Method and Device for Utilizing Analyte Levels to Assist in the Treatment of Diabetes

• US 20110046051A1
• Filed: 08/11/2010
• Published: 02/24/2011
• Est. Priority Date: 04/01/2003
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Moerman, Piet
• Application Number:
  US12/854,699
• Publication Number:
  US 20110046051A1
• Time in Patent Office: Days
• US Class Current: 514/5.9
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A health-monitoring device assesses the health of a user based on levels of two analytes in a biological fluid. A first analyte that is utilized to assess a user'"'"'s health is a fat metabolism analyte, such as ketones, free fatty acids and glycerol, which is indicative of fat metabolism. A second analyte that is utilized is a glucose metabolism analyte, such as glucose. The levels of the two analytes may be used to assess insulin sensitivity, to detect both recent hypoglycemia and the cause of high glucose levels, and/or to guide therapeutic intervention. The dual analyte model may calculate a discrepancy between an actual insulin activity level and a theoretical insulin activity level. The dual analyte model of the present invention may be used to identify individuals at risk for metabolic syndrome, insulin resistance and non-insulin dependent diabetes, and allows monitoring of the progression of those disease states, as well as progress made by therapeutic interventions.

Claims

1-20. -20. (canceled)

21. A health-monitoring device for use in treating Type II diabetes, comprising:

a housing;

a test port in communication with the housing, wherein the test port is configured to receive a test element;

a processor in communication with the housing and configured to receive one or more signals associated with an analyte sample received at the test port;

a storage unit in communication with the housing and configured to store one or more programs executable by the processor for determining a dosage information for long acting insulin based at least in part on the one or more signals associated with the analyte sample;

a display coupled to the housing and configured to provide graphic representations and/or text summaries of output data associated with the one or more signals associated with an analyte sample and/or the determined dosage information for long acting insulin; and

a data communication port operatively coupled to the processor.

22. The health-monitoring device of claim 21, wherein the analyte is glucose.

23. The health-monitoring device of claim 21, wherein the analyte is a ketone.

24. The health-monitoring device of claim 21, wherein the processor is configured to receive at least a first signal associated with a first analyte and a second signal associated with a second analyte.

25. The health-monitoring device of claim 24, wherein the first analyte is glucose and the second analyte is a fat metabolism analyte.

26. The health-monitoring device of claim 25, wherein the fat metabolism analyte is a ketone.

27. The health-monitoring device of claim 21, wherein the program comprises an algorithm for determining the dosage information for long acting insulin.

28. The health-monitoring device of claim 21, wherein the test element is a test strip.

29. The health-monitoring device of claim 28, wherein the test strip is an electrochemical test strip or a photometric test strip.

30. The health-monitoring device of claim 21, wherein the test element is a skin inserted device.

31. The health-monitoring device of claim 30, wherein the skin inserted device is a catheter.

32. The health-monitoring device of claim 21, wherein the data communication port is configured for one or more of electrical communication, acoustic communication, optical communication, or radio wave communication.

33. The health-monitoring device of claim 21, wherein the data communication port is configured for infrared communication.

34. The health-monitoring device of claim 21, wherein the data communication port is configured to communicate with a database at a remote site.

35. The health-monitoring device of claim 21, wherein the data communication port is configured to download data from the database at the remote site through a network.

36. The health-monitoring device of claim 21, wherein the data communication port is configured to upload data to the database at the remote site through a network.

37. The health-monitoring device of claim 21, wherein the data communication port is configured to download a program to the storage unit through a network.

38. The health-monitoring device of claim 36, wherein the data comprises one or more signals associated with an analyte sample received at the test port.

39. The health-monitoring device of claim 21, wherein the one or more signals associated with an analyte sample are indicative of an analyte concentration in the sample.

40. The health-monitoring device of claim 39, wherein the health-monitoring device continuously measures the analyte concentration.

41. The health-monitoring device of claim 39, wherein the analyte concentration is a blood glucose concentration.

42. The health-monitoring device of claim 39, wherein the analyte concentration is a fasting blood glucose concentration.

43. The health-monitoring device of claim 21, wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, or saliva.

44. The health-monitoring device of claim 21, wherein the display is configured to provide graphic representations and/or text summaries of the output data.

45. The health-monitoring device of claim 21, wherein the display is configured to provide information relating to food consumption, hypoglycemia, hyperglycemia, or medication dosage.

46. The health-monitoring device of claim 21, wherein the processor is configured to process a daily regimen of output data associated with the one or more signals associated with an analyte sample and display the output data over the course of a period of time.

47. The health-monitoring device of claim 46, wherein the period of time is at least one month.

48. The health-monitoring device of claim 21, wherein the storage unit is further configured to comprise an algorithm executable by the processor for determining an insulin resistance factor based at least in part on the one or more signals associated with the analyte sample.

49. The health-monitoring device of claim 48, wherein the output data comprises the insulin resistance factor associated with the one or more signals associated with an analyte sample.

50. The health-monitoring device of claim 21, wherein the processor provides for automatic or manual entry of user defined data.

51. The health-monitoring device of claim 50, wherein the health-monitoring device comprises a user interface for the manual entry of user defined data.

52. The health-monitoring device of claim 50, wherein the user defined data comprises analyte levels, gender, exercise, body mass index, weight, body composition, meal intake, or mediation dosages and times.

53. The health-monitoring device of claim 41, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hypoglycemia.

54. The health-monitoring device of claim 41, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hyperglycemia.

55. The health-monitoring device of claim 41, wherein the processor is configured to provide a preventative recommendation to the user to avoid imminent hypoglycemia through the display.

