Analyte monitoring systems

Abstract

Improved digital interfaces and graphical user interfaces for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for a self-check questionnaire. In addition, various embodiments of interfaces for a treatment decision guide and related knowledge check are described.

Description

ANALYTE MONITORING SYSTEMSFIE D

[0001] The subject matter described herein relates generally to analyte monitoring systems, as well as systems, methods, and devices relating thereto, including digital interfaces and user interfaces.BACKGROUND

[0002] The detection and / or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like, can be vitally important to the overall health of a person, particularly for an individual having diabetes. Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Persons with diabetes are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and / or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.

[0003] Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, however, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.

[0004] To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized, in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor and can be applied by the individual with a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user’s analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with the bodily fluid. The analyte monitoring system may also be configured to transmit analyte data to another device, from which a caregiver such as, for example, a parent, a spouse, or a health care provider (“HCP”), can review the data and make therapy decisions.

[0005] Despite their advantages, however, some people are reluctant to use analyte monitoring systems for various reasons, including the complexity and volume of data presented, a learning curve associated with the software and user interfaces for analyte monitoring systems, and an overall paucity of actionable information presented.

[0006] Thus, needs exist for digital interfaces and graphical user interfaces for analyte monitoring systems, as well as methods and devices relating thereto, that are robust, user- friendly, and provide for sufficient guidance and timely and actionable responses.SUMMARY

[0007] Provided herein are example embodiments of analyte monitoring systems including digital and user interfaces. Aspects of the inventions are set out in the independent claims and preferred features are set out in the dependent claims. Preferred features of each aspect may be provided in combination with each other within particular embodiments and may also be provided in combination with other aspects. According to some embodiments, methods, systems, and interfaces relating to determining the intended use population using a self-select questionnaire are described. In some embodiments, methods, systems, and interfaces for providing treatment decision guide and related treatment decision guide knowledge check are described.

[0008] In some embodiments, systems, methods, and interfaces for an analyte monitoring system are provided, wherein the analyte monitoring system comprises a sensor control device configured to collect data indicative of an analyte level in a subject. The analyte monitoring system further comprises a reader device (e.g., smart phone) having wireless communication circuitry, and one or more processors coupled with a memory storing an analyte monitoring software program that, when executed by the one or more processors, cause the processors to provide an interactive graphical user interface for displaying a questionnaire on a display of the reader device, allowing the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program.

[0009] In some embodiments, the disqualification criteria include a non-minimum age indication. In some embodiments, the non-minimum age indication is that the subject is youngerthan 18 years old. Tn other embodiments, the disqualification criteria include a non-diabetic indication. In some embodiments, the non-diabetic indication is that the subject is not diagnosed with diabetics. In some embodiments, the disqualification criteria include an insulin usage indication. In some embodiments, the insulin usage indication is that the subject is not using insulin. In some embodiments, the disqualification criteria include a pregnancy indication. In some embodiments, the disqualification criteria include a dialysis indication. In other embodiments, the disqualification criteria include a critical illness indication.

[0010] According to some embodiments, methods, systems, and interfaces relating to displaying a user interface including a treatment decision guide relating to different scenarios are described. In some embodiments, different scenarios include a wake-up scenario, a before and after meal scenario, an in-between meals scenario, and an after exercising scenario. In some embodiments, the subject interface also includes treatment decision guide knowledge check corresponding to the different scenarios in the treatment decision guide.

[0011] The reader device, which receives sensor data from the sensor control device, can be a smart phone, tablet computer, personal digital assistant or other proprietary or non-proprietary mobile computing platform.

[0012] Many of the embodiments provided herein are improved GUIs or GUI features for analyte monitoring systems that are highly intuitive, user-friendly, and provide for rapid access to physiological information of a user. More specifically, these embodiments allow a user to easily navigate through and between different user interfaces that can quickly indicate to the subject various physiological conditions and / or actionable responses, without requiring the subject (or an HCP) to go through the arduous task of examining large volumes of analyte data. Furthermore, some of the GUIs and GUI features and interfaces allow for users (and their caregivers) to better understand and improve their respective levels of engagement with their analyte monitoring systems. Other improvements and advantages are provided as well. The various configurations of these devices are described in detail by way of the embodiments which are only examples.

[0013] Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. Where a method is described and claimed herein, analyte monitoring systems comprising means for performing each of the steps of the method arealso expressly disclosed and provided. Moreover, computer programs, computer program products and computer readable media for implementing the steps of the method are also disclosed and provided. It is intended that all such additional systems, devices, methods, features, and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims.BRIEF DESCRIPTION OF THE FIGURES

[0014] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0015] FIG. 1 is a system overview of an analyte monitoring system comprising a sensor applicator, a sensor control device, a reader device, a network, a trusted computer system, and a local computer system.

[0016] FIG. 2A is a block diagram depicting an example embodiment of a reader device.

[0017] FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control devices.

[0018] FIGS. 3 A to 3D are example embodiments of GUIs relating to self-select questionnaire.

[0019] FIGS. 4A to 4B are additional example embodiments of GUIs relating to self-select questionnaire.

