Method and apparatus for detecting false hypoglycemic conditions

• US 8,185,181 B2
• Filed: 10/29/2010
• Issued: 05/22/2012
• Est. Priority Date: 10/30/2009
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feldman, Benjamin Jay, Heller, Adam, Kiaie, Namvar
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/916,481
• Publication Number:
  US 20110105873A1
• Time in Patent Office: 571 Days
• Field of Search: 600345-347, 600/365, 435/4, 435/14, 422/50, 20440301-40315, 702/23
• US Class Current: 600/345
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Embodiments of the present disclosure include detecting a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirming a presence of an impending hypoglycemic condition, and asserting a notification corresponding to the confirmed impending hypoglycemic condition. Devices, methods, systems and kits incorporating the same are also provided.

Claims

1. A method, comprising:

receiving, using one or more processors, a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with interstitial fluid during a first time period;

detecting, using the one or more processors, when one or more of the received plurality of time spaced analyte related data crosses a predetermined analyte threshold level during the first time period;

receiving, using the one or more processors, a plurality of time spaced temperature data during the first time period;

determining, using the one or more processors, a rate of change of the received plurality of time spaced temperature data and detecting when the determined rate of change crosses a predetermined rate of temperature change;

determining, using the one or more processors, a rate of change of the received plurality of time spaced analyte related data and comparing a slope of the determined rate of change of the received plurality of time spaced analyte related data to a slope of the rate of change of the received plurality of time spaced temperature data; and

asserting, using the one or more processors, a notification when the determined rate of change of the received plurality of the time spaced temperature data reaches the predetermined rate of temperature change and when the one or more of the received plurality of time spaced analyte related data reaches the predetermined threshold analyte level during the first time period.

2. The method of claim 1 further including determining, using the one or more processors, when the monitored analyte level based on the received plurality of time spaced analyte related data indicates approaching the predetermined analyte threshold level during a second time period.

3. The method of claim 2 wherein the first time period precedes the second time period.

4. The method of claim 1 wherein the asserted notification includes one or more of an audible alert, a vibratory alert, a visual alert, or one or more combinations thereof.

5. The method of claim 1 wherein the predetermined analyte threshold level is associated with one of an impending hypoglycemic condition or an onset of hypoglycemic condition.

6. The method of claim 1 wherein the slope of the determined rate of change of the received plurality of analyte related data and the slope of the rate of change of the received plurality of time spaced temperature data are coincident.

7. The method of claim 1 wherein the asserted notification includes an impending hypoglycemic condition.

8. The method of claim 1 wherein when the determined rate of change of the received plurality of the time spaced temperature data does not exceed the predetermined rate of temperature change, deactivating a notification function.

9. The method of claim 8 wherein the deactivated notification function includes a hypoglycemic alarm.

10. An apparatus, comprising:

one or more processors; and

a memory storing instructions which, when executed by the one or more processors, causes the one or more processors to receive a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with interstitial fluid during a first time period, determine a rate of change of the received plurality of time spaced analyte related data, receive a plurality of time spaced temperature data during the first time period, determine a rate of change of the received plurality of time spaced temperature data, compare the determined rate of change of the received plurality of time spaced temperature data to a first predetermined threshold level when the determined rate of change of the received plurality of time spaced analyte related data exceeds a second predetermined threshold level, and assert a notification when the determined rate of change of the received plurality of the time spaced temperature data exceeds the first predetermined threshold level.

11. The apparatus of claim 10 wherein the asserted notification includes one or more of an audible alert, a vibratory alert, a visual alert, or one or more combinations thereof.

12. The apparatus of claim 10 wherein the second predetermined threshold level includes 3% decrease between each adjacent time spaced analyte related data, and further, wherein the first predetermined threshold level includes 3% decrease between each adjacent time spaced temperature data.

13. The apparatus of claim 10 wherein the determined rate of change of the received plurality of time spaced analyte related data and the determined rate of change of the received plurality of time spaced temperature data are temporally coincident.

14. The apparatus of claim 10 wherein the asserted notification is associated with a medically significant condition.

15. The apparatus of claim 14 wherein the medically significant condition includes an impending hypoglycemic condition.

16. The apparatus of claim 10 wherein the notification is asserted only when the determined rate of change of the received plurality of time spaced temperature data and the determined rate of change of the received analyte related data exceeds the respective first and second predetermined threshold levels substantially at the same time during the first time period.

