Method and Apparatus for Detecting False Hypoglycemic Conditions

• US 20120265031A1
• Filed: 05/21/2012
• Published: 10/18/2012
• 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: Feldman, Benjamin Jay, Heller, Adam, Kiaie, Namvar
• Granted Patent: US 9,050,041 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 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.

2. The method of claim 1 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.

3. The method of claim 1 wherein the hypoglycemic alarm is asserted when the glucose level directional change and the first physiological parameter direction change are the same.

4. The method of claim 3 wherein the alarm is asserted only when the second physiological parameter directional change is opposite the first physiological parameter directional change.

5. The method of claim 1 wherein the monitored directional change in glucose level has a negative slope.

6. The method of claim 1 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.

7. The method of claim 1 wherein the monitoring time period includes approximately five days or seven days.

8. The method of claim 1 wherein the hypoglycemic alarm initialization is detected when the monitored directional change in glucose level exceeds a predetermined threshold.

9. The method of claim 8 wherein the predetermined threshold includes a decreasing rate of glucose level of approximately 2 mg/dL/minute.

10. The method of claim 1 wherein comparing the directional change includes temporarily disabling the hypoglycemic alarm initialization based on the comparison.

11. The method of claim 10 wherein the hypoglycemic alarm initialization is disabled when the directional change of the first and second physiological parameters are the same.

12. The method of claim 11 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.

13. 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.

14. The apparatus of claim 13 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.

15. The apparatus of claim 13 wherein the hypoglycemic alarm is asserted when the glucose level directional change and the first physiological parameter direction change are the same.

16. The apparatus of claim 15 wherein the alarm is asserted only when the second physiological parameter directional change is opposite the first physiological parameter directional change.

17. The apparatus of claim 13 wherein the monitored directional change in glucose level has a negative slope.

18. The apparatus of claim 13 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.

19. The apparatus of claim 13 wherein the monitoring time period includes approximately five days or seven days.

20. The apparatus of claim 13 wherein the hypoglycemic alarm initialization is detected when the monitored directional change in glucose level exceeds a predetermined threshold.

21. The apparatus of claim 20 wherein the predetermined threshold includes a decreasing rate of glucose level of approximately 2 mg/dL/minute.

22. The apparatus of claim 13 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.

23. The apparatus of claim 22 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.

24. The apparatus of claim 23 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.