Analyte sensor calibration management

• US 9,320,462 B2
• Filed: 05/05/2014
• Issued: 04/26/2016
• Est. Priority Date: 03/28/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Harper, Wesley Scott, Dunn, Timothy Christian, Budiman, Erwin Satrya, Doniger, Kenneth J., Hayter, Gary Alan
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/270,332
• Publication Number:
  US 20140243638A1
• Time in Patent Office: 722 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorizing the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period, managing if and when to request additional reference signal measurements, and managing if and when to temporarily not display results.

Claims

1. A method, comprising:

programming a processor of an in vivo glucose monitoring system to;

determine if a predetermined number of signals from a glucose sensor positioned in fluid contact with interstitial fluid is below a threshold level during a predefined period of time following glucose sensor positioning;

detect attenuation in the predetermined number of signals when it is determined that the predetermined number of signals is below the threshold level during the predefined period of time following glucose sensor positioning;

report information related to a monitored glucose level when the predetermined number of signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning;

report information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning; and

control administration of therapy based on the reported information related to the monitored glucose level;

wherein the detected attenuation in the predetermined number of signals is associated with a condition of the glucose sensor.

2. The method of claim 1, wherein the predefined time period is a fixed time period during the time period of sensor wear between glucose sensor positioning and glucose sensor life expiration.

3. The method of claim 1, wherein the detected attenuation is associated with an early signal attenuation condition.

4. The method of claim 1, wherein programming the processor of the in vivo glucose monitoring system to report information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning includes programming the processor to report information related to the glucose sensor condition.

5. The method of claim 4, wherein information related to the glucose sensor condition includes glucose sensor status.

6. The method of claim 1, wherein programming the processor of the in vivo glucose monitoring system to report information related to the monitored glucose level when the predetermined number of the signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning includes programming the processor to report one or more of real time or historical monitored glucose level in the interstitial fluid.

7. The method of claim 1, wherein the glucose sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

8. An apparatus, comprising:

an in vivo glucose sensor for monitoring glucose level and having at least a portion positioned in fluid contact with interstitial fluid; and

a processor programmed to determine if a predetermined number of signals from the in vivo glucose sensor is below a threshold level during a predefined period of time following glucose sensor positioning, to detect attenuation in the predetermined number of signals when it is determined that the predetermined number of signals is below the threshold level during the predefined period of time following glucose sensor positioning, to report information related to a monitored glucose level when the predetermined number of the signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning, to report information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning, and to control administration of therapy based on the reported information related to the monitored glucose level, wherein the detected attenuation in the predetermined number of signals is associated with a condition of the glucose sensor.

9. The apparatus of claim 8, wherein the predefined time period is a fixed time period during the time period of sensor wear between glucose sensor positioning and glucose sensor life expiration.

10. The apparatus of claim 8, wherein the detected attenuation is associated with an early signal attenuation condition.

11. The apparatus of claim 8, wherein the processor programmed to report information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning is programmed to report information related to the glucose sensor condition.

12. The apparatus of claim 11, wherein information related to the glucose sensor condition includes glucose sensor status.

13. The apparatus of claim 8, wherein the processor programmed to report information related to the monitored glucose level when the predetermined number of the signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning is programmed to report one or more of real time or historical monitored glucose level in the interstitial fluid.

14. The apparatus of claim 8, wherein the glucose sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

15. A method, comprising:

detecting, using one or more processors, attenuation in a predetermined number of signals from a glucose sensor when the predetermined number of signals is below a threshold level during a predefined period of time following positioning the glucose sensor in fluid contact with interstitial fluid;

reporting information related to a monitored glucose level when the predetermined number of the signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning;

reporting information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning; and

control administration of therapy based on the reported information related to the monitored glucose level;

wherein the detected attenuation in the predetermined number of signals is associated with a condition of the glucose sensor.

16. The method of claim 15, wherein the predefined time period is a fixed time period during a time period of sensor wear between glucose sensor positioning and glucose sensor life expiration.

17. The method of claim 15, wherein reporting information related to the glucose sensor when the predetermined number of signals is determined to be below the threshold level during the predefined period of time following glucose sensor positioning includes reporting information related to the glucose sensor condition.

18. The method of claim 17, wherein information related to the glucose sensor condition includes glucose sensor status.

19. The method of claim 15, wherein reporting information related to the monitored glucose level when the predetermined number of the signals is not determined to be below the threshold level during the predefined period of time following glucose sensor positioning includes reporting one or more of real time or historical monitored glucose levels in the interstitial fluid.

20. The method of claim 15, wherein the glucose sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.