preparing...Time Remaining: XX" (XX may be expressed in minutes and seconds). For example, if the biosensor is to start in 55 minutes and 10 seconds, the banner 1002 may display "Preparing...Time Remaining: 55:10".

[0110] application 7A-7C are exemplary embodiments of an application that utilizes the software library 400 and the sensor control module 500. FIG.

[0111] In one example, application 420 may be an application for tracking the value of an analyte, such as lactate as shown in Figure 7A, ketones or ketone bodies (e.g., beta-hydroxybutyrate) as shown in Figure 7B, or glucose as shown in Figure 7C. The display representation may be partially derived from sensor control module interface 520 and partially based on processing within the underlying application 420.

[0112] Additionally, according to some embodiments, applications 720, 722, 724 are representative of applications 422, 424, 426 that communicate with sensor control module 500 to enable receipt of sensor data. Using sensor control module 500 and remote management module 600, a consistent user experience can be provided across different applications. Additionally, the application can further incorporate updated software library 400 as additional analyte values ​​need to be detected and sensed, without the need to develop an entire architecture for communication, account management, user privacy, and consent.

[0113] The GUI improvements in various aspects described herein and in the claims provide at least the technical effect of assisting the 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 the technical task of operating the system, thereby enabling the user to read the required measurements and obtain the required information accurately and efficiently.

[0114] Biosensor module banner As described above, the user interface 510 of the sensor control module 500 can include various components. As seen in FIG. 10A, the GUI 1000 can include a banner 1002 generated by the user interface 510. The banner 1002 can be incorporated into a GUI generated by a host application (e.g., application 422, 424, 426 or third party application 428). The banner 1002 generated by the user interface 510 can show different interfaces depending on the host application in which the banner 1002 is incorporated. The banner 1002 can include real-time concentration values ​​1004, trend arrows 1006, an icon 1008 indicating the status of the biosensor, information 1010 regarding the status of the biosensor, and additional indications 1012 of the status of the biosensor. The banner 1002, or elements within the banner 1002, can be configured to be selectable to link to other GUIs with additional information regarding the biosensor. For example, if the host application is a glucose health application, the banner 1002 may include real-time concentration values ​​1004, status icons 1008, and information regarding the status of the biosensor 1010. Additionally, the real-time concentration values ​​1004 may be located in a different portion of the GUI than the other banner elements (e.g., as part of the analyte graph).

[0115] A variety of different status icons 1008 and information 1010 regarding the status of the biosensor may be displayed. In some embodiments, a status icon 1008 including a circle of dots (which may be animated or not) may be displayed next to status information 1010 indicating that the biosensor is not connected or not ready. For example, the status information 1010 may indicate that the biosensor will be ready in a certain amount of time (e.g., "Ready in 30 mins"). In some embodiments, the status information 1010 may also display "Searching" to indicate that the application is attempting to connect to the biosensor.

[0116] As shown in FIG. 10B, in some embodiments, a pop-up screen 1016 may also be displayed on the GUI 1000. The pop-up screen 1016 may convey a message regarding the start-up of the biosensor. The pop-up screen 1016 may indicate the time remaining (e.g., in hours, minutes, or hours and minutes) until the biosensor is ready. For example, the pop-up screen may indicate "Preparing biosensor... Time remaining: 55 minutes." In other embodiments, if the reading device, such as a smartphone, is locked, a notification indicating that the biosensor is ready may also be displayed on the lock screen. In some embodiments, as shown in FIG. 10A, a status icon 1008 including a circle with a progress indicator in color can be displayed next to status information 1010 indicating that the biosensor is connected and working properly. For example, the status information 1010 may display "LIVE." In some embodiments, the progress indicator of the circle with a progress indicator 1008 may be colored, and the colored portion may be proportional to the remaining sensor life of the current biosensor. In some embodiments, the color of the progress indicator may vary depending on the remaining amount of sensor life. For example, the color of the progress indicator may be blue if the sensor has at least about 50% remaining life, or at least about 40% remaining life, or at least about 30% remaining life, or at least about 25% remaining life, or at least about 20% remaining life, or at least about 10% remaining life. In some embodiments, the color of the progress indicator may be a different color (e.g., orange or red) if the sensor has less than a certain amount of remaining life. For example, the color of the progress indicator may be orange when the remaining life of the sensor is less than about 50%, or less than about 40%, or less than about 30%, or less than about 20%, or less than about 10%, or less than about 5%.

[0117] In some embodiments, the status information 1010 may display a phrase such as "Learn more" to indicate that the user needs to know more about the status of the biosensor. Selecting a portion of the banner such as "Learn more" may display one of a number of explanations indicating that the biosensor may have an error or problem. In some embodiments, if there is a problem with the biosensor and the status information 1010 displays "Learn more," the real-time concentration value 1004 may not be displayed. In some embodiments, multiple dashes or dots (e.g., two dashes) may be displayed in place of the real-time concentration value 1004, which is the analyte concentration value measured by the biosensor.

[0118] In some embodiments, the banner 1002 can include the real-time concentration value 1004, an icon 1008 indicating the status of the biosensor, and information 1010 regarding the status of the biosensor. Also, as shown in FIG. 10C, the real-time analyte concentration value 1004 can be a GUI 1020 that is located in a separate portion of the banner 1002 from other components. For example, the real-time analyte concentration value 1004 can be located within a graph 1024 that is part of a GUI 1014 generated by the host application. The graph can include an analyte curve 1028 and a mark 1026 indicating the current analyte concentration, and the real-time analyte concentration value 1004 can be located on top of the mark 1026. In other embodiments, the real-time analyte concentration value 1004 can be included within a statement 1032 regarding the user's analyte concentration in a GUI 1030, as shown in FIG. 10D. For example, text 1032 may be placed above the graph 1024 and may read, for example, "Your current glucose level is 124 mg / dL. Your numbers are stable, so you're doing great."

[0119] In some embodiments, the banner 1002 can include the real-time concentration value 1004, an icon 1008 indicating the status of the biosensor, and information 1010 regarding the status of the biosensor. As shown in FIG. 10E, the real-time analyte concentration value 1004 of the GUI 1040 can be placed within a graphic element 1042 provided by the host application. The graphic element 1042 can be a shape such as a colored circle. As described elsewhere herein, if the analyte value is within a target range or is determined to be stable, the color of the graphic element 1042 can be a first color (e.g., green). However, if the analyte value is outside of a target range or is determined to be unstable, or if a sudden change in the analyte concentration is detected (as described elsewhere herein), the color of the graphic element 1042 can be a second color (e.g., orange). The color of the graphic element can be the same color as the analyte curve 1028 of the analyte graph 1024.

[0120] System Messages If there is a problem with the biosensor, a system message may be displayed regarding the status of the biosensor. The system message may be displayed in a pop-up window or an alert notification, or alternatively, in some embodiments, the system message may be displayed after the user selects "View Details."

[0121] In some embodiments, the detailed message 1210 may include a "Pairing Error" message to indicate that the pairing failed. Additionally, the application may recommend that you try pairing the biosensor again.

[0122] As shown in FIG. 12A, the user interface 510 of the sensor control module 500 can be configured to display one of several messages in the GUI 1200 when the user selects "View Details." The message can include a details message 1210, a serial number 1106 of the current biosensor, and several selectable links 1110, 1112, 1114, 1116 that, when selected by the user, can display additional information to the user as described elsewhere. In some embodiments, the details message 1210 can be presented within a circular graphic that includes a progress indicator that visually indicates the remaining life of the current biosensor. As described in the discussion of other embodiments, the graphic can be circular and the progress indicator can be differently colored portions of the circumference. The progress indicator can be proportional to the remaining sensor life of the current biosensor. Also, as described in the discussion of other embodiments, the color of the progress indicator can change depending on the amount of sensor life remaining.

[0123] In some embodiments, if there is a problem with the biosensor, the banner 1002 may display multiple dashes or dots (e.g., two dashes) instead of the analyte concentration value or analyte value 1004 measured by the biosensor. If the banner 1002 does not display the real-time analyte concentration or value, for example if multiple dashes or dots are displayed, then when the user taps on the banner 1002, one of multiple system messages regarding the biosensor problem may be displayed. When the user taps or selects the banner, a detailed message GUI may be displayed that provides additional information regarding the status of the biosensor.

[0124] In some embodiments, the detailed message 1210 may include a "Check Biosensor" message indicating that the biosensor may not be properly attached to the user. The detailed message 1210 may further include instructions indicating that the user should attach and pair a new biosensor if the biosensor is not securely attached to the user's skin. The detailed message 1210 may also include instructions indicating that the user should reattempt to pair the biosensor if the biosensor is properly attached. Optionally, the detailed message 1210 may also include a selectable "Pair" or "Pair Biosensor" button that, when selected, may display a GUI to assist the user in initiating the pairing process.

[0125] In some embodiments, the detailed message 1210 may include a "Signal Loss" message that alerts the user to keep the cell phone within range of the biosensor at all times, and may also instruct the user to try turning "Bluetooth" off and on on the cell phone or rebooting the cell phone if that does not resolve the issue.

[0126] In some embodiments, the detail message may also be a message related to the temperature of the biosensor. In some embodiments, the detail message 1210 may include a "Biosensor Too Hot" message to inform the user that the biosensor became too hot to obtain a reading from the biosensor. The detail message 1210 may further request the user to check again in a few minutes. In some embodiments, the detail message 1210 may include a "Biosensor Too Cold" message to inform the user that the biosensor became too cold to obtain a reading from the biosensor. The detail message 1210 may further request the user to check again in a few minutes.

[0127] In some embodiments, the detail message 1210 may include a "Biosensor Error" message informing the user that a biosensor reading could not be obtained, and may further request the user to check again after a certain period of time, such as 5 minutes, 10 minutes, or 30 minutes.

[0128] In some embodiments, if the signal from the biosensor is suddenly lost, the biosensor state can immediately switch to "SEARCHING" and selecting or tapping on the "SEARCHING" indication can display a detailed message 1210 encouraging the user to keep the mobile phone within range of the biosensor at all times. If this does not resolve the issue, the application can also advise the user to try turning "BLUETOOTH" off and on on the mobile phone or rebooting the mobile phone.

[0129] In some embodiments, the details message 1210 may include a "Biosensor Incompatible" message informing the user that the biosensor cannot be used with this version of the application, and may recommend removing the biosensor and pairing it with a new one.

[0130] In some embodiments, the detail message 1210 may include a "Biosensor Ended" message that informs the user that the biosensor is finished and instructs the user to pair with a new biosensor.

[0131] In some embodiments, the details message 1210 may include a "Biosensor already in use" message informing the user that the biosensor cannot be used because it is already in a paired state, and may also instruct the user to remove the biosensor and pair it with a new one.

[0132] In some embodiments, the details message 1210 can also include a "Current Biosensor" message. This message can be displayed in a different color than messages indicating problems or errors, and can indicate that the biosensor the user is pairing with is the one the user is currently using, and that analyte readings will soon be automatically received in real time directly to their device. The message can also include a different icon, such as a check mark.

[0133] In some embodiments, the detailed message 1210 may include a "ENABLE BLUETOOTH" message requesting the user to turn on "BLUETOOTH." Additionally, the detailed message 1210 may explain that "BLUETOOTH" is required to receive biosensor readings.

[0134] In some embodiments, the details message 1210 can include "Replace Biosensor" to inform the user that the biosensor is not working, and can also request that the biosensor be removed and paired with a new one.

[0135] 12B, a pop-up window 1220 may be displayed to include a detail message in the pop-up window 1220. The content of the detail message in the pop-up window 1220 may be the same or substantially the same as that described above in the description of the multiple detail messages 1210 that may be displayed in the GUI 1200.

[0136] The biosensor module can also create and store an error log.

[0137] "Biosensor module details" GUI The user interface 510 of the sensor control module 500 can be configured to output a "Biosensor Module Details" GUI 1100 as shown in FIG. 11A when a user selects any element in the banner 1002. The "Biosensor Module Details" GUI 1100 can include a graphic 1102 that includes a progress indicator that visually indicates the remaining life of the current biosensor. In some embodiments, the graphic 1102 can be circular and the progress indicator can be differently colored portions of the circumference. The progress indicator can be proportional to the remaining sensor life length of the current biosensor. For example, if a biosensor with a total life of X days has a remaining life of Y days, then the circumference color indicator of Y / X*100% of the circumference of the circular graphic 1102 is a different color (e.g., blue). For example, if a biosensor with a total life of 14 days has a remaining life of 12 days, then about 85.7% of the circumference color indicator of the circle 1102 is blue.

[0138] In some embodiments, the color of the progress indicator may vary depending on the amount of sensor life remaining. For example, the color of the progress indicator may be blue when the sensor has at least about 50% remaining life, or at least about 40% remaining life, or at least about 30% remaining life, or at least about 25% remaining life, or at least about 20% remaining life, or at least about 10% remaining life. In some embodiments, the color of the progress indicator may be a different color (e.g., orange or red) when the sensor has less than a certain amount of remaining life. For example, the color of the progress indicator may be orange when the sensor has less than about 50% remaining life, or less than about 40% remaining life, or less than about 30% remaining life, or less than about 20% remaining life, or less than about 10% remaining life, or less than about 5% remaining life.