56. The health-monitoring device of claim 55, wherein the preventative recommendation is consumption of slow absorbing carbohydrates.

57. The health-monitoring device of claim 21, wherein the health-monitoring device further comprises a sampling device for providing a biological fluid sample from a user.

58. The health-monitoring device of claim 57, wherein the sampling device is a lancet or a needle.

59. The health-monitoring device of claim 57, wherein the sampling device is a lancet and the lancet comprises a variable depth selector for setting the penetration depth of the lancet.

60. A system for use in treating Type II diabetes, comprising:

a health monitoring device, comprising;

a housing;

a test port in communication with the housing, wherein the test port is configured to receive a test element;

a processor in communication with the housing and configured to receive one or more signals associated with an analyte sample received at the test port;

a storage unit in communication with the housing and configured to store one or more programs executable by the processor for determining a dosage information for long acting insulin based at least in part on the one or more signals associated with the analyte sample;

a display coupled to the housing and configured to provide graphic representations and/or text summaries of output data associated with the one or more signals associated with an analyte sample and/or the dosage information for long acting insulin; and

a data communication port operatively coupled to the processor;

an injection pen; and

long acting insulin.

61. The system of claim 60, wherein the analyte is glucose.

62. The system of claim 60, wherein the analyte is a ketone.

63. The system of claim 60, wherein the processor is configured to receive at least a first signal associated with a first analyte and a second signal associated with a second analyte.

64. The system of claim 63, wherein the first analyte is glucose and the second analyte is a fat metabolism analyte.

65. The system of claim 64, wherein the fat metabolism analyte is a ketone.

66. The system of claim 60, wherein the program comprises an algorithm for determining the dosage information for long acting insulin.

67. The system of claim 60, wherein the test element is a test strip.

68. The system of claim 67, wherein the test strip is an electrochemical test strip or a photometric test strip.

69. The system of claim 60, wherein the test element is a skin inserted device.

70. The system of claim 60, wherein the data communication port is configured for one or more of electrical communication, acoustic communication, optical communication, or radio wave communication.

71. The system of claim 60, wherein the data communication port is configured for infrared communication.

72. The system of claim 60, wherein the data communication port is configured to communicate with a database at a remote site.

73. The system of claim 60, wherein the data communication port is configured to download data from the database at the remote site through a network.

74. The system of claim 60, wherein the data communication port is configured to upload data to the database at the remote site through a network.

75. The system of claim 60, wherein the data communication port is configured to download a program to the storage unit through a network.

76. The system of claim 74, wherein the data comprises one or more signals associated with an analyte sample received at the test port.

77. The system of claim 60, wherein the one or more signals associated with an analyte sample are indicative of an analyte concentration in the sample.

78. The system of claim 75, wherein the health-monitoring device continuously measures the analyte concentration.

79. The system of claim 75, wherein the analyte concentration is a blood glucose concentration.

80. The system of claim 75, wherein the analyte concentration is a fasting blood glucose concentration.

81. The system of claim 60, wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, or saliva.

82. The system of claim 60, wherein the display is configured to provide graphic representations and/or text summaries of the output data.

83. The system of claim 60, wherein the display is configured to provide information relating to food consumption, hypoglycemia, hyperglycemia, or medication dosage.

84. The system of claim 60, wherein the processor is configured to process a daily regimen of output data associated with the one or more signals associated with an analyte sample and display the output data over the course of a period of time.

85. The system of claim 84, wherein the period of time is at least one month.

86. The system of claim 60, wherein the storage unit is further configured to comprise an algorithm executable by the processor for determining an insulin resistance factor based at least in part on the one or more signals associated with the analyte sample.

87. The system of claim 86, wherein the output data comprises an insulin resistance factor associated with the one or more signals associated with an analyte sample.

88. The system of claim 60, wherein the processor provides for automatic or manual entry of user defined data.

89. The system of claim 88, wherein the health-monitoring device comprises a user interface for the manual entry of user defined data.

90. The system of claim 88, wherein the user defined data comprises analyte levels, gender, exercise, body mass index, weight, body composition, meal intake, or mediation dosages and times.

91. The system of claim 79, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hypoglycemia.

92. The system of claim 79, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hyperglycemia.

93. The system of claim 79, wherein the processor is configured to provide a preventative recommendation to the user to avoid imminent hypoglycemia through the display.

94. The system of claim 96, wherein the preventative recommendation is consumption of slow absorbing carbohydrates.

95. The system of claim 60, wherein the health-monitoring device further comprises a sampling device for providing a biological fluid sample from a user.

96. The system of claim 95, wherein the sampling device is a lancet or a needle.

97. The system of claim 95, wherein the sampling device is a lancet and the lancet comprises a variable depth selector for setting the penetration depth of the lancet.

98. A health-monitoring device for use in treating diabetes with injections, comprising:

a housing;

a test port in communication with the housing, wherein the test port is configured to receive a test element;

a processor in communication with the housing and configured to receive one or more signals associated with an analyte sample received at the test port;

a storage unit in communication with the housing and configured to store one or more programs executable by the processor for determining a dosage information for long acting insulin based at least in part on the one or more signals associated with the analyte sample;

a display coupled to the housing and configured to provide graphic representations and/or text summaries of output data associated with the one or more signals associated with an analyte sample and/or the determined dosage information for long acting insulin; and

a communication port operatively coupled to the processor.

99. The health-monitoring device of claim 98, wherein the diabetes is Type II diabetes.