System and methods for processing analyte sensor data for sensor calibration

• US 10,716,498 B2
• Filed: 11/21/2019
• Issued: 07/21/2020
• 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:
  US16/691,325
• Publication Number:
  US 20200085356A1
• Time in Patent Office: 243 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 one or more glucose monitoring systems, the method comprising:

manufacturing one or more transcutaneous electrochemical glucose sensors, each transcutaneous electrochemical glucose sensor having an in vivo portion and an ex vivo portion;

examining an in vitro signal response of at least one of the one or more transcutaneous electrochemical glucose sensors for each of a plurality of known glucose concentrations;

calculating an in vitro sensitivity for at least one of the one or more transcutaneous electrochemical glucose sensors, based on the in vitro signal responses;

predicting an in vivo sensitivity for at least one of the one or more transcutaneous electrochemical glucose sensors based at least in part on (1) the calculated in vitro sensitivity and (2) a relationship between in vivo responses and in vitro data empirically established in at least one previously performed clinical study;

storing the predicted in vivo sensitivity in a memory; and

configuring one or more processors to calibrate data generated by at least one of the one or more transcutaneous electrochemical glucose sensors using the predicted in vivo sensitivity without reliance on any manual calibrations by a user of at least one of the one or more glucose monitoring systems following insertion of at least a portion of the at least one of the one or more transcutaneous electrochemical glucose sensors.

2. One or more glucose monitoring systems made by the method of claim 1.

3. The method of making one or more glucose monitoring systems of claim 1, further comprising manufacturing one or more sensor electronics, wherein each of the sensor electronics is configured to be placed in electrical communication with one of the one or more transcutaneous electrochemical glucose sensors.

4. The method of making one or more glucose monitoring systems of claim 3, wherein each of the sensor electronics is configured to receive the data generated by the at least one of the one or more transcutaneous electrochemical glucose sensors.

5. A glucose monitoring system comprising:

a transcutaneous electrochemical glucose sensor having an in vivo portion and an ex vivo portion, wherein the in vivo portion is configured for insertion into a host; and

sensor electronics that are configured to provide calibrated glucose data based on sensor data provided by the transcutaneous electrochemical glucose sensor and a predicted in vivo sensitivity based at least in part on (1) a calculated in vitro sensitivity and (2) a relationship between in vivo responses and in vitro data empirically established in at least one previously performed clinical study associated with a plurality of transcutaneous electrochemical glucose sensors,

wherein the sensor electronics are in electrical communication with the transcutaneous electrochemical glucose sensor.

6. The glucose monitoring system of claim 5, wherein the calibrated glucose data provided by the sensor electronics are not based on manual calibrations by a user of the glucose monitoring system following insertion of the in vivo portion of the transcutaneous electrochemical glucose sensor into a host.