System and methods for processing analyte sensor data for sensor calibration

• US 10,610,135 B2
• Filed: 06/28/2019
• Issued: 04/07/2020
• Est. Priority Date: 03/10/2005
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Brauker, James H., Goode, Jr., Paul V., Mahalingam, Aarthi, Pryor, Jack
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US16/457,383
• Publication Number:
  US 20190320951A1
• Time in Patent Office: 284 Days
• Field of Search: 600309, 600345-366
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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

1. A method of making a glucose concentration measuring system comprising:

measuring glucose sensitivity characteristics of a sample set of transcutaneous glucose sensors;

manufacturing at least one transcutaneous glucose sensor, wherein the at least one transcutaneous glucose sensor comprises;

an in vivo portion configured for insertion and existence within a living body of a host during sensor use; and

an ex vivo portion configured to remain outside the living body of the host during sensor use, wherein the ex vivo portion is configured to operably connect to sensor electronics via contacts during sensor use;

assigning information associated with a sensor sensitivity to the at least one transcutaneous glucose sensor based at least in part on the measurements of glucose sensitivity characteristics of the sample set of transcutaneous glucose sensors;

storing the information associated with the sensor sensitivity in the sensor electronics;

configuring the sensor electronics to receive sensor input signals; and

configuring a processor to use the information associated with the sensor sensitivity to calibrate received sensor input signals after implantation of the at least one sensor in the host, without use of reference glucose concentration values from the host obtained after implantation of the at least one transcutaneous glucose sensor in the host.

2. The method of claim 1, wherein the processor is incorporated in a receiver.

3. The method of claim 2, wherein the receiver comprises a display screen.

4. The method of claim 1, wherein the processor is incorporated in the sensor electronics.

5. The method of claim 1, wherein the information associated with the sensor sensitivity is also based at least in part on an in vivo versus in vitro sensitivity relationship derived from clinical data obtained in at least one experiment using a plurality of transcutaneous glucose sensors.

6. The method of claim 1, wherein measuring glucose sensitivity characteristics of the sample set of transcutaneous glucose sensors is performed in one or more reference solutions.