[0020] FIG. 5 is a flowchart illustrating a process for an analyte monitoring software application that is configured to display a GUI relating to self-select questionnaire.

[0021] FIGS. 6A to 6D are example embodiments of GUIs relating to treatment decision guide.

[0022] FIGS. 7A to 7D are example embodiments of GUIs relating to treatment decision guide knowledge check.DETAILED DESCRIPTION

[0023] Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0024] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0025] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0026] Generally, embodiments of the present disclosure include GUIs and digital interfaces for analyte monitoring systems, and systems, methods, and devices relating thereto. Accordingly, many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0027] Furthermore, for each and every embodiment of a method disclosed herein, systems and devices capable of performing each of those embodiments are covered within the scope of the present disclosure. For example, embodiments of sensor control devices, reader devices, local computer systems, and trusted computer systems are disclosed, and these devices and systems can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and / or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps.

[0028] As previously described, a number of embodiments described herein provide for improved GUIs and digital interfaces for analyte monitoring systems, wherein the GUIs areactionable, user-friendly, and provide for rapid access to physiological information of a user. According to some embodiments, methods, systems, and interfaces relating to determining the intended use population using a self-select questionnaire are described. In some embodiments, methods, systems, and interfaces for providing treatment decision guide and related treatment decision guide knowledge check are described.

[0029] Before describing these aspects of the embodiments in detail, however, it is first desirable to describe examples of devices that can be present within, for example, an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described herein.

[0030] There are various types of in vivo analyte monitoring systems. “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems), for example, can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule. “Flash Analyte Monitoring” systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0031] In vivo analyte monitoring systems can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the subject, which can be analyzed to determine the subject’s blood sugar level.

[0032] In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the subject and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the subject and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.

[0033] In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and / or displays that sensed analyte data, in any number of forms, to the subject. This device, and variations thereof, can be referred to as a“handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.Example Embodiment of In Vivo Analyte Monitorins System

[0034] FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user’s skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123. While only one reader device 120 is shown, sensor control device 102 can communicate with multiple reader devices 120. Each of the reader devices 120 can communicate and share data with one another. More details about reader device 120 is set forth with respect to FIG. 2A below. Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired or wireless communication protocol. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any of a number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi or others. Local computer system 170 can communicate via communications path 143 with a network 190 similar to how reader device 120 can communicate via a communications path 142 with network 190, by a wired or wireless communication protocol as described previously. Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth. A trusted computer system 180 can include a cloud-based platform or server, and can provide for authentication services, secured data storage,report generation, and can communicate via communications path 144 with network 190 by wired or wireless technique. In addition, although FIG. 1 depicts trusted computer system 180 and local computer system 170 communicating with a single sensor control device 102 and a single reader device 120, it will be appreciated by those of skill in the art that local computer system 170 and / or trusted computer system 180 are each capable of being in wired or wireless communication with a plurality of reader devices and sensor control devices.Examule Embodiment of Reader Device

[0035] FIG. 2A is a block diagram depicting an example embodiment of a reader device 120, which, in some embodiments, can comprise a smart phone. Here, reader device 120 can include a display 122, input component 121, and a processing core 206 including a communications processor 222 coupled with memory 223 and an applications processor 224 coupled with memory 225. Also included can be separate memory 230, RF transceiver 228 with antenna 229, and power supply 226 with power management module 238. Further, reader device 120 can also include a multi-functional transceiver 232, which can comprise wireless communication circuitry, and which can be configured to communicate over Wi-Fi, NFC, Bluetooth, BTLE, and GPS with an antenna 234. As understood by one of skill in the art, these components are electrically and communicatively coupled in a manner to make a functional device.Example Embodiments of Sensor Control Devices

[0036] FIGS. 2B and 2C are block diagrams depicting example embodiments of sensor control devices 102 having analyte sensors 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have the majority of the processing capability for rendering endresult data suitable for display to the subject. In FIG. 2B, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC). Shown within ASIC 161 are certain high-level functional units, including an analog front end (AFE) 162, power management (or control) circuitry 164, processor 166, and communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment, both AFE 162 and processor 166 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 166 can include one or more processors, microprocessors,controllers, and / or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips.

[0037] A memory 163 is also included within ASIC 161 and can be shared by the various functional units present within ASIC 161, or can be distributed amongst two or more of them. Memory 163 can also be a separate chip. Memory 163 can be volatile and / or non-volatile memory. In this embodiment, ASIC 161 is coupled with power source 172, which can be a coin cell battery, or the like. AFE 162 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 166 in digital form, which in turn processes the data to arrive at the end-result glucose discrete and trend values, etc. This data can then be provided to communication circuitry 168 for sending, by way of antenna 171, to reader device 120 (not shown), for example, where minimal further processing is needed by the resident software application to display the data. According to some embodiments, for example, a current glucose value can be transmitted from sensor control device 102 to reader device 120 every minute, and historical glucose values can be transmitted from sensor control device 102 to reader device 120 every five minutes.

