Multi-Function Analyte Monitor Device and Methods of Use

• US 20120232520A1
• Filed: 03/09/2012
• Published: 09/13/2012
• Est. Priority Date: 03/10/2011
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sloan, Mark K., Arbogast, Frederic, Cole, Jean-Pierre, Kiaie, Namvar, Fern, Jonathan, Matievich, William Jr., Dixon, Lynn, Jesser, Mark P., Vogel, Matthew T., Karan, Jai, Taub, Marc B., Lyons, Lynne K., Crouther, Nathan C.
• Granted Patent: US 10,010,273 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/31533 Dosing mechanisms, i.e. setting a dose administrating mechanisms A61M5/31565
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods, systems and devices for detecting an analyte sample, determining an analyte concentration associated with the detected analyte sample, storing the determined analyte concentration and a time associated with the determined analyte concentration, retrieving two or more stored analyte concentrations, and determining an adjusted dose level based at least in part on a current dose level and data associated with the two or more retrieved analyte concentrations are provided. For example, adjustments to dosage levels of long-acting insulin may be provided to assist in the management of diabetes and related conditions.

Claims

1-12. -12. (canceled)

13. A device, comprising:

a housing;

a processor coupled to the housing; and

a memory device coupled to the housing and the processor, wherein the memory device comprises instructions which, when executed by the processor, cause the processor to;

detect an analyte sample;

determine an analyte concentration associated with the detected analyte sample;

store the determined analyte concentration and a time associated with the determined analyte concentration;

retrieve two or more stored analyte concentrations; and

determine an adjusted dose level based at least in part on a current dose level and data associated with the two or more retrieved analyte concentrations.

14. The device of claim 13, wherein the current dose level comprises a long acting insulin dose amount or a rapid acting insulin dose amount.

15. The device of claim 13, wherein the determined analyte concentration is associated with a blood glucose concentration.

16. The device of claim 13, wherein the determined analyte concentration is associated with a fasting blood glucose concentration.

17. The device of claim 13, wherein the data associated with the two or more retrieved analyte concentrations comprises an average of the two or more retrieved analyte concentrations.

18. The device of claim 13, wherein the instructions to determine the adjusted dose level comprise instructions, which, when executed by the processor, cause the processor to:

calculate an average of the two or more retrieved analyte concentrations; and

compare the average of the two or more retrieved analyte concentrations to a threshold range, wherein if the average of the two or more retrieved analyte concentrations is less than the threshold range, a predetermined dose adjustment amount is subtracted from the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is greater than the threshold range, a predetermined dose adjustment amount is added to the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is within the threshold range, no adjustment is made to the current dose level.

19. The device of claim 13, wherein the memory further comprises instructions which, when executed by the processor causes the processor to determine the adjusted dose level according to a predetermined schedule.

20. The device of claim 13, further comprising an output unit coupled to the processor, wherein the memory comprises instructions which, when executed by the processor causes the processor to output using the output unit one or more of the adjusted dose level, the determined analyte concentration, the two or more retrieved analyte concentrations, the data associated with the two or more retrieved analyte concentrations, and a request for predetermined information.

21. The device of claim 20, wherein the output unit comprises a touch-screen display.

22. The device of claim 20, wherein the output unit comprises one or more of a visual output unit, an audible output unit and a vibratory output unit, or one or more combinations thereof.

23. The device of claim 20, wherein the request for predetermined information comprises a request for an additional analyte sample, a request for an acknowledgment confirming whether a hypoglycemic event occurred, or a request to confirm the adjusted dose level.

24. The device of claim 13, further comprising an input unit coupled to the processor, wherein the memory comprises instructions which, when executed by the processor causes the processor to detect one or more input commands received from the input unit.

25. The device of claim 24, wherein the one or more input commands comprise an acknowledgement confirming the adjusted dose level.

26. The device of claim 24, wherein the one or more input commands comprises a rejection of the adjusted dose level.

27. The device of claim 24, wherein the one or more input commands comprises a request to recalculate the adjusted dose level.

28. The device of claim 13, including a communication module operatively coupled to the processor, wherein the communication module is configured to transmit one or more of the adjusted dose level and the determined analyte concentration to a remote location.

29. The device of claim 28, wherein the communication module comprises one or more of an RF transmitter, an RF transceiver, a ZigBee communication module, a WiFi communication module, a Bluetooth communication module, an infrared communication module, and a wired communication module.