[0139] The GUI 1100 may also include a real-time display 1104 of the remaining biosensor life. For example, in the above example, "12 days" may be displayed in the center of the circular graphic 1102. The real-time display 1104 may also be proportional to the progress display of the graphic 1102. The real-time display 1104 may display the remaining biosensor life in days when the remaining biosensor life is greater than about 1 day or greater than about 23 hours and 59 minutes. The real-time display 1104 may display the remaining biosensor life in hours when the remaining biosensor life falls below about 24 hours. In some embodiments, the progress display may switch color (e.g., from blue, green, orange, red) when the remaining biosensor life falls below about 24 hours. The real-time display 1104 may display the remaining biosensor life in minutes when the remaining biosensor life falls below about 1 hour or below about 61 minutes. The GUI may also include an additional message 1105 that the biosensor life is "Ending Soon."

[0140] The GUI 1100 may assist a user in seeking assistance from customer service by posting the current biosensor serial number 1106. As shown in FIG. 11B, when the user selects the serial number 1106, a pop-up screen 1120 may be displayed containing additional details about the biosensor. The pop-up screen 1120 may include the current biosensor serial number 1106 and the current biosensor status 1122. The pop-up screen 1120 may also include a list of past biosensors 1124, 1126, 1128. The list of past biosensors may include dates 1124a, 1126a, 1128a associated with each of the past biosensors (e.g., the date the biosensor was activated or the date the biosensor was unlinked), along with the past biosensor serial numbers and statuses 1124b, 1126b, 1128b. In some embodiments, information such as the current and past biosensor serial numbers may be copied to assist the user in communicating this information (e.g., to an HCP, customer support, etc.) as needed.

[0141] The GUI 1100 may also include multiple selectable links 1110, 1112, 1114, 1116 that, when selected by a user, may display additional information about how to install the biosensor, options for purchasing additional biosensors, instructions for use, how to replace the biosensor, support, application details, biosensor details, etc.

[0142] support When the user taps or selects the link to "Support," a GUI may be displayed that includes a "Help and Learning" section, an "About" section, and a "Customer Care" section that includes more information on how to contact the helpline. The "Help and Learning" section may include links to "FAQs," "Understanding Glucose Readings," and "App Tutorial." The "About" section may include links to "Biosensor IDs," "Error History," and "App and Biosensor information." As described elsewhere, the "Biosensor IDs" link may display a GUI that shows the serial number of the current biosensor alongside a list of past biosensors. The list of past biosensors may include a date associated with each past biosensor (e.g., the date the biosensor was activated or the date the biosensor was unlinked), along with the serial number of the past biosensor and the status of the biosensor. The "Error History" link takes you to a GUI that lists for each error the error code, a brief description, and the date and time the error occurred. The "App and Biosensor Information" link takes you to a GUI that lists the application name, full software version, SDK version, OS version, smartphone model, country, and reference number.

[0143] notification In some embodiments, the biosensor module can provide in-app notifications to alert the user to the status of the biosensor. The in-app notifications can also alert the user to actions that can be taken in relation to the biosensor. The biosensor module can function to assist the host application in displaying operating system based notifications related to the status of the biosensor (e.g., a notification informing the user that the biosensor has finished). If the host application is in the foreground, the in-app notifications can be displayed in a pop-up notification. In some embodiments, the biosensor module can provide in-app notifications issued by third party applications related to the status of the biosensor.

[0144] As described elsewhere herein, the notification may be about the status of the biosensor. The notification may be about enabling "BLUETOOTH" and may alert the user that "Bluetooth" is required to receive biosensor readings and may request the user to turn on "Bluetooth" now. The notification may be about checking the biosensor and may alert the user that the biosensor is not properly installed. The notification may be about replacing the biosensor and may alert the user that the biosensor is not working and may instruct the user to remove the biosensor and pair a new one. The notification may be about the end of a biosensor session and may alert the user that the biosensor session has ended and it is time to pair a new biosensor to continue working on their glucose levels. The notification may be about the biosensor being ready and may indicate that biosensor data is being received and will be automatically displayed in due course. The notification may also prompt the user to explore within the glucose health maintenance application. The notification may also be about the biosensor expiring in a certain time (hours) and may prompt the user to purchase a new biosensor and replace the current biosensor immediately. The time remaining until the biosensor expires may be 24 hours, 12 hours, 6 hours, 1 hour, or 30 minutes. The notification may also indicate that the biosensor has lost signal and the user's mobile phone is out of range of the biosensor.The notification may also be about a biosensor that is too hot to get a reading from the biosensor and may request the user to check again in a few minutes, or about a biosensor that is too cold to get a reading from the biosensor and may request the user to check again in a few minutes, or about a biosensor error that informs the user that a biosensor reading was not able to be obtained and may request the user to check again in 10 minutes.

[0145] End Biosensor / End Session When a biosensor session ends and it is time to replace the biosensor, the sensor control module 500 can provide a variety of ways to remind the user to pair a new biosensor. As shown in Figures 10A and 10B, in some embodiments, an icon 1008 and a status information message 1010 can be displayed to remind the user to switch to a new biosensor. The icon 1008 for the new biosensor can be different from the other icons used for the biosensor status, and can be an icon that resembles a full moon, a light bulb, etc.

[0146] In some embodiments, in addition to or instead of the status information message 1010, a pop-up window 1016 may be displayed. The pop-up window 1016 may remind the user that the biosensor session has ended and that a new biosensor needs to be paired. In some embodiments, if the biosensor has a 14-day life span, the pop-up window 1016 may be displayed when the user has just completed a 14-day session, indicating that the biosensor session has ended. The pop-up window 1016 may also remind the user that it is time to replace the biosensor by pairing a new biosensor. The pop-up window 1016 may also include a selectable button, a "Pair" or "Pair Biosensor" button, which, when selected, may display a GUI to assist the user in starting the pairing process. The pop-up window 1016 may also include a link to instructions on how to wear the biosensor, a link to a website where the user can purchase the biosensor, or both.

[0147] As shown in FIG. 10B, in some embodiments, a pop-up window 1016 may be displayed when the user returns to the host application without setting up a new sensor. In some embodiments, the pop-up window 1016 may welcome the user back to the application. The pop-up window 1016 may also remind the user to pair a new biosensor. The pop-up window 1016 may also include a selectable button "Pair" or "Pair Biosensor" that, when selected, may display a GUI to assist the user in starting the pairing process. The pop-up window 1016 may also include a link to instructions on how to wear the biosensor, a link to a website where the user can purchase the biosensor, or both. A notification may be displayed on the device (e.g., on the lock screen) when the user is not viewing the application, or when the application is running in the background, or when the application is closed. In some embodiments, the notification may indicate "Your session is completed!" and invite the user to pair a new biosensor to continue their journey to know their body.

[0148] 11A and 11B, the "Biosensor Module Details" GUI 1100 may also display a message associated with the graphic 1102 to remind the user to start a new biosensor. The message may also advise the user to remove the biosensor and pair with a new biosensor. The GUI 1100 may also include a selectable button "Pair" or "Pair Biosensor" button that, when selected, may display a GUI to assist the user in starting the pairing process. In some embodiments, after the user selects the "Pair" or "Pair Biosensor" button, a pop-up window 1120 may be displayed with a reminder that the new biosensor is ready to be scanned. The pop-up window 1120 may include a graphic showing a mobile phone or reading device and may also include instructions to remind the user to hold the top of the phone very close to the biosensor. A pop-up window 1120 may also remind the user that if the biosensor scan is successful, the user will be notified by, for example, vibrating the mobile phone (eg, making a sound).

[0149] As mentioned in the discussion of other GUIs (e.g., the "Details" GUI), the application can also display a link to "how to replace your biosensor" that may be useful to new users. If the user selects the "how to replace your biosensor" link, a GUI is displayed with the options to (1) remove the biosensor or (2) insert a new biosensor. This GUI can also include an option to replace the sensor before the current biosensor expires.

[0150] If the user wishes to remove the biosensor, a GUI may be displayed that includes a warning that the removed biosensor cannot be replaced. Once the biosensor is removed, the user must switch to a new biosensor. The GUI may also include instructions to pull up on the adhesive edge that holds the biosensor to the user's skin and slowly peel it off the skin in one motion, and instructions that any residue left on the skin can be removed with warm soapy water or isopropyl alcohol. The GUI may also include instructions instructing the user to dispose of the used biosensor according to local regulations. In addition, an "Apply New Biosensor" link may be displayed and the user may be instructed to follow the instructions in this link when they are ready to apply the new biosensor. Selecting or tapping the "Apply New Biosensor" link may then display the GUIs described in the "Setup" section.

[0151] If the user chooses to replace the sensor before the biosensor has finished, a popup window can be displayed asking if they want to end the biosensor early. If the user taps "END BIOSENSOR", the current biosensor will be terminated and the user will have to remove the current biosensor and insert a new biosensor. The popup can also include a warning that this action cannot be undone. If the user selects the link to end the biosensor, the application can display a GUI related to replacing the biosensor as described elsewhere.

[0152] Additionally, once the first biosensor has finished, a pop-up may be displayed prompting the user to evaluate the monitoring application.

[0153] Replacement of biosensor due to sensor error If the biosensor needs replacing, the application may display a pop-up or alert notification to that effect. The pop-up or alert notification may include a warning icon (e.g., an orange triangle with an exclamation point) that warns the user that the biosensor is not working and instructs the user to replace the biosensor and pair a new biosensor. The pop-up may also include a selectable link to "Perform Pairing" or "Perform Biosensor Pairing" and instructions on how to replace the biosensor. The live display may also include an indication that the biosensor is not working properly. Instead of displaying the current analyte value, the banner may display dashes (e.g., "--") in place of the value and text information that reads "Learn More." When the user taps anywhere on the banner, a "Details" GUI, as described elsewhere, may be displayed with a message to replace the biosensor. The "Details" GUI, as described elsewhere, may include links to additional information. For example, the "Details" GUI may include links to information on how to replace the biosensor, ordering the biosensor, support, and monitoring applications.

[0154] Communication between sensors and applications FIG. 8 illustrates an exemplary method for communicating sensor data from a sensor to a third-party application 428. At the outset, one of ordinary skill in the art will appreciate that any or all of the method steps and / or routines described herein may include instructions (e.g., software, firmware, etc.) stored in non-volatile memory of a sensor control device, a remote device (e.g., smartphone, reader), and / or any other computing device that is part of or in communication with the analyte monitoring system. Moreover, the instructions, when executed by one or more processors of each such computing device, may cause the one or more processors to perform one or more of the method steps described herein. The computing device may be a receiving device 200. Additionally, while one or more of the method steps and / or routines described herein may be comprised of software and / or firmware stored on a single computing device, one of ordinary skill in the art will appreciate that in certain embodiments, the software and / or firmware may be distributed across multiple homogeneous or heterogeneous computing devices or software modules.

[0155] According to one aspect of the embodiment, the method 800 can assist the application 422, 424, 426 or the third party application 428 to receive sensor data for use within the application. At step 810, the third party application 428 sends a request for sensor data within the system. The request is sent to the sensor control module 500 via the sensor control module interface 520, which communicates with the sensor assembly 300 using the communication control module 540. At step 820, the sensor control module 500 verifies the authenticity and session integrity of the third party application 428. Additionally, the sensor control module 500 can communicate with the remote management module 600, which assists with user authentication, to obtain content specific information for the third party application 428. These modules can be provided within the software library 400, allowing the developer of the third party application 428 to integrate these modules as a framework within the system of the third party application 428. At step 830, the sensor control module 500 can use logic to identify the type of third party application and the desired sensor data.

[0156] At step 840, the sensor control module 500 may issue a request for sensor data from the sensor assembly. Alternatively, the sensor control module 500 may receive the sensor data based on a predetermined transmission rate (e.g., every 30 seconds, every minute, every 5 minutes, etc.). According to some embodiments, the sensor data may include data indicative of an analyte value, such as, for example, a glucose value, a glucose rate of change, a glucose trend, or a glucose alarm condition. At step 850, the sensor data is delivered over the communication link 102 for storage in the database 530 of the sensor control module 500 and displayed on the user interface 510 at step 860 as shown.

[0157] The sensor control module 500 includes a database 530 that can store individual sensor data for each value generated by the various sensor assemblies 300. The sensor data is stored in one or more databases 530 for each of the various sensors included in the sensor assembly 300, and the database manager 532 can control the one or more databases 530. The sensor data can also be stored together in one database 530. Note that the illustrated database 530 is for illustrative purposes and not for limiting purposes. The database 530 of the sensor control module 500 can also include a separate dedicated database for storing alarm conditions for each alarm and the alarm results or alarm notifications triggered thereby.

[0158] The user interface 510 may also be utilized to generate alarm notifications to the user for alarms triggered based on the sensor data or based on the state of the sensor assembly 300. The sensor control module 500 may also need to alert the user as to the presence or absence of an alarm. This communication is made by the user interface 510 via the sensor control module interface 520.

[0159] It is further within the subject matter of this disclosure that the remote management module 600 may store alarm notifications and events of the applications 422, 424, 426 or third party applications 428 in a remote server 640 as a backup. This allows alarm events to be generated for the applications 422, 424, 426 or third party applications 428 that may be stored outside of the module that requires regulatory review and approval. In this manner, alarm events may be used by various applications developed to monitor the health and wellness of a user for wellness purposes that do not require regulatory approval. The applications 422, 424, 426 or third party applications 428 may also store sensor data, alarm conditions, or notifications in their own databases or shared databases separate from the database 530 in the sensor control module 500.

