SYSTEM AND METHOD FOR DYNAMICALLY CALIBRATING AND MEASURING ANALYTE CONCENTRATION IN DIABETES MANAGEMENT MONITORS

• US 20150185225A1
• Filed: 07/31/2014
• Published: 07/02/2015
• Est. Priority Date: 12/27/2013
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Zheng, Ling, Petisce, James, Edney, Paul
• Granted Patent: US 10,379,125 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

Claims

1. An optical analyte sensor for determining a concentration of an analyte, comprising:

a matrix for receiving a sample containing the analyte at an unknown concentration;

a light emitter for emitting light at a stimulation frequency upon the sample;

a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, and for measuring an intensity of the fluorescence signal at the first and second frequencies;

a processor for determining a concentration of the analyte based on the respective intensities measured at the first and second frequencies.

2. The optical analyte sensor as claimed in claim 1, wherein the sensor is an in-vitro sensor.

3. The optical analyte sensor as claimed in claim 1, wherein the sensor is an in-vivo sensor.

4. The optical analyte sensor as claimed in claim 1, wherein the sensor is a continuous sensor.

5. The optical analyte sensor as claimed in claim 1, wherein the analyte is glucose.

6. The optical analyte sensor as claimed in claim 1, wherein the analyte is hemoglobin HbA1c.

7. The optical analyte sensor as claimed in claim 1, wherein the analyte is glycated albumin.

8. The optical analyte sensor as claimed in claim 1, wherein the matrix comprises a glucose binding protein that adopts a first conformation in the presence of glucose, and a second conformation in the absence of glucose.

9. The optical analyte sensor as claimed in claim 1, wherein the matrix comprises boronic acid.

10. The optical analyte sensor as claimed in claim 1, wherein the matrix comprises any analyte binding compound.

11. The optical analyte sensor as claimed in claim 1, wherein the matrix comprises any glucose binding compound.

12. A diabetes management system comprising an optical analyte sensor and an insulin infusion device, wherein the optical analyte sensor comprises:

a matrix for receiving a sample containing the analyte at an unknown concentration;

a light emitter for emitting light at a stimulation frequency upon the sample;

a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, and for measuring an intensity of the fluorescence signal at the first and second frequencies;

a processor for determining a concentration of the analyte based on the respective intensities measured at the first and second frequencies; and

wherein the analyte sensor further comprises a transceiver for transmitting a signal to the insulin infusion device.

13. The diabetes management system of claim 12, wherein the processor further determines an insulin requirement and wherein the signal transmitted to the insulin infusion device comprises an insulin requirement based on the determined insulin requirement.

14. The diabetes management system of claim 12, wherein the sensor is an in-vitro sensor.

15. The diabetes management system of claim 12, wherein the sensor is an in-vivo sensor.

16. The diabetes management system of claim 12, wherein the sensor is a continuous sensor.

17. The diabetes management system of claim 12, wherein the analyte is glucose.

18. The diabetes management system of claim 12, wherein the analyte is hemoglobin HbA1c.

19. The diabetes management system of claim 12, wherein the analyte is glycated albumin.

20. An optical analyte sensor comprising:

a matrix for receiving a sample containing the analyte at an unknown concentration;

a light emitter for emitting light at a stimulation frequency upon the sample;

a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, and for measuring an intensity of the fluorescence signal at the first and second frequencies;

a processor for determining a concentration of the analyte based on the respective intensities measured at the first and second frequencies;

wherein said processor further determines a sensor drift based on previous intensity measurements and corrects the determined concentration based on the determined sensor drift.

21. The optical analyte sensor of claim 20, further comprising a transceiver for transmitting signals indicative of determine analyte concentration to a remote device.

22. The optical analyte sensor of claim 21, wherein the remote device is a smartphone.

23. The optical analyte sensor of claim 21, wherein the transceiver transmits signals to a remote storage device.

24. The optical analyte sensor of claim 20, wherein the optical sensor comprises an energy source and is adapted for at least one day of continuous use.

25. The optical analyte sensor of claim 20, wherein the optical sensor is used in the subcutaneous space of a host.

26. The optical analyte sensor of claim 20, wherein the optical sensor is used in the intradermal space of a host.

27. The optical analyte sensor of claim 20, wherein the optical sensor is used in the supradermal space of a host.

28. The optical analyte sensor of claim 20, wherein the optical sensor is used in the intravascular space of a host.

29. The optical analyte sensor of claim 20, wherein the optical sensor is used in a bodily fluid.

30. The optical analyte sensor of claim 20, wherein the optical analyte sensor is an in-vitro sensor.