IP Library › Granted Patent US 10,925,524
Granted Patent B2
US 10,925,524 · App. 16/742,793 · Granted Feb 23, 2021

System and methods for processing analyte sensor data for sensor calibration

Inventors: Jack Pryor (Ladera Ranch, CA); Apurv Ullas Kamath (San Diego, CA); Paul V. Goode, Jr. (Round Rock, TX); James H. Brauker (Addison, MI); Aarthi Mahalingam (San Diego, CA)
Assignee: DexCom, Inc.
A61B5/14546A61B5/0031A61B5/1451A61B5/1473A61B5/1495A61B5/14532A61B5/14865A61B5/1468A61B5/1486A61B5/14503A61B5/14735A61B2560/0223Y02A90/10
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Quick Facts
Patent No.
US 10,925,524
App. No.
16/742,793
Granted
Feb 23, 2021
Kind
B2
Abstract

Systems and methods for processing sensor analyte data are disclosed, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. The sensor can be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. Reference data resulting from benchtop testing an analyte sensor prior to its insertion can be used to provide initial calibration of the sensor data. Reference data from a short term continuous analyte sensor implanted in a user can be used to initially calibrate or update sensor data from a long term continuous analyte sensor.

Claims (36)

1. A method for calibrating a transcutaneous analyte sensor, comprising:

receiving sensor data from a transcutaneous analyte sensor, wherein the sensor data is indicative of an analyte concentration in a host;

determining a conversion function, using a processor module, wherein the conversion function comprises at least one of a slope or a baseline, wherein the slope is representative of a sensor sensitivity, and wherein the at least one of the slope or the baseline is determined by selecting a most probable slope and/or baseline based at least in part on prior distribution information of slopes or baselines, wherein the prior distribution information is generated before insertion of the transcutaneous analyte sensor in the host;

converting the sensor data using the conversion function;

generating an estimated analyte value based at least in part on the converted sensor data; and

displaying, on a display, the generated estimated analyte value.

2. The method of claim 1 , wherein determining the conversion function comprises determining the slope based at least in part on prior slope distribution information.

3. The method of claim 2 , wherein determining the slope comprises selecting a most probable slope from a distribution of slopes based at least in part on the prior slope distribution information.

4. The method of claim 1 , wherein determining the conversion function comprises determining the baseline based at least in part on prior baseline distribution information.

5. The method of claim 4 , wherein determining the baseline comprises selecting a most probable baseline from a distribution of baselines based at least in part on the prior baseline distribution information.

6. The method of claim 1 , wherein determining the conversion function comprises determining the slope and the baseline based at least in part on prior slope and baseline distribution information.

7. The method of claim 6 , wherein determining the slope and the baseline comprises selecting a most probable slope and baseline from a distribution of slopes and baselines based at least in part on the prior slope and baseline distribution information.

8. The method of claim 7 , wherein selecting the most probable slope and baseline comprises selecting a slope and baseline closest to the maximum joint probability of both the slope and baseline distributions.

9. The method of claim 1 , where determining the conversion function comprises selecting one of a plurality of possible calibration lines having various baselines and slopes based at least in part on prior information indicative of typical distribution of slopes and/or baselines.

10. The method of claim 1 , wherein the slope is determined, at least in part, based on in-vitro slope information determined by a benchtop calibration process.

11. The method of claim 1 , further comprising receiving reference data from a reference analyte monitor, wherein the slope is determined, at least in part, based on the reference analyte value.

12. The method of claim 1 , wherein the prior distribution information is derived from in vivo testing of at least one other transcutaneous analyte sensor or in vitro testing of at least one other transcutaneous analyte sensor.

13. The method of claim 1 , wherein displaying the generated estimated analyte value is performed in substantially real time.

14. The method of claim 1 , wherein the analyte is glucose.

15. The method of claim 1 , wherein the prior distribution information comprises normal distributions.

16. The method of claim 1 , wherein the slope of the conversion function is determined based at least in part on corrections for a difference between an in viva sensor sensitivity and an in vitro sensor sensitivity.

17. The method of claim 1 , wherein receiving the sensor data from the transcutaneous analyte sensor is performed before determining the conversion function.

18. The method of claim 1 , wherein determining the conversion function is performed before receiving the sensor data from the transcutaneous analyte sensor.

19. A system for calibrating a transcutaneous analyte sensor, comprising:

a transcutaneous analyte sensor configured to provide sensor data indicative of an analyte concentration in a host;

a processor module configured to determine a conversion function, wherein the conversion function comprises at least one of a slope or a baseline, wherein the slope is representative of a sensor sensitivity, wherein the at least one of the slope or the baseline is determined by selecting a most probable slope and/or baseline based at least in part on prior distribution information, wherein the prior distribution information is generated before insertion of the transcutaneous analyte sensor in the host, wherein the processor module is configured to convert the sensor data using the conversion function, and wherein the processor module is configured to generate an estimated analyte value based at least in part on the converted sensor data; and

a display configured to display the generated estimated analyte value.

20. The system of claim 19 , wherein the processor module is configured to determine the slope based at least in part on prior slope distribution information.

21. The system of claim 20 , wherein the processor module is configured to determine the slope by selecting a most probable slope from a distribution of slopes based at least in part on the prior slope distribution information.

22. The system of claim 19 , wherein the processor module is configured to determine the baseline based at least in part on prior baseline distribution information.

23. The system of claim 22 , wherein the processor module is configured to determine the baseline by selecting a most probable baseline from a distribution of baselines based at least in part on the prior baseline distribution information.

24. The system of claim 19 , wherein the processor module is configured to determine the slope and the baseline based at least in part on prior slope and baseline distribution information.

25. The system of claim 16 , wherein the prior distribution information comprises normal distributions.

26. The system of claim 19 , wherein the slope of the conversion function is determined based at least in part on corrections for a difference between an in viva sensor sensitivity and an in vitro sensor sensitivity.

27. The system of claim 19 , wherein the prior distribution information is derived from in viva testing of at least one other transcutaneous analyte sensor or in vitro testing of at least one other transcutaneous analyte sensor.

28. The system of claim 19 , wherein the analyte is glucose.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2020
From: MAHALINGAM, AARTHI
To: DEXCOM, INC.
Reel/Frame 054031/0757 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2020
From: GOODE, PAUL V., JR.; BRAUKER, JAMES H.; KAMATH, APURV U.
To: DEXCOM, INC.
Reel/Frame 053018/0426 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2020
From: PRYOR, JACK
To: DEXCOM, INC.
Reel/Frame 053018/0447 →
Continuity (8)
Continuation 16457383 · Jun 28, 2019
Continuation 15787595 · Oct 18, 2017
Continuation 15065623 · Mar 9, 2016
Continuation 13607162 · Sep 7, 2012
Continuation 12683755 · Jan 7, 2010
Continuation 11373628 · Mar 9, 2006
Provisional Application 60660743 · Mar 10, 2005
Related Publication 20200146600A1 · May 14, 2020
Cited By (4)
US 12,453,494 US 12,458,257 US 12,458,258 US 12,690,787