30. A method, comprising:

detecting an analyte sample;

determining an analyte concentration associated with the detected analyte sample;

storing the determined analyte concentration and a time associated with the determined analyte concentration;

retrieving two or more stored analyte concentrations; and

determining an adjusted dose level based at least in part on a current dose level and data associated with the two or more retrieved analyte concentrations.

31. The method of claim 30, wherein the current dose level comprises a long acting insulin dose amount or a rapid acting insulin dose amount.

32. The method of claim 30, wherein the determined analyte concentration is associated with a blood glucose concentration.

33. The method of claim 30, wherein the determined analyte concentration is associated with a fasting blood glucose concentration.

34. The method of claim 30, wherein the data associated with the two or more retrieved analyte concentrations comprises an average of the two or more retrieved analyte concentrations.

35. The method of claim 30, wherein the determining an adjusted dose level comprises:

calculating an average of the two or more retrieved analyte concentrations; and

comparing the average of the two or more retrieved analyte concentrations to a threshold range, wherein if the average of the two or more retrieved analyte concentrations is less than the threshold range, a predetermined dose adjustment amount is subtracted from the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is greater than the threshold range, a predetermined dose adjustment amount is added to the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is within the threshold range, no adjustment is made to the current dose level.

36. The method of claim 30, wherein the determining an adjusted dose level is performed according to a predetermined schedule.

37. The method of claim 30, further comprising outputting information associated with one or more of the adjusted dose level, the determined analyte concentration, the two or more retrieved analyte concentrations, the data associated with the two or more retrieved analyte concentrations, and a request for predetermined information.

38. The method of claim 37, wherein the outputting comprises outputting a visual indication, an audible indication, a vibratory indication, or one or more combinations thereof.

39. The method of claim 37, wherein the request for predetermined information comprises a request for an additional analyte sample, a request for an acknowledgment confirming whether a hypoglycemic event occurred, or a request to confirm the adjusted dose level.

40. The method of claim 30, including detecting one or more input commands received from an input unit.

41. The method of claim 40, wherein the one or more input commands comprise an acknowledgement confirming the adjusted dose level.

42. The method of claim 40, wherein the one or more input commands comprise a rejection of the adjusted dose level.

43. The method of claim 40, wherein the one or more input commands comprise a request to recalculate the adjusted dose level.

44. The method of claim 30, including transmitting one or more of the adjusted dose level and the determined analyte concentration to a remote location.

45. The method of claim 44, wherein the transmitting comprises transmitting over one or more of an RF transmission protocol, a ZigBee transmission protocol, a WiFi transmission protocol, a Bluetooth transmission protocol, an infrared transmission protocol, and a wired transmission protocol.

46. A glucose meter, comprising:

a housing;

a memory device coupled to the housing;

a controller unit coupled to the housing and the memory device;

an input unit coupled to the controller unit and the housing for inputting one or more commands or information;

an output unit coupled to the controller unit and the housing for outputting one or more output data; and

a strip port provided on the housing and configured to receive an analyte test strip,

wherein the controller unit is configured to retrieve one or more routines stored in the memory device to;

detect an analyte sample on the received analyte test strip;

determine an analyte concentration associated with the detected analyte sample;

store the determined analyte concentration and a time associated with the determined analyte concentration;

retrieve two or more stored analyte concentrations; and

determine an adjusted medication dose amount based at least in part on a current medication dose amount and data associated with the two or more retrieved analyte concentrations.

47. The meter of claim 46, wherein the current medication dose amount comprises a long acting insulin dose amount or a rapid acting insulin dose amount.

48. The meter of claim 46, wherein the determined analyte concentration comprises a blood glucose concentration.

49. The meter of claim 46, wherein the determined analyte concentration comprises a fasting blood glucose concentration.

50. The meter of claim 46, wherein the one or more routines stored in the memory device comprise instructions to:

calculate an average of the two or more retrieved analyte concentrations; and

compare the average of the two or more retrieved analyte concentrations to a threshold range, wherein if the average of the two or more retrieved analyte concentrations is less than the threshold range, a predetermined dose adjustment amount is subtracted from the current medication dose amount to determine the adjusted medication dose amount, and wherein if the average of the two or more retrieved analyte concentrations is greater than the threshold range, a predetermined dose adjustment amount is added to the current medication dose amount to determine the adjusted medication dose amount, and wherein if the average of the two or more retrieved analyte concentrations is within the threshold range, no adjustment is made to the current dose level.

