Method and apparatus for detecting false hypoglycemic conditions

• US 9,050,041 B2
• Filed: 05/21/2012
• Issued: 06/09/2015
• 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
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US13/477,026
• Publication Number:
  US 20120265031A1
• Time in Patent Office: 1,114 Days
• Field of Search: 600/309, 600/316, 600345-347, 600/365
• US Class Current: 1/1
• 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 system, comprising:

a glucose sensor positioned in fluid contact with interstitial fluid under a skin layer and configured to generate signals corresponding to a monitored glucose level in the interstitial fluid;

sensor electronics including a power supply electrically coupled to the glucose sensor and configured to communicate signals generated by the glucose sensor; and

a data receiver configured to receive the signals generated by the glucose sensor and communicated by the sensor electronics, the data receiver including;

one or more processors;

an output unit operatively coupled to the 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 the glucose level based on the signals generated by the glucose sensor and received from the sensor electronics during a monitoring time period, monitor a directional change in a first physiological parameter including a temperature level during the monitoring time period, monitor a directional change in a second physiological parameter during the monitoring time period, the second physiological parameter including one of a perspiration level, heart rate, detected tremor, or oxygen saturation level, 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.

2. The system of claim 1, wherein the hypoglycemic alarm is asserted when the glucose level directional change and the first physiological parameter directional change are the same.

3. The system of claim 2, wherein the alarm is asserted only when the second physiological parameter directional change is opposite the first physiological parameter directional change.

4. The system of claim 1, wherein the monitored directional change in the glucose level has a negative slope.

5. The system 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.

6. The system of claim 1, wherein the monitoring time period includes approximately five days or seven days.

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

8. The system of claim 7, wherein the predetermined threshold includes a decreasing rate of the glucose level of approximately 2 mg/dL/minute.

9. The system of claim 1, 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.

10. The system of claim 9, 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 the second physiological parameters are the same.

11. The system of claim 10, 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 the second physiological parameters.