SYSTEMS AND METHODS FOR PROCESSING SENSOR DATA

• US 20090192366A1
• Filed: 10/24/2008
• Published: 07/30/2009
• Est. Priority Date: 12/17/2007
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Mensinger, Michael Robert, Ruppert, Deborah M., Yang, Richard C., Li, Ying
• Granted Patent: US 9,135,402 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• 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 data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

Claims

1. A system for processing data from a continuous analyte sensor, comprising:

a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and provide continuous analyte sensor data associated therewith; and

a processor module configured to set a mode selected from a plurality of predetermined modes, wherein the processor module is configured to process the continuous analyte sensor data based at least in part on the mode.

2. The system of claim 1, wherein the processor module is configured to set the mode at least in part responsive to receipt of a user input.

3. The system of claim 2, wherein the system comprises one or more buttons, and wherein the processor module is configured to receive the user input by selection of one or more buttons.

4. The system of claim 2, wherein the system comprises a screen, wherein the processor module is configured to display one or more menus on the screen, and wherein the processor module is configured to receive the user input by selection of one or more items from the one or more menus.

5. The system of claim 2, wherein the system is configured to operably connect with an external system such that data can be transmitted from the external system to the system, and wherein the processor module is configured to receive the user input by a data transmission received from the external system.

6. The system of claim 5, wherein the operable connection is a wired connection.

7. The system of claim 5, wherein the operable connection is a wireless connection.

8. The system of claim 5, wherein the external system comprises a programming configured to schedule events on a calendar.

9. The system of claim 1, wherein the processor module is configured to automatically set the mode based at least in part on a comparison of data with one or more criteria.

10. The system of claim 9, further comprising an accelerometer, wherein the data comprises data received from the accelerometer.

11. The system of claim 9, further comprising a temperature sensor, wherein the data comprises data received from the temperature sensor.

12. The system of claim 1, wherein the continuous analyte sensor comprises a continuous glucose sensor, wherein the data comprises glucose sensor data, and wherein the one or more criteria comprise one or more thresholds associated with hyperglycemia and/or hypoglycemia.

13. The system of claim 1, wherein the processor module comprises programming configured to automatically set the mode at least in part responsive to an adaptive mode learning module, wherein the adaptive mode learning module is configured to process sensor data and time-corresponding mode over time and subsequently modify the automatic mode-setting programming at least in part responsive thereto.

14. The system of claim 1, wherein the system is further configured to provide an alarm responsive to the sensor data meeting one or more criteria.

15. The system of claim 14, wherein the one or more criteria are based at least in part on the mode.

16. The system of claim 14, wherein the system is configured to provide the alarm via an audible sound, visual display, vibration, alphanumeric message, and/or wireless transmission based on the mode.

17. The system of claim 1, wherein the system is further configured to determine a therapy instruction based at least in part on the mode.

18. The system of claim 17, wherein the system is further configured to determine the therapy instruction based at least on the continuous analyte sensor data.

19. The system of claim 17, wherein the system is operably connected with a medicament delivery module, and wherein the medicament delivery module comprises programming configured to require a validation of the therapy instruction prior to delivery of the therapy via the medicament delivery module, and wherein validation requirement is dependent upon the mode.

20. The system of claim 1, wherein the processor module is further configured to classify a level of noise in the continuous analyte sensor data

22. The system of claim 1, wherein the plurality of predetermined modes include two or more modes selected from the group consisting of resting mode, do not disturb mode, exercise mode, illness mode, menstruation mode, mealtime mode, day mode, night mode, hypoglycemic mode, hyperglycemic mode, noise mode.

23. The system of claim 1, wherein the processor module further comprises a timer associated with one or more modes, wherein the timer is configured to set the mode for a predetermined amount of time.

24. The system of claim 23, wherein the timer is user settable.

25. The system of claim 1, wherein the processor module is further configured to set the mode at least in part responsive to a mode profile.

26. The system of claim 25, wherein the mode profile is user settable.

21. The system of claim 21, wherein the processor module is configured to set the mode responsive at least in part to the level of noise.

27. A method for processing of a continuous analyte sensor, comprising:

receiving continuous analyte sensor data from a continuous analyte sensor;

setting a mode selected from a plurality of predetermined modes; and

processing the continuous analyte sensor data based at least in part on the mode.

28. The method of claim 27, wherein the step of setting the mode comprises receiving a user input.

29. The method of claim 28, wherein the step of receiving user input comprises receiving a selection of one or more buttons.

30. The method of claim 28, wherein the step of receiving user input comprises receiving a selection of one or more items from the one or more menus displayed on a screen.