51. The meter of claim 46, wherein the output unit comprises one or more of a visual display unit, an audible output unit, and a vibratory output unit, or one or more combinations thereof.

52. The meter of claim 46, further comprising a communication module coupled to the controller unit, the communication module configured to, at least in part communicate one or more of the adjusted medication dose amount and the determined analyte concentration to a remote location.

53. The meter of claim 52, wherein the remote location comprises a medication delivery device.

54. The meter of claim 53, wherein the medication delivery device comprises an insulin delivery device.

55. A glucose meter, comprising:

a housing;

a memory device coupled to the housing;

a controller unit coupled to the housing and the memory device;

an input unit coupled to the controller unit and the housing for inputting one or more commands or information;

an output unit coupled to the controller unit and the housing for outputting one or more output data; and

a strip port provided on the housing and configured to receive an analyte test strip,

wherein the controller unit is configured to retrieve one or more routines stored in the memory device and perform one or more of the following;

detect an analyte sample;

determine an analyte concentration associated with the detected analyte sample;

store the determined analyte concentration and a time associated with the determined analyte concentration;

determine a rapid acting insulin dose level based at least in part on the determined analyte concentration and dose determination information; and

determine an adjusted medication dose amount based at least in part on a current long acting insulin dose amount and data associated with two or more stored analyte concentrations.

56. The meter of claim 55, wherein the determined analyte concentration comprises a blood glucose concentration.

57. The meter of claim 55, wherein the determined analyte concentration comprises a pre-meal or a post-meal blood glucose concentration.

58. The meter of claim 55, wherein the determined analyte concentration comprises a fasting blood glucose concentration.

59. The meter of claim 55, wherein the dose determination information comprises insulin on board information including one or more of an administered medication dose amount, an administered medication dose time, and an administered dose frequency information over a predetermined time period.

60. The meter of claim 55, wherein the one or more routines to determine an adjusted medication dose amount comprise instructions to:

calculate an average of the two or more stored analyte concentrations; and

compare the average of the two or more stored analyte concentrations to a threshold range, wherein if the average of the two or more stored analyte concentrations is less than the threshold range, a predetermined dose adjustment amount is subtracted from the current medication dose amount to determine the adjusted medication dose amount, and wherein if the average of the two or more stored analyte concentrations is greater than the threshold range, a predetermined dose adjustment amount is added to the current medication dose amount to determine the adjusted medication dose amount, and wherein if the average of the two or more retrieved analyte concentrations is within the threshold range, no adjustment is made to the current dose level.

61. The meter of claim 55, wherein the output unit comprises one or more of a visual display unit, an audible output unit, and a vibratory output unit, or one or more combinations thereof.

62. The meter of claim 55, further comprising a communication module coupled to the controller unit, the communication module configured to, at least in part communicate one or more of the determined analyte concentration, the determined rapid acting insulin dose level, and the adjusted medication dose amount to a remote location.

63. The meter of claim 62, wherein the remote location comprises a medication delivery device.

64. The meter of claim 63, wherein the medication delivery device comprises an insulin delivery device.

65. A device, comprising:

a housing;

a processor coupled to the housing; and

a memory device coupled to the housing and the processor, wherein the memory device comprises instructions which, when executed by the processor, cause the processor to;

detect an analyte sample;

determine an analyte concentration associated with the detected analyte sample;

store the determined analyte concentration and a time associated with the determined analyte concentration;

retrieve two or more stored analyte concentrations; and

determine an adjusted dose level based at least in part on a current dose level and an average of the two or more retrieved analyte concentrations,

wherein the instructions to determine the adjusted dose level comprise instructions which, when executed by the processor, cause the processor to;

calculate the average of the two or more retrieved analyte concentrations; and

compare the average of the two or more retrieved analyte concentrations to two or more threshold ranges each having a corresponding predetermined dose adjustment amount, wherein if the average of the two or more retrieved analyte concentrations is within one of the two or more threshold ranges, the corresponding predetermined dose adjustment amount is added to the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is less than the two or more threshold ranges, a predetermined dose adjustment amount is subtracted from the current dose level to determine the adjusted dose level.

66. The device of claim 65, wherein the current dose level comprises a long acting insulin dose amount or a rapid acting insulin dose amount.

67. The device of claim 65, wherein the determined analyte concentration is associated with a blood glucose concentration.

68. The device of claim 65, wherein the determined analyte concentration is associated with a fasting blood glucose concentration.

