IP Library Granted Patent US 10,835,162
Granted Patent B2
US 10,835,162 · App. 16/586,610 · Granted Nov 17, 2020

Advanced analyte sensor calibration and error detection

Inventors: Sebastian Böhm (San Diego, CA); Daiting Rong (San Diego, CA); Peter C. Simpson (Cardiff, CA)
Assignee: DexCom, Inc.
A61B5/1495A61B5/1451A61B5/1473A61B5/1486A61B5/14503A61B5/14517A61B5/14532A61B5/7257A61B5/7267G01D18/00G01N27/026G01N27/3274G01N33/49H05K999/00H05K999/99A61B5/14546A61B2560/0276
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Quick Facts
Patent No.
US 10,835,162
App. No.
16/586,610
Granted
Nov 17, 2020
Kind
B2
Abstract

Systems and methods for processing sensor data and self-calibration are provided. In some embodiments, systems and methods are provided which are capable of calibrating a continuous analyte sensor based on an initial sensitivity, and then continuously performing self-calibration without using, or with reduced use of, reference measurements. In certain embodiments, a sensitivity of the analyte sensor is determined by applying an estimative algorithm that is a function of certain parameters. Also described herein are systems and methods for determining a property of an analyte sensor using a stimulus signal. The sensor property can be used to compensate sensor data for sensitivity drift, or determine another property associated with the sensor, such as temperature, sensor membrane damage, moisture ingress in sensor electronics, and scaling factors.

Claims (54)

1. A method comprising:

manufacturing a plurality of transcutaneous electrochemical glucose sensors, wherein the plurality of transcutaneous electrochemical glucose sensors comprise a first transcutaneous electrochemical glucose sensor, wherein the first transcutaneous electrochemical glucose sensor is configured to measure glucose in an interstitial fluid of the host, wherein the first transcutaneous electrochemical glucose sensor comprises an ex vivo portion and an in vivo portion, wherein the first transcutaneous electrochemical glucose sensor is configured to operably connect to sensor electronics during a sensor session;

obtaining data associated with a first characteristic of the first transcutaneous electrochemical glucose sensor prior to the sensor session;

determining, based at least in part on the data associated with the first characteristic, a first sensitivity associated with the first transcutaneous electrochemical glucose sensor;

assigning a calibration code to the first transcutaneous electrochemical glucose sensor, wherein the calibration code is based at least in part on the first sensitivity;

storing information associated with the calibration code on the sensor electronics;

obtaining data associated with a second characteristic of the first transcutaneous electrochemical glucose sensor during the sensor session;

determining, based at least in part on the data associated with the second characteristic, a second sensitivity associated with the first transcutaneous electrochemical glucose sensor;

generating, based at least in part on the second sensitivity, a glucose value associated with an estimated glucose concentration; and

displaying the glucose value on a user interface.

2. The method of claim 1 , wherein the calibration code is part of a calibration encoded label.

3. The method of claim 1 , wherein the first transcutaneous electrochemical glucose sensor is formed as a wire.

4. The method of claim 1 , further comprising measuring a length of time the first transcutaneous electrochemical glucose sensor was dipped in a particular coating solution, and wherein the calibration code is further based at least in part on the measured dipping length of time.

5. The method of claim 1 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the first characteristic of the first transcutaneous electrochemical glucose sensor is associated with a thickness of the membrane of the first transcutaneous electrochemical glucose sensor.

6. The method of claim 5 , wherein the membrane is a membrane system.

7. The method of claim 5 , wherein the membrane is a membrane layer.

8. The method of claim 1 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the first characteristic of the first transcutaneous electrochemical glucose sensor is associated with a permeability of the membrane to glucose.

9. The method of claim 1 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the first characteristic of the first transcutaneous electrochemical glucose sensor is associated with a property of the membrane.

10. The method of claim 1 , wherein the second characteristic of the first transcutaneous electrochemical glucose sensor is associated with a measured temperature.

11. The method of claim 1 , wherein the first sensitivity is a sensitivity value.

12. The method of claim 1 , wherein the first sensitivity is a sensitivity distribution.

13. The method of claim 1 , wherein the second sensitivity is a sensitivity value.

14. The method of claim 1 , wherein the second sensitivity is a sensitivity distribution.

15. A method comprising:

manufacturing a plurality of transcutaneous electrochemical glucose sensors, wherein the plurality of transcutaneous electrochemical glucose sensors comprise a first transcutaneous electrochemical glucose sensor, wherein the first transcutaneous electrochemical glucose sensor is configured to measure glucose in an interstitial fluid of the host, wherein the first transcutaneous electrochemical glucose sensor comprises an ex vivo portion and an in vivo portion, wherein the first transcutaneous electrochemical glucose sensor is configured to operably connect to sensor electronics during a sensor session;

determining a first distribution associated with a sensitivity of the first transcutaneous electrochemical glucose sensor;

obtaining data associated with a characteristic of the first transcutaneous electrochemical glucose sensor prior to the sensor session; and

determining, based at least in part on the first distribution and based at least in part on the data associated with the characteristic of the first transcutaneous electrochemical glucose sensor, a second distribution associated with sensor sensitivity of the first transcutaneous electrochemical glucose sensor.

16. The method of claim 15 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a thickness of the membrane of the first transcutaneous electrochemical glucose sensor.