[0160] One advantage of using the software library 400 and sensor control module 500 in a modular manner as disclosed herein is that it allows users and application developers to discover and develop a variety of health-related applications for the sensor data. This allows users who have not previously tracked analytes, such as glucose monitoring, to consider adding such tracking applications for health and wellness purposes, such as non-regulated uses such as food tracking and customizable diabetes management. With the modular sensor control module 500, the third party application 428 can utilize the sensor data in any non-regulated manner without going through a regulatory approval process. This allows the manufacturer to expand the user base of the sensor assembly 300 by providing more functionality to users who are considering using the manufacturer's sensors. These capabilities can be implemented and improved in the third party application 428 without the need to submit modifications and improvements for regulatory review and approval, which also shows how the present disclosure enhances the user's health and wellness efforts.

[0161] This also allows for the software library to be expanded to collect and provide sensor data for sensors that are yet to be developed using the sensor control module 500. The modular approach disclosed herein reduces the need to rewrite common functions and methods for reading data from various existing and newly developed sensors, minimizes the cost of introducing new sensors, and expands the functionality and options for utilizing the sensor data in health and fitness applications. The system is scalable, so the entire system can be expanded for future generations of sensor assemblies 300 and applications of the sensor data to further health and fitness use cases. The modular approach allows the third party application 428 to take a mix and match approach to build or extend the underlying third party application 428 and to extend the functionality provided by the third party application 428. The third party application 428 can select which analytes to monitor and incorporate into the health and fitness program based on the sensor data.

[0162] Additionally, in step 870, the sensor control module may issue an event notification to the third party application 428 indicating that sensor data is available. Additionally, the sensor control module interface 520 may be utilized to transmit the sensor data.

[0163] FIG. 9 illustrates an exemplary method for communicating sensor data from a sensor to a third-party application 428. At the outset, one skilled in the art will appreciate that any or all of the method steps and / or routines described herein may include instructions (e.g., software, firmware, etc.) stored in non-volatile memory of a sensor control device, a remote device (e.g., smartphone, reader), and / or any other computing device that is part of or in communication with the analyte monitoring system. Furthermore, when the instructions are executed by one or more processors of each such computing device, the instructions may cause the one or more processors to perform one or more of the method steps described herein. The computing device may be a receiving device 200. Additionally, while one or more of the method steps and / or routines described herein may be comprised of software and / or firmware stored on a single computing device, one skilled in the art will appreciate that in certain embodiments, the software and / or firmware may be distributed across multiple homogeneous or heterogeneous computing devices or software modules.

[0164] According to one aspect of the embodiment, the method 900 can assist the application 422, 424, 426 or the third party application 428 to receive sensor data for use in the application. In step 910, the third party application 428 sends a request for sensor data in the system or the sensor assembly 300 automatically connects to the third party application 428. This can be done, for example, by using a BLE connection to send a detection request from the sensor assembly 300 for a BLE-enabled receiver device 200 with the third party application 428. In step 920, the sensor control module 500 verifies the integrity of the third party application 428 and performs authentication. Furthermore, the sensor control module 500 can communicate with the remote management module 600, which supports the integrity, to obtain content-specific information of the third party application 428. These modules can be provided in the software library 400, which allows the developer of the third party application 428 to integrate these modules as a framework into the system of the third party application 428. At step 930, the sensor control module 500 may use logic to identify the type of third-party application 428 and the desired sensor data and issue a request for the desired data. Optionally, the sensor assembly 300 may also transmit the sensor data via the communication control module 540 and the sensor control module interface 520 without a request because the session has already been authenticated.

[0165] At step 940, the sensor control module 500 receives the sensor data. As discussed above, the sensor data may include data indicative of an analyte value, such as a glucose value, a glucose rate of change, a glucose trend, or a glucose alarm condition.

[0166] At step 950, the sensor data in the sensor control module 500 is sent to the third party application via the sensor control module interface 520. Then, at step 960, the sensor data is displayed on the user interface 510 of the sensor control module.

[0167] At step 970, the third party application 428 displays additional messages related to the sensor assembly 300. The additional messages may include sensor data related to the analyte value, notifications, alarms, messages, or other issues related to the sensor, or dietary or exercise advice based on the sensor data received via step 950. Thus, some of the displays on the third party application 428 may be related to the analyte value via the sensor control module 500, while other portions of the displays on the third party application 428 may be displays specifically provided by the third party application 428 that are not under the control of the sensor control module 500.

[0168] The software library 400 and sensor control module 500 disclosed herein may be used with applications 422, 424, 426, which may include a variety of existing applications, such as glucose sensors for diabetes monitoring, glucose and ketone sensors for diabetes monitoring, glucose sensors and insulin delivery devices for diabetes monitoring, closed loop insulin delivery systems, glucose sensors for health and fitness applications, etc. As disclosed herein, these applications may require various regulated functionality and may be required to go through all regulatory approval procedures. However, as disclosed herein, these applications may also include various modifications and additional functionality that are not part of the core functionality of diabetes monitoring and insulin delivery, and the extension of the functionality provided by the applications based on sensor data is not subject to regulation. As further disclosed herein, the additional functionality may be implemented by the health and fitness applications 422, 424, 426 or third party applications 428. Such health and fitness applications may include glucose sensors for sports or fitness monitoring or health and diet, ketone sensors for health or diet plans (e.g., ketogenic diet plans), lactate sensors for sports and fitness monitoring, or any number of other applications for monitoring alcohol for therapeutic or compliance purposes, sST2, calprotectin, HNL, NT-pro-BNP, etc. Such functionality may be performed by applications 422, 424, 426 or third party applications 428 and may be considered outside of the core functionality that requires regulatory review. Thus, extending these functions using the modular framework disclosed herein does not require a request for regulatory approval before the extended functionality can be introduced into the consumer market.

[0169] Other configurations of the test substance system FIG. 14 is a conceptual diagram illustrating an exemplary embodiment of an analyte monitoring system 2100 including a sensor applicator 2150, a sensor control device 2102, and a reading device 2120. In this example, the sensor applicator 2150 can be used to deliver the sensor control device 2102 to a monitoring location on the skin of a user. Upon delivery of the sensor control device 2102 to the monitoring location, an adhesive patch 2105 maintains the sensor 2104 in place for a period of time. As further described in FIG. 15B and FIG. 15C, the sensor control device 2102 can communicate with the reading device 2120 via a communication channel 2140 using any wired or wireless technology. Examples of wireless protocols include "Bluetooth", "Bluetooth" Low Energy (BLE, BTLE, "Bluetooth" SMART, etc.), Near Field Communication (NFC), etc. A user can view and use applications installed in the memory of the reading device 2120 using the screen 2122 (in many embodiments, the screen 2122 can be configured as a touch panel) and the input unit 2121. The device battery of the reading device 2120 can be charged using a power port 2123. Although only one reading device 2120 is shown in the figure, the sensor control device 2102 can communicate with multiple reading devices 2120. The reading devices 2120 can communicate with each other to share data. The reading device 2120 will be described in detail in the description of FIG. 15A below. The reading device 2120 can communicate with the local computer system 2170 via a communication path 2141 using a wired or wireless communication protocol. The local computer system 2170 can include one or more computing devices such as a laptop computer, a desktop computer, a tablet terminal, a phablet (a device that combines a phone and a tablet terminal), a smartphone, a set-top box, a video game console, and the like.For wireless communication, many wireless network protocols are available, such as "Bluetooth", "Bluetooth Low Energy (BTLE)", and WiFi, and any of the wireless network protocols can be used. By using the wired or wireless communication protocols described above, the local computer system 2170 can communicate with the network 2190 via the communication path 2143, and similarly, the reading device 2120 can communicate with the network 2190 via the communication path 2142. The network 2190 can be any of many networks, such as a private network, a public network, a local area network, or a wide area network. The trusted computer system 2180 can include a server and can provide authentication services and secure data storage. In addition, the trusted computer system 2180 can communicate with the network 2190 via the communication path 2144 by using wired or wireless technology.

[0170] Exemplary embodiments of a reading device 15A is a block diagram illustrating an exemplary embodiment of a reading device 2120. The reading device 2120 may be a smartphone in some embodiments. In this example, the reading device 2120 may include a display 2122, an input component 2121, and a processing core 2206, which may include a communication processor 2222 coupled to a memory 2223, and an application processor 2224 coupled to a memory 2225. The reading device 2120 may also include a separate memory 2230, an RF transceiver 2228 having an antenna 2229, and a power supply 2226 having a power management module 2238. The reading device 2120 may also include a multi-function transceiver 2232 capable of communicating with an antenna 2234 via WiFi, NFC, "Bluetooth", BTLE, and GPS. As will be appreciated by those skilled in the art, these components are electrically and communicatively coupled to form a functional device.

[0171] Exemplary embodiments of a sensor control device 15B and 15C are block diagrams illustrating an exemplary embodiment of a sensor control device 2102 having an analyte sensor 2104 and a sensor electronics 2160 (including analyte monitoring circuitry). The sensor electronics 2160 is responsible for most of the processing power to render the final result data in a form suitable for display to a user. In FIG. 15B, a single semiconductor chip 2161 is shown. The semiconductor chip 2161 can be a custom application specific integrated circuit (ASIC). Inside the ASIC 2161, there are several higher level functional units, such as an analog front end (AFE) 2162, a power management (control) circuit 2164, a processor 2166, and a communication circuit 2168 (which can be implemented as a transmitter, receiver, transceiver, passive circuitry, etc., depending on the communication protocol). In this embodiment, both the AFE 2162 and the processor 2166 are utilized as analyte monitoring circuitry, but in other embodiments, either circuitry can perform the analyte monitoring function. The processor 2166 may comprise one or more processors, microprocessors, controllers, and / or microcontrollers, each of which may be separate chips or may be distributed across several different chips (and portions thereof).

[0172] Also included within the ASIC 2161 is a memory 2163. The memory 2163 may be shared among various functional units present within the ASIC 2161 or may be distributed among two or more of such functional units. The memory 2163 may be a separate chip. The memory 2163 may be a volatile and / or non-volatile memory. In this embodiment, the ASIC 2161 is coupled to a power source 2172, which may be a coin cell battery or the like. The AFE 2162 interfaces with the in-vivo analyte sensor 2104 to receive measurement data from the sensor 2104 and outputs such data in digital form to the processor 2166. The processor 2166 then processes the data to determine final results such as discrete glucose values ​​and trend values. The data may then be provided to a communication circuit 2168 for transmission via an antenna 2171 to a reading device 2120 (not shown). In the reading device 2120, for example, this data may be displayed with minimal further processing by a resident software application.

[0173] FIG. 15C is similar to FIG. 15B, except that it includes two different semiconductor chips 2162, 2174. The semiconductor chips 2162, 2174 can be packaged together or can be packaged separately. In this example, the AFE 2162 is located in the ASIC 2161. The processor 2166 is integrated with the power management circuitry 2164 and the communication circuitry 2168 in the chip 2174. The AFE 2162 includes memory 2163, and the chip 2174 includes memory 2165. The memory 2165 can be an isolated memory or can be integrated as a distributed memory. In an exemplary embodiment, the AFE 2162 is combined with the power management circuitry 2164 and the processor 2166 in one chip, and the communication circuitry 2168 is in another chip. In another exemplary embodiment, the AFE 2162 and communications circuitry 2168 are on one chip, and the processor 2166 and power management circuitry 2164 are on another chip. Other chip organizations are also possible, such as three or more chips, where each chip may independently perform the functions described herein or the chips may share one or more functions for fail-safe redundancy.

[0174] Glucose Health App In some embodiments, a wellness application that monitors a subject's or user's glucose levels can communicate with the sensor control module 500 to obtain glucose data. In other embodiments, the wellness application can also communicate with a sensor control device to obtain glucose data. Users who do not have diabetes may still wish to monitor their glucose levels to improve their health. When a user first launches or logs into the glucose wellness application, a series of GUIs can be displayed that customize the user's experience and assist the user in setting goals for monitoring with the glucose wellness application.

[0175] Live Screen The glucose health maintenance application may include a live home screen that may include a banner 1002 as described elsewhere in this application. As described elsewhere, the banner 1002 may include any of the following: a real-time concentration value 1004, a trend arrow 1006, an icon 1008 indicating a status of the biosensor, information about the status of the biosensor 1010, and additional indications of the status of the biosensor 1012. In some embodiments, the banner may include an icon 1008 indicating a status of the biosensor, information about the status of the biosensor 1010, and the real-time concentration value 1004. As shown in Figures 16A and 16B, these banner elements may not be located adjacent to each other on the GUI 3000, 3030 of the glucose health maintenance live screen. For example, the icon 1008 indicating a status of the biosensor and information about the status of the biosensor 1010 may be located at the top of the GUI, and the real-time concentration value 1004 may be located within the graph.

[0176] As shown in FIG. 16A and FIG. 16B, the glucose health maintenance live screen or home screen GUI 3000, 3030 may include a date 3002 of the currently displayed data and arrows 3004, 3006. The arrows 3004, 3006 allow the user to switch between dates. The glucose health maintenance live GUI 3000, 3030 may include a colored graphic 3008 indicating the user's current glucose status. Alternatively, the glucose health maintenance live GUI 3000, 3030 may only include a description 3010 of the user's current glucose variability status. The user's current glucose status may be based on the user's glucose variability metric. In some embodiments, the graphic 3008 may be a circle. In some embodiments, the graphic 3008 may be green if the user's current glucose status is stable (in a stable state), as described in FIG. 16A. In some embodiments, as illustrated in FIG. 16B, if the user's current glucose status is unstable (a sudden change in glucose value is detected), the color of the graphic 3008 may be orange.