69. The device of claim 65, wherein the memory further comprises instructions which, when executed by the processor causes the processor to determine the adjusted dose level according to a predetermined schedule.

70. The device of claim 65, further comprising an output unit coupled to the processor, wherein the memory comprises instructions which, when executed by the processor causes the processor to output using the output unit one or more of the adjusted dose level, the determined analyte concentration, the two or more retrieved analyte concentrations, the average of the two or more retrieved analyte concentrations, and a request for predetermined information.

71. The device of claim 70, wherein the output unit comprises a touch-screen display.

72. The device of claim 70, wherein the output unit comprises one or more of a visual output unit, an audible output unit and a vibratory output unit, or one or more combinations thereof.

73. The device of claim 70, wherein the request for predetermined information comprises a request for an additional analyte sample, a request for an acknowledgment confirming whether a hypoglycemic event occurred, or a request to confirm the adjusted dose level.

74. The device of claim 65, further comprising an input unit coupled to the processor, wherein the memory comprises instructions which, when executed by the processor causes the processor to detect one or more input commands received from the input unit.

75. The device of claim 74, wherein the one or more input commands comprise an acknowledgement confirming the adjusted dose level.

76. The device of claim 74, wherein the one or more input commands comprises a rejection of the adjusted dose level.

77. The device of claim 74, wherein the one or more input commands comprises a request to recalculate the adjusted dose level.

78. The device of claim 65, including a communication module operatively coupled to the processor, wherein the communication module is configured to transmit one or more of the adjusted dose level and the determined analyte concentration to a remote location.

79. The device of claim 78, wherein the communication module comprises one or more of an RF transmitter, an RF transceiver, a ZigBee communication module, a WiFi communication module, a Bluetooth communication module, an infrared communication module, and a wired communication module.

80. A method, comprising:

detecting an analyte sample;

determining an analyte concentration associated with the detected analyte sample;

storing the determined analyte concentration and a time associated with the determined analyte concentration;

retrieving two or more stored analyte concentrations; and

determining an adjusted dose level based at least in part on a current dose level and an average of the two or more retrieved analyte concentrations,

wherein the determining an adjusted dose level comprises;

calculating the average of the two or more retrieved analyte concentrations; and

comparing the average of the two or more retrieved analyte concentrations to two or more threshold ranges each having a corresponding predetermined dose adjustment amount, wherein if the average of the two or more retrieved analyte concentrations is within one of the two or more threshold ranges, the corresponding predetermined dose adjustment amount is added to the current dose level to determine the adjusted dose level, and wherein if the average of the two or more retrieved analyte concentrations is less than the two or more threshold ranges, a predetermined dose adjustment amount is subtracted from the current dose level to determine the adjusted dose level.

81. The method of claim 80, wherein the current dose level comprises a long acting insulin dose amount or a rapid acting insulin dose amount.

82. The method of claim 80, wherein the determined analyte concentration is associated with a blood glucose concentration.

83. The method of claim 80, wherein the determined analyte concentration is associated with a fasting blood glucose concentration.

84. The method of claim 80, wherein the determining an adjusted dose level is performed according to a predetermined schedule.

85. The method of claim 80, further comprising outputting information associated with one or more of the adjusted dose level, the determined analyte concentration, the two or more retrieved analyte concentrations, the average of the two or more retrieved analyte concentrations, and a request for predetermined information.

86. The method of claim 85, wherein the outputting comprises outputting a visual indication, an audible indication, a vibratory indication, or one or more combinations thereof.

87. The method of claim 85, wherein the request for predetermined information comprises a request for an additional analyte sample, a request for an acknowledgment confirming whether a hypoglycemic event occurred, or a request to confirm the adjusted dose level.

88. The method of claim 80, including detecting one or more input commands received from an input unit.

89. The method of claim 88, wherein the one or more input commands comprise an acknowledgement confirming the adjusted dose level.

90. The method of claim 88, wherein the one or more input commands comprise a rejection of the adjusted dose level.

91. The method of claim 88, wherein the one or more input commands comprise a request to recalculate the adjusted dose level.

92. The method of claim 80, including transmitting one or more of the adjusted dose level and the determined analyte concentration to a remote location.

93. The method of claim 92, wherein the transmitting comprises transmitting over one or more of an RF transmission protocol, a ZigBee transmission protocol, a WiFi transmission protocol, a Bluetooth transmission protocol, an infrared transmission protocol, and a wired transmission protocol.

94-296. -296. (canceled)