Analyte monitoring: stabilizer for subcutaneous glucose sensor with incorporated antiglycolytic agent

• US 10,219,728 B2
• Filed: 07/29/2014
• Issued: 03/05/2019
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ouyang, Tianmei, Liu, Zenghe, Cho, Hyun, Feldman, Benjamin J.
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US14/445,750
• Publication Number:
  US 20140336486A1
• Time in Patent Office: 1,680 Days
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Claims

1. A method for monitoring levels of glucose in a subject, the method comprising:

determining over a period of time substantially immediately clinically accurate levels of glucose from signals generated by a glucose sensor after the glucose sensor is positioned into skin of a subject at an analyte determination site, the glucose sensor comprising;

a working electrode comprising a sensing layer disposed thereon, the sensing layer comprising a glucose responsive enzyme,

a membrane comprising at least one active agent comprising an antiglycolytic agent or precursor, the membrane disposed over at least a portion of the sensing layer, and

a counter electrode,

wherein the at least one active agent comprising the antiglycolytic agent or precursor thereof contacts the analyte determination site.

2. The method according to claim 1, wherein a Clark Error Grid is used to determine the clinically accurate levels of glucose from signals generated by the glucose sensor.

3. The method according to claim 1, wherein a MARD analysis is used to determine the clinically accurate levels of glucose from signals generated by the glucose sensor.

4. The method according to claim 1, wherein a Parks Error Grid is used to determine the clinically accurate levels of glucose from signals generated by the glucose sensor.

5. The method according to claim 1, wherein a Continuous Glucose Error Grid is used to determine the clinically accurate levels as of glucose from signals generated by the glucose sensor.

6. The method according to claim 1, wherein the clinically accurate levels of glucose from the signals generated by the glucose sensor are determined automatically.

7. The method according to claim 1, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined continuously.

8. The method according to claim 1, wherein clinically accurate levels of glucose from the signals generated by the glucose sensor are determined periodically.

9. The method according to claim 1, wherein the period of time is one hour.

10. The method according to claim 1, wherein the period of time is three days or more.

11. The method according to claim 1, wherein the period of time is greater than one week.

12. The method according to claim 1, wherein the glucose sensor is positioned into the skin of the subject after one calibration of the glucose sensor.

13. The method according to claim 1, wherein the glucose sensor is positioned into the skin of the subject without calibrating the glucose sensor.

14. The method according to claim 1, wherein determining the clinically accurate levels of glucose from the signals generated by the glucose sensor comprises observing no spurious glucose measurements.

15. The method according to claim 1, wherein the sensing layer further comprises an electron transfer agent.

16. The method according to claim 15, wherein the glucose responsive enzyme and electron transfer agent are bonded to the sensing layer.

17. The method according to claim 1, wherein the glucose sensor further comprises one of:

an interferent-eliminating layer; and

a biocompatible layer.

18. The method according to claim 1, wherein the membrane is a mass transfer limiting membrane.

19. The method according to claim 1, wherein the glucose sensor is integrated with a drug delivery system and, further comprising, administering a drug based on the signals generated by the glucose sensor.