[0038] In some embodiments, data acquired from sensor control device 102 can be stored on reader device 120. According to one aspect of some embodiments, such data can include the model number and serial number of sensor control device 102, as well as information relating to the sensor control device 102’s status, market code, or network address. In some embodiments, such data can also include error events detected by sensor control device 102. In addition, in some embodiments, either or both of current glucose values and historical glucose values can include one or more time stamps (e.g., factory time, UTC time, user’s local time based on time zone, and the current time zone).

[0039] In some embodiments, sensor control device 102 can store data such that if reader device 120 is not in communication with sensor control device 102 (e.g., if reader device 120 is out of a wireless communication range, is powered off, or is otherwise unable to communicate with sensor control device 102), when reader device 120 re-establishes communication with sensor control device 102, data can then be backfilled to reader device 120. According to some embodiments, data that can be backfilled can include, but is not limited to, current and historical glucose values, as well as error events. Further details regarding data backfilling can be found inU.S. Patent No. 10,820,842, as well as U.S. Publ. No. 2021 / 0282672 (“the ’672 Publication”), both of which are hereby incorporated by reference in their entireties for all purposes.

[0040] According to some embodiments, each current glucose value and / or historical glucose value acquired from sensor control device 102 can further be validated on reader device 120, such as, for example, by performing a CRC integrity check to ensure that the data has been transferred accurately. In some embodiments, for example, a data quality mask of the current glucose value and / or historical glucose value can be checked to ensure that the reading is correct and can be displayed as a valid reading on the reader device 120.

[0041] According to another aspect of some embodiments, reader device 120 can include a database for storing any or all of the aforementioned data. In some embodiments, the database can be configured to retain data for a predetermined period of time (e.g., 30 days, 60 days, 90 days, six months, one year, etc ). According to some embodiments, the database can be configured to delete data after it has been uploaded to a cloud server. In other embodiments, database can be configured for a clinical setting, in which data is retained for a longer period of time (e.g., one year) relative to a non-clinical setting. In addition to the aforementioned data (e g., current and / or historical glucose values, error events, etc.), the database on reader device 120 can also store user configuration information (e.g., login ID, notification settings, regional settings, and other preferences), as well as application configuration information (e.g., cloud settings, URLs for uploading data and / or error events, version information, etc.). The database can be encrypted to prevent a user from inspecting the data content directly even if the operating system of reader device 120 is compromised.

[0042] In some embodiments, to conserve power and processing resources on sensor control device 102, digital data received from AFE 162 can be sent to reader device 120 (not shown) with minimal or no processing. In still other embodiments, processor 166 can be configured to generate certain predetermined data types (e.g., current glucose value, historical glucose values) either for storage in memory 163 or transmission to reader device 120 (not shown), and to ascertain certain alarm conditions (e.g., sensor fault conditions), while other processing and alarm functions (e.g., high / low glucose threshold alarms) can be performed on reader device 120. Those of skill in the art will understand that the methods, functions, and interfaces described herein can be performed - in whole or in part — by processing circuitry on sensor control device 102, reader device 120, local computer system 170, or trusted computer system 180.

[0043] FIG. 2C is similar to FIG. 2B but instead includes two discrete semiconductor chips 162 and 174, which can be packaged together or separately. Here, AFE 162 is resident on ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE 162 may include memory 163 and chip 174 includes memory 165, which can be isolated or distributed within. In one example embodiment, AFE 162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another example embodiment, both AFE 162 and communication circuitry 168 are on one chip, and processor 166 and power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each bearing responsibility for the separate functions described, or sharing one or more functions for fail-safe redundancy.Example Embodiments of Graphical User Interfaces for Analyte Monitoring Systems

[0044] Described herein are example embodiments of GUIs for analyte monitoring systems, as well as methods and system relating thereto. As an initial matter, it will be understood by those of skill in the art that the GUIs and related methods described herein comprise instructions stored in a non-transitory memory of reader device 120, local computer system 170, trusted computer system 180, and / or any other device or system that is part of, or in communication with, analyte monitoring system 100. These instructions, when executed by one or more processors of the reader device 120, local computer system 170, trusted computer system 180, or other device or system of analyte monitoring system 100, cause the one or more processors to perform the method steps and / or output the GUIs described herein. Those of skill in the art will further recognize that the GUIs described herein can be stored as instructions in the non- transitory memory of a single centralized device or, in the alternative, can be distributed across multiple discrete devices in geographically dispersed locations.Example Embodiments of Graphical User Interfaces relating to Self-select Questionnaire

[0045] Example embodiments of methods, systems, and related GUIs for self-select questionnaire will now be described. According to some embodiments, the various GUIs described in the previous sections can be associated with an analyte monitoring software application residing in memory of a reader device 120 (or other computing devices used in conjunction with an analyte monitoring system). Thus, in such embodiments, it would beadvantageous to include certain self-select questionnaire during the setup of the analyte monitoring software application to ensure that the subject is the intended user of the analyte monitor system. For example, in some embodiments, the intended user can be people with diabetes, ages 18 and older, not using insulin, not pregnant, not on dialysis, and not critically ill.

