End of life detection for analyte sensors

• US 9,977,010 B2
• Filed: 05/26/2017
• Issued: 05/22/2018
• Est. Priority Date: 01/03/2013
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Bhavaraju, Naresh C., Garcia, Arturo, Hampapuram, Hari, Kamath, Apurv Ullas, Mahalingam, Aarthi, Sokolovskyy, Dmytro, Vanslyke, Stephen J.
• Primary Examiner(s): Macchiarolo, Peter
• Assistant Examiner(s): Megna Fuentes, Anthony W
• Application Number:
  US15/606,954
• Publication Number:
  US 20170261491A1
• Time in Patent Office: 361 Days
• Field of Search: 600319, 600316, 600347, 600364, 600365, 600323-340
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0266 for monitoring or limiting apparatus function
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: G01M 99/008 by doing functionality tests
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16C 20/80 Data visualisation
• CPC Class Codes: G16C 99/00 Subject matter not provided for in other groups of this subclass

Abstract

Systems and methods for processing sensor data and end of life detection are provided. In some embodiments, a method for determining the end of life of a continuous analyte sensor includes evaluating a plurality of risk factors using an end of life function to determine an end of life status of the sensor and providing an output related to the end of life status of the sensor. The plurality of risk factors may be selected from the list including the number of days the sensor has been in use, whether there has been a decrease in signal sensitivity, whether there is a predetermined noise pattern, whether there is a predetermined oxygen concentration pattern, and error between reference BG values and EGV sensor values.

Claims

1. A system for determining end of life of a continuous analyte sensor, the system comprising sensor electronics configured to be operably connected to a continuous analyte sensor, the sensor electronics configured to:

evaluate a rate of change of sensor sensitivity factor associated with end of life symptoms of the continuous analyte sensor, wherein the rate of change of sensor sensitivity factor is based at least in part on a skew moving average of uncalibrated sensor data;

determine an end of life status of the continuous analyte sensor by comparing the evaluated rate of change of sensor sensitivity factor to a rate of change threshold; and

provide an output related to the end of life status of the continuous analyte sensor, wherein the sensor electronics are configured to provide the output by disabling display of sensor data.

2. The system of claim 1, wherein the sensor electronics are configured to evaluate the rate of change of sensor sensitivity factor by evaluating at least one of a direction of rate of change of sensor sensitivity, an amplitude of rate of change of sensor sensitivity, a derivative of rate of change of sensor sensitivity, or a comparison of the rate of change of sensor sensitivity to a priori rate of change sensitivity information.

3. The system of claim 1, wherein the sensor electronics comprise a processor module, the processor module comprising instructions stored in memory, wherein the instructions, when executed by the processor module, cause the sensor electronics to evaluate the rate of change of sensor sensitivity factor, determine the end of life status, and provide the output.

4. The system of claim 1, wherein the sensor electronics is configured to evaluate the rate of change of sensor sensitivity factor, determine the end of life status, and provide the output within a predetermined time frame after sensor initialization of the continuous analyte sensor, wherein the sensor initialization is determined by the sensor electronics in response to an event that indicates a new sensor has been implanted, including one or more of:

a user providing input to the system that a new sensor has been implanted, the system detecting electrical connection to a sensor, a predetermined amount of time transpiring since the system prompted a user to use a new sensor.

5. The system of claim 1, wherein the sensor electronics are configured to collect a data point or series of data points from the continuous analyte sensor being used, and wherein the evaluation of the rate of change of sensor sensitivity factor associated with end of life symptoms of the continuous analyte sensor comprises evaluation of the collected data point or series of data points.

6. The system of claim 1, wherein the uncalibrated sensor data includes raw sensor data including raw data counts.

7. The system of claim 1, wherein the rate of change threshold includes an average value or a range of values of an average of the uncalibrated sensor data.

8. The system of claim 1, wherein the output comprises a quantitative value corresponding to the moving average of the uncalibrated sensor data.

9. The system of claim 1, wherein the output comprises a binary indicator of the end of life status.

10. The system of claim 1, wherein the output further includes an indicator of sensitivity decline of the continuous analyte sensor.

11. A method for determining end of life of a continuous analyte sensor, comprising:

evaluating a rate of change of sensor sensitivity factor associated with end of life symptoms of a continuous analyte sensor, wherein the rate of change of sensor sensitivity factor is based at least in part on a moving average of uncalibrated sensor data;

determining an end of life status of the continuous analyte sensor by comparing the evaluated rate of change of sensor sensitivity factor to a rate of change threshold; and

providing an output related to the end of life status of the continuous analyte sensor, wherein the providing the output comprises disabling display of sensor data.

12. The method of claim 11, wherein evaluating the rate of change of sensor sensitivity factor comprises evaluating at least one of a direction of rate of change of sensor sensitivity, an amplitude of rate of change of sensor sensitivity, a derivative of rate of change of sensor sensitivity or a comparison of the rate of change of sensor sensitivity to a priori rate of change sensitivity information.

13. The method of claim 11, wherein the evaluating the rate of change of sensor sensitivity factor, the determining the end of life status, and the providing the output is performed within a predetermined time frame after sensor initialization of the continuous analyte sensor, the method further comprising determining the sensor initialization in response to an event that indicates a new sensor has been implanted, including one or more of:

a user providing input to a sensor system that a new sensor has been implanted, the sensor system detecting electrical connection to a sensor, a predetermined amount of time transpiring since the system prompted a user to use a new sensor.

14. The method of claim 11, further comprising collecting a data point or series of data points from the continuous analyte sensor being used, wherein the evaluating the rate of change of sensor sensitivity factor associated with end of life symptoms of the continuous analyte sensor comprises evaluating the collected data point or series of data points.

15. The method of claim 11, wherein the uncalibrated sensor data includes raw sensor data including raw data counts.

16. The method of claim 11, wherein the rate of change threshold includes an average value or a range of values of an average of the uncalibrated sensor data.

17. The method of claim 11, wherein the output comprises a quantitative value corresponding to the moving average of the uncalibrated sensor data.

18. The method of claim 11, wherein the output comprises a binary indicator of the end of life status.

19. The method of claim 11, wherein the output further includes an indicator of sensitivity decline of the continuous analyte sensor.