31. The method of claim 28, wherein the step of receiving user input comprises receiving a data transmission from an external system.

32. The method of claim 31, wherein the step of receiving a data transmission comprises receiving a wired data transmission.

33. The method of claim 31, wherein the step of receiving a data transmission comprises receiving a wireless data transmission.

34. The method of claim 31, wherein the step of receiving a data transmission comprises receiving a data transmission from an event scheduling software.

35. The method of claim 27, wherein the step of processing comprises comparing the continuous analyte sensor data with one or more criteria.

36. The method of claim 35, further comprising receiving data from an accelerometer, wherein the step of setting the mode is responsive at least in part to the data received from an accelerometer.

37. The method of claim 35, further comprising receiving data from a temperature sensor, wherein the step of setting the mode is responsive at least in part to the received data.

38. The method of claim 35, wherein the step of receiving continuous analyte sensor data comprises receiving data from a continuous glucose sensor and wherein the one or more criteria comprise one or more thresholds associated with hypoglycemia and/or hyperglycemia.

39. The method of claim 27, wherein the step of setting the mode comprises automatically setting the mode.

40. The method of claim 39, further comprising processing sensor data and time-corresponding mode settings over time and wherein the step of automatically setting the mode is based at least in part on one or more modes.

41. The method of claim 27, wherein the step of processing comprises initiating an alarm responsive to the sensor data meeting one or more criteria.

42. The method of claim 41, wherein the one or more criteria are based at least in part on the mode.

43. The method of claim 41, wherein the alarm comprises an audible alarm, visual alarm, vibration alarm, alphanumeric message alarm, and/or wireless transmission alarm based at least in part on the mode.

44. The method of claim 27, wherein the step of processing comprises determining a therapy instruction based at least in part on the mode.

45. The method of claim 44, wherein the step of determining the therapy instruction is based at least in part on the continuous analyte sensor data.

46. The method of claim 44, wherein the step of determining a therapy instruction further comprises requiring a validation of the therapy instruction prior to delivery of the therapy via the medicament delivery device, and wherein validation is based at least in part on the mode.

47. The method of claim 27, wherein the step of processing comprises classifying a level of noise in the continuous analyte sensor data.

48. The method of claim 47, wherein the step of classifying a level of noise comprises setting the mode based at least in part on the level of noise.

49. The method of claim 27, wherein the step of setting a mode from a plurality of predetermined modes comprise two or more modes selected from the group consisting of resting mode, do not disturb mode, exercise mode, illness mode, menstruation mode, mealtime mode, day mode, night mode, hypoglycemic mode, hyperglycemic mode, noise mode.

50. The method of claim 27, wherein the step of setting the mode comprises setting a mode for a predetermined amount of time based at least in part upon a timer.

51. The method of claim 50, wherein the timer is user settable.

52. The method of claim 27, wherein the step of setting the mode comprises setting the mode based at least in part on a mode profile.

53. The method of claim 52, wherein setting the mode profile is user settable.

54. A method for processing of a continuous glucose sensor signal, the method comprising:

receiving sensor data from a continuous analyte sensor, including one or more sensor data points;

comparing sensor data against one or more criteria for at least one of hypoglycemia, hyperglycemia, predicted hypoglycemia, and predicted hyperglycemia; and

triggering an alarm when the sensor data meets one or more predetermined criteria.

55. The method of claim 54, wherein the alarm comprises first and second user selectable alarms.

56. The method of claim 55, wherein the first alarm is configured to alarm during a first time of day and wherein the second alarm is configured to alarm during a second time of day.

57. The method of claim 54, wherein the alarm is configured to turn on a light.

58. The method of claim 54, wherein the alarm is configured to alarm a remote device.

59. The method of claim 54, wherein the alarm comprises sending a text message to a remote device.

60. A system for processing continuous glucose sensor data, the system comprising:

a continuous glucose sensor configured to generate sensor data associated with a glucose concentration in a host; and

a computer system that compares sensor data against predetermined criteria for at least one of hypoglycemia, hyperglycemia, predicted hypoglycemia and predicted hyperglycemia, and triggers an alarm when the sensor data meets predetermined criteria.

61. The system of claim 60, wherein the alarm comprises first and second user selectable alarms.

62. The system of claim 61, wherein the first alarm is configured to alarm during a first time of day and wherein the second alarm is configured to alarm during a second time of day.

63. The system of claim 60, wherein the alarm is configured to turn a light on.

64. The system of claim 60, wherein the alarm is configured to alarm a remote device located more than about 10 feet away from the continuous glucose sensor.

65. The system of claim 60, wherein the alarm comprises a text message, and wherein the computer system is configured to send the text message a remote device.