[0046] FIGS. 3A to 3D depict example embodiments of self-select questionnaire interfaces for use during the setup of an analyte monitoring software application. According to one aspect of the embodiments, the analyte monitoring software application may cause the processor to display a questionnaire. FIG. 3A is a GUI 310 that prompts the subject to start the self-select questionnaire. GUI 310 may include text providing instructions to the subject to complete the self-select questionnaire. For example, the GUI may include instructions for the user to answer a few questions to find out if the system is right for them, such as “Answer a few questions to find out if this system is right for you.” Moreover, the GUI may include instructions that suggest that the user consult their doctor if they are unsure about an answer, such as “If you are not sure about an answer, please ask your doctor.” In some embodiments, GUI 310 includes an icon, link, or button 312 that, when pressed by the subject, will navigate the subject to GUI 320 of FIG. 3B.

[0047] FIG. 3B is GUI 320 depicting a self-select questionnaire. According to one aspect of the embodiments, the analyte monitoring software application may cause the processor to prompt the subject to select one or more answers to each of a plurality of questions in the self-select questionnaire. GUI 320 may include radio buttons for the subject to select one or more answers from the self-select questionnaire. FIG. 3C is GUI 330 depicting a self-select questionnaire after the subject has selected one or more answers from the self-select questionnaire. For example, as shown in FIG. 3C, the subject has selected answers indicating that he / she is 18 years old or older, has been diagnosed with diabetes, is not using insulin to manage his / her diabetes, and is not pregnant, on dialysis, or critically ill. In some embodiments, GUI 330 may include a next button 332 to prompt the subject to submit the one or more answers.

[0048] According to another aspect of the embodiments, the analyte monitoring software application may cause the processor to determine whether the one or more of the selected answers include at least one disqualification criteria. In some embodiments, the disqualification criteria include a non-minimum age indication. In some embodiments, the non-minimum age indication may be that the subject is younger than 18 years old. In other embodiments, thedisqualification criteria may include a non-diabetic indication. In some embodiments, the nondiabetic indication is that the subject is not diagnosed with diabetics. In some embodiments, the disqualification criteria may include an insulin usage indication. In some embodiments, the insulin usage indication is that the subject is using insulin. In some embodiments, the disqualification criteria include a pregnancy indication. In some embodiments, the pregnancy indication is that the subject is pregnant. In some embodiments, the disqualification criteria include a dialysis indication. In some embodiments, the dialysis indication is that the subject is currently on dialysis. In other embodiments, the disqualification criteria include a critical illness indication. In some embodiments, the critical illness indication is that the subject is currently critically ill.

[0049] A person skilled in the art would understand that not all disqualification criteria need to be present in every self-select questionnaire. For example, in some embodiments, the selfselect questionnaire may omit the nondiabetic indication. In other embodiments, the self-select questionnaire may only include a nondiabetic indication and a non-minimum age indication. This flexibility allows the self-select questionnaire to be tailored to the specific needs and requirements of different applications, ensuring that only the most pertinent disqualification criteria are assessed for each unique situation. According to another aspect of some embodiments, the application can include a configuration function that is inaccessible to the user and can only be modified by the manufacturer or other administrator. This configuration function provides flexibility in how the self-select questionnaire is managed before the initial use of the analyte monitoring system. In some embodiments, this setting can allow the manufacturer or other administrator to disable the self-select questionnaire before the analyte monitoring system is used for the first time. This could be useful in scenarios where the questionnaire is deemed unnecessary or where alternative methods of user assessment are preferred. In other embodiments, the setting can allow the manufacturer or other administrator to update or modify the self-select questionnaire prior to the initial use of the analyte monitoring system. This ensures that the most current and relevant disqualification criteria are applied, adapting to new medical guidelines or specific use-case requirements. Furthermore, the setting can be configured in various ways depending on the system’s architecture. In some embodiments, the setting can be established within the application downloaded to the reader device, allowing for direct controland updates through the mobile app interface. In other embodiments, the setting can be managed at the server level, providing centralized control over multiple devices and users.

[0050] According to another aspect of some embodiments, after the processor determines that the selected answers do not include any disqualification criteria, the analyte monitoring software application may cause the processor to display GUI 340, as shown in FIG. 3D. This indicates that the subject is the intended user for the analyte monitoring system. GUI 340 may include a next button 342 to prompt the subject to start using the analyte monitoring system.

[0051] FIG. 4A is GUI 410 depicting a self-select questionnaire after the subject has selected one or more answers from the self-select questionnaire. As shown in FIG. 4A, the subject has selected answers indicating that he / she is 18 years old or older, has been diagnosed with diabetes, is using insulin to manage his / her diabetes, and is not pregnant, on dialysis, or critically ill. In this instance, according to one aspect of some embodiments, the subject’s answers include at least one disqualification criteria, i.e., the user has indicated that they are currently using insulin to manage their diabetes (i.e., the insulin usage indication).

