Method for non-invasive blood glucose monitoring

• US 8,676,284 B2
• Filed: 10/15/2010
• Issued: 03/18/2014
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Novanex, Inc.
• Original Assignee: Novanex, Inc.
• Inventors: He, Zongyan
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US12/905,817
• Publication Number:
  US 20120095303A1
• Time in Patent Office: 1,250 Days
• Field of Search: 600300-529
• US Class Current: 600/316
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6817 Ear canal

Abstract

A method for noninvasive blood glucose monitoring involves metabolic heat measurement and algorithm to correct interferences from environmental factors, and physiological or pathological conditions of subjects.

Claims

1. A method for noninvasively determining blood glucose in a subject, comprising:

setting an initial temperature for a blood glucose index probe, wherein the blood glucose index is a period for a defined temperature rise or temperature rise for a defined period;

in body cavity(s) measuring;

the blood glucose index with the initialized blood glucose index probe; and

a local humidity;

measuring an environmental temperature;

measuring an environmental humidity; and

deducing from the measured values and calibration data including chemically measured blood glucose the current blood glucose value.

2. The method of claim 1, further comprising measuring a basal body temperature, wherein the deducing is from the measured values including the basal body temperature.

3. The method of claim 1, further comprising measuring a basal metabolism, wherein the deducing is from the measured values including the basal metabolism.

4. The method of claim 1, further comprising measuring a body temperature, wherein the deducing is from the measured values including the body temperature.

5. The method of claim 4, wherein the blood glucose index is measured in one ear canal, and the local humidity and body temperature are measured in the second ear canal.

6. The method of claim 1, wherein the a blood glucose index is measured in an ear canal.

7. The method of claim 6, wherein the local humidity and body temperature are measured in an ear canal.

8. The method of claim 1, further comprising measuring one or more of a pulse or a blood oxygen level, wherein the deducing is from the measured values including the pulse and/or blood oxygen level.

9. The method of claim 1, further comprising:

inputting data including one or more of fasting blood glucose, 2-hour postprandial blood glucose, basal body temperature, basal metabolic rate or medical condition data;

categorizing the subject into one of at least two categories;

selecting one of two or more separate empirical formulas dependent on the categorizing; and

conducting the deducing with the selected empirical formula.

10. The method of claim 9, wherein the categorization is in part based on whether a normal range of fasting blood glucose or one or more ranges of elevated fasting blood glucose pertains.

11. The method of claim 9, wherein the categorization is in part based on whether a low range, normal range, or elevated range of 2-hour postprandial blood glucose pertains.

12. The method of claim 9, wherein the categorization is in part based on whether a low range, a normal range, or one or more elevated ranges of basal body temperature pertains.

13. The method of claim 9, wherein the categorization is in part based on whether one or more low ranges, a normal range, or one or more elevated ranges of basal metabolism pertains.

14. The method of claim 1, wherein calibration data including chemically measured blood glucose includes data taken under the basal metabolic state.

15. The method of claim 14, wherein calibration data including chemically measured blood glucose further includes data taken the subjects more current physiological state.

16. The method of claim 1, wherein the blood glucose index is measured in one ear canal, and the local humidity is measured in the second ear canal.

17. The method of claim 1, wherein deducing utilizes a estimate for the normal body temperature at the given time of day of the operation of the method, and wherein the estimate for various times of day are refined from data collected with each operation of the method.

18. An apparatus for measuring the blood glucose in a subject comprising:

a controller;

connected to the controller, a blood glucose index probe;

connected to the controller, local humidity probe;

connected to the controller, an environmental temperature probe; and

connected to the controller, an environmental humidity probe;

a heater and/or cooler for bringing the blood glucose index probe to an initial temperature,

wherein the controller is programmed to deduce from values obtained from the probes and calibration data including chemically measured blood glucose the current blood glucose value, wherein the blood glucose index is a period for a defined temperature rise or temperature rise for a defined period.

19. The apparatus of claim 18, wherein the controller is connected to a probe local temperature and/or a probe for heart rate and/or a probe for blood oxygen saturation, and uses the values obtained from one or more of these probes to deduce the current blood glucose value.

20. The apparatus of claim 18, wherein the controller is connected to a probe local temperature, a probe for heart rate and a probe for blood oxygen saturation, and uses the values obtained from these probes to deduce the current blood glucose value.

21. The apparatus of claim 18, wherein the blood glucose index and the local humidity probes are configured to fit in separate ear canals.