[0177] The glucose health maintenance live GUI 3000, 3030 (or elsewhere in the application) may include a description 3010 of the user's current glucose variability status based on the user's glucose variability metrics. In some embodiments, as shown in FIG. 16A, if the user's current glucose status is stable or balanced, the description "Steady, It's Steady", "Balanced", or "You're Okay" may be displayed. In some embodiments, as shown in FIG. 16B, if the user's current glucose status is not stable, unbalanced, or a spike is detected, the description "Spike Detected", "Out of Balance", "Unbalanced", "Unsteady", or "Oh No!" may be displayed.

[0178] In some embodiments, the determination of the current glucose excursion state (which may be based on the user's glucose excursion metric) for a time window may be a binary decision. In some embodiments, the user's glucose excursion state may be one of two possible states: "good" with low variability and "bad" with high variability. The state determination may be made with reference to a threshold. In some embodiments, the two possible states may be "stable" vs. "unstable", "stable" vs. "excursion detected", "stable" vs. "not stable", "balanced" vs. "unbalanced", or "okay" vs. "bad!". In some embodiments, the user's glucose excursion metric for a time window may also be a ternary decision. In that case, the user's glucose state may be one of three possible states.

[0179] In some embodiments, the glucose excursion status or glucose excursion metric of the user may be determined by performing an analysis over a rolling window starting from a current time or a current glucose concentration. The rolling window may be calculated from a specific time frame prior to the current timestamp. For example, the glucose status of the user may be determined by performing an analysis over a rolling window starting from a specific time (e.g., the current time or a point in the past) of about 1 hour, or about 1.5 hours, or about 2 hours, or about 2.5 hours, or about 3 hours, or about 3.5 hours, or about 4 hours. The rolling window may slide at regular time intervals. For example, the rolling window may slide by 10 minutes, or by 15 minutes, or by 20 minutes, or by 30 minutes, or by 40 minutes, or by 45 minutes, or by 50 minutes, or by 60 minutes. The glucose status or glucose excursion metric of the user may be determined at regular time intervals each time the rolling window is slid. For example, a fixed length time window (e.g., a 1-hour or 2-hour long time window) may slide in 30-minute increments to identify a user's glucose status or glucose variability metric every 30 minutes. In some embodiments, the length of the moving window may be constant. In other embodiments, the length of the moving window may vary from time period to time period. In some embodiments, the sliding width of the moving window may be constant. In other embodiments, the sliding width of the moving window may vary from time period to time period.

[0180] In some embodiments, the user's glucose excursion state may be determined to be low variability, i.e., stable, stable, or balanced, if the variation in the user's glucose values ​​from a running baseline during the moving window does not exceed a predefined threshold. In some embodiments, the running baseline may be the average of the glucose values ​​during the moving window. In other embodiments, the running baseline may be the median of the glucose values ​​during the moving window. In some embodiments, the predefined threshold may be about ±20 mg / dL, or about ±25 mg / dL, or about ±30 mg / dL, or about ±35 mg / dL, or about ±40 mg / dL. In some embodiments, an acute event may be detected if the deviation of the glucose values ​​from the baseline is determined to be outside of a predefined threshold. The glucose health maintenance live GUI 3000, 3030 may also include a link 3012 that allows the user to tap on the link 3012 to view more details regarding their current glucose status.

[0181] In some embodiments, the user's glucose excursion status may also be determined to be low, i.e., stable, steady state, or balanced, if the difference between the maximum and minimum glucose values ​​over a period of time is below a predetermined threshold, which may be about 20 mg / dL, or about 25 mg / dL, or about 30 mg / dL, or about 35 mg / dL, or about 40 mg / dL.

[0182] In other embodiments, the user's current glucose excursion state based on the glucose excursion metric may be determined to be low excursion, i.e., stable, stable, or balanced, if the user's glucose value does not exceed the upper threshold or fall below the lower threshold during the moving window, i.e., remains within the target range. The user's current glucose excursion state may also be determined to be balanced or stable if the amount of time in range is above a threshold. The threshold for evaluating the time in range may be about 100% of the period, or about 95%, or about 90%, or about 85%, or about 80%, or about 75%, or about 70%. Thus, if the period is about 2 hours, the excursion metric may be balanced (in good condition) if the user is in range for more than about 84 minutes, or more than about 90 minutes, or more than about 96 minutes, or more than about 102 minutes, or more than about 108 minutes, or more than about 114 minutes. Alternatively, the user's current glucose variability status based on the glucose variability metric may be determined to be balanced or stable if the amount of time out of range is below a threshold. The threshold for evaluating the amount of time out of range may be about 5%, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35% of the period. Thus, for a period of about 2 hours, the variability metric may be balanced if the user is out of range for less than about 6 minutes, or less than about 12 minutes, or less than about 18 minutes, or less than about 24 minutes, or less than about 28 minutes, or less than about 32 minutes.

[0183] In other embodiments, the user's current glucose variability state based on the glucose variability metric may be determined to be low variability, i.e., stable, stable, or balanced, if the user's glucose values ​​do not exceed an upper threshold or fall below a lower threshold during the moving window, i.e., remain within the target range, if the user's glucose values ​​do not fluctuate beyond a predefined threshold from the moving baseline, or both. The user may be considered balanced if the user's glucose values ​​do not deviate from the target range for more than about 0 minutes, or for about 5 minutes or less, or for about 10 minutes or less, or for about 15 minutes or less, or for about 20 minutes or less, or for about 30 minutes or less.

[0184] The user's glucose variability state or status based on the glucose variability metric can be displayed in real time. The glucose variability status display is on a moving window basis, and the glucose variability status display can be cycled through after each moving window evaluation. In some embodiments, a summary or report of the user's glucose status can be displayed as a percentage of a period of time, for example, as a percentage of time per day, a percentage of time per week, a percentage of time per two weeks, or a percentage of time per month.

[0185] In some embodiments, a user's current glucose state or glucose variability metric may be a binary state, e.g., one of two states, such as "above threshold" and "below threshold," "in range" and "out of range," "stable" and "acute change detected," "stable" and "unstable," or "balanced" and "unbalanced."

[0186] In an exemplary method 3270, as shown in FIGURE 21A, in step 3272, the system can receive data indicative of glucose values ​​for a subject. A glucose variability metric for a first time period can then be determined from the received glucose data in step 3274. As described elsewhere herein, the glucose variability metric can be a measure of variation from a running baseline, the difference between maximum and minimum glucose values, the amount of time within or outside a target range during the subject time period, or a combination thereof.

[0187] The glucose excursion metric may then be compared to a threshold in step 3276. The threshold may vary for each type of glucose excursion metric being compared. When assessing the range of excursions from a moving baseline, the threshold may be about ±20 mg / dL, or about ±25 mg / dL, or about ±30 mg / dL, or about ±35 mg / dL, or about ±40 mg / dL. When assessing the difference between maximum and minimum glucose values, the threshold may be about 20 mg / dL, or about 25 mg / dL, or about 30 mg / dL, or about 35 mg / dL, or about 40 mg / dL. When assessing the time out of range, the threshold may be about 5% of the period, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%. Thus, if the time period is about 2 hours, the threshold for the user to be considered balanced for the time that the user is out of range can be about 6 minutes, or about 12 minutes, or about 18 minutes, or about 24 minutes, or about 28 minutes, or about 32 minutes.

[0188] If the glucose excursion metric is not above the threshold, a first indication may be displayed in step 3278. The first indication may be a positive indication that the subject's condition was in a balanced or stable state during the time period being evaluated.

[0189] On the other hand, if the glucose excursion metric is above the threshold, a second indication may be displayed in step 3280. The second indication may be a negative indication that the subject's condition during the time period being evaluated was unbalanced, poorly balanced, unstable, unstable, or changing.

[0190] In another exemplary method 3290, as shown in Figure 21B, in step 3292, the system can receive data indicative of glucose values ​​for a subject. A first glucose variability metric for a first time period can then be determined from the received glucose data in step 3294. As described elsewhere herein, the first glucose variability metric can be a measure such as the difference between maximum and minimum glucose values, a range of variation from a running baseline, the amount of time within or outside a target range during the subject time period, or a combination thereof.

[0191] Then, in step 3296, the first glucose excursion metric is compared to a threshold value. The threshold value can vary depending on the type of glucose excursion metric being compared. When evaluating the range of excursions from a moving baseline, the threshold value can be about ±20 mg / dL, or about ±25 mg / dL, or about ±30 mg / dL, or about ±35 mg / dL, or about ±40 mg / dL. When evaluating the difference between the maximum and minimum glucose values, the threshold value can be about 20 mg / dL, or about 25 mg / dL, or about 30 mg / dL, or about 35 mg / dL, or about 40 mg / dL. When evaluating the time out of range, the threshold value can be about 5% of the period, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%. Thus, if the time period is about 2 hours, the threshold for the user being out of range can be about 6 minutes, or about 12 minutes, or about 18 minutes, or about 24 minutes, or about 28 minutes, or about 32 minutes.

[0192] In step 3298, depending on the comparison of the first glucose variability metric to the threshold, either a first indication or a second indication may be displayed. For example, if the first glucose variability metric does not exceed the threshold, the first indication may be displayed. The first indication may be a positive indication indicating that the subject's condition during the time period being evaluated was balanced or stable. On the other hand, if the first glucose variability metric exceeds the threshold, the second indication may be displayed. The second indication may be a negative indication indicating that the subject's condition during the time period being evaluated was unbalanced, unbalanced, unstable, unstable, or changing.

[0193] At least one further glucose variability metric for at least one further time period may then be identified from the received glucose data in step 3300. As described elsewhere herein, the at least one further glucose variability metric may be a measure such as the difference between maximum and minimum glucose values, the range of variation from a moving baseline, the amount of time in or out of a target range during the time period, or a combination thereof. In some embodiments, the at least one further glucose variability metric is of the same type as the first glucose variability metric. As described elsewhere herein, the time period may be a moving time window, e.g., a moving time window that moves in increments of 15 minutes, or 30 minutes, or 45 minutes, or 1 hour, etc. The length of the time window may be about 1 hour, or about 2 hours, or about 3 hours, or a combination thereof.

[0194] Then, in step 3302, the at least one glucose excursion metric is compared to a threshold. In some embodiments, this threshold is the same as the threshold used to compare the first glucose excursion metric. The threshold can vary depending on the type of glucose excursion metric being compared. When evaluating the range of excursions from a moving baseline, the threshold can be about ±20 mg / dL, or about ±25 mg / dL, or about ±30 mg / dL, or about ±35 mg / dL, or about ±40 mg / dL. When evaluating the difference between the maximum and minimum glucose values, the threshold can be about 20 mg / dL, or about 25 mg / dL, or about 30 mg / dL, or about 35 mg / dL, or about 40 mg / dL. When evaluating the time out of range, the threshold can be about 5% of the period, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%. Thus, if the time period is about 2 hours, the threshold for the user being out of range can be about 6 minutes out of range, or about 12 minutes out of range, or about 18 minutes out of range, or about 24 minutes out of range, or about 28 minutes out of range, or about 32 minutes out of range.

[0195] In step 3304, depending on the comparison of the at least one further glucose variability metric, either a first indication or a second indication may be displayed. For example, if the at least one further glucose variability metric does not exceed a threshold, a first indication may be displayed. The first indication may be a positive indication indicating that the subject's condition during the evaluated time period was balanced or stable. On the other hand, if the at least one further glucose variability metric exceeds a threshold, a second indication may be displayed. The second indication may be a negative indication indicating that the subject's condition during the evaluated time period was unbalanced, unbalanced, unstable, unstable, or rapidly changing.

[0196] In another example method 3320, as shown in Figure 21C, the system can receive data indicative of a subject's glucose level in step 3322. A maximum glucose value and a minimum glucose value for a time period can then be identified from the received glucose data in step 3324. A difference between the maximum glucose value and the minimum glucose value can then be calculated in step 3326.

[0197] The difference between the maximum and minimum glucose values ​​can then be compared to a threshold value in step 3328. The threshold value can be about ±20 mg / dL, or about ±25 mg / dL, or about ±30 mg / dL, or about ±35 mg / dL, or about ±40 mg / dL.

[0198] If the calculated difference is not above the threshold, a first indication may be displayed in step 3330. The first indication may be a positive indication that the subject's condition was in a balanced or stable state during the time period being evaluated.

[0199] On the other hand, if the calculated difference is above the threshold, a second indication may be displayed in step 3332. The second indication may be a negative indication that the subject's condition during the time period being evaluated was unbalanced, poorly balanced, unstable, unstable, or changing.

[0200] In some embodiments, a further step may include identifying at least one further maximum value and at least one further minimum value during at least one further time period. A difference between the at least one further maximum value and the at least one further minimum value may then be calculated. This difference may then be compared to a threshold value to determine whether the difference is above or below the threshold. If the difference between the at least one further maximum value and the at least one further minimum value is not above the threshold value, a first indication may be displayed. However, if the difference between the at least one further maximum value and the at least one further minimum value is above the threshold value, a second indication may be displayed.

[0201] It should be noted that for all the methods described thus far, the first or second indication may be displayed graphically, textually, or iconic, and may optionally be color coded.