[0052] According to one aspect of some embodiments, after the processor determines that the selected answers include one or more disqualification criteria, the analyte monitoring software application may cause the processor to display GUI 420, as shown in FIG. 4B. According to one aspect of some embodiments, after the processor determines that the selected answers include one or more disqualification criteria, the analyte monitoring software application may cause the processor to disable one or more functions of the analyte monitoring software program. GUI 420 may include text explaining why the subject is not the intended user for the analyte monitoring system. For example, GUI 420 may include text such as “This product is only intended for people with diabetes ages 18+ not using insulin. Do not use if you are pregnant, on dialysis, and / or critically ill. Talk to your doctor about other options available to you.” GUI 420 may also include text such as “If your conditions change, you can retake the questionnaire to find out if this product is right for you.” GUI 420 may further include an “I UNDERSTAND” button 422 that, when pressed, will disable one or more functions of the analyte monitoring software program. In some embodiments, the one or more functions of the analyte monitoring software program is receiving the analyte data indicative of the analyte level of the subject from the sensor control device.

[0053] FIG. 5 is a flowchart 500 further illustrating a process for an analyte monitoring software application that is configured to display a GUI relating to self-select questionnaire. At step 510, the analyte monitoring software application causes the processor to display a questionnaire on a display of the reader device, allowing the subject to select one or more answers from the questionnaire. At step 520, the processor determines whether the one or more of the selected answers include at least one disqualification criteria. If the selected answers do not include at least one disqualification criteria, the processor will prompt the subject to start using the analyte monitoring software program, as shown in step 530. If the selected answers include at least one disqualification criteria, the processor may disable one or more functions of the analyte monitoring software program, as shown in step 540.

[0054] It will be understood by those of skill in the art that any of the GUIs (or portions thereof) described herein, are meant to be illustrative only, and that the individual elements, or any combination of elements, depicted and / or described for a particular embodiment or figure are freely combinable with any other element, or any combination of other elements, depicted and / or described with respect to any of the other embodiments.Example Embodiments of Graphical User Interfaces relating to treatment decision guide and related treatment decision guide knowledge check

[0055] Example embodiments of methods, systems, and related GUIs for providing a treatment decision guide and related treatment decision guide knowledge check will now be described. According to some embodiments, the various GUIs described in the previous sections can be associated with an analyte monitoring software application residing in memory of a reader device 120 (or other computing devices used in conjunction with an analyte monitoring system). Thus, in such embodiments, it would be advantageous to include certain treatment decision guide and related treatment decision guide knowledge check in the analyte monitoring software application to ensure that the subject understands the data indicative of an analyte level at different scenarios and what next steps he or she should be taking in response to the measured analyte level. In some embodiments, such scenarios include wake-up scenario, before and after meal scenario, in-between meals scenario, and after exercising scenario.

[0056] FIGS. 6A to 6D depict various GUIs of an analyte monitoring software application configured to display a treatment decision guide. FIG. 6A, for example, depicts GUI 610, whichis configured to display a treatment decision guide relating to a wake-up scenario. According to one aspect of some embodiments, GUI 610 can include a display 612 with a numeric analyte level value and trend arrow indicator. In some embodiments, display 612 may be a bar. Display 612 can be color-coded as a further indication of readings or analyte levels that are inside or outside of the target range. For example, green may indicate that the analyte level is within a target range and yellow or orange may indicate that the analyte level is outside of the target range. Trend arrows may include a diagonal right arrow pointed upward to indicate that the analyte level is rising, a vertical arrow pointed up to indicate that the analyte level is quickly rising, a horizontal right or left (preferably right) arrow to indicate that the analyte level is steady or changing slowly, a diagonal arrow pointed downward to indicate that the analyte level is falling, and / or a vertical arrow pointed down to indicate that the analyte level is falling quickly. According to another aspect of some embodiment, GUI 610 can include text providing information about the wake-up scenario and instructing about next steps to be taken by the subject. For example, GUI 610 may include a scenario when the subject wakes up on their first day of wearing a Sensor, their current glucose is 110 mg / dL with a horizontal right trend arrow and there is a symbol or icon, e.g., a magnifying glass and a red drop of blood, with their reading. GUI 610 may further include text explaining that during the first 12 hours of sensor wear, the symbol with a magnifying glass and a red drop of blood will display and the subject cannot use sensor values to make any decisions during this time. GUI 610 may also include text suggesting the subject to confirm sensor glucose readings with a blood glucose test before making decisions during the first 12 hours of sensor wear when they see the symbol.

[0057] FIG. 6B depicts GUI 620, which is configured to display a treatment decision guide relating to a before and after meal scenario. According to one aspect of some embodiments, GUI 620 can include a display 622 with a numeric analyte level value and trend arrow indicator corresponding to the analyte level before a meal, and a display 624 with a numeric analyte level value and trend arrow indicator corresponding to the analyte level after a meal. In some embodiments, displays 622 and 624 may be bars. As described elsewhere, displays 622 and 624 can be color-coded as a further indication of readings or analyte levels that were outside of the target range. According to another aspect of some embodiment, GUI 620 can include text providing information about the before and after meal scenario and instructing about next steps to be taken by the subject. For example, GUI 620 may include a scenario when the subject’sglucose before a meal was 85 mg / dL with a diagonal trend arrow pointed up, and the subject’s glucose after a meal was 225 mg / dL with a diagonal trend arrow pointed downward. GUI 620 may further include text explaining that in this scenario, the subject’s glucose rose above the target range after the meal but may be coming down now and suggesting that the subject to think about the meal and portion size that might have caused their glucose to rise and to follow their doctor’s recommendation and check their glucose again later.

