Method and Apparatus for Detecting False Hypoglycemic Conditions

• US 20110105873A1
• Filed: 10/29/2010
• Published: 05/05/2011
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kiaie, Namvar, Feldman, Benjamin Jay, Heller, Adam
• Granted Patent: US 8,185,181 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with an analyte during a first time period;

detecting 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 a plurality of time spaced temperature data during the first time period;

determining 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; and

asserting 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 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 further including determining 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.

7. The method of claim 6 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.

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

9. 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.

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

11. A method, comprising:

receiving a plurality of time spaced analyte related data monitored by an analyte sensor in fluid contact with an analyte during a first time period;

detecting 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 a plurality of time spaced temperature data during the first time period;

detecting when one or more of the time spaced temperature related data crosses a predetermined threshold temperature level during the first time period; and

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

12. The method of claim 11 further including determining 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.

13. The method of claim 12 wherein the first time period precedes the second time period.

14. The method of claim 11 wherein the asserted notification is associated with a medically significant condition.

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

16. A method, comprising:

monitoring a variation in on-skin temperature in proximity to a transcutaneously positioned analyte sensor having at least a portion in fluid contact with an analyte during a monitoring time period;

detecting the variation in the monitored temperature exceeding a predetermined threshold level;

confirming a presence of a medically significant condition when the detected variation in the monitored temperature exceeds the predetermined threshold level; and

asserting a notification associated with the medically significant condition when it is confirmed;

wherein confirming the presence of the medically significant condition includes determining a variation in the monitored analyte level exceeding the predetermined threshold level based on comparing a slope indicative of the change in the monitored analyte level substantially to a slope indicative of the change in the monitored on-skin temperature variation.

17. A method, comprising:

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.

18. The method of claim 17 wherein the decrease in the monitored analyte level includes a decrease exceeding approximately 2 mg/dL/minute.

19. The method of claim 17 wherein the decrease in the monitored on-skin temperature includes a temperature decrease exceeding approximately 2°

C./15 minutes.

20. The method of claim 17 wherein detecting the concurrent occurrence includes:

determining a rate of change of the monitored analyte level during a predetermined time period;

determining a rate of change of the monitored on-skin temperature during the predetermined time period; and

verifying the determined rate of change of the monitored analyte level and the determined rate of change of the monitored on-skin temperature exceeds a predetermined threshold level substantially at the same time.

21. A method of confirming hypoglycemic condition in a patient, comprising:

monitoring a directional change in glucose level based on data stream received from an analyte sensor during a monitoring time period;

monitoring a directional change in a first physiological parameter during the monitoring time period;

monitoring a directional change in a second physiological parameter during the monitoring time period;

detecting an initialization of a hypoglycemic alarm based at least in part on the directional change of the monitored glucose level; and

comparing the directional change in one or more of the first or the second physiological parameters relative to the directional change in the glucose level prior to the assertion of the hypoglycemic alarm.

22. The method of claim 21 wherein the first physiological parameter or the second physiological parameter is one of a temperature level, a perspiration level, heart rate, detected tremor, or oxygen saturation level.

23. The method of claim 21 wherein the hypoglycemic alarm is asserted when the glucose level directional change and the first physiological parameter direction change are the same.

24. The method of claim 23 wherein the alarm is asserted only when the second physiological parameter directional change is opposite the first physiological parameter directional change.

25. The method of claim 21 wherein the monitored directional change in glucose level has a negative slope.

26. The method of claim 21 wherein the monitored directional change in the first physiological parameter has a negative slope, and further, wherein the monitored directional change in the second physiological parameter has a positive slope.

27. The method of claim 21 wherein the monitoring time period includes approximately five days or seven days.

28. The method of claim 21 wherein the hypoglycemic alarm initialization is detected when the monitored directional change in glucose level exceeds a predetermined threshold.

29. The method of claim 28 wherein the predetermined threshold includes a decreasing rate of glucose level of approximately 2 mg/dL/minute.

30. The method of claim 21 wherein comparing the directional change includes temporarily disabling the hypoglycemic alarm initialization based on the comparison.

31. The method of claim 30 wherein the hypoglycemic alarm initialization is disabled when the directional change of the first and second physiological parameters are the same.

32. The method of claim 31 wherein the hypoglycemic alarm initialization is disabled when the directional change of the monitored glucose level does not coincide with the directional change of either of the first and second physiological parameters.

33. An apparatus, comprising:

one or more processors; and

a memory for 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 an analyte 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 the time spaced temperature data to the predetermined threshold level when the determined rate of change of the received plurality of time spaced analyte related data exceeds a 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 predetermined threshold level.