[0202] In addition, in some embodiments of all the methods described above, when it is determined that the first or second display is an appropriate display for a certain period, the appropriate one of the first and second displays is displayed in real time. Then, when an appropriate display for at least one further period is determined, the appropriate display for the at least one further period is displayed in place of the display for the first period. In this way, the display can be switched from the display for the previous period to the display for the next period for each successive period of the moving window.

[0203] The glucose health maintenance live GUI 3000, 3030 may also include a graph 3014 including a glucose curve 3016. A large mark 3050 may be placed on the glucose curve 3016 in the graph 3046 to highlight the current glucose value. In some embodiments, the graph 3014 may also include the user's current glucose value 1004. The current glucose value may be displayed on the x-axis of the graph 3014 at the end of the glucose curve 3016 that extends over an appropriate time period. The glucose curve 3016 may also include a portion 3018 that is colored differently from the rest of the glucose curve 3016. In some embodiments, the portion 3018 may correspond to a portion of the graph that corresponds to a moving window in which the analysis is currently taking place to determine the user's glucose status. In some embodiments, the portion 3018 may be the same color as the graphic 3008 that indicates the current glucose status. For example, if the user's current glucose status is "stable," then both the color of the graphic 3008 and the color of the portion 3018 may be green. In other embodiments, if the user's current glucose status is "acute change detected" or "not stable," the color of graphic 3008 and the color of portion 3018 may both be orange.

[0204] In some embodiments, the glucose health application can have a target concentration range for the user. The target concentration range can be set automatically by the glucose health application or manually by the user or the user's healthcare provider. In some embodiments, the portion of the glucose curve within the moving window can be colored a first color (e.g., green) if the portion is within the target range, and a second color (e.g., orange) if the portion of the glucose curve within the moving window is outside the target range. Additionally, the portion of the glucose curve outside the moving window can be colored a third color (e.g., gray). In some embodiments, the area below the glucose curve can be colored the same as the glucose curve. In some embodiments, the area below the curve for the portion of the glucose curve within the moving window that is above the upper threshold of the target range can be colored two colors if the portion of the glucose curve within the moving window is above the upper threshold of the target range. The area under the curve from the glucose curve to the upper threshold of the target range can be colored a second color (e.g., orange), and the area under the curve from the upper threshold to the lower threshold can be colored a first color (e.g., green).

[0205] In some embodiments, the glucose health maintenance live GUI 3000, 3030 may not prominently display the current glucose value in a large font. In some embodiments, the glucose health maintenance live GUI 3000, 3030 may display the current glucose value in a verbal representation, such as a sentence, rather than a large font (e.g., larger than size 16) graphic. Also, since too much data can confuse or stress a user, in some embodiments, the glucose health maintenance live GUI 3000, 3030 may not include the current glucose value. In some embodiments, the y-axis of the graph 3043 may not include units of concentration so that the user can see the relative glucose value but not the actual numerical concentration.

[0206] The glucose health maintenance live GUI 3000, 3030 may also include one or more cards 3020 with links to articles. The articles may include supporting information or tips. The articles shown on the cards 3020 may be selected to be articles related to user information such as the user's current glucose status. For example, the articles shown on the cards 3020 may be articles based on goals entered by the user or based on past data collected by the glucose health maintenance application based on the user's glucose patterns. For example, if the user's current glucose status is "stable", the article shown on the cards 3020 may be an article providing information on how to maintain a stable state and how stable glucose values ​​can help with weight loss. In other embodiments, if the user's current glucose status is "excursion detected" or "not stable", the article shown on the cards 3020 may be an article providing information on how to avoid excursions.

[0207] The live glucose health maintenance GUI 3000, 3030 can also include small daily tips to assist the user in maintaining stable glucose levels.

[0208] The user can also view data from the past few days in the glucose health maintenance application. In some embodiments, the user can move to a previous date by tapping the back arrow 3004. Alternatively, the user can tap the current date to display a calendar where the user can select the day they want to view. The calendar can be a drop-down window, a pop-up window, or another separate full-screen window. The GUI for a past day can include a 24-hour graph and can also include statistics for that day. In some embodiments, the statistics can include the amount or percentage of time in a stable state (e.g., "70% stable") or the amount or percentage of the longest period of time in a stable state (e.g., "4.5 hours stable"). In some embodiments, the statistics may include a breakdown of the amount or percentage of time that the user was stable ("Awesome") for that day, the amount of time that they had low fluctuations (e.g., fluctuations above a first threshold (e.g., ±20 mg / dL)) ("Nice Effort"), and the amount of time that they had high fluctuations (e.g., fluctuations above a second threshold that is greater than the first threshold (e.g., ±30 mg / dL) and needs improvement) ("Keep it flat!").

[0209] "Deepen your understanding (see details)" screen When the user taps or selects the "View Details" link 3012 in FIG. 16A and FIG. 16B, a pop-up window GUI 3042, a drop-down window GUI, or another separate window GUI may be displayed, as shown in FIG. 17A and FIG. 17B. The pop-up window 3042 may include a graphic 3008 and a description 3010 of the user's glucose status, e.g., the user's current glucose status. The pop-up window 3042 may also include further details 3048 regarding the user's glucose status. For example, if the user's current glucose status is in a "stable" status as shown in FIG. 17A, the further details 3048 may inform the user that the user is working to optimize their own body for optimal health. On the other hand, if the user's current glucose status is in a "change detected" status as shown in FIG. 17B, the further details 3048 may inform the user that the detected change may be causing hunger, fatigue, or cravings. Further details 3048 may instruct the user not to worry as their body is able to return glucose levels to normal. The pop-up window 3042 may also include displays 3044a, 3044b that present a carousel of cards containing links to various articles. As discussed above, the articles presented in the carousel displays 3044a, 3044b may be selected to be articles related to user information such as the user's glucose status that has been determined (or is being displayed).

[0210] The pop-up window 3042 may also include a graph 3046 that includes the glucose curve portion 3018 used to determine the current glucose status. For example, if the determination was made over a two hour long moving window, the graph 3046 may include the last two hours of data. In some embodiments, the color of the glucose graph portion 3018 may be the same color as that shown in the graphic 3008 or graph 3014 indicating the current glucose status. In some embodiments, the portion of the glucose curve included in the graph 3046 may be a smaller portion of the glucose curve portion 3018 used to determine the current glucose status. The graph 3046 may also include a large mark 3050 on the glucose curve portion 3018 to highlight the current glucose value.

[0211] In some embodiments, the glucose health application may also display the amount of time the user was within a target range, the range having a lower threshold and an upper threshold, the range being the target range from the lower threshold to the upper threshold. The glucose health application may indicate how many hours or a percentage of the user was within the target range for the day, week, and / or overall time. The glucose health application may also indicate the longest recorded amount of time the user was within the target range for the day, week, and / or overall time.

[0212] " "Share" screen The pop-up window 3042 may also include a share link. When the share link is selected, a "share" GUI 3060 may be displayed, as shown in FIG. 18, that allows the user to share the progress. The "share" GUI 3060 may include a link 3062 to associate a photo with the progress. This can be done either by taking a new photo or by associating a photo from a library. The shared progress may also include some version of the glucose graph 3016. The user may zoom in or crop the graph to share only a portion of the graph. The "share" GUI 3060 may also include a link to share the user's progress through a message 3064 or a third party messaging or social media application (e.g., Facebook 3066, Instagram 3068, or other options 3070).

[0213] Additionally, the various GUIs of the glucose health application may also include sharing links 1050 that allow for the sharing of various data or information.

[0214] "Tracking" screen The glucose health maintenance application may also include a "track" GUI 3080 as shown in FIG. 19. The "track" GUI 3808 may include multiple cards 3082a, 3082b showing the user's glucose response to various situations. Such situations may include the ingestion of various foods and drinks, activities (e.g., exercise) performed before and after the ingestion of the foods and drinks, the user's mood, and other activities. The cards may be displayed to allow the user to quickly see how these various activities have affected his or her glucose value. In some embodiments, each card 3082a, 3082b may include a glucose curve 3090 corresponding to a time window that includes the situation or activity (e.g., food ingestion). The time window may include a portion of time before and after the situation or activity. For example, the time window may include a 2 hour long time window, a 2.5 hour long time window, a 3 hour long time window, a 3.5 hour long time window, a 4 hour long time window, a 4.5 hour long time window, and a 5 hour long time window. In some embodiments, the time window may be selected such that the time at which the situation or activity occurred is within the first fifth of the time window, or the first quarter of the time window, or the first third of the time window, or the first half of the time window.

[0215] The glucose curve 3090 may also include a colored portion 3092 that is a different color than the rest of the glucose curve 3090. In some embodiments, the colored portion 3092 may correspond to a portion of the graph that corresponds to the user's response to the event. The colored portion may extend a predetermined length of time from the time the event occurred or was logged. In some embodiments, the predetermined length of time may be about 1.5 hours, or about 2 hours, or about 2.5 hours, or about 3 hours, or about 3.5 hours, or about 4 hours. In some embodiments, the portion 3092 may be the same color as the graphic 3008 that indicates the glucose status determined for the predetermined length of time. For example, if the glucose status determined for the predetermined length of time is "stable," the portion 3092 may be green. However, if a sudden change is detected during the predetermined length of time, the graph portion 3092 may be orange.

[0216] Each glucose graph card 3082a, 3082b may include a glucose curve 3090 and an icon 3084a, 3084b. The icon 3084a, 3084b is placed on the glucose curve 3090 at the time the event occurred or was logged (e.g., the time a meal was eaten). The icon may include a graphic related to the event logged (or entered). For example, an icon representing the consumption of food or drink may be a graphic of a knife and fork, a plate and drink, a bowl of cereal, etc., and an icon representing exercise may be a graphic of a running stick figure. Each glucose graph card 3082a, 3082b may also include a description 3086 of the event. For example, the description may state "fries" if only fries were eaten, or "salad + fries" if salad was eaten along with fries. In some embodiments, each glucose graph card 3082a, 3082b may also include an image or pictorial representation 3088 that indicates the type of food consumed or event entered. If an explanation 3086 or image 3088 is provided, it may be located adjacent to the icon 3084a, 3084b, such as above the icon 3084a, 3084b. Each glucose graph card 3082a, 3082b may also include a date and time associated with the event, such as the date and time the event or event occurred or was logged.

[0217] The cards 3082a, 3082b displayed in the "track" GUI 3080 may be related to each other. In some embodiments, the cards 3082a, 3082b may all be cards showing logged events for the same day or week. In some embodiments, the cards 3082a, 3082b may all be cards showing logged events related to each other. For example, the cards 3082a, 3082b may all show logged events including the consumption of a particular food (e.g., pizza). Some of the cards 3082a, 3082b may also include logged exercises performed before or after eating pizza, or salads consumed with pizza, so that the user can see how the glucose response changes in different situations. Some of the cards 3082a, 3082b may also include logged moods and energy levels. Thus, by presenting multiple cards 3082a, 3082b, a user can be shown how complex events or situations interact with each other.

[0218] Let's find out, let's find out As shown in FIG. 20, a user may tap on link 3026 to display a "learn and explore" GUI 3100 that provides additional information on various related topics. The "learn and explore" GUI 3100 may include multiple selectable tabs 3102a-d, each containing content related to a different topic of interest. The multiple selectable tabs 3102a-d may include, but are not limited to, themes such as user-specific content (e.g., "for you"), basic glucose health maintenance content (e.g., "basic"), dietary content (e.g., "food"), health-related content (e.g., "health"), lifestyle-related content (e.g., "lifestyle"), and the like. The "learn and explore" GUI 3100 may also include a button 3104 that allows the user to bookmark or save the page for easy future access.

[0219] Under each selectable tab 3102a-3102d, multiple pieces of content can be displayed in selectable cards 3106a-3106c. Such content can include, but is not limited to, articles, photos, text, graphs, tips, and summaries. For example, content displayed under a user's dedicated tab can include an article explaining how to stabilize glucose levels, an article explaining how sudden changes in glucose levels can lead to cravings, and an article explaining the effects of eating carbohydrates when you're hungry.

[0220] The order of presentation of content in the displayed selectable cards 3106a-3106c can be changed. In some embodiments, the order of presentation of content can be randomized to keep the user experience fresh. In some embodiments, the content presented can be tailored based on where the user is in the user experience process. For example, at the beginning of the user experience, the user can first be presented with content about basic information such as how to get started, how stable glucose levels can help with weight loss, and how sudden changes in glucose levels can create cravings. As more data about the user is collected, the glucose health application can tailor the content presented to the user. Such data can be collected based on the user's answers to questions or prompts, the user's glucose levels, or patterns identified from the user's glucose data. The glucose health application can also prompt the user at the end of the article or in a separate GUI to provide inputs necessary to further customize the user experience.

[0221] The glucose health application may also include quick links to access various aspects of the application. For example, at the bottom of each GUI, there may be a link 3022 to a "Live" GUI, a link 3024 to a "Track" GUI, a link 3026 to a "Learn" GUI, and a link 3028 to a "Settings" GUI.

[0222] 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.

[0223] In various embodiments, a method of monitoring glucose excursion in a subject is described that includes receiving data indicative of a glucose value of the subject from a sensor control device, identifying a first glucose excursion metric for the subject during a first time period, comparing the first glucose excursion metric to a threshold, and displaying a first indication if the first glucose excursion metric does not exceed the threshold and displaying a second indication if the first glucose excursion metric exceeds the threshold.