[0058] FIG. 6C depicts GUI 630, which is configured to display a treatment decision guide relating to an in-between meals scenario. According to one aspect of some embodiments, GUI 630 can include a display 632 with a numeric analyte level value and trend arrow indicator. In some embodiments, display 632 may be a bar. As described elsewhere, display 632 can be color-coded as a further indication of readings or analyte levels that were outside of the target range. According to another aspect of some embodiment, GUI 630 can include text providing information about the in-between meals scenario and instructing about next steps to be taken by the subject. For example, GUI 630 may include a scenario when between meals the subject’s current glucose is 72 mg / dL with a diagonal trending arrow pointed downward. GUI 630 may further include text explaining that in this scenario, the subject may want to think about what might be causing their glucose to go low and to consider eating a snack or fast-acting carbohydrate to stay within the target range. GUI 630 may further include text encouraging the subject to follow their doctor’s recommendation and check their glucose again later.

[0059] FIG. 6D depicts GUI 640, which is configured to display a treatment decision guide relating to an after-exercising scenario. According to one aspect of some embodiments, GUI 640 can include a display 642 with a numeric analyte level value and trend arrow indicator. In some embodiments, display 642 may be a bar. As described elsewhere, display 642 can be color- coded as a further indication of readings or analyte levels that were outside of the target range. According to another aspect of some embodiment, GUI 640 can include text providing information about the after-exercising scenario and instructing about next steps to be taken by the subject. For example, GUI 640 may include a scenario when after exercising, the subject is feeling shaky, sweaty, and dizzy and other symptoms that indicate low glucose or hypoglycemia, but their current glucose is 204 mg / dL, with a horizontal right trend arrow. GUI 640 may include text suggesting that the subject should do a blood glucose test anytime they get a reading that doesn’t match how they feel.

[0060] According to one aspect of some embodiments, the analyte monitoring software application can be configured to further display a treatment decision guide knowledge check corresponding to the different scenarios in the treatment decision guide. In some embodiments, the subject is prompted to answer questions based on the text provided in the relevant treatment decision guide. FIGS. 7A to 7D are example embodiments of GUIs configured to display an interactive treatment knowledge check corresponding to different scenarios in the treatment decision guide. For example, FIG. 7A is GUI 710 depicting a treatment decision knowledge check corresponding to the treatment decision guide relating to the wake-up scenario, as depicted in FIG. 6A. GUI 710 may have one or more questions relating to the wake-up scenario and information provided in GUI 610. GUI 710 may have radio buttons to prompt the subject to provide answers to one or more questions relating to what the subject would do if they checked their glucose on the first day of wear and saw a symbol or icon, e.g., a magnifying glass and a red drop of blood, with their reading. The answers may include choosing to not make a decision based on this reading and checking their blood glucose with a test strip. Another answer may be to use the reading to make a decision.

[0061] According to one aspect of some embodiments, if the user chooses the correct answer, a green checkmark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “That’s Right!” In some embodiments, the correct answer is not to make a decision based on this reading and check their blood glucose with a test strip. In some embodiments, the GUI may also include a display prompting the user to continue to the next screen. In some embodiments, the display may be a bar, with the text “Continue.” According to another aspect of some embodiments, if the user chooses the wrong answer, a red exclamation mark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “Incorrect Answer.” In some embodiments, the incorrect answer is to use the reading to make a decision. In some embodiments, the GUI may also include text explaining the wake-up scenario. In some embodiments, the text may state, “When you see the symbol with a magnifying glass and a red drop of blood during the first 12 hours of wearing a Sensor, it’s a reminder that your body may still be getting used to the new Sensor. Confirm glucose reading with a blood glucose test before making treatment decisions.” In some embodiments, the GUI may also include a display prompting the user to try again. In some embodiments, the display may be a bar, with the text “Try Again.”

[0062] FIG. 7B is GUI 720 depicting a treatment decision knowledge check corresponding to the treatment decision guide relating to the before and after meal scenario, as depicted in FIG. 6B. GUI 720 may have one or more questions relating to the before and after meal scenario and information provided in GUI 620. GUI 720 may have radio buttons to prompt the subject to provide answers to the one or more questions relating to what the subject would do if he or she checked their glucose between meals and saw that their glucose was going low. The answers may include choosing to do nothing. Another answer may be to consider eating a snack to stay within target range.

[0063] According to one aspect of some embodiments, if the user chooses the correct answer, a green checkmark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “That’s Right!” In some embodiments, the correct answer is to choose to do nothing. In some embodiments, the GUI may also include a display prompting the user to continue to the next screen. In some embodiments, the display may be a bar, with the text “Continue.” According to another aspect of some embodiments, if the user chooses the wrong answer, a red exclamation mark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “Incorrect Answer.” In some embodiments, the incorrect answer is to eat a snack to stay within target range. In some embodiments, the GUI may also include text explaining the before and after meal scenario. In some embodiments, the text may state, “Eating a snack may cause your glucose to rise even more. Consider not doing anything and checking your glucose again later.” In some embodiments, the GUI may also include a display prompting the user to try again. In some embodiments, the display may be a bar, with the text “Try Again.”