17. The method of claim 15 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a permeability of the membrane to glucose.

18. The method of claim 15 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a property of the membrane.

19. A method comprising:

manufacturing a plurality of transcutaneous electrochemical glucose sensors, wherein the plurality of transcutaneous electrochemical glucose sensors comprise a first transcutaneous electrochemical glucose sensor, wherein the first transcutaneous electrochemical glucose sensor is configured to measure glucose in an interstitial fluid of the host, wherein the first transcutaneous electrochemical glucose sensor comprises an ex vivo portion and an in vivo portion, wherein the first transcutaneous electrochemical glucose sensor is configured to operably connect to sensor electronics during a sensor session;

determining a distribution associated with a sensitivity of the first transcutaneous electrochemical glucose sensor;

obtaining data associated with a characteristic of the first transcutaneous electrochemical glucose sensor prior to the sensor session; and

determining, based at least in part on the first distribution and based at least in part on the data associated with the characteristic of the first transcutaneous electrochemical glucose sensor, a value associated with a sensitivity of the first transcutaneous electrochemical glucose sensor.

20. The method of claim 19 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a thickness of the membrane of the first transcutaneous electrochemical glucose sensor.

21. The method of claim 19 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a permeability of the membrane to glucose.

22. The method of claim 19 , wherein the first transcutaneous electrochemical glucose sensor comprises a membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a property of the membrane.

23. A method comprising:

manufacturing a plurality of transcutaneous electrochemical glucose sensors, wherein the plurality of transcutaneous electrochemical glucose sensors comprise a first transcutaneous electrochemical glucose sensor and a second transcutaneous electrochemical glucose sensor, wherein the first transcutaneous electrochemical glucose sensor and the second transcutaneous electrochemical analyte sensor are each configured to measure glucose in an interstitial fluid of a host, wherein the first transcutaneous electrochemical glucose sensor and the second transcutaneous electrochemical glucose sensor each comprises an ex vivo portion and an in vivo portion, wherein the first transcutaneous electrochemical glucose sensor and the second transcutaneous electrochemical glucose sensor are each configured to operably connect to sensor electronics during a sensor session;

obtaining data associated with a characteristic of the first transcutaneous electrochemical glucose sensor prior to the sensor session;

determining, based at least in part on the data associated with the first transcutaneous electrochemical glucose sensor, a first sensitivity, wherein the first sensitivity is associated with a sensitivity of the first transcutaneous electrochemical glucose sensor;

assigning, to the first transcutaneous electrochemical glucose sensor, a first code associated with calibration, wherein the first code is associated with the first sensitivity;

obtaining data associated with a characteristic of the second transcutaneous electrochemical glucose sensor prior to the sensor session;

determining, based at least in part on the data associated with the second transcutaneous electrochemical glucose sensor, a second sensitivity, wherein the second sensitivity is associated with a sensitivity of the second transcutaneous electrochemical glucose sensor; and

assigning, to the second transcutaneous electrochemical glucose sensor, a second code associated with calibration, wherein the second code is associated with the second sensitivity;

wherein the first code and the second code are different.

24. The method of claim 23 , wherein the characteristic of the first transcutaneous electrochemical glucose sensor and the characteristic of the second transcutaneous electrochemical glucose sensor are the same.

25. The method of claim 23 , wherein the first transcutaneous electrochemical glucose sensor comprises a first membrane, wherein the second transcutaneous electrochemical glucose sensor comprises a second membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a thickness of the first membrane of the first transcutaneous electrochemical glucose sensor, wherein the characteristic of the second transcutaneous electrochemical glucose sensor is associated with a thickness of the second membrane of the second transcutaneous electrochemical glucose sensor.

26. The method of claim 23 , wherein the first transcutaneous electrochemical glucose sensor comprises a first membrane, wherein the second transcutaneous electrochemical glucose sensor comprises a second membrane, wherein the characteristic of the first transcutaneous electrochemical glucose sensor is associated with a permeability of the first membrane to glucose, wherein the characteristic of the second transcutaneous electrochemical glucose sensor is associated with a permeability of the second membrane to glucose.

27. The method of claim 23 , wherein the first transcutaneous electrochemical glucose sensor and the second transcutaneous each comprises a membrane, wherein the first characteristic of the first transcutaneous electrochemical glucose sensor and the second characteristic of the second transcutaneous electrochemical sensor are each associated with a property of the membrane.

28. The method of claim 23 , wherein the first sensitivity and the second sensitivity are sensitivity values.

29. The method of claim 23 , wherein the first sensitivity and the second sensitivity are sensitivity distributions.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2020
From: BOHM, SEBASTIAN; RONG, DAITING; SIMPSON, PETER C.
To: DEXCOM, INC.
Reel/Frame 051482/0882 →
Continuity (8)
Continuation 16460943 · Jul 2, 2019
Continuation 16405887 · May 7, 2019
Continuation 15994905 · May 31, 2018
Continuation 14860392 · Sep 21, 2015
Continuation 13446977 · Apr 13, 2012
Continuation 13446848 · Apr 13, 2012
Provisional Application 61476145 · Apr 15, 2011
Related Publication 20200037936A1 · Feb 6, 2020
Cited By (3)
US 12,318,200 US 12,343,143 US 12,666,543