DIABETES CARE MANAGEMENT SYSTEM

• US 20080097180A1
• Filed: 10/26/2007
• Published: 04/24/2008
• Est. Priority Date: 01/10/1997
• Status: Active Grant

• Current Assignee: Stephen Brown
• Original Assignee: Stephen Brown
• Inventors: Brown, Stephen
• Granted Patent: US 7,920,998 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/6896 Toys
• 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: G01N 2035/00891 Displaying information to the operator
• 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: G09B 19/00 Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A medical device for diabetes management, comprising (a) a memory comprising one or more optimal blood glucose values, one or more insulin dose values of a patient, one or more measured blood glucose values, and one or more scaling factors for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose actions performed by the individual patient, (b) a microprocessor, in communication with the memory, programmed to calculate a further value, the further value being based on the insulin dose values, the optimal blood glucose values, and the scaling factors, and (c) a display configured to display information according to the further value.

Claims

1. A medical device for diabetes management, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more insulin dose values of a patient, one or more measured blood glucose values, and one or more scaling factors for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose actions performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said insulin dose values, said optimal blood glucose values, and said scaling factors; and

(c) a display configured to display information according to said further value.

2. The device of claim 1, wherein said memory further comprises one or more carbohydrate intake values, wherein said microprocessor is also programmed to calculate said further value based on said one or more carbohydrate intake values.

3. The device of claim 1, wherein said display is configured for displaying multiple values in graphical form.

4. The device of claim 1, wherein said display of said further value enables the patient to consider appropriate insulin dose actions.

5. The device of claim 1, further comprising an electronic data recording device configured for receiving prior blood glucose values.

6. The device of claim 1, wherein said memory further comprises one or more optimal insulin dose values, and said further value is calculated based further upon said one or more optimal insulin dose values.

7. The device of claim 1, wherein said memory is further programmed to determine said one or more scaling factors from one or more physiological parameters including body mass, metabolism rate, fitness level or hepatic or peripheral insulin sensitivity, or combinations thereof.

8. The device of claim 1, wherein said memory is further programmed to determine said one or more scaling factors from insulin sensitivity.

9. A medical device for diabetes management, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more carbohydrate intake values of a patient, one or more measured blood glucose values, and one or more scaling factors for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of carbohydrate intake actions performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said carbohydrate intake values, said optimal blood glucose values, and said scaling factors; and

(c) a display configured to display information according to said further value.

10. The device of claim 9, wherein said memory further comprises one or more exercise values, wherein said microprocessor is also programmed to calculate said further value based on said one or more exercise values.

11. The device of claim 9, wherein said display of said further value enables the patient to consider appropriate carbohydrate actions.

12. The device of claim 9, wherein said memory further comprises one or more optimal carbohydrate intake values, and said further value is calculated based further upon said optimal carbohydrate intake values.

13. The device of claim 9, wherein said memory is further programmed to determine said one or more scaling factors from one or more physiological parameters including body mass, metabolism rate, fitness level or hepatic or peripheral insulin sensitivity, or combinations thereof.

14. The device of claim 9, wherein said memory is further programmed to determine said one or more scaling factors from body mass or metabolism rate or both.

15. The device of claim 14, wherein the memory further comprises one or more optimal self care values including an optimal food exchange parameter value expressed in grams of carbohydrates, an optimal insulin dose parameter value expressed in units of insulin, or an optimal exercise duration parameter value expressed in fifteen minute units of exercise, or combinations thereof.

16. The device of claim 15, wherein said values are respectively determined based on one gram of carbohydrate being expected to raise the patient'"'"'s blood glucose level by 4 mg/dL, one unit of insulin being expected to lower the patient'"'"'s blood glucose level by 40 mg/dL, or fifteen minutes of exercise being expected to lower the patient'"'"'s blood glucose level by 5 mg/dL, or said combinations thereof.

17. A medical device for diabetes management, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more insulin dose, food intake or exercise values of a patient, or combinations thereof, one or more measured blood glucose values, and one or more scaling factors for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose, food intake or exercise actions, or combinations thereof, performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said insulin dose, food intake or exercise values, or combinations thereof, and on said one or more optimal blood glucose values, and on said one or more scaling factors; and

(c) a display configured to display information according to said further value.

