SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA FOR SENSOR CALIBRATION

• US 20100168545A1
• Filed: 01/07/2010
• Published: 07/01/2010
• 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, Paul V.
• Granted Patent: US 8,579,816 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 for analyzing data from a continuous glucose sensor, comprising:

receiving data from the continuous glucose sensor, the data comprising at least one sensor data point; and

calibrating the at least one sensor data point, wherein the step of calibrating comprises utilizing prior information to calibrate the continuous glucose sensor, and wherein the prior information comprises information obtained from at least one of in vitro testing of at least one continuous glucose sensor and in vivo use of at least one continuous glucose sensor.

2. The method of claim 1, wherein the prior information is configured to guide or validate at least one of the baseline and sensitivity of the continuous glucose sensor.

3. The method of claim 1, wherein the step of calibrating comprises determining at least one of a sensitivity or a baseline, and wherein the prior information comprises at least one boundary applied to the at least one of the sensitivity or the baseline.

4. The method of claim 3, further comprising determining an acceptability of the at least one of the sensitivity or the baseline, wherein an acceptability is determined if the sensitivity falls with at least one boundary.

5. The method of claim 3, further comprising determining an acceptability of at least one of the sensitivity and the baseline, wherein an acceptability is determined if the baseline falls with at least one boundary.

6. The method of claim 1, wherein the step of calibrating comprises drawing a calibration line, and wherein the prior information comprises at least one boundary applied to the calibration line.

7. The method of claim 6, further comprising determining an acceptability of the calibration, wherein the calibration is acceptable if the calibration line falls within the at least one boundary.

8. The method of claim 6, further comprising determining an acceptability of the calibration, wherein the calibration is not acceptable if the calibration line does not fall within the at least one boundary.

9. The method of claim 1, wherein the prior information comprises baseline information, whereby a baseline is obtained for sensor calibration.

10. The method of claim 1, wherein the prior information comprises sensitivity information, whereby a sensitivity is obtained for sensor calibration.

11. The method of claim 1, wherein the prior information comprises prior distribution information.

12. The method of claim 11, wherein the prior distribution information comprises at least one of a slope or a baseline geometrically determined closest to a maximum joint probability.

13. The method of claim 1, wherein the step of is performed without manual glucose measurements.

14. A system for analyzing data from a continuous glucose sensor, comprising:

a sensor data receiving module configured to receive sensor data from the continuous glucose sensor, the sensor data comprising at least one sensor data point; and

a processor module configured to calibrate the at least one sensor data point utilizing prior information, wherein the prior information comprises information obtained from at least one of in vitro testing of at least one continuous glucose sensor and in vivo use of at least one continuous glucose sensor.

15. A system for detecting analyte levels in a host, comprising:

an introducer; and

an analyte sensor coupled to the introducer for inserting at least a portion of the analyte sensor transcutaneously, wherein the analyte sensor is configured to be calibrated using information obtained prior to inserting in a host by the introducer.

16. The system of claim 15, wherein the analyte sensor is calibrated without non-continuous analyte measurements.

17. The system of claim 15, further comprising sensor electronics configured to receive one or more signals from the analyte sensor.

18. The system of claim 17, wherein the one or more signals are associated with an analyte level.

19. The system of claim 17, further including a processor module configured to receive data from the sensor electronics.

20. The system of claim 19, wherein the processor module is configured to receive data from the sensor electronics wirelessly.

21. The system of claim 19, wherein the data processor is configured to output information associated with the received data.

22. The system of claim 19, wherein the system further comprises an external device, and wherein the data processor is configured to output information to the external device.

23. The system of claim 22, wherein the external device comprises an insulin delivery device.

24. The system of claim 22, wherein the external device comprises at least one of a server, a personal computer, a personal digital assistant, an insulin pump, and an insulin pen, a medical device, a pacemaker, a telemetry device, an infusion device, and an analyte sensor patch.

25. The system of claim 19, wherein the system comprises a receiver, and wherein the receiver comprises the data processor.

26. The system of claim 25, wherein the receiver comprises an insulin delivery device, and wherein the analyte sensor comprises a glucose sensor.

27. The system of claim 25, wherein the receiver comprises at least one of a server, a personal computer, a personal digital assistant, an insulin pump, or an insulin pen.

28. The system of claim 27, wherein the receiver is integral with at least one of a personal computer, a personal digital assistant, a cell phone, a non-continuous glucose sensor, or an insulin delivery device.