[0224] In some embodiments, the method further comprises determining a second glucose variability metric for the subject during a second time period overlapping with the first time period, comparing the second glucose variability metric to a threshold, and displaying a first indication if the second glucose variability metric is not above the threshold and displaying a second indication if the second glucose variability metric is above the threshold. In some embodiments, the second time period begins a time interval after the first time period begins. In some embodiments, the time interval is about 30 minutes.

[0225] In some embodiments, the total length of time of the first time period and the total length of time of the second time period are the same total length of time, hi some embodiments, the same total length of time is about 2 hours.

[0226] In some embodiments, the total length of time of the first period and the total length of time of the second period are different total lengths of time.

[0227] In some embodiments, the first indication is one of an indication of being in a balanced state and an indication of being in a steady state.

[0228] In some embodiments, the second indication is one of an indication of imbalance, an indication of instability, an indication of not being stable, or an indication of sudden change.

[0229] In some embodiments, the first glucose excursion metric is a binary decision.

[0230] In some embodiments, the first glucose excursion metric is the difference between the maximum and minimum glucose values ​​during the first period of time.

[0231] In some embodiments, the first glucose excursion metric is the variation from a moving baseline during a first period of time. In some embodiments, the moving baseline is the median glucose value during the first period of time. In some embodiments, the moving baseline is the average glucose value during the first period of time. In some embodiments, the threshold value is about ±30 mg / dL.

[0232] In some embodiments, the first glucose excursion metric is the amount of time outside a target glucose range. In some embodiments, the target glucose range is defined by an upper glucose threshold and a lower glucose threshold. In some embodiments, the threshold is about 20 minutes.

[0233] In some embodiments, a state of displaying a first or second display for a first glucose variability metric is switched to a state of displaying a first or second display for a second glucose variability metric.

[0234] In some embodiments, the method further includes identifying a third glucose excursion metric for the subject during a third time period that overlaps with the second time period, where the total length of the first time period, the total length of the second time period, and the total length of the third time period are the same total length; comparing the third glucose excursion metric to a threshold; and displaying a first indication if the third glucose excursion metric does not exceed the threshold and displaying a second indication if the third glucose excursion metric is above the threshold.

[0235] In many embodiments, a system for monitoring glucose excursion in a subject includes an input configured to receive glucose measurement data, a display configured to visually present information, and one or more processors coupled to the input, the display, and a memory storing instructions that, when executed by the one or more processors, cause the system to determine a first glucose excursion metric for the subject during a first time period, compare the first glucose excursion metric to a threshold value, and display a first indication if the first glucose excursion metric is not above the threshold value and display a second indication if the first glucose excursion metric is above the threshold value.

[0236] In some embodiments, the instructions further cause the one or more processors to determine a second glucose variability metric for the subject during a second time period that overlaps with the first time period, compare the second glucose variability metric to a threshold value, and display a first indication if the second glucose variability metric does not exceed the threshold value and display a second indication if the second glucose variability metric is above the threshold value.

[0237] In some embodiments, the total length of time of the first period and the total length of time of the second period are the same total length of time, hi some embodiments, this same total length of time is about 2 hours.

[0238] In some embodiments, the first indication is one of an indication of being in a balanced state and an indication of being in a steady state.

[0239] In some embodiments, the second indication is one of an indication of imbalance, an indication of instability, an indication of not being stable, or an indication of sudden change.

[0240] In some embodiments, the first glucose excursion metric is a binary decision.

[0241] In some embodiments, the first glucose excursion metric is the difference between the maximum and minimum glucose values ​​during the first period of time.

[0242] In some embodiments, the first glucose excursion metric is the variation from a moving baseline during a first period of time. In some embodiments, the moving baseline is the median glucose value during the first period of time. In some embodiments, the moving baseline is the average glucose value during the first period of time. In some embodiments, the threshold value is about ±30 mg / dL.

[0243] In some embodiments, the first glucose excursion metric is the amount of time outside a target glucose range. In some embodiments, the target glucose range is defined by an upper glucose threshold and a lower glucose threshold. In some embodiments, the threshold is about 20 minutes.

[0244] In some embodiments, a state of displaying a first or second display for a first glucose variability metric is switched to a state of displaying a first or second display for a second glucose variability metric.

[0245] In some embodiments, the instructions further cause the one or more processors to determine a third glucose excursion metric for the subject during a third time period that overlaps with the second time period, where a total duration of the first time period, a total duration of the second time period, and a total duration of the third time period are the same total duration; comparing the third glucose excursion metric to a threshold; and displaying a first indication if the third glucose excursion metric does not exceed the threshold and displaying a second indication if the third glucose excursion metric is above the threshold.

[0246] In various embodiments, a method of monitoring glucose excursions in a subject is described that includes receiving data indicative of glucose values ​​in a subject from a sensor control device, identifying a maximum and minimum glucose value over a period of time, calculating a difference between the maximum and minimum glucose values ​​over the period of time, comparing the difference to a threshold, and displaying a first indication if the difference does not exceed the threshold and displaying a second indication if the difference exceeds the threshold.

[0247] In some embodiments, the time period is a first time period, the maximum glucose value is a first maximum glucose value, and the minimum glucose value is a second maximum glucose value, and the method further includes identifying a second maximum glucose value and a second minimum glucose value in the second time period, calculating a second difference between the second maximum glucose value and the second minimum glucose value in the second time period, comparing the second difference between the second maximum glucose value and the second minimum glucose value in the second time period to a threshold, and displaying a first indication if the second difference does not exceed the threshold and displaying a second indication if the second difference exceeds the threshold.

[0248] In some embodiments, the period is about 1 hour.

[0249] In some embodiments, the period is about 2 hours.

[0250] In some embodiments, the second time period begins a time interval after the first time period begins.

[0251] In some embodiments, the time interval is about 30 minutes.

[0252] In some embodiments, the second period of time overlaps with the first period of time.

[0253] In some embodiments, the total length of time of the first period and the total length of time of the second period are the same total length of time.

[0254] In some embodiments, the total length of time of the first period and the total length of time of the second period are different total lengths of time.

[0255] In some embodiments, the first indication is one of an indication of being in a balanced state and an indication of being in a steady state.

[0256] In some embodiments, the second indication is one of an indication of imbalance, an indication of instability, an indication of not being stable, or an indication of sudden change.

[0257] In some embodiments, the threshold is about 30 mg / dL.

[0258] In many embodiments, a system for monitoring glucose variability in a subject is described, the system comprising an input configured to receive glucose measurement data, a display configured to visually present information, and one or more processors coupled to the input, the display, and a memory storing instructions that, when executed by the one or more processors, cause the system to identify a maximum glucose value and a minimum glucose value over a period of time, calculate a difference between the maximum glucose value and the minimum glucose value over the period of time, compare the difference to a threshold, and display a first indication if the difference is not greater than the threshold and display a second indication if the difference is greater than the threshold.

[0259] In some embodiments, the time period is a first time period, the maximum glucose value is a first maximum glucose value, and the minimum glucose value is a second maximum glucose value, and the instructions further cause the one or more processors to identify a second maximum glucose value and a second minimum glucose value in the second time period, calculate a second difference between the second maximum glucose value and the second minimum glucose value in the second time period, compare the second difference between the second maximum glucose value and the second minimum glucose value in the second time period to a threshold, and display a first indication if the second difference is not greater than the threshold and display a second indication if the second difference is greater than the threshold.

[0260] In some embodiments, the period is about 1 hour.

[0261] In some embodiments, the period of time is about 2 hours. In some embodiments, the second period of time begins a time interval after the first period of time begins. In some embodiments, the time interval is about 30 minutes.

[0262] In some embodiments, the second period of time overlaps with the first period of time.

[0263] In some embodiments, the total length of time of the first period and the total length of time of the second period are the same total length of time.

[0264] In some embodiments, the total length of time of the first period and the total length of time of the second period are different total lengths of time.

[0265] In some embodiments, the first indication is one of an indication of being in a balanced state and an indication of being in a steady state.

[0266] In some embodiments, the second indication is one of an indication of imbalance, an indication of instability, an indication of not being stable, or an indication of sudden change.

[0267] In some embodiments, the threshold is about 30 mg / dL.

[0268] In many embodiments, a system for displaying metrics associated with a subject is described. The system includes an input configured to receive glucose measurement data, a display configured to visually present information, and one or more processors coupled to the input, the display, and a memory storing instructions that, when executed by the one or more processors, cause the system to: determine a glucose status of the subject based on the glucose data received during a moving window; display an indication of the glucose status of the subject in a graphical user interface (GUI), the indication including a text description and a graphic having a first color; and display a graph in the GUI. The graph includes a glucose profile including a first portion and a second portion, the first portion and the second portion being different colors, and the second portion being the first color.

[0269] In some embodiments, the graphic is circular.

[0270] In some embodiments, the glucose state is a binary state. In some embodiments, the binary glucose state consists of a stable state and an unstable state. In some embodiments, the binary glucose state consists of a stable state and a state in which a sudden change is detected.

[0271] In some embodiments, the instructions further cause the system to display the subject's current glucose concentration. In some embodiments, the subject's current glucose concentration is displayed in a graph.

[0272] In some embodiments, the graph further comprises a mark on the glucose profile that corresponds to the current glucose value, hi some embodiments, the mark is a large circle.

[0273] In some embodiments, the GUI does not include a numerical display of the subject's current glucose level.

[0274] In some embodiments, the duration of the moving window comprises a predetermined time interval measured backward from a time, which in some embodiments is the current time, in some embodiments, the predetermined time interval is about two hours.

[0275] In some embodiments, the glucose status is determined by determining the variation of the glucose data received during the moving window. In some embodiments, the glucose status is determined to be stable if the variation from the moving baseline is below a predetermined threshold. In some embodiments, the predetermined threshold is about ±30 mg / dL. In some embodiments, the moving baseline is the median glucose concentration during the moving window. In some embodiments, the moving baseline is the average glucose concentration during the moving window.

[0276] In some embodiments, the glucose status is determined to be unstable if the received glucose data during the moving window varies from the moving baseline by more than a predetermined threshold. In some embodiments, the predetermined threshold is about ±30 mg / dL. In some embodiments, the moving baseline is the median glucose concentration during the moving window. In some embodiments, the moving baseline is the average glucose concentration during the moving window.

[0277] In some embodiments, the glucose status is determined by analyzing the plurality of glucose concentration values ​​during the moving window against a target range having an upper threshold and a lower threshold. In some embodiments, the glucose status is determined to be stable if all of the plurality of glucose concentration values ​​during the moving window are within the target range. In some embodiments, the glucose status is determined to be unstable if any of the plurality of glucose concentration values ​​during the moving window are above an upper threshold or below a lower threshold.

[0278] In some embodiments, the glucose status is determined by (a) analyzing a plurality of glucose concentration values ​​during a moving window relative to a target range having upper and lower thresholds, and (b) determining the range of variation from a moving baseline of the glucose data received during the moving window.

[0279] In some embodiments, if the subject has a stable glucose status, the first color is green.

[0280] In some embodiments, if the subject's glucose status is unstable, the first color is orange.

[0281] In some embodiments, the instructions further cause the system to display a summary of the plurality of articles. In some embodiments, the summary of the plurality of articles includes links to the plurality of articles. In some embodiments, the displayed summary of the plurality of articles relates to the glucose status of the subject.

[0282] In some embodiments, the instructions further cause the system to display a link to a second GUI including further details regarding the glucose status of the subject. In some embodiments, the GUI graph is a first graph of a first GUI, and the instructions further cause the system to display, in response to selection of the link, a second GUI including further details regarding the glucose status of the subject.

[0283] In some embodiments, the second GUI includes an indication of the subject's glucose status and a second graph that includes a second portion of the first graph of the first GUI.

[0284] In some embodiments, the second GUI further includes additional instructions regarding the subject's glucose status.

[0285] In some embodiments, the second GUI further includes a plurality of article summaries. In some embodiments, the plurality of article summaries are displayed in a carousel display. In some embodiments, the plurality of article summaries displayed relate to the subject's current glucose status.

[0286] In some embodiments, the second GUI further includes a link to a third GUI for sharing the information regarding the glucose status of the subject. In some embodiments, the instructions further cause the system to display a third GUI including a graph to share and links to a plurality of third party applications. In some embodiments, the graph to share is a first graph of the first GUI. In some embodiments, the plurality of links includes at least one link to a messaging application and at least one link to a social media application. In some embodiments, the third GUI further includes a link for associating a photo with the information regarding the glucose status of the subject.

[0287] In various embodiments, a system for displaying metrics associated with a subject is described that includes an input configured to receive glucose measurement data and logged activity information, a display configured to visually present the information, and one or more processors coupled to the input, the display, and a memory storing instructions. The instructions, when executed by the one or more processors, cause the system to determine multiple glucose states of the subject based on the glucose data received for multiple moving windows, each of the moving windows including a logged activity; displaying a first graph including a first glucose profile for a first moving window and a description of the first logged activity, wherein the first glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a second color; and displaying a second graph including a second glucose profile for a second moving window and a description of the second logged activity, wherein the second glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a third color.

[0288] In some embodiments, the first graph further includes a first graphical representation representative of the first logged activity, and the second graph further includes a second graphical representation representative of the second logged activity.

[0289] In some embodiments, the second color and the third color are the same color.

[0290] In some embodiments, the second color and the third color are different colors.