17. The apparatus of claim 10 wherein the first time period corresponds to an analyte sensor life.

18. The apparatus of claim 10 further comprising the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to, when the determined rate of change of the received plurality of the time spaced temperature data does not exceed the first predetermined threshold level, deactivate a notification function configured to be asserted when the determined rate of change of the analyte related data exceeds the second predetermined threshold level.

19. The apparatus of claim 18 wherein the deactivated notification function includes a hypoglycemic alarm.

20. An apparatus, comprising:

one or more processors; and

a memory storing instructions which, when executed by the one or more processors, causes the one or more processors to receive a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with interstitial fluid during a first time period, detect when one or more of the received plurality of time spaced analyte related data crosses a predetermined analyte threshold level during the first time period, receive a plurality of time spaced temperature data during the first time period, determine a rate of change of the received plurality of time spaced temperature data and detect when the determined rate of change crosses a predetermined rate of temperature change, determine a rate of change of the received plurality of time spaced analyte related data, compare a slope of the determined rate of change of the received plurality of time spaced analyte related data to a slope of the rate of change of the received plurality of time spaced temperature data, and assert a notification when the determined rate of change of the received plurality of the time spaced temperature data reaches the predetermined rate of temperature change and when the one or more of the received plurality of time spaced analyte related data reaches the predetermined threshold analyte level during the first time period.

21. The apparatus of claim 20 further comprising the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to determine when the monitored analyte level based on the received plurality of time spaced analyte related data indicates approaching the predetermined analyte threshold level during a second time period.

22. The apparatus of claim 21 wherein the first time period precedes the second time period.

23. The apparatus of claim 20 wherein the asserted notification includes one or more of an audible alert, a vibratory alert, a visual alert, or one or more combinations thereof.

24. The apparatus of claim 20 wherein the predetermined analyte threshold level is associated with one of an impending hypoglycemic condition or an onset of hypoglycemic condition.

25. The apparatus of claim 20 wherein the slope of the determined rate of change of the received plurality of analyte related data and the slope of the rate of change of the received plurality of time spaced temperature data are coincident.

26. The apparatus of claim 20 wherein the asserted notification includes an impending hypoglycemic condition.

27. The apparatus of claim 20 further comprising the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to deactivate a notification function when the determined rate of change of the received plurality of the time spaced temperature data does not exceed the predetermined rate of temperature change.

28. The apparatus of claim 27 wherein the deactivated notification function includes a hypoglycemic alarm.

29. A method, comprising:

receiving, using one or more processors, a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with interstitial fluid during a first time period;

determining, using the one or more processors, a rate of change of the received plurality of time spaced analyte related data;

receiving, using the one or more processors a plurality of time spaced temperature data during the first time period;

determining, using the one or more processors, a rate of change of the received plurality of time spaced temperature data;

comparing, using the one or more processors, the determined rate of change of the received plurality of time spaced temperature data to a first predetermined threshold level when the determined rate of change of the received plurality of time spaced analyte related data exceeds a second predetermined threshold level; and

asserting, using the one or more processors, a notification when the determined rate of change of the received plurality of the time spaced temperature data exceeds the first predetermined threshold level.

30. The method of claim 29 wherein the asserted notification includes one or more of an audible alert, a vibratory alert, a visual alert, or one or more combinations thereof.

31. The method of claim 29 wherein the second predetermined threshold level includes 3% decrease between each adjacent time spaced analyte related data, and further, wherein the first predetermined threshold level includes 3% decrease between each adjacent time spaced temperature data.

32. The method of claim 29 wherein the determined rate of change of the received plurality of time spaced analyte related data and the determined rate of change of the received plurality of time spaced temperature data are temporally coincident.

33. The method of claim 29 wherein the asserted notification is associated with a medically significant condition.

34. The method of claim 33 wherein the medically significant condition includes an impending hypoglycemic condition.

35. The method of claim 29 including asserting the notification only when the determined rate of change of the received plurality of time spaced temperature data and the determined rate of change of the received analyte related data exceeds the respective first and second predetermined threshold levels substantially at the same time during the first time period.

36. The method of claim 29 wherein the first time period corresponds to an analyte sensor life.

37. The method of claim 29 further including when the determined rate of change of the received plurality of the time spaced temperature data does not exceed the first predetermined threshold level, deactivating a notification function configured to be asserted when the determined rate of change of the analyte related data exceeds the second predetermined threshold level.

38. The method of claim 37 wherein the deactivated notification function includes a hypoglycemic alarm.