[0064] FIG. 7C is GUI 730 depicting a treatment decision knowledge check corresponding to the treatment decision guide relating to the in-between scenario, as depicted in FIG. 6C. GUI 730 may have one or more questions relating to the in-between scenario and information provided in GUI 630. GUI 730 may have radio buttons to prompt the subject to provide answers to the one or more questions relating to what the subject would do if he or she has eaten their lunch and checked their glucose and got a glucose reading that is above their target range and rising quickly with an upward arrow. The answers may include eating a snack and checking their glucose again later. Another answer may be to do nothing and check their glucose again later and follow the doctor’s recommendation.

[0065] According to one aspect of some embodiments, if the user chooses the correct answer, a green checkmark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “That’s Right!” In some embodiments, the correct answer is to eat a snack and check their glucose again later. In some embodiments, the GUI may also include a display prompting the user to continue to the next screen. In some embodiments, the display may be a bar, with the text “Continue.” According to another aspect of some embodiments, if the user chooses the wrong answer, a red exclamation mark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “Incorrect Answer.” In some embodiments, the incorrect answer is to do nothing and check their glucose again later and follow the doctor’s recommendation. In some embodiments, the GUI may also include text explaining the inbetween scenario. In some embodiments, the text may state, “Doing nothing may cause your glucose reading to go below your target range. Consider eating a snack.” In some embodiments, the GUI may also include a display prompting the user to try again. In some embodiments, the display may be a bar, with the text “Try Again.”

[0066] FIG. 7D is GUI 740 depicting a treatment decision knowledge check corresponding to the treatment decision guide relating to the after exercising scenario, as depicted in FIG. 6D. GUI 740 may have one or more questions relating to the after exercising scenario and information provided in GUI 640. GUI 740 may have radio buttons to prompt the subject to provide answers to the one or more questions relating to what the subject would do if their glucose reading does not match how they feel. The answers may include not using this reading and checking their blood glucose with a test strip and following their doctor’s recommendation. Another answer may be to ignore how they are feeling and do nothing.

[0067] According to one aspect of some embodiments, if the user chooses the correct answer, a green checkmark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “That’s Right!” In some embodiments, the correct answer is not to use this reading and check their blood glucose with a test strip and follow their doctor’s recommendation. In some embodiments, the GUI may also include a display prompting the user to continue to the next screen. In some embodiments, the display may be a bar, with the text “Continue.” According to another aspect of some embodiments, if the user chooses the wrong answer, a red exclamation mark may be displayed on the GUI. In some embodiments, the GUI may also include the text, “Incorrect Answer.” In some embodiments, the incorrect answer is to ignorehow they are feeling and do nothing. In some embodiments, the GUI may also include text explaining the after exercising scenario. In some embodiments, the text may state, “Any time you get a reading that doesn’t match how you feel, check your blood glucose with a test strip before making a treatment decision. The Sensor can sometimes be inaccurate, so trust your symptoms.” In some embodiments, the GUI may also include a display prompting the user to try again. In some embodiments, the display may be a bar, with the text “Try Again.”

[0068] According to one aspect of some embodiments, the analyte monitoring software application is configured to determine whether the subject has answered the questions correctly. According to another aspect of some embodiments, the analyte monitoring software application is further configured to provide the subject with additional information in response to their incorrect answers. In some embodiments, the analyte monitoring software application is configured to prompt the subject to redo the treatment decision guide knowledge check upon determining that the subject has provided incorrect answers to the one or more questions.

[0069] It will be understood by those of skill in the art that any of the GUIs (or portions thereof) described herein, are meant to be illustrative only, and that the individual elements, or any combination of elements, depicted and / or described for a particular embodiment or figure are freely combinable with any other element, or any combination of other elements, depicted and / or described with respect to any of the other embodiments.

[0070] Although many of the embodiments described herein relate to glucose monitoring, those of skill in the art will appreciate that these same embodiments can be implemented for purposes of monitoring other analytes, such as, for example, lactate and ketones.

[0071] Furthermore, those of skill in the art will appreciate that the embodiments described herein are not limited to the monitoring one analyte at a time, although each embodiment described herein is capable of doing so. For example, according to some embodiments, a single sensor control device can include within its housing, for example, an analyte sensor capable of sensing an in vivo glucose level and an in vivo lactate level in a bodily fluid of the subject. Likewise, any and all of the aforementioned embodiments of processes and methods can be configured for purposes of monitoring multiple analytes at once (e.g., glucose and lactate, glucose and ketone, etc.).

[0072] In summary, improved digital interfaces and graphical user interfaces for analyte monitoring systems are provided. For example, disclosed herein are various embodiments ofmethods, systems, and interfaces for a self-check questionnaire. In addition, various embodiments of interfaces for a treatment decision guide and related knowledge check are described.

[0073] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

[0074] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.

[0075] Various aspects of the present subject matter are set forth below, in review of, and / or in supplementation to, the embodiments described thus far, with the emphasis here being on the interrelation and interchangeability of the following embodiments. In other words, an emphasis is on the fact that each feature of the embodiments can be combined with each and every other feature unless explicitly stated otherwise or logically implausible. The embodiments describedherein are restated and expanded upon in the following paragraphs without explicit reference to the figures.

