TRANSCUTANEOUS ANALYTE SENSOR

• US 20090192724A1
• Filed: 02/03/2009
• Published: 07/30/2009
• Est. Priority Date: 08/01/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Brauker, James H., Goode, Paul
• Granted Patent: US 8,915,849 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• 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 5/0031 Implanted circuitry
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• 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 device for monitoring glucose concentration in a biological sample of a host, the device comprising:

a substantially continuous glucose sensor that produces a data stream indicative of a glucose concentration in a host, the data stream comprising a plurality of time spaced sensor data points;

an integrated receiver that receives the data stream from the substantially continuous glucose sensor, wherein the integrated receiver comprises;

an in vitro single point glucose monitor configured to receive a biological sample from the host and to measure the concentration of glucose in the sample;

a processor; and

a computer readable memory comprising;

instructions configured to cause the processor to calibrate the data stream received from the continuous glucose sensor;

instructions configured to cause the processor to determine a rate of change of the calibrated data stream from the substantially continuous analyte sensor; and

instructions configured to cause the processor to not re-calibrate and/or update calibration of the data stream using a glucose concentration measured by the single point glucose monitor when the rate of change of the calibrated data stream is determined to be aberrant, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

2 mg/dL/min.

2. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

3 mg/dL/min.

3. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

4 mg/dL/min.

4. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

5 mg/dL/min.

5. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

6 mg/dL/min.

6. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

10% over 5 minutes and/or +/−

2 mg/dL/min.

7. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

15% over 5 minutes and/or +/−

3 mg/dL/min.

8. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

20% over 5 minutes and/or +/−

4 mg/dL/min.

9. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

25% over 5 minutes and/or +/−

5 mg/dL/min.

10. The device of claim 1, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

30% over 5 minutes and/or +/−

6 mg/dL/min.

11. The device of claim 1, wherein the integrated receiver comprises a user interface, wherein the user interface is configured to request a biological sample for measurement via the single point glucose monitor only when the rate of change of the calibrated data stream is not determined to be aberrant.

12. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor to receive user information from an external source and process the user information received from the external source.

13. The device of claim 12, wherein the user information comprises information selected from the group consisting of mealtime information, exercise information, insulin administration, therapy recommendations and reference analyte values.

14. The device of claim 1, wherein the computer readable memory further comprises instructions configured to detect at least one condition selected from the group consisting of present hypoglycemia, predicted hypoglycemia, present hypergylcemia and predicted hypoglycemia, wherein the instructions are configured to trigger an alarm or alert in response to the detection.

15. The device of claim 1, wherein the integrated receiver comprises a user interface configured to display continuous glucose sensor data and single point glucose monitor data.

16. The device of claim 1, wherein the computer readable memory further comprises instructions configured to process and send data to an external device.

17. The device of claim 16, wherein the instructions configured to process and send data to an external device are configured to process and send at least one of an alert, a warning, and a message to a telecommunication device.

18. The device of claim 16, wherein the instructions configured to process and send data to an external device are configured to process and send a therapy recommendation to an insulin delivery device.

19. The device of claim 18, wherein the therapy recommendation comprise at least one of an amount insulin and a time for insulin delivery.

20. The device of claim 16, wherein the external device comprises at least one device selected from the group consisting of a pacemaker, an infusion device, and a telemetry device.

21. The device of claim 1, wherein the computer readable memory further comprises instructions configured to receive and process a therapy recommendation from an external source.

22. The device of claim 1, wherein the computer readable memory further comprises instructions configured to receive and process software updates from an external source.

23. The device of claim 1, wherein the dimensions of the integrated receiver comprise a length of less than about 15 cm, a width of less than about 10 cm, and a thickness of less than about 3.5 cm.

24. The device of claim 1, wherein a volume of the integrated receiver is less than about 180 cm³.

25. The device of claim 1, wherein a weight of the integrated receiver is less than about 130 g.

26. The device of claim 1, wherein the integrated receiver comprises a cell phone.

27. A device for monitoring glucose concentration in a biological sample of a host, the device comprising:

a substantially continuous glucose sensor that produces a data stream indicative of a glucose concentration in a host, the data stream comprising a plurality of time spaced sensor data points;

a receiver that receives the data stream from the substantially continuous glucose sensor, wherein the receiver comprises;

a single point glucose monitor configured to receive a biological sample from the host and to measure the concentration of glucose in the sample;

a processor; and

a computer readable memory comprising;

instructions configured to cause the processor to calibrate the data stream received from the continuous glucose sensor;

instructions configured to cause the processor to determine a rate of change of the calibrated data stream from the substantially continuous analyte sensor; and

instructions configured to cause the processor to not re-calibrate and/or update calibration of the data stream when the rate of change of the calibrated data stream is determined to be aberrant, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

2 mg/dL/min.

28. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

3 mg/dL/min.

29. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

4 mg/dL/min.

30. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

5 mg/dL/min.

31. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

6 mg/dL/min.

32. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

10% over 5 minutes and/or +/−

2 mg/dL/min.

33. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

15% over 5 minutes and/or +/−

3 mg/dL/min.

34. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

20% over 5 minutes and/or +/−

4 mg/dL/min.

35. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

25% over 5 minutes and/or +/−

5 mg/dL/min.

36. The device of claim 27, wherein the rate of change of the calibrated data stream is determined to be aberrant when the rate of change of the calibrated data stream is greater than +/−

30% over 5 minutes and/or +/−

6 mg/dL/min.

37. The device of claim 27, wherein the receiver comprises a user interface, wherein the user interface is configured to request a biological sample for measurement via the single point glucose monitor only when the rate of change of the calibrated data stream is not determined to be aberrant.

38. The device of claim 27, wherein the computer readable memory further comprises instructions configured to cause the processor to receive user information from an external source and process the user information received from the external source.

39. The device of claim 38, wherein the user information comprises information selected from the group consisting of mealtime information, exercise information, insulin administration, therapy recommendations and reference analyte values.

40. The device of claim 27, wherein the computer readable memory further comprises instructions configured to detect at least one condition selected from the group consisting of present hypoglycemia, predicted hypoglycemia, present hypergylcemia and predicted hypoglycemia, wherein the instructions are configured to trigger an alarm or alert in response to the detection.

41. The device of claim 27, wherein the receiver comprises a user interface configured to display continuous glucose sensor data and single point glucose monitor data.

42. The device of claim 27, wherein the computer readable memory further comprises instructions configured to process and send data to an external device.

43. The device of claim 42, wherein the instructions configured to process and send data to an external device are configured to process and send at least one of an alert, a warning, and a message to a telecommunication device.

44. The device of claim 42, wherein the instructions configured to process and send data to an external device are configured to process and send a therapy recommendation to an insulin delivery device.

45. The device of claim 44, wherein the therapy recommendation comprise at least one of an amount insulin and a time for insulin delivery.

46. The device of claim 42, wherein the external device comprises at least one device selected from the group consisting of a pacemaker, an infusion device, and a telemetry device.

47. The device of claim 27, wherein the computer readable memory further comprises instructions configured to receive and process a therapy recommendation from an external source.

48. The device of claim 27, wherein the computer readable memory further comprises instructions configured to receive and process software updates from an external source.

49. The device of claim 27, wherein the dimensions of the receiver comprise a length of less than about 15 cm, a width of less than about 10 cm, and a thickness of less than about 3.5 cm.

50. The device of claim 27, wherein a volume of the receiver is less than about 180 cm³.

51. The device of claim 27, wherein a weight of the receiver is less than about 130 g.

52. The device of claim 27, wherein the receiver comprises a cell phone.