System and methods for processing analyte sensor data for sensor calibration

• US 10,709,364 B2
• Filed: 11/21/2019
• Issued: 07/14/2020
• 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:
  US16/690,977
• Publication Number:
  US 20200085354A1
• Time in Patent Office: 236 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 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.