Electrochemical impedance spectroscopy enabled continuous glucose monitoring sensor system

• US 8,868,151 B2
• Filed: 08/16/2010
• Issued: 10/21/2014
• Est. Priority Date: 08/14/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Telson, Stanley A., Gifford, Raeann, Fei, Jiangfeng, Reynolds, Jeffery S.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BERHANU, ETSUB D
• Application Number:
  US12/857,116
• Publication Number:
  US 20110040163A1
• Time in Patent Office: 1,527 Days
• Field of Search: 600/345, 600/347, 600/354
• US Class Current: 600/345
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

The use of electrical impedance spectroscopy to adjust calibration settings in an in vivo monitoring system, such as an in vivo continuous glucose monitoring sensor. The adjustments can compensate for the condition of the sensor membrane in vivo.

Claims

1. A method of testing the condition of a continuous analyte monitoring sensor in vivo comprising:

obtaining a reference capacitance value for the continuous analyte sensor;

inserting the continuous analyte sensor in vivo;

performing electrochemical impedance spectroscopy on the in vivo sensor to obtain an in vivo capacitance value; and

comparing, by electrochemical impedance equipment, the in vivo capacitance value to the reference capacitance value to identify particular characteristics of the in vivo sensor, wherein the step of performing electrochemical impedance spectroscopy is conducted during in vivo insertion.

2. The method of claim 1, wherein the sensor further comprises an external counter electrode, wherein when the in vivo capacitance value is zero or intermittently zero during insertion, the sensor is not in sufficient contact with interstitial fluid or the external counter electrode is not in contact with a skin of a user.

3. The method of claim 2, further comprising warning the user to reinsert the sensor.

4. The method of claim 1, wherein when the in vivo capacitance value is greater than the reference capacitance value during insertion, the sensor coating is damaged, and a warning to the user to replace the sensor is provided.

5. The method of claim 1, wherein the step of obtaining the reference capacitance value is conducted after the step of inserting.

6. The method of claim 1, wherein the step of comparing is conducted by a Bode plot to identify phase shifts.

7. The method of claim 1, wherein the sensor further comprises a working electrode within a sensor membrane and a membrane layer overlies an outer surface of the sensor membrane.

8. The method of claim 7, wherein the comparing step identifies whether the sensor is in a proper position and whether the membrane layer is damaged.

9. The method of claim 1, further comprising determining whether the in vivo capacitance value is equal to, less than, or greater than the reference capacitance value during insertion to identify the particular characteristic of the sensor.

10. The method of claim 9, further comprising an external electrode, wherein when the in vivo capacitance value is zero or intermittently zero during insertion, the sensor is identified as being in an improper position.

11. The method of claim 9, wherein when the in vivo capacitance value is greater than the reference capacitance value during insertion, the sensor coating is identified as being damaged.

12. The method of claim 9, wherein when the in vivo capacitance value is less than the reference capacitance value during insertion, the sensor coating is identified as being intact.

13. The method of claim 1, wherein the in vivo capacitance value is a first in vivo capacitance value, the method further comprising:

performing electrochemical impedance spectroscopy on the in vivo sensor to obtain a second in vivo capacitance value, and

comparing the second in vivo capacitance value to the first in vivo capacitance value to adjust a calibration profile of the continuous glucose sensor in vivo.

14. A method of testing the condition of a continuous analyte monitoring sensor in vivo comprising:

obtaining a reference impedance value for the continuous analyte sensor;

inserting the continuous analyte sensor in vivo;

performing electrochemical impedance spectroscopy on the in vivo sensor to obtain an in vivo impedance value; and

comparing, by electrochemical impedance equipment, the in vivo impedance value to the reference impedance value to identify particular characteristics of the in vivo sensor, wherein the step of performing electrochemical impedance spectroscopy is conducted during in vivo insertion.

15. The method of claim 14, wherein the sensor further comprises a working electrode within a sensor membrane and a membrane layer overlies an outer surface of the sensor membrane, and wherein the comparing step identifies whether the sensor is in a proper position or whether the membrane layer is damaged.

16. The method of claim 14, wherein the sensor further comprises an external counter electrode.

17. The method of claim 14, wherein the step of comparing is further conducted by using a Bode plot to identify phase shifts.