18. The device of claim 17, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

19. The device of claim 17, further comprising an output port coupled to said processor for establishing a communication link between said device and a healthcare provider computer and for transmitting and receiving data therebetween.

20. The device of claim 17, further comprising an electronic data recording device including a glucose measurement device for measuring the blood glucose values, and from which the measured blood glucose values are stored in the memory.

21. The device of claim 17, wherein said display of said further value enables the patient to consider appropriate insulin dose action including injecting units of insulin, food intake actions including intake of grams of carbohydrates, or exercise actions including minutes of exercise or durations of exercise in 15 minute units, or combinations thereof.

22. The device of claim 17, further comprising an electronic data recording device configured for receiving prior blood glucose values.

23. The device of claim 17, wherein said memory further comprises one or more optimal insulin dose, food intake or exercise values, or combinations thereof, and said further value is calculated based further upon said one or more optimal insulin dose, food intake or exercise values, or combinations thereof.

24. The device of claim 17, wherein said memory is further programmed to determine said one or more scaling factors from one or more physiological parameters including body mass, metabolism rate, fitness level or hepatic or peripheral insulin sensitivity, or combinations thereof.

25. The device of claim 17, wherein the memory further comprises one or more optimal self care values including an optimal food exchange parameter value expressed in grams of carbohydrates, an optimal insulin dose parameter value expressed in units of insulin, or an optimal exercise duration parameter value expressed in fifteen minute units of exercise, or combinations thereof.

26. A medical device for diabetes management, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more self care values of a patient, one or more measured blood glucose values, and one or more scaling factors for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of self care actions performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to

(i) determine said one or more scaling factors from one or more physiological parameters including body mass, metabolism rate, fitness level or hepatic or peripheral insulin sensitivity, or combinations thereof, and

(ii) calculate a further value, said further value being based on said self care values, and on said one or more optimal blood glucose values, and on said one or more scaling factors; and

(c) a display configured to display information according to said further value.

27. The device of claim 26, wherein said one or more physiological parameters include insulin sensitivity.

28. The device of claim 26, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

29. The device of claim 26, wherein said memory comprises one or more carbohydrate intake values, wherein said microprocessor is programmed to calculate said further value based on said one or more carbohydrate intake values.

30. The device of claim 29, wherein said carbohydrate intake values comprise grams of carbohydrates.

31. The device of claim 26, wherein said memory comprises one or more insulin dose values, wherein said microprocessor is programmed to calculate said further value based on said one or more insulin dose values.

32. The device of claim 31, wherein said insulin dose values comprise units of insulin.

33. The device of claim 26, further comprising an electronic data recording device including a glucose measurement device for measuring the blood glucose values, and from which the measured blood glucose values are stored in the memory.

34. The device of claim 26, wherein said display of said further value enables the patient to consider appropriate insulin dose action including injecting units of insulin, food intake actions including intake of grams of carbohydrates, or exercise actions including minutes of exercise or durations of exercise in 15 minute units, or combinations thereof.

35. The device of claim 26, wherein said memory further comprises one or more optimal insulin dose, food intake or exercise values, or combinations thereof, and said further value is calculated based further upon said one or more optimal insulin dose, food intake or exercise values, or combinations thereof.

36. The device of claim 26, wherein said memory comprises one or more food intake values, wherein said microprocessor is also programmed to calculate said further value based on said one or more food intake values.

37. The device of claim 36, wherein said food intake values comprise grams of carbohydrates.

38. The device of claim 26, wherein the memory comprises one or more optimal self care values including an optimal food exchange parameter value expressed in grams of carbohydrates, an optimal insulin dose parameter value expressed in units of insulin, or an optimal exercise duration parameter value expressed in fifteen minute units of exercise, or combinations thereof.

39. The device of claim 38, wherein said values are respectively determined based on one gram of carbohydrate being expected to raise the patient'"'"'s blood glucose level by 4 mg/dL, one unit of insulin being expected