TRANSCUTANEOUS ANALYTE SENSOR

• US 20070208244A1
• Filed: 04/11/2007
• Published: 09/06/2007
• Est. Priority Date: 08/01/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Brauker, James, Goode, Paul, Kamath, Apurv
• Granted Patent: US 8,160,669 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 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/14865 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: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A system for monitoring a glucose concentration in a host, the system comprising:

a continuous glucose sensor configured to produce a signal indicative of a glucose concentration in a host; and

a receiver operably connected to the sensor, wherein the receiver comprises a single point glucose measuring device, wherein the single point glucose measuring device is built into the receiver, and wherein the single point glucose measuring device is configured to receive a biological sample from the host and to measure a concentration of glucose in the biological sample, wherein the measured glucose concentration in the biological sample comprises reference data, and wherein the receiver further comprises programming configured to calibrate or confirm the signal based at least in part on the reference data.

2. The system of claim 1, wherein the receiver comprises programming configured to calibrate and confirm the signal based at least in part on the reference data.

3. The system of claim 1, wherein the receiver comprises programming configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold.

4. The system of claim 3, wherein the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min.

5. The system of claim 1, wherein the receiver comprises programming configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data.

6. The system of claim 1, wherein the receiver comprises programming configured to prompt the host to provide a biological sample to the single point glucose measuring device.

7. The system of claim 6, wherein the programming configured to prompt the host is based at least in part on events.

8. The system of claim 6, wherein the programming configured to prompt the host is based at least in part on timing.

9. The system of claim 6, wherein the receiver comprises programming configured to calibrate the signal, and wherein the programming is configured to prompt the host based at least in part a value of the calibrated signal or at least in part rate of change of the calibrated signal.

10. The system of claim 1, wherein the programming configured to calibrate or confirm is configured to calibrate the signal, wherein the receiver further comprises a user interface, and wherein the receiver comprises programming configured to display at least one of the calibrated signal and the reference data on the user interface.

11. The system of claim 10, wherein the receiver comprises programming configured to display the calibrated signal and the reference data on the user interface.

12. The system of claim 1, wherein the receiver comprises an alarm, wherein the receiver comprises programming configured to estimate glucose data for a future time, and wherein the receiver comprises programming further configured to trigger the alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold.

13. The system of claim 1, wherein the receiver comprises a user interface, and wherein the programming configured to calibrate or confirm is configured to calibrate the signal, to display a graphical representation of the calibrated signal on the user interface, and to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface.

14. A device comprising a computer readable memory, the computer readable memory comprising code for processing data from a continuous glucose measuring device and a single point glucose measuring device, wherein the code comprises:

instructions configured to process a signal received from a continuous glucose measuring device;

instructions configured to measure a concentration of glucose in a biological sample received from a host, the measured glucose concentration in the sample comprising reference data; and

instructions configured to calibrate or confirm the signal based at least in part on the reference data.

15. The device of claim 14, wherein the instructions configured to calibrate or confirm the glucose data are configured to calibrate and confirm the signal based at least in part on the reference data.

16. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold.

17. The device of claim 16, wherein the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min.

18. The device of claim 14, further comprising instructions configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data.

19. The device of claim 14, further comprising instructions configured to prompt the host to provide a biological sample to the single point glucose measuring device.

20. The device of claim 19, wherein the instructions configured to prompt the host are based at least in part on events.

21. The device of claim 19, wherein the instructions configured to prompt the host are based at least in part on timing.

22. The device of claim 19, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the instructions configured to prompt the host are based at least in part on a value of the calibrated signal or at least in part on a rate of change of the calibrated signal.

23. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the device further comprises instructions configured to display at least one of the calibrated signal and the reference data on a user interface.

24. The device of claim 23, wherein the instructions configured to display at least one of the calibrated signal and the reference data on the user interface are configured to display the calibrated signal and the reference data on the user interface.

25. The device of claim 14, further comprising instructions configured to estimate glucose data for a future time and instructions configured to trigger an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold.

26. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, wherein the device further comprises instructions configured to display a graphical representation of the calibrated signal on a user interface and instructions configured to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface.

27. A method for monitoring glucose concentration in a host, the method comprising:

generating a signal from a continuous glucose measuring device indicative of a glucose concentration in a host;

receiving the signal from the continuous glucose measuring device in a receiver;

measuring a concentration of glucose in a biological sample in a single point glucose measuring device built into the receiver, the measured glucose concentration in the biological sample comprising reference data; and

calibrating or confirming the signal based at least in part on the reference data.

28. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating and confirming the signal based at least in part on the reference data.

29. The method of claim 27, wherein the step of calibrating the signal is allowed only when a rate of change of the signal is less than a predetermined threshold.

30. The method of claim 29, wherein the step of calibrating or confirming the signal comprises calibrating the signal and wherein the predetermined threshold is 2 mg/dL/min.

31. The method of claim 27, further comprising evaluating an accuracy of the reference data as compared to time-corresponding signal data.

32. The method of claim 27, further comprising prompting the host through a user interface to provide a biological sample to the single point glucose measuring device.

33. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying at least one of the calibrated signal and the reference data on a user interface.

34. The method of claim 33, wherein the step of displaying at least one of the calibrated signal and the reference data on a user interface comprises displaying the calibrated signal and the reference data on the user interface.

35. The method of claim 27, further comprising estimating glucose data for a future time and triggering an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold.

36. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on a user interface.