METHOD AND APPARATUS FOR PROVIDING ANALYTE MONITORING AND THERAPY MANAGEMENT SYSTEM ACCURACY

• US 20180344220A1
• Filed: 03/08/2018
• Published: 12/06/2018
• Est. Priority Date: 07/31/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary Alan, Budiman, Erwin Satrya
• Granted Patent: US 10,660,554 B2
• Time in Patent Office: Days
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Methods, systems and devices for providing improved calibration accuracy of continuous and/or in vivo analyte monitoring systems based at least in part on insulin delivery information are provided. Many of the embodiments disclosed herein can determine appropriate conditions for performing a calibration of the analyte sensor in view of the scheduled delivery of insulin or administered insulin amount. One or more other parameters or conditions can also be incorporated to improve calibration accuracy including, for example, the physiological model associated with a patient, meal information, exercise information, activity information, disease information, historical physiological condition information, as well as other types of information. Furthermore, according to some embodiments, calibration of the analyte sensor can be delayed or not performed at all, if appropriate conditions are not met.

Claims

1-26. -26. (canceled)

27. A method implemented using one or more processors, the method comprising:

determining one or more parameters associated with a calibration routine corresponding to a calibration start event; and

executing the calibration routine based on the one or more determined parameters;

wherein executing the calibration routine includes calibrating, by the one or more processors, an analyte sensor if a first condition is met, and wherein the one or more determined parameters includes a time of insulin delivery relative to the calibration start event.

28. The method of claim 27, wherein the calibration start event is based at least in part on monitoring an elapsed time period from an initial positioning of the analyte sensor.

29. The method of claim 27, wherein the calibration start event is based at least in part on a predetermined schedule.

30. The method of claim 27, wherein the one or more determined parameters further includes at least one of an insulin delivery amount, an insulin sensitivity parameter, an insulin on board information, an exercise information, a meal intake information, or an activity information.

31. The method of claim 27, wherein executing the calibration routine further includes delaying calibration of the analyte sensor by a predetermined time period if the first condition is not met.

32. The method of claim 31, wherein the first condition includes one or more of a threshold amount of insulin on board, a threshold time since a logged meal event, or a threshold rate of change of blood glucose.

33. The method of claim 27, wherein executing the calibration routine further includes not calibrating the analyte sensor if the first condition is not met, wherein the first condition is not met when at least one of the one or more determined parameters deviates from a predetermined threshold level.

34. The method of claim 33, wherein the predetermined threshold level is dynamically modified based on a variation in at least one of the one or more determined parameters.

35. The method of claim 27, wherein executing the calibration routine further includes one or more of determining a reference measurement value or determining a sensitivity value associated with the analyte sensor.

36. A device, comprising:

one or more processors;

a memory operatively coupled to the one or more processors, the memory storing instructions therein which, when executed by the one or more processors, cause the one or more processors to;

determine one or more parameters associated with a calibration routine corresponding to a calibration start event, and

execute the calibration routine based on the one or more determined parameters by calibrating an analyte sensor if a first condition is met, wherein the one or more determined parameters includes a time of insulin delivery relative to the calibration start event.

37. The device of claim 36, wherein the memory stores instructions which, when executed by the one or more processors, cause the one or more processors to monitor an elapsed time period from an initial positioning of the analyte sensor to the start of the calibration event.

38. The device of claim 36, wherein the start of the calibration event is based at least in part on a predetermined schedule.

39. The device of claim 36, wherein the one or more determined parameters further includes at least one of an insulin delivery amount, an insulin sensitivity parameter, an insulin on board information, an exercise information, a meal intake information, or an activity information.

40. The device of claim 36, wherein the memory stores instructions which, when executed by the one or more processors, cause the one or more processors to delay the calibration of the analyte sensor by a predetermined time period if the first condition is not met.

41. The device of claim 40, wherein the first condition includes one or more of a threshold amount of insulin on board, a threshold time since a logged meal event, or a threshold rate of change of blood glucose.

42. The device of claim 36, wherein the analyte sensor is not calibrated if the first condition is not met, wherein the first condition is not met when at least one of the one or more determined parameters deviates from a predetermined threshold level.

43. The device of claim 42, wherein the predetermined threshold level is dynamically modified based on a variation in at least one of the one or more determined parameters.

44. The device of claim 36, wherein the memory stores instructions which, when executed by the one or more processors, further cause the one or more processors to execute the calibration routine by at least one of determining a reference measurement value or determining a sensitivity value associated with the analyte sensor.

45. A method implemented using one or more processors, the method comprising:

detecting a calibration start event associated with an initialized analyte sensor;

determining one or more parameters associated with an insulin dose administration; and

executing a calibration routine based on the one or more determined parameters, wherein executing the calibration routine includes calibrating, by the one or more processors, an analyte sensor if a first condition is met,

wherein the one or more determined parameters includes a time of insulin delivery relative to the calibration start event.

46. The method of claim 45, further comprising displaying a notification to a user of a failed or delayed calibration event if the first condition is not met.