Method and system for providing calibration of an analyte sensor in an analyte monitoring system

• US 10,278,630 B2
• Filed: 11/30/2017
• Issued: 05/07/2019
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary Alan, Doniger, Kenneth J., Budiman, Erwin Satrya, Zhang, Songbiao, Mazza, John Charles
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US15/828,410
• Publication Number:
  US 20180085037A1
• Time in Patent Office: 523 Days
• Field of Search: 600309, 600345-366
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Method and apparatus for providing calibration of analyte sensor including applying a control signal, detecting a measured response to the control signal, determining a variance in the detected measured response, and estimating a sensor sensitivity based on the variance in the detected measured response is provided.

Claims

1. A method of calibrating an analyte sensor, comprising:

applying one or more control signals to the analyte sensor, including a most recent control signal;

receiving one or more measured responses to the one or more control signals, including a most recent measured response to the most recent control signal;

for each of the one or more measured responses and the one or more control signals, determining a difference in the measured response to the control signal between a beginning of a half duty cycle and an end of a half duty cycle of the measured response to the control signal;

determining that the number of the one or more control signals exceeds a predetermined threshold; and

in response to determining that the number of the one or more control signals exceeds the predetermined threshold, determining an analyte sensor sensitivity based on the difference in the measured response between the beginning of the half duty cycle and the end of the half duty cycle of the most recent measured response to the most recent control signal.

2. The method of claim 1, wherein applying the one or more control signals comprises providing one or more perturbations of the analyte sensor.

3. The method of claim 2, wherein applying the one or more control signals to the analyte sensor include controlling a poise voltage for the analyte sensor.

4. The method of claim 2, wherein applying the one or more control signals to the analyte sensor includes providing one or more perturbations by a mechanical transducer.

5. The method of claim 4, wherein the analyte sensor comprises a membrane;

and wherein determining the analyte sensor sensitivity further comprises detecting one or more fluctuations in the membrane of the analyte sensor in response to the one or more perturbations by the mechanical transducer, and determining a thickness of the membrane based on the one or more fluctuations in the membrane of the analyte sensor.

6. The method of claim 1, wherein receiving the one or more measured responses comprises determining one or more voltage signals which are substantially proportional to a current signal level on an electrode of the analyte sensor.

7. The method of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

8. The method of claim 7, wherein the analyte-responsive enzyme is chemically bonded to the polymer.

9. The method of claim 7, wherein the working electrode further comprises a mediator.

10. The method of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

11. The method of claim 10, wherein the mediator is chemically bonded to the polymer.

12. A device, comprising:

an analyte sensor;

a processor; and

a memory storing instructions which, when executed by the processor, cause the processor to;

apply one or more control signals to the analyte sensor, including a most recent control signal;

receive one or more measured responses to the one or more control signals, including a most recent measured response to the most recent control signal;

for each of the one or more measured responses and the one or more control signals, determine a difference in the measured response to the control signal between a beginning of a half duty cycle and an end of a half duty cycle of the measured response to the control signal;

determine that the number of the one or more control signals exceeds a predetermined threshold; and

in response to determining that the number of the one or more control signals exceeds the predetermined threshold, determine an analyte sensor sensitivity based on the difference in the measured response between the beginning of the half duty cycle and the end of the half duty cycle of the most recent measured response to the most recent control signal.

13. The device of claim 12, storing instructions to apply the one or more control signals by at least providing one or more perturbations of the analyte sensor.

14. The device of claim 13, storing instructions to apply the one or more control signals to the analyte sensor by at least controlling a poise voltage for the analyte sensor.

15. The device of claim 13, further comprising a mechanical transducer;

wherein the analyte sensor comprises a membrane; and

storing instructions to apply the one or more control signals to the analyte sensor by at least providing one or more perturbations by the mechanical transducer, determine the analyte sensor sensitivity by at least detecting one or more fluctuations in the membrane of the analyte sensor in response to the one or more perturbations by the mechanical transducer, and determine a thickness of the membrane based on the one or more fluctuations in the membrane of the analyte sensor.

16. The device of claim 12, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

17. The device of claim 16, wherein the analyte-responsive enzyme is chemically bonded to the polymer.

18. The device of claim 16, wherein the working electrode further comprises a mediator.

19. The device of claim 12, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

20. The device of claim 19, wherein the mediator is chemically bonded to the polymer.