Sensitivity calibration of in vivo sensors used to measure analyte concentration

• US 9,675,290 B2
• Filed: 10/29/2013
• Issued: 06/13/2017
• Est. Priority Date: 10/30/2012
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Budiman, Erwin Satrya, Hayter, Gary Alan
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/066,650
• Publication Number:
  US 20140121480A1
• Time in Patent Office: 1,323 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods, devices, systems, and computer program products are provided to improve sensitivity calibration of an in vivo analyte sensor and usability of an associated analyte monitoring system. In certain embodiments, methods are provided that improve the user experience of using an analyte monitoring system. Certain embodiments of the present disclosure include features that reduce the amount of calibration or re-calibration performed by the analyte monitoring system. More specifically methods of using a suspect calibration attempt to avoid having to recalibrate by adjusting the calibration or mitigating effects of sensor signal attenuation that caused the calibration attempt to be suspect are provided. Additional features are disclosed.

Claims

1. A computer-implemented method, comprising:

receiving a signal representative of sensor data from an analyte sensor configured to monitor an analyte level over time;

calibrating the analyte sensor if attenuation of the received signal from the analyte sensor is not detectable;

deferring calibration of the analyte sensor if attenuation of the received signal from the analyte sensor is detectable when calibration is requested, wherein the calibration is deferred until the attenuation of the received signal is no longer detected;

storing the signal from the analyte sensor for a period of time spanning from before the calibration to after the calibration;

determining whether a previously undetected signal attenuation has occurred during the calibration based on the stored signal after the calibration has been completed;

performing reconstruction of the received signal based on the stored signal from the analyte sensor for the period of time spanning from before the calibration to after the calibration, when it is determined that the previously undetected signal attenuation has occurred, to generate a reconstructed signal;

determining whether the previously undetected signal attenuation is continuing to occur in the reconstructed signal according to at least one attenuation characterization;

in response to the previously undetected signal attenuation not continuing to occur in the reconstructed signal, updating the calibration of the analyte sensor based on the reconstructed signal; and

in response to the previously undetected signal attenuation continuing to occur in the reconstructed signal, invalidating the calibration of the analyte sensor and requesting a new calibration of the analyte sensor.

2. The method of claim 1, further including displaying an analyte concentration value corresponding to the monitored analyte level if the previously undetected signal attenuation did not occur during calibration based on the stored signal.

3. The method of claim 2, further comprising suspending displaying the analyte concentration value if the calibration of the analyte sensor is invalidated and the previously undetected signal attenuation is greater than a predefined threshold.

4. The method of claim 1, further comprising displaying an analyte concentration value when the new calibration is performed and the previously undetected signal attenuation is less than a predefined threshold.

5. The method of claim 1, further comprising delaying invalidating the calibration if the previously undetected signal attenuation is determined to be continuing to occur.

6. The method of claim 1, wherein deferring calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further includes detecting signal attenuation from at least one of a hardware system condition, an environmental condition, and a physiological condition.

7. The method of claim 1, wherein deferring calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further includes detecting signal attenuation from at least one of early signal attenuation and a dropout.

8. A system for monitoring an analyte using an in vivo sensor, the system comprising:

a processor; and

a memory operatively coupled to the processor, the memory storing instructions which, when executed by the processor, causes the processor to;

receive a signal representative of sensor data from an analyte sensor configured to monitor an analyte level over time;

calibrate the analyte sensor if attenuation of the received signal from the analyte sensor is not detectable;

defer calibration of the analyte sensor if attenuation of the received signal from the analyte sensor is detectable when calibration is requested, wherein the calibration is deferred until the attenuation of the received signal is no longer detected;

store the signal from the analyte sensor for a period of time spanning from before the calibration to after the calibration;

determine whether a previously undetected signal attenuation has occurred during the calibration based on the stored signal after the calibration has been completed;

perform reconstruction of the received signal based on the stored signal from the analyte sensor for the period of time spanning from before the calibration to after the calibration, when it is determined that the previously undetected signal attenuation has occurred, to generate a reconstructed signal;

determine whether the previously undetected signal attenuation is continuing to occur in the reconstructed signal according to at least one attenuation characterization;

in response to the previously undetected signal attenuation not continuing to occur in the reconstructed signal, update the calibration of the analyte sensor based on the reconstructed signal; and

in response to the previously undetected signal attenuation continuing to occur in the reconstructed signal, invalidate the calibration of the analyte sensor and request a new calibration of the analyte sensor.

9. The system of claim 8, further including instructions to display an analyte concentration value corresponding to the monitored analyte level if the previously undetected signal attenuation did not occur during calibration based on the stored signal.

10. The system of claim 9, further including instructions to suspend displaying the analyte concentration value if the calibration of the analyte sensor is invalidated and the previously undetected signal attenuation is greater than a predefined threshold.

11. The system of claim 8, further including instructions to display an analyte concentration value when the new calibration is performed and the previously undetected signal attenuation is less than a predefined threshold.

12. The system of claim 8, further including instructions to delay invalidating the calibration if the previously undetected signal attenuation is determined to be continuing to occur.

13. The system of claim 8, wherein the instructions to defer calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further include instructions to detect signal attenuation from at least one of a hardware system condition, an environmental condition, and a physiological condition.

14. The system of claim 8, wherein the instructions to defer calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further include instructions to detect signal attenuation from at least one of early signal attenuation and a dropout.

15. A computer program product stored on a computer-readable medium comprising instructions to:

receive a signal representative of sensor data from an analyte sensor configured to monitor an analyte level over time;

calibrate the analyte sensor if attenuation of the received signal from the analyte sensor is not detectable;

defer calibration of the analyte sensor if attenuation of the received signal from the analyte sensor is detectable when calibration is requested, wherein the calibration is deferred until the attenuation of the received signal is no longer detected;

store the signal from the analyte sensor for a period of time spanning from before the calibration to after the calibration;

determine whether a previously undetected signal attenuation has occurred during the calibration based on the stored signal after the calibration has been completed;

perform reconstruction of the received signal based on the stored signal from the analyte sensor for the period of time spanning from before the calibration to after the calibration, when it is determined that the previously undetected signal attenuation has occurred, to generate a reconstructed signal;

determine whether the previously undetected signal attenuation is continuing to occur in the reconstructed signal according to at least one attenuation characterization;

in response to the previously undetected signal attenuation not continuing to occur in the reconstructed signal, update the calibration of the analyte sensor based on the reconstructed signal; and

in response to the previously undetected signal attenuation continuing to occur in the reconstructed signal, invalidate the calibration of the analyte sensor and request a new calibration of the analyte sensor.

16. The computer program product of claim 15, further including instructions to display an analyte concentration value corresponding to the monitored analyte level if the previously undetected signal attenuation did not occur during calibration based on the stored signal.

17. The computer program product of claim 16, further including instructions to suspend displaying the analyte concentration value if the calibration of the analyte sensor is invalidated and the previously undetected signal attenuation is greater than a predefined threshold.

18. The computer program product of claim 15, further including instructions to display an analyte concentration value when the new calibration is performed and the previously undetected signal attenuation is less than a predefined threshold.

19. The computer program product of claim 15, further including instructions to delay invalidating the calibration if the previously undetected signal attenuation is determined to be continuing to occur.

20. The computer program product of claim 15, wherein the instructions to defer calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further include instructions to detect signal attenuation from at least one of a hardware system condition, an environmental condition, and a physiological condition.

21. The computer program product of claim 15, wherein the instructions to defer calibration if attenuation of the signal from the analyte sensor is determined to be continuing to occur further include instructions to detect signal attenuation from at least one of early signal attenuation and a dropout.