IP Library Granted Patent US 10,709,364
Granted Patent B2
US 10,709,364 · App. 16/690,977 · Granted Jul 14, 2020

System and methods for processing analyte sensor data for sensor calibration

Inventors: Apurv Ullas Kamath (San Diego, CA); James H. Brauker (Addison, MI); Paul V. Goode, Jr. (Round Rock, TX); Aarthi Mahalingam (San Diego, CA); Jack Pryor (Ladera Ranch, CA)
Assignee: DexCom, Inc.
A61B5/14546A61B5/0031A61B5/1451A61B5/1473A61B5/1495A61B5/14532A61B5/14865A61B5/1468A61B5/1486A61B5/14503A61B5/14735A61B2560/0223Y02A90/26
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Quick Facts
Patent No.
US 10,709,364
App. No.
16/690,977
Granted
Jul 14, 2020
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 (20)

1. A glucose monitoring system comprising:

a transcutaneous electrochemical glucose sensor comprising an in vivo portion and an ex vivo portion, wherein the transcutaneous electrochemical sensor is characterized by an in vivo sensitivity and an in vitro sensitivity, wherein the in vivo sensitivity is different from the in vitro sensitivity, and wherein the in vitro sensitivity is predictive of the in vivo sensitivity due to a relationship therebetween;

sensor electronics configured to be operably connected to the transcutaneous electrochemical glucose sensor;

a processor configured to be operably connected to the sensor electronics;

a memory configured to be operably connected to the processor, wherein the memory has stored therein information associated with the in vivo sensitivity of the transcutaneous electrochemical glucose sensor, wherein the information associated with the in vivo sensitivity is based at least in part on corrections for the difference between the in vivo sensitivity and the in vitro sensitivity of the transcutaneous electrochemical glucose sensor.

2. The glucose monitoring system of claim 1 , wherein the relationship between the in vivo sensitivity and the in vitro sensitivity is established empirically by performing a clinical study and comparing in vivo sensitivities with in vitro sensitivities of a plurality of transcutaneous glucose sensors.

3. The glucose monitoring system of claim 1 , wherein the in vivo sensitivity is greater than the in vitro sensitivity.

4. The glucose monitoring system of claim 1 , wherein the processor is configured to calibrate sensor data from the transcutaneous electrochemical glucose sensor using the information associated with in vivo sensitivity of the transcutaneous electrochemical glucose sensor without reliance on reference glucose concentration values obtained after insertion of at least a portion of the transcutaneous electrochemical glucose sensor in a host.

5. A method for calibrating data from a transcutaneous electrochemical glucose sensor, the method comprising:

receiving sensor data from the transcutaneous electrochemical glucose sensor after at least a portion of the transcutaneous electrochemical glucose sensor is inserted in a host, wherein the sensor data is indicative of a glucose concentration in the host; and

calibrating, using a processor, the sensor data received from the transcutaneous electrochemical glucose sensor, wherein the calibrating is based at least in part on information associated with an in vivo sensitivity of the transcutaneous electrochemical glucose sensor, wherein the information associated with the in vivo sensitivity is based at least in part on corrections for a difference between the in vivo sensitivity and an in vitro sensitivity for the transcutaneous electrochemical glucose sensor.

6. The method for calibrating data from a transcutaneous electrochemical glucose sensor of claim 5 , wherein the calibrating requires no user calibrations after the at least a portion of the transcutaneous electrochemical glucose sensor is inserted in the host.

7. The method for calibrating data from a transcutaneous electrochemical glucose sensor of claim 5 , wherein the difference between the in vivo sensitivity and the in vitro sensitivity for the transcutaneous electrochemical glucose sensor is determined prior to the insertion of the at least a portion of the transcutaneous electrochemical glucose sensor into the host.

8. The method for calibrating data from a transcutaneous electrochemical glucose sensor of claim 5 , wherein the in vitro sensitivity for the transcutaneous electrochemical glucose sensor is based at least in part on sampling a plurality of transcutaneous electrochemical glucose sensors prior to inserting the at least a portion of the transcutaneous electrochemical glucose sensor in the host.

9. The method for calibrating data from a transcutaneous electrochemical glucose sensor of claim 8 , wherein the in vitro sensitivity is calculated at least in part by examining a signal response of each of the plurality of transcutaneous electrochemical glucose sensors to a set of known glucose concentrations.

10. A method for providing calibrated glucose information based on sensor data from a transcutaneous electrochemical glucose sensor, the method comprising:

receiving, by a processor, post-implantation sensor data from the transcutaneous electrochemical glucose sensor, wherein the sensor data is indicative of a glucose concentration in a host;

receiving, by the processor, information associated with an in vivo sensitivity of the transcutaneous electrochemical glucose sensor, wherein the information associated with the in vivo sensitivity is based at least in part on corrections for a difference between the in vivo sensitivity and an in vitro sensitivity for the transcutaneous electrochemical glucose sensor;

generating calibrated sensor data, using the processor, by using the information associated with the in vivo sensitivity of the transcutaneous electrochemical glucose sensor to calibrate the sensor data received from the transcutaneous electrochemical glucose sensor; and

providing the calibrated sensor data to a user to facilitate monitoring a glucose level of the host.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2020
From: MAHALINGAM, AARTHI
To: DEXCOM, INC.
Reel/Frame 052808/0695 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2019
From: GOODE, PAUL V., JR.; BRAUKER, JAMES H.; KAMATH, APURV ULLAS
To: DEXCOM, INC.
Reel/Frame 051131/0769 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 27, 2019
From: PRYOR, JACK
To: DEXCOM, INC.
Reel/Frame 051132/0062 →
Continuity (8)
Continuation 16457628 · 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 20200085354A1 · Mar 19, 2020
Cited By (13)
US 12,279,865 US 12,279,867 US 12,285,251 US 12,285,252 US 12,350,042 US 12,453,494 US 12,458,257 US 12,458,258 US 12,478,296 US 12,589,204 US 12,666,543 US 12,690,787 US 12,690,789