Analyte Sensor Calibration Management

• US 20090247857A1
• Filed: 01/30/2009
• Published: 10/01/2009
• Est. Priority Date: 03/28/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Doniger, Kenneth J., Hayter, Gary, Harper, Wesley Scott, Dunn, Timothy Christian, Budiman, Erwin S.
• Granted Patent: US 8,346,335 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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:

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; and

performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period.

2. The method of claim 1 wherein the signal from the analyte sensor is associated with a monitored analyte level.

3. The method of claim 1 wherein the detected attenuation in the signal from the analyte sensor is associated with an early signal attenuation condition.

4. The method of claim 1 wherein the predetermined time period does not exceed approximately 24 hours.

5. The method of claim 1 wherein categorizing the detected analyte sensor signal attenuation is based at least in part on a predetermined plurality of signal attenuation conditions.

6. The method of claim 5 wherein the plurality of signal attenuation conditions includes a reportable signal condition, a conditional reportable signal condition, and an unreportable signal condition.

7. The method of claim 6 including outputting data associated with the monitored analyte level based on the detected analyte sensor signal when the detected analyte sensor signal attenuation includes a reportable signal condition or a conditional reportable signal condition.

8. The method of claim 7 wherein outputting data associated with the monitored analyte level includes outputting data for a preset time period when the detected analyte sensor signal attenuation includes the conditional reportable signal condition.

9. The method of claim 8 wherein the preset time period does not exceed approximately two hours.

10. The method of claim 8 including requesting a reference blood glucose measurement during the preset time period.

11. The method of claim 10 including calibrating the analyte sensor signal based at least in part on the reference blood glucose measurement received during the preset time period.

12. The method of claim 8 including disabling outputting of the data associated with the monitored analyte level after the preset time period has elapsed.

13. The method of claim 1 wherein performing signal processing includes:

requesting a reference data; and

determining a sensitivity value associated with the analyte sensor based on the reference data.

14. The method of claim 13 wherein the reference data includes an in vitro blood glucose measurement data.

15. The method of claim 13 including calibrating the analyte sensor based at least in part on the determined sensitivity value.

16. A method, comprising:

monitoring for a signal level below a predetermined threshold associated with analyte level from an analyte sensor during a predefined time period; and

reporting analyte level associated with the analyte sensor when the signal level monitored is not detected during the predefined time period.

17. The method of claim 16, wherein the predefined time period is less than approximately one hour.

18. The method of claim 16, including:

receiving a blood glucose measurement; and

calibrating the analyte sensor based on the received blood glucose measurement.

19. The method of claim 16 wherein the predetermined threshold is associated with one or more of an impending hypoglycemic state, or a predefined signal attenuation level.

20. The method of claim 16 wherein reporting the analyte level includes one or more of storing the analyte level, confirming the analyte level, or outputting the analyte level.

21. A method of initializing a glucose sensor, the method comprising:

inserting at least a portion of a glucose sensor beneath a skin surface of an individual;

analyzing glucose-related signal from the sensor to determine sensor stability; and

reporting glucose related information to the individual only when it is determined that the sensor is stable;

wherein the glucose related information is not reported prior to determination that the sensor is stable.

22. The method of claim 21 wherein sensor stability is determined using reference data.

23. The method of claim 21 wherein the reference data comprises sampling blood of the individual.

24. The method of claim 21 wherein the reference data is obtained from a glucose test strip.

25. The method of claim 24 including analyzing the sensor signal to determine whether there exists a decrease in sensor signal.

26. The method of claim 24 wherein the analyte sensor reports the glucose related information in about one hour following the insertion.

27. An apparatus, comprising:

a data communication interface;

one or more processors operatively coupled to the data communication interface; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to position an analyte sensor in fluid contact with an analyte, detect an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, categorize the detected attenuation in the analyte sensor signal based, at least in part, on one or more characteristics of the signal, and perform signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period.

28. The apparatus of claim 27 wherein the signal from the analyte sensor is associated with a monitored analyte level.

29. The apparatus of claim 27 wherein the detected attenuation in the signal from the analyte sensor is associated with an early signal attenuation condition.

30. The apparatus of claim 27 wherein the predetermined time period does not exceed approximately 24 hours.

39. The apparatus of claim 27 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to request a reference data, and determine a sensitivity value associated with the analyte sensor based on the reference data.

40. The apparatus of claim 39 wherein the reference data includes an in vitro blood glucose measurement data.

41. The apparatus of claim 39 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the analyte sensor based at least in part on the determined sensitivity value.

31. The apparatus of claim wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to categorize the detected analyte sensor signal attenuation based at least in part on a predetermined plurality of signal attenuation conditions.

32. The apparatus of claim 31 wherein the plurality of signal attenuation conditions includes a reportable signal condition, a conditional reportable signal condition, and an unreportable signal condition.

33. The apparatus of claim 32 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to output data associated with the monitored analyte level based on the detected analyte sensor signal when the detected analyte sensor signal attenuation includes a reportable signal condition or a conditional reportable signal condition.

34. The apparatus of claim 33 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to output data for a preset time period when the detected analyte sensor signal attenuation includes the conditional reportable signal condition.

35. The apparatus of claim 34 wherein the preset time period does not exceed approximately two hours.

36. The apparatus of claim 34 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to request a reference blood glucose measurement during the preset time period.

37. The apparatus of claim 36 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the analyte sensor signal based at least in part on the reference blood glucose measurement received during the preset time period.

38. The apparatus of claim 34 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to disable the outputting of the data associated with the monitored analyte level after the preset time period has elapsed.

42. One or more storage devices having processor readable code embodied thereon, said processor readable code for programming one or more processors to estimate an analyte level, comprising:

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; and

performing signal processing to generate a reportable data associated with the detected analyte sensor signal during the predetermined time period.