EP-4739211-A1 - ANALYTE MONITORING SYSTEMS

EP4739211A1EP 4739211 A1EP4739211 A1EP 4739211A1EP-4739211-A1

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.

Inventors

NAGRA, Saranpreet S.
KABEL-ECKES, SABINE
PARTHASARATHY, VYSHNNAVI
LOREY, Daniel J.

Assignees

Abbott Diabetes Care Inc.

Dates

Publication Date: 20260513
Application Date: 20240705

Claims (14)

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.

Description

ANALYTE MONITORING SYSTEMS FIE 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 younger than 18 years old. Tn other embodiments, the disqualification criteria include a non-diabetic indicati