Transcutaneous analyte sensors and monitors, calibration thereof, and associated methods

• US 10,470,661 B2
• Filed: 09/09/2016
• Issued: 11/12/2019
• Est. Priority Date: 09/10/2015
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Garcia, Arturo, Simpson, Peter C., Kamath, Apurv Ullas, Bhavaraju, Naresh C., Vanslyke, Stephen J.
• Primary Examiner(s): Ngon, Ricky
• Application Number:
  US15/261,816
• Publication Number:
  US 20170071511A1
• Time in Patent Office: 1,159 Days
• Field of Search: 702 85
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

Systems and methods are provided to calibrate an analyte concentration sensor within a biological system, generally using only a signal from the analyte concentration sensor. For example, at a steady state, the analyte concentration value within the biological system is known, and the same may provide a source for calibration. Similar techniques may be employed with slow-moving averages. Variations are disclosed.

Claims

1. A method of calibrating an analyte concentration sensor within a biological system, using a signal from the analyte concentration sensor, wherein at a steady state, the analyte concentration value within the biological system is known, comprising:

on a monitoring device, receiving a seed value of a calibration parameter;

on the monitoring device, detecting when an analyte concentration value as measured by an analyte concentration sensor indwelling in a biological system is at a steady state; and

on the monitoring device or on a device or server operatively coupled to the monitoring device, correlating a measurement of the analyte concentration value when the biological system is at the detected steady state to the known analyte concentration value;

subsequent to the correlating, receiving a signal from the sensor; and

calculating and displaying a value corresponding to the received signal, the calculated value based on the received signal, the known analyte concentration value, and the seed value.

2. The method of claim 1, wherein the received seed value is received from a source including factory calibration information.

3. The method of claim 1, further comprising:

detecting a behavior in the received signal outside of a pre-prescribed parameter; and

prompting a user to enter external calibration information.

4. The method of claim 3, wherein the displayed value is further based on the external calibration information.

5. The method of claim 3, wherein the external calibration information is received from an SMBG or a fingerstick calibration.

6. The method of claim 3, further comprising resetting the known calibration value to a new known calibration value, the resetting based at least partially on the external calibration information.

7. The method of claim 3, further comprising resetting the seed value to a new seed value, the resetting based at least partially on the external calibration information.

8. The method of claim 1, further comprising altering the display based on a determined accuracy of the value.

9. The method of claim 8, wherein the altering the displaying includes displaying a range rather than a value, or vice versa.

10. The method of claim 1, wherein the received seed value of a calibration parameter is a user-entered characterization of disease state.

11. The method of claim 10, wherein the user entered characterization of disease state includes an indication of type I diabetes, type II diabetes, nondiabetic, or prediabetic.

12. The method of claim 1, wherein the received seed value of a calibration parameter is a value based on one or more user-entered blood glucose values.

13. The method of claim 1, wherein the displaying of a value corresponding to the received signal includes displaying a graph or table indicating currently measured and historic values of the analyte concentration, and further comprising:

detecting that a change in calibration has occurred;

adjusting one or more calibration parameters of the analyte concentration sensor according to the change in calibration; and

following the adjusting, updating the display of the graph or table indicating currently measured and historic values of the analyte concentration according to the adjusted calibration parameters.

14. The method of claim 13, wherein the detecting that a change in calibration has occurred includes:

detecting a change in a slow-moving average;

or

detecting a change in the steady state value.

15. The method of claim 13, wherein the adjusting is configured to occur at a time when a sensor reading is substantially stable, or within a predetermined range of readings for a threshold period of time, whereby an occurrence of unexpected jumps in readings is reduced.

16. An analyte concentration sensor system, comprising:

an analyte concentration sensor configured to be calibrated within a biological system, using a signal from the analyte concentration sensor, wherein at a steady state, the analyte concentration value within the biological system is known;

a processor comprising a component of a monitoring device or a device or server operatively connected to the monitoring device, wherein the processor is configured to;

receive a seed value of a calibration parameter;

detect when an analyte concentration value as measured by the analyte concentration sensor indwelling in a biological system is at a steady state;

correlate a measurement of the analyte concentration value when the biological system is at the detected steady state to the known analyte concentration value;

thereafter receive a signal from the sensor; and

calculate a value corresponding to the received signal, the calculated value based on the received signal, the known analyte concentration value, and the seed value; and

a display device, wherein the display device is configured to display the calculated value.

17. The system of claim 16, wherein the received seed value is received from a source including factory calibration information.

18. The system of claim 16, wherein the processor is configured to:

detect a behavior in the received signal outside of a pre-prescribed parameter; and

prompt a user to enter external calibration information.

19. The system of claim 18, wherein the processor is configured to reset the known calibration value to a new known calibration value based at least partially on the external calibration information.

20. The system of claim 18, wherein the processor is configured to reset the seed value to a new seed value based at least partially on the external calibration information.

21. The system of claim 16, wherein the processor is configured to alter the display based on a determined accuracy of the value.

22. The system of claim 16, wherein the display device is configured to display a graph or table indicating currently measured and historic values of the analyte concentration, and wherein the processor is further configured to:

detect that a change in calibration has occurred;

adjust one or more calibration parameters of the analyte concentration sensor according to the change in calibration; and

thereafter

update the display of the graph or table indicating currently measured and historic values of the analyte concentration according to the adjusted calibration parameters.

23. The system of claim 22, wherein the processor is configured to detect that a change in calibration has occurred by detecting a change in a slow-moving average or detecting a change in the steady state value.

24. The system of claim 16, wherein the processor is configured to adjust one or more calibration parameters at a time when a sensor reading is substantially stable, or within a predetermined range of readings for a threshold period of time, whereby an occurrence of unexpected jumps in readings is reduced.