34. The apparatus of claim 33 wherein the asserted notification includes one or more of an audible alert, a vibratory alert, a visual alert, or one or more combinations thereof.

35. The apparatus of claim 33 wherein the predetermined threshold level includes 3% decrease between each adjacent time spaced analyte related data and 3% decrease between each adjacent time temperature data.

36. The apparatus of claim 33 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.

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

38. The apparatus of claim 37 wherein the medically significant condition includes an impending hypoglycemic condition.

39. The apparatus of claim 33 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 the exceeds the predetermined threshold level substantially at the same time during the first time period.

40. The apparatus of claim 33 wherein the first time period corresponds to an analyte sensor life.

41. The apparatus of claim 33 wherein when the determined rate of change of the received plurality of the time spaced temperature data does not exceed the predetermined threshold level, deactivating a notification function configured to be asserted when the determined rate of change of the analyte related data exceeds the predetermined threshold level.

42. The apparatus of claim 41 wherein the deactivated notification function includes a hypoglycemic alarm.

43. An apparatus, comprising:

one or more processors; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor a variation in on-skin temperature in proximity to a transcutaneously positioned analyte sensor having at least a portion in fluid contact with an analyte during a monitoring time period, detect the variation in the monitored temperature exceeding a predetermined threshold level, confirm a presence of a medically significant condition when the detected variation in the monitored temperature exceeds the predetermined threshold level, and assert a notification associated with the medically significant condition when it is confirmed;

wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a variation in the monitored analyte level exceeding the predetermined threshold level based on comparing a slope indicative of the change in the monitored analyte level substantially to a slope indicative of the change in the monitored on-skin temperature variation.

44. An apparatus, comprising:

one or more processors; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to detect a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirm a presence of an impending hypoglycemic condition, and assert a notification corresponding to the confirmed impending hypoglycemic condition.

45. The apparatus of claim 44 wherein the decrease in the monitored analyte level includes a decrease exceeding approximately 2 mg/dL/minute.

46. The apparatus of claim 44 wherein the decrease in the monitored on-skin temperature includes a temperature decrease exceeding approximately 2°

C./15 minutes.

47. The apparatus of claim 44 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a rate of change of the monitored analyte level during a predetermined time period, determine a rate of change of the monitored on-skin temperature during the predetermined time period, and verify the determined rate of change of the monitored analyte level and the determined rate of change of the monitored on-skin temperature exceeds a predetermined threshold level substantially at the same time.

48. An apparatus, comprising:

one or more processors; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor a directional change in glucose level based on data stream received from an analyte sensor during a monitoring time period, monitor a directional change in a first physiological parameter during the monitoring time period, monitor a directional change in a second physiological parameter during the monitoring time period, detect an initialization of a hypoglycemic alarm based at least in part on the directional change of the monitored glucose level, and compare the directional change in one or more of the first or the second physiological parameters relative to the directional change in the glucose level prior to the assertion of the hypoglycemic alarm.

49. The apparatus of claim 48 wherein the first physiological parameter or the second physiological parameter is one of one of a temperature level, a perspiration level, heart rate, detected tremor, or oxygen saturation level.

50. The apparatus of claim 48 wherein the hypoglycemic alarm is asserted when the glucose level directional change and the first physiological parameter direction change are the same.

51. The apparatus of claim 50 wherein the alarm is asserted only when the second physiological parameter directional change is opposite the first physiological parameter directional change.

52. The apparatus of claim 48 wherein the monitored directional change in glucose level has a negative slope.

53. The apparatus of claim 48 wherein the monitored directional change in the first physiological parameter has a negative slope, and further, wherein the monitored directional change in the second physiological parameter has a positive slope.

54. The apparatus of claim 48 wherein the monitoring time period includes approximately five days or seven days.

55. The apparatus of claim 48 wherein the hypoglycemic alarm initialization is detected when the monitored directional change in glucose level exceeds a predetermined threshold.

56. The apparatus of claim 50 wherein the predetermined threshold includes a decreasing rate of glucose level of approximately 2 mg/dL/minute.

57. The apparatus of claim 48 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to temporarily disable the hypoglycemic alarm initialization based on the comparison.

58. The apparatus of claim 57 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to disable the hypoglycemic alarm initialization when the directional change of the first and second physiological parameters are the same.

59. The apparatus of claim 58 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to disable the hypoglycemic alarm initialization when the directional change of the monitored glucose level does not coincide with the directional change of either of the first and second physiological parameters.