Automatic analyte sensor calibration and error detection

Patent metadata

Field	Value
Publication number	US-11714060-B2
Application number	US-201916402124-A
Country	US
Kind code	B2
Filing date	May 2, 2019
Priority date	May 3, 2018
Publication date	Aug 1, 2023
Grant date	Aug 1, 2023

Abstract

Systems and methods are provided that address the need to frequently calibrate analyte sensors, according to implementation. In more detail, systems and methods provide a preconnected analyte sensor system that physically combines an analyte sensor to measurement electronics during the manufacturing phase of the sensor and in some cases in subsequent life phases of the sensor, so as to allow an improved recognition of sensor environment over time to improve subsequent calibration of the sensor.

First claim

What is claimed is:

1. A method for self-calibration of an analyte sensor system that includes an analyte sensor operatively coupled to sensor electronics, comprising:
taking a first measurement at a first time during a first life phase by applying a bias voltage with the sensor electronics to the analyte sensor to generate sensor data, the analyte sensor system having an initial characteristic metric determined at the first time, when the analyte sensor is operatively connected to one or more components of the sensor electronics,
wherein the first life phase comprises manufacturing, and the initial characteristic metric is based on one or more manufacturing and/or environmental parameters related to the first life phase;
storing, in the sensor electronics, information associated with the first life phase of the analyte sensor and information associated with a second life phase, the second life phase comprising one or more of shipping, storage, pre in vivo, or sensor session;
taking a second measurement at a second time during the second life phase subsequent to the first time to determine a change to the initial characteristic metric of the analyte sensor system based on one or more parameters, wherein the one or more parameters impact the analyte sensor sensitivity during the first and second life phases; and
using the sensor electronics to automatically calibrate, without user intervention, the analyte sensor system based at least in part on the determined change to the initial characteristic metric.

2. A method for self-calibrating an analyte sensor system that includes an analyte sensor operatively coupled to sensor electronics, comprising:
applying a bias voltage with the sensor electronics to the analyte sensor to generate sensor data, the analyte sensor system having an initial calibration factor that is used to convert sensor data to analyte concentration values;
storing, in the sensor electronics, information describing a plurality of life phases of the analyte sensor and a plurality of times, the plurality of times comprising a first time corresponding to a first life phase of the plurality of life phases and a second time corresponding to a second life phase of the plurality of life phases, wherein one or more parameters impact the analyte sensor sensitivity during each of the plurality of life phases,
wherein the first life phase comprises manufacturing, and the second life phase comprises one of shipping, storage, pre in vivo, or sensor session;
using the sensor electronics to update the initial calibration factor of the analyte sensor system at the plurality of times based at least in part on the one or more parameters that are monitored during one or more of the plurality of life phases; and
using the sensor electronics to automatically calibrate, without user intervention, the analyte sensor system based at least in part on the updated calibration factor.

3. The method of claim 2 , wherein using the sensor electronics to update the initial calibration factor of the analyte sensor system includes determining a complex adaptive calibration value that is based at least in part on manufacturing conditions and environmental conditions experienced by the analyte sensor during one or more of the plurality of life phases of the analyte sensor.

4. The method of claim 2 , wherein the one or more manufacturing parameters include process parameters and design parameters, wherein the process parameters include temperature, humidity, curing time, and dip time, and wherein the design parameters include analyte sensor membrane thickness and raw material characteristics.

5. The method of claim 2 , wherein the one or more manufacturing parameters include process parameters, the process parameters including temperature, humidity, curing, time and dip time.

6. The method of claim 2 , wherein the one or more manufacturing parameters include design parameters, the design parameters including analyte sensor membrane thickness and raw material characteristics.

7. The method of claim 2 , further comprising using the sensor electronics to receive remotely stored sensor performance data to update the initial calibration factor.

8. The method of claim 7 , wherein the remotely stored sensor performance data that is received concerns analyte sensors that have experienced or been exposed to manufacturing and/or environmental parameters that are most similar to one or more of the monitored manufacturing and/or environmental parameters.

9. A method for self-calibration of an analyte sensor system that includes an analyte sensor operatively couplable to sensor electronics, comprising:
operatively coupling at a first time the analyte sensor to one or more components of the sensor electronics to define a packagable analyte sensor arrangement, the packagable sensor arrangement having an initial sensitivity metric determined subsequent to the first time, wherein the first time correspond to a manufacturing life stage;
identifying a second time subsequent to the first time, the second time being selected to correspond to a life phase of the analyte sensor, wherein the life phase comprises one of shipping, storage, pre in vivo, and sensor session;
applying an analyte interrogation signal with the one or more components of the sensor electronics to the analyte sensor at the second time;
measuring a signal response to the analyte interrogation signal;
based at least in part on the measured signal response and the life phase of the analyte sensor, determining a second sensitivity metric; and
automatically calibrating, without user intervention, the packagable sensor arrangement based at least in part on the initial sensitivity metric and the second sensitivity metric.

10. The method of claim 9 , wherein the analyte sensor is continuously operatively coupled to the one or more components of the sensor electronics between the first and second times without interruption.

11. The method of claim 9 , wherein measuring the signal response includes measuring an impedance of the packagable analyte sensor arrangement.

12. The method of claim 9 , wherein automatically calibrating the packagable sensor arrangement is based on an established relationship between an impedance of the packagable analyte sensor arrangement and analyte sensor sensitivity.

13. The method of claim 9 , wherein automatically calibrating the packagable sensor arrangement includes automatically calibrating the packagable sensor arrangement in vivo.

14. A method for performing an action with an analyte sensor system that includes an analyte sensor operatively coupled to sensor electronics, comprising:
applying a bias voltage with the sensor electronics to the analyte sensor to generate sensor data, the analyte sensor system having an initial characteristic metric determined at a first time when the analyte sensor is operatively connected to one or more components of the sensor electronics, the first time within a manufacturing life stage;
storing, in the sensor electronics, information associated with a plurality of life phases of the analyte sensor, the plurality of life phases comprising manufacturing, shipping, storage, pre in vivo, and sensor session;
identifying a second time subsequent to the first time, the second time being selected to correspond to one of the plurality of life phases of the analyte sensor, the second time within the shipping, storage, pre in vivo, or sensor session life phase;
using the sensor electronics at the second time to determine a change to the initial characteristic metric of the analyte sensor system based at least in part on one or more manufacturing and/or

Assignees

• Dexcom Inc

Inventors

• Bhavaraju Naresh C
• Clark Becky L
• Crabtree Vincent P
• Dring Chris W
• Garcia Arturo
• Halac Jason
• Hughes Jonathan
• Jackson Jeff
• Jepson Lauren Hruby
• Lee David I-Chun
• Lee Ted Tang
• Ma Rui
• Mcdaniel Zebediah L
• Mitchell Jason
• Pal Andrew Attila
• Rong Daiting
• Sheth Disha B
• Simpson Peter C
• Vanslyke Stephen J
• Wightlin Matthew D
• Davis Anna Leigh
• Hampapuram Hari
• Mandapaka Aditya Sagar
• Teeter Alexander Leroy
• Wang Liang

Classifications

• G01N27/3274 Primary

  Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771) · CPC title

• A61B5/1495

  Calibrating or testing of in-vivo probes · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B2560/0223

  of calibration, e.g. protocols for calibrating sensors · CPC title