[0076] In many embodiments, an analyte monitoring system includes: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, allowing the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program, wherein the qualification criteria include a non-minimum age indication and a nondiabetic indication.

[0077] In some embodiments, the non-minimum age indication is an indication that the subject is younger than 18 years old.

[0078] In some embodiments, the non-diabetic indication is an indication that the subject is not diagnosed with diabetics.

[0079] In some embodiments, the disqualification criteria further include an insulin usage indication. In some embodiments, the insulin usage indication is an indication that the subject is using insulin.

[0080] In some embodiments, the disqualification criteria further include a pregnancy indication.

[0081] In some embodiments, the disqualification criteria further include a dialysis indication.

[0082] In some embodiments, the disqualification criteria further include a critical illness indication.

[0083] In some embodiments, the reader device is a smart phone.

[0084] In many embodiments, an analyte monitoring system includes: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor isconfigured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, allowing the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program.

[0085] Exemplary embodiments of the invention are set out in the following numbered clauses.Clause 1. An analyte monitoring system, comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, receive an input from the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program, wherein the qualification criteria include a non-minimum age indication and a non-diabetic indication.Clause 2. The analyte monitoring system of clause 1, wherein the non-minimum age indication is an indication that the subject is younger than 18 years old.Clause 3. The analyte monitoring system of clause 1 or 2, wherein the non-diabetic indication is an indication that the subject is not diagnosed with diabetics.Clause 4. The analyte monitoring system of clause 1, 2 or 3, wherein the disqualification criteria further include an insulin usage indication.Clause 5. The analyte monitoring system of clause 4, wherein the insulin usage indication is an indication that the subject is using insulin.Clause 6. The analyte monitoring system of any preceding clause, wherein the disqualification criteria further include a pregnancy indication.Clause 7. The analyte monitoring system of any preceding clause, wherein the disqualification criteria further include a dialysis indication.Clause 8. The analyte monitoring system of any preceding clause, wherein the disqualification criteria further include a critical illness indication.Clause 9. The analyte monitoring system of any preceding clause, wherein the reader device is a smart phone.Clause 10. The analyte monitoring system of any preceding clause, wherein the one or more functions of the analyte monitoring software program is receiving the analyte data indicative of the analyte level of the subject from the sensor control device.Clause 11. The analyte monitoring system of any preceding clause, wherein in response to a determination that the selected answers do not include at least one disqualification criteria, prompt the subject to start using the system.Clause 12. The analyte monitoring system of any preceding clause, wherein the reader device comprises a transceiver configured to communicate with a computer system.Clause 13. The analyte monitoring system of any preceding clause, wherein in response to a determination that the selected answers include at least one disqualification criteria, the one or more processors are further caused to: display a notification indicating that the subject is not the intended user for the analyte monitoring system; and receive an input from the user in response to the notification; before disabling the one or more functions of the analyte monitoring software application.Clause 14. An analyte monitoring system, comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, receiving an input from the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program.

Claims

What is claimed is:

1. An analyte monitoring system, comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, receive an input from the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software application, wherein the qualification criteria include a non-minimum age indication and a non-diabetic indication.

2. The analyte monitoring system of claim 1, wherein the non-minimum age indication is an indication that the subject is younger than 18 years old.

3. The analyte monitoring system of claim 1 , wherein the non-diabetic indication is an indication that the subject is not diagnosed with diabetics.

4. The analyte monitoring system of claim 1, wherein the disqualification criteria further include an insulin usage indication.

5. The analyte monitoring system of claim 4, wherein the insulin usage indication is an indication that the subject is using insulin.

6. The analyte monitoring system of claim 1, wherein the disqualification criteria further include a pregnancy indication.

7. The analyte monitoring system of claim 1, wherein the disqualification criteria further include a dialysis indication.

8. The analyte monitoring system of claim 1, wherein the disqualification criteria further include a critical illness indication.

9. The analyte monitoring system of claim 1, wherein the reader device is a smart phone.

10. The analyte monitoring system of claim 1, wherein the one or more functions of the analyte monitoring software program is receiving the analyte data indicative of the analyte level of the subject from the sensor control device.

11. The analyte monitoring system of claim 1, wherein in response to a determination that the selected answers do not include at least one disqualification criteria, prompt the subject to start using the system.

12. The analyte monitoring system of claim 1, wherein the reader device comprises a transceiver configured to communicate with a computer system.

13. The analyte monitoring system of claim 1 , wherein in response to a determination that the selected answers include at least one disqualification criteria, the one or more processors are further caused to: display a notification indicating that the subject is not the intended user for the analyte monitoring system; and receive an input from the user in response to the notification;before disabling the one or more functions of the analyte monitoring software application.

14. An analyte monitoring system, comprising: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of an analyte level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application that, when executed by the one or more processors, cause the one or more processors to: display a questionnaire on a display of the reader device, receiving an input from the subject to select one or more answers from the questionnaire, determine whether the one or more of the selected answers include at least one disqualification criteria, and in response to a determination that the selected answers include at least one disqualification criteria, disable one or more functions of the analyte monitoring software program.

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