[0291] In some embodiments, the instructions further cause the system to display at least one further graph including at least one further glucose profile for at least one moving window period and a description of the at least one logged activity, the at least one further glucose profile including a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a second color or a third color.

[0292] In some embodiments, the first graph further includes a first icon on the first glucose profile associated with the first logged activity, the first icon being located at a transition from the first portion to the second portion of the first glucose profile.

[0293] In some embodiments, the second graph further includes a second icon on the second glucose profile associated with the second logged activity, the second icon being located at a transition from the first portion to the second portion of the second glucose profile. In some embodiments, the at least one graph further includes at least one further icon on the at least one glucose profile associated with at least one further logged activity, the further at least one further icon being located at a transition from the first portion to the second portion of the at least one further glucose profile.

[0294] In some embodiments, the second portion of the first graph is about a two hour long period of the first graph.

[0295] In some embodiments, the second portion of the second graph is about a two hour period of the second graph. In some embodiments, the second portion of the at least one further graph is about a two hour period of the at least one further graph.

[0296] In some embodiments, the logged activity information includes logged food, logged drinks, logged exercise, logged feelings, and combinations thereof.

[0297] In some embodiments, the first moving window period and the second moving window period are for the same day.

[0298] In some embodiments, the first logged activity and the second logged activity are related to each other.

[0299] Conclusion 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. Therefore, the above description of specific embodiments of the subject matter of the present disclosure has been presented for illustration and explanation. It is clearly recognized that it would be an undue burden to explicitly list every possible combination or permutation, especially since one of ordinary skill in the art would readily recognize the permissibility of every such combination or permutation.

[0300] Various modifications and variations are possible in the embodiments, and specific examples thereof are shown in the drawings and described in detail herein. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and system of the subject matter of the present disclosure without departing from the spirit and scope of the subject matter of the present disclosure. Therefore, the subject matter of the present disclosure is intended to include modifications and variations that are within the scope of the appended claims and their equivalents. Furthermore, any feature, function, step, or element of the embodiment may be described or included in the scope of the claims, and the scope of the invention of the claims may be defined by negative limitations of any feature, function, step, or element not included in the scope of the claims.

[0301] Itemized Description Exemplary embodiments are described below in numbered sections.

[0302] Section 1 1. A method for monitoring glucose excursions in a subject, comprising: receiving data indicative of a glucose level of the subject from a sensor control device; determining a first glucose variability metric for the subject during a first time period; comparing the first glucose excursion metric to a threshold; displaying a first indication if the first glucose excursion metric is not above the threshold and displaying a second indication if the first glucose excursion metric is above the threshold; The method includes:

[0303] Section 2 determining a second glucose excursion metric for the subject during a second time period that overlaps with the first time period; comparing the second glucose excursion metric to the threshold; displaying the first indication if the second glucose excursion metric is not above the threshold and displaying the second indication if the second glucose excursion metric is above the threshold; 2. The method of claim 1, further comprising:

[0304] Section 3 3. The method of claim 2, wherein the second time period begins a time interval after the first time period begins.

[0305] Section 4 4. The method of claim 3, wherein the time interval is about 30 minutes.

[0306] Section 5 3. The method of claim 2, wherein the total length of the first period and the total length of the second period are the same total length of time.

[0307] Section 6 6. The method of claim 5, wherein said same total period of time is about 2 hours.

[0308] Section 7 3. The method of claim 2, wherein the total length of the first period and the total length of the second period are different total lengths of time.

[0309] Section 8 2. The method of claim 1, wherein the first indication is one of an indication of being in a balanced state and an indication of being in a steady state.

[0310] Section 9 2. The method of claim 1, wherein the second indication is one of an indication of an imbalanced state, an indication of an unstable state, an indication of a non-stable state, and an indication of a sudden change state.

[0311] Section 10 2. The method of claim 1, wherein the first glucose excursion metric is a binary decision.

[0312] Section 11 2. The method of claim 1, wherein the first glucose excursion metric is the difference between a maximum glucose value and a minimum glucose value during the first period of time.

[0313] Section 12 2. The method of claim 1, wherein the first glucose excursion metric is a fluctuation from a fluid baseline during the first time period.

[0314] Section 13 13. The method of claim 12, wherein the current baseline is a median of the glucose values ​​during the first period.

[0315] Section 14 13. The method of claim 12, wherein the current baseline is an average of the glucose values ​​during the first period of time.

[0316] Section 15 13. The method of claim 12, wherein the threshold is about ±30 mg / dL.

[0317] Section 16 2. The method of claim 1, wherein the first glucose excursion metric is a length of time outside a target glucose range.

[0318] Section 17 17. The method of claim 16, wherein the target glucose range is defined by an upper glucose threshold and a lower glucose threshold.

[0319] Section 18 17. The method of claim 16, wherein the threshold is about 20 minutes.

[0320] Section 19 3. The method of claim 2, wherein a state of displaying the first display or the second display for the first glucose fluctuation metric is switched to a state of displaying the first display or the second display for the second glucose fluctuation metric.

[0321] Section 20 determining a third glucose excursion metric for the subject during a third time period that overlaps with the second time period, wherein a total length of the first time period, a total length of the second time period, and a total length of the third time period are the same total length of time; comparing the third glucose excursion metric to the threshold; displaying the first indication if the third glucose excursion metric is not above the threshold and displaying the second indication if the third glucose excursion metric is above the threshold; 2. The method of claim 1, further comprising:

[0322] Section 21 1. A system for monitoring glucose excursions in a subject, the system comprising: an input configured to receive glucose measurement data; a display configured to visually present information; one or more processors coupled to the input, the display, and a memory storing instructions; Equipped with The instructions, when executed by the one or more processors, cause the system to: determining a first glucose variability metric for the subject during a first time period; comparing the first glucose excursion metric to a threshold; displaying a first indication if the first glucose excursion metric is not above the threshold and displaying a second indication if the first glucose excursion metric is above the threshold; A system that executes the above.

[0323] Section 22 The instructions cause the one or more processors to: determining a second glucose excursion metric for the subject during a second time period that overlaps with the first time period; comparing the second glucose excursion metric to the threshold; displaying the first indication if the second glucose excursion metric is not above the threshold and displaying the second indication if the second glucose excursion metric is above the threshold; 22. The system according to claim 21, further comprising:

[0324] Section 23 23. The system of claim 22, wherein the same total time period is about 2 hours.

[0325] Section 24 23. The system of claim 22, wherein a total length of the first period and a total length of the second period are the same total length of time.

[0326] Section 25 22. The system of claim 21, wherein the first indication is one of an indication of a balanced condition and an indication of a steady condition.

[0327] Section 26 22. The system of claim 21, wherein the second indication is one of an indication of an imbalance, an indication of an unstable condition, an indication of a non-stable condition, and an indication of a sudden change.

[0328] Section 27 22. The system of clause 21, wherein the first glucose excursion metric is a binary decision.

[0329] Section 28 22. The system of claim 21, wherein the first glucose excursion metric is the difference between a maximum glucose value and a minimum glucose value during the first period of time.

[0330] Section 29 22. The system of claim 21, wherein the first glucose excursion metric is a fluctuation range from a fluid baseline during the first time period.

[0331] Section 30 30. The system of claim 29, wherein the current baseline is a median glucose value during the first period.

[0332] Section 31 30. The system of claim 29, wherein the current baseline is an average of the glucose values ​​during the first period.

[0333] Section 32 30. The system of claim 29, wherein the threshold is about ±30 mg / dL.

[0334] Section 33 22. The system of claim 21, wherein the first glucose excursion metric is a length of time outside a target glucose range.

[0335] Section 34 34. The system of claim 33, wherein the target glucose range is defined by an upper glucose threshold and a lower glucose threshold.

[0336] Section 35 34. The system of claim 33, wherein the threshold is about 20 minutes.

[0337] Section 36 23. The system of claim 22, wherein a state of displaying the first display or the second display for the first glucose fluctuation metric is switched to a state of displaying the first display or the second display for the second glucose fluctuation metric.

[0338] Section 37 The instructions cause the one or more processors to: determining a third glucose excursion metric for the subject during a third time period that overlaps with the second time period, wherein a total length of the first time period, a total length of the second time period, and a total length of the third time period are the same total length of time; comparing the third glucose excursion metric to the threshold; displaying the first indication if the third glucose excursion metric is not above the threshold and displaying the second indication if the third glucose excursion metric is above the threshold; 23. The system according to claim 22, further comprising:

[0339] Section 38 1. A method for monitoring glucose excursions in a subject, comprising: receiving data indicative of a glucose level of the subject from a sensor control device; identifying a maximum glucose value and a minimum glucose value over a period of time; calculating the difference between the maximum glucose value and the minimum glucose value during the period; comparing the difference with a threshold; displaying a first indication if the difference does not exceed the threshold and displaying a second indication if the difference exceeds the threshold; The method includes:

[0340] Section 39 the period of time is a first period of time, the maximum glucose value is a first maximum glucose value; the minimum glucose value is a second maximum glucose value; The method further comprising: identifying a second maximum glucose value and a second minimum glucose value during a second period of time; calculating a second difference between the second maximum glucose value and the second minimum glucose value during the second period of time; comparing the second difference between the second maximum glucose value and the second minimum glucose value during the second time period to the threshold value; displaying a first indication if the second difference does not exceed the threshold and displaying a second indication if the second difference exceeds the threshold; 40. The method of claim 38, further comprising:

[0341] Section 40 39. The method of claim 38, wherein the period of time is about 1 hour.

[0342] Section 41 39. The method of claim 38, wherein the period of time is about 2 hours.

[0343] Section 42 40. The method of claim 39, wherein the second time period begins a time interval after the first time period begins.

[0344] Section 43 43. The method of claim 42, wherein the time interval is about 30 minutes.

[0345] Section 44 40. The method of claim 39, wherein the second period of time overlaps with the first period of time.

[0346] Section 45 40. The method of claim 39, wherein the total length of the first period and the total length of the second period are the same total length of time.

[0347] Section 46 40. The method of claim 39, wherein the total length of the first period and the total length of the second period are different total lengths of time.

[0348] Section 47 40. The method of claim 38, wherein the first indication is one of an indication of a balanced state and an indication of a steady state.

[0349] Section 48 40. The method of claim 38, wherein the second indication is one of an indication of an imbalance, an indication of an unstable condition, an indication of a non-stable condition, and an indication of a sudden change.

[0350] Section 49 40. The method of claim 38, wherein the threshold is about 30 mg / dL.

[0351] Section 50 1. A system for monitoring glucose excursions in a subject, the system comprising: an input configured to receive glucose measurement data; a display configured to visually present information; one or more processors coupled to the input, the display, and a memory storing instructions; Equipped with The instructions, when executed by the one or more processors, cause the system to: identifying a maximum glucose value and a minimum glucose value over a period of time; calculating the difference between the maximum glucose value and the minimum glucose value during the period; comparing the difference with a threshold; displaying a first indication if the difference does not exceed the threshold and displaying a second indication if the difference exceeds the threshold; A system that executes the above.

[0352] Section 51 the period of time is a first period of time, the maximum glucose value is a first maximum glucose value; the minimum glucose value is a second maximum glucose value; The instructions cause the one or more processors to: identifying a second maximum glucose value and a second minimum glucose value during a second period of time; calculating a second difference between the second maximum glucose value and the second minimum glucose value during the second period of time; comparing the second difference between the second maximum glucose value and the second minimum glucose value during the second time period to the threshold value; displaying a first indication if the second difference does not exceed the threshold and displaying a second indication if the second difference exceeds the threshold; 51. The system of claim 50, further comprising:

[0353] Section 52 51. The system of claim 50, wherein the period is about 1 hour.

[0354] Section 53 51. The system of claim 50, wherein the period is about 2 hours.

[0355] Section 54 52. The system of claim 51, wherein the second period of time begins a time interval after the first period of time begins.

[0356] Section 55 55. The system of claim 54, wherein the time interval is about 30 minutes.

[0357] Section 56 52. The system of claim 51, wherein the second period overlaps with the first period.

[0358] Section 57 52. The system of claim 51, wherein the total length of the first period and the total length of the second period are the same total length of time.

[0359] Section 58 52. The system of claim 51, wherein the total length of the first period and the total length of the second period are different total lengths of time.

[0360] Section 59 51. The system of claim 50, wherein the first indication is one of an indication of a balanced state and an indication of a stable state.

[0361] Section 60 51. The system of claim 50, wherein the second indication is one of an indication of an imbalance, an indication of an unstable condition, an indication of a non-stable condition, and an indication of a sudden change.

[0362] Section 61 51. The system of claim 50, wherein the threshold is about 30 mg / dL.

[0363] Section 62 1. A system for displaying metrics related to a subject, the system comprising: an input configured to receive glucose measurement data; a display configured to visually present information; one or more processors coupled to the input, the display, and a memory storing instructions; Equipped with The instructions, when executed by the one or more processors, cause the system to: determining a glucose status of the subject based on glucose data received during a moving window; displaying, on a graphical user interface (GUI), an indication of the subject's glucose status, the indication of the glucose status including a text description and a graphic having a first color; displaying a graph on the GUI; Run the command, the graph comprises a glucose profile comprising a first portion and a second portion; The system wherein the first portion and the second portion are different colors and the second portion is the first color.

[0364] Section 63 63. The system of clause 62, wherein the graphic is circular.

[0365] Section 64 63. The system of clause 62, wherein the glucose state is a binary state.

[0366] Section 65 65. The system of claim 64, wherein the binary glucose state comprises a stable state and an unstable state.

[0367] Section 66 65. The system of claim 64, wherein the binary glucose state comprises a stable state and a state in which an abrupt change is detected.

[0368] Section 67 63. The system of claim 62, wherein the instructions further cause the system to perform the step of displaying the subject's current glucose concentration.

[0369] Section 68 68. The system of clause 67, wherein the subject's current glucose concentration is displayed in the graph.

[0370] Section 69 Item 63. The system of item 62, wherein the graph further includes a mark on the glucose profile corresponding to a current glucose value.

[0371] Section 70 70. The system of claim 69, wherein the mark is a large circle.

[0372] Section 71 63. The system described in clause 62, wherein the GUI does not include a numerical display of the subject's current glucose value.

[0373] Section 72 63. The system of claim 62, wherein the duration of the moving window has a predetermined time interval measured backward from a certain time.

[0374] Section 73 73. The system of claim 72, wherein the time is the current time.

[0375] Section 74 73. The system of claim 72, wherein the predetermined time interval is about two hours.

[0376] Section 75 63. The system of claim 62, wherein the glucose status is determined by determining a range of variation in the glucose data received during the moving window.

[0377] Section 76 76. The system of claim 75, wherein the glucose status is determined to be stable if the fluctuation from a fluid baseline is below a predetermined threshold.

[0378] Section 77 77. The system of claim 76, wherein the predetermined threshold is ± about 30 mg / dL.

[0379] Section 78 77. The system of claim 76, wherein the moving baseline is a median glucose concentration during the moving window.

[0380] Section 79 77. The system of claim 76, wherein the moving baseline is an average glucose concentration during the moving window.

[0381] Section 80 The system of claim 75, wherein the glucose state is determined to be unstable if the fluctuation range of the glucose data received during the moving window from a fluid baseline exceeds a predetermined threshold.

[0382] Section 81 Item 81. The system of item 80, wherein the predetermined threshold is ± about 30 mg / dL.

[0383] Section 82 81. The system of claim 80, wherein the moving baseline is the median glucose concentration during the moving window.

[0384] Section 83 81. The system of claim 80, wherein the moving baseline is the average glucose concentration during the moving window.

[0385] Section 84 63. The system of claim 62, wherein the glucose status is determined by analyzing a plurality of glucose concentration values ​​during the moving window relative to a target range having an upper threshold and a lower threshold.

[0386] Section 85 85. The system of claim 84, wherein the glucose status is determined to be stable if all of the plurality of glucose concentration values ​​during the moving window are within the target range.

[0387] Section 86 85. The system of claim 84, wherein the glucose state is determined to be unstable if any of the plurality of glucose concentration values ​​during the moving window is above the upper threshold or below the lower threshold.

[0388] Section 87 63. The system of claim 62, wherein the glucose status is determined by (a) analyzing a plurality of glucose concentration values ​​during the moving window based on a target range having an upper threshold and a lower threshold, and (b) determining a range of fluctuation from a moving baseline of the glucose data received during the moving window.

[0389] Section 88 63. The system of clause 62, wherein the first color is green if the glucose status of the subject is stable.

[0390] Section 89 63. The system of clause 62, wherein the first color is orange if the glucose status of the subject is unstable.

[0391] Section 90 63. The system of claim 62, wherein the instructions further cause the system to perform the step of displaying summaries of a plurality of articles.

[0392] Section 91 91. The system of claim 90, wherein the summaries of the articles include links to the articles.

[0393] Section 92 91. The system of claim 90, wherein the summaries of the plurality of articles displayed relate to the glucose status of the subject.

[0394] Section 93 63. The system of claim 62, wherein the instructions further cause the system to perform the step of displaying a link to a second GUI containing further details regarding the glucose status of the subject.

[0395] Section 94 the graph of the GUI is a first graph of a first GUI, 94. The system of claim 93, wherein the instructions further cause the system to perform the step of displaying the second GUI including the further details regarding the glucose status of the subject in response to selection of the link.

[0396] Section 95 95. The system of claim 94, wherein the second GUI includes the display of the glucose status of the subject and a second graph comprising the second portion of the first graph of the first GUI.

[0397] Section 96 96. The system of claim 95, wherein the second GUI further includes additional explanations regarding the glucose status of the subject.

[0398] Section 97 96. The system of claim 95, wherein the second GUI further includes summaries of a plurality of articles.

[0399] Section 98 98. The system of claim 97, wherein the summaries of the plurality of articles are displayed in a carousel display.

[0400] Section 99 98. The system of claim 97, wherein the summaries of the plurality of articles displayed relate to the subject's current glucose status.

[0401] Section 100 95. The system of claim 94, wherein the second GUI further comprises a link to a third GUI for sharing information regarding the glucose status of the subject.

[0402] Section 101 101. The system of claim 100, wherein the instructions further cause the system to perform the step of displaying the third GUI including a shared graph and links to a plurality of third party applications.

[0403] Section 102 102. The system of claim 101, wherein the shared graph is the first graph of the first GUI.

[0404] Section 103 102. The system of claim 101, wherein the plurality of links includes at least one link to a messaging application and at least one link to a social media application.

[0405] Section 104 Item 102. The system of item 101, wherein the third GUI further includes a link for associating a photograph with the information regarding the glucose status of the subject.

[0406] Section 105 1. A system for displaying metrics related to a subject, the system comprising: an input configured to receive glucose measurement data and logged activity information; a display configured to visually present information; one or more processors coupled to the input, the display, and a memory storing instructions; Equipped with The instructions, when executed by the one or more processors, cause the system to: determining a plurality of glucose states of the subject based on glucose data received during a plurality of moving windows, each of the moving windows including a logged activity; displaying a first graph including a first glucose profile for a first moving window period and a description of the first logged activity, the first glucose profile including a first portion, a second portion, and a third portion, the first portion and the third portion being a first color and the second portion being a second color; displaying a second graph including a second glucose profile for a second moving window period and a description of the second logged activity, the second glucose profile including a first portion, a second portion, and a third portion, the first portion and the third portion being the first color and the second portion being a third color; A system that executes the above.

[0407] Section 106 106. The system of claim 105, wherein the first graph further includes a first pictorial representation of the first logged activity, and the second graph further includes a second pictorial representation of the second logged activity.

[0408] Section 107 106. The system of clause 105, wherein the second color and the third color are the same color.

[0409] Section 108 106. The system of clause 105, wherein the second color and the third color are different colors.

[0410] Section 109 106. The system of claim 105, wherein the instructions further cause the system to perform the step of displaying at least one further graph including at least one further glucose profile for at least one moving window period and a description of at least one further logged activity, wherein the at least one further glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being the first color, and the second portion being the second color or the third color.

[0411] Section 110 the first graph further includes a first icon on the first glucose profile that is associated with the first logged activity; 106. The system of claim 105, wherein the first icon is located at a transition from the first portion to the second portion of the first glucose profile.

[0412] Section 111 the second graph further includes a second icon on the second glucose profile associated with the second logged activity; 106. The system of claim 105, wherein the second icon is located at a transition from the first portion to the second portion of the second glucose profile.

[0413] Section 112 the at least one further graph further includes at least one further icon associated with the at least one further logged activity on the at least one further glucose profile; 110. The system of claim 109, wherein the at least one further icon is located at a transition from the first portion to the second portion of the at least one further glucose profile.

[0414] Section 113 106. The system of claim 105, wherein the second portion of the first graph is about a two hour period of the first graph.

[0415] Section 114 106. The system of claim 105, wherein the second portion of the second graph is an approximately two hour long period of the second graph.

[0416] Section 115 113. The system of claim 112, wherein the second portion of the at least one further graph is about a two hour period of the at least one further graph.

[0417] Section 116 106. The system of claim 105, wherein the logged activity information includes logged food, logged drinks, logged exercise, logged feelings, and combinations thereof.

[0418] Section 117 106. The system of claim 105, wherein the first moving window period and the second moving window period are same-day periods.

[0419] Section 118 106. The system of claim 105, wherein the first logged activity and the second logged activity are related to each other. [Explanation of symbols]

[0420] 100 Systems 102, 710 Communication Links 104 Sensor control module message transmission / reception channel 106 Remote management module message transmission channel 200 receiving devices 202 Receiving device display 204 Input component of receiving device 206 Receiving Device Processor 208 Memory of the receiving device 210 Receiving device communication circuit 212 Receiving device antenna 214 Power supply for receiving device 300 Sensor Assembly 302 Sensor of sensor assembly, glucose sensor 304 Sensor Electronics of Sensor Assembly 306 Sensor Assembly Application Specific Integrated Circuit (ASIC) Analog Front End (AFE) for 308 Sensor Assembly 310 Sensor Assembly Power Management (Control) Circuit 312 Sensor Assembly Processor 314 Sensor Assembly Communication Circuit 316 Sensor Assembly Memory 318 Sensor Assembly Power Supply 320 Sensor Assembly Antenna 400 Software Library 420, 422, 424, 426 Applications 428 Third Party Applications 450 Module Interface 500 Sensor Control Module 510 Sensor Control Module User Interface 520 Sensor Control Module Interface 530 Database 532 Database Manager 540 Communication Control Module 600 Remote Management Module 610 Remote Management Module User Interface 620 Remote Management Module Interface 630 Remote Control Module 640 Remote Server 700 Remote Cloud 2100 Test substance monitoring system 2102 Sensor control device 2104 In vivo test substance sensor 2105 Adhesive Patch 2120 Reading Device 2121 Input component of reading device 2122 Reading device display 2123 Reader device power port 2140, 2141, 2142, 2143, 2144 communication channels 2150 Sensor Applicator 2160 Sensor electronics for sensor control devices 2161 Semiconductor chips (ASIC) 2162 Semiconductor Chip (AFE) 2163, 2165 Sensor Control Device Memory 2164 Power management (control) circuit for sensor control device 2166 Sensor Control Device Processor 2168 Sensor control device communication circuit 2170 Local Computer System 2171 Sensor Control Device Antenna 2172 Sensor Control Device Power Supply 2174 Semiconductor Chip 2180 Highly Reliable Computer System 2190 Network 2206 Processing core of the reading device 2222 Communication processor of reading device 2223, 2225, 2230 Reader device memory 2224 Application Processor 2226 Reader device power supply 2228 RF Transmitter / Receiver for Reading Device 2229, 2234 Antenna of reading device 2232 Multifunction Transmitter / Receiver for Reading Device 2238 Reader device power management module

Claims

1. A system (100) for displaying metrics related to a subject, the system comprising: a communication circuit configured to receive glucose measurement data and logged activity information; a display (202) configured to visually present information; one or more processors (206) coupled to the communication circuitry, the display, and memory storing instructions; Equipped with The instructions, when executed by the one or more processors, cause the system to: determining a plurality of glucose states of the subject based on glucose data received during a plurality of moving windows, each of the moving windows including a logged activity; displaying a first graph (3082a) including a first glucose profile (3090) for a first moving window period and a description of the logged first activity, the first glucose profile including a first portion, a second portion, and a third portion, the first portion and the third portion being a first color, and the second portion (3092) being a second color; displaying a second graph (3082b) including a second glucose profile (3090) for a second moving window period and a description of the second logged activity, the second glucose profile including a first portion, a second portion, and a third portion, the first portion and the third portion being the first color, and the second portion (3092) being a third color; The system (100) executes the above.

2. 2. The system of claim 1, wherein the first graph further comprises a first graphical representation of the logged first activity, and the second graph further comprises a second graphical representation of the logged second activity.

3. The system (100) of claim 1, wherein the second color and the third color are the same color.

4. The system (100) of claim 1, wherein the second color and the third color are different colors.

5. 2. The system (100) of claim 1, wherein the instructions further cause the system to perform the step of displaying at least one further graph including at least one further glucose profile for at least one moving window period and at least one further description of logged activity, wherein the at least one further glucose profile includes a first portion, a second portion, and a third portion, the first portion and the third portion being the first color, and the second portion being the second color or the third color.

6. the first graph (3082a) further includes a first icon (3084a) on the first glucose profile (3090) associated with the logged first activity; The system (100) of claim 1, wherein the first icon is located at a transition from the first portion to the second portion (3092) of the first glucose profile.

7. the second graph (3082b) further includes a second icon (3084b) on the second glucose profile (3090) associated with the second logged activity; The system (100) of claim 1, wherein the second icon is located at a transition from the first portion to the second portion (3092) of the second glucose profile.

8. the at least one further graph further includes at least one further icon associated with the at least one further logged activity on the at least one further glucose profile; 6. The system (100) of claim 5, wherein the at least one further icon is located at a transition from the first portion to the second portion of the at least one further glucose profile.

9. 2. The system of claim 1, wherein the second portion of the first graph is an approximately two-hour long period of the first graph.

10. The system (100) of claim 1, wherein the second portion (3092) of the second graph is an approximately two-hour long period of the second graph (3082b).

11. 9. The system (100) of claim 8, wherein the second portion of the at least one further graph is about a two-hour long period of the at least one further graph.

12. 10. The system of claim 1, wherein the logged activity information comprises logged food, logged drinks, logged exercise, logged feelings, and combinations thereof.

13. The system (100) of claim 1, wherein the first moving window period and the second moving window period are same-day periods.

14. The system (100) of claim 1, wherein the first logged activity and the second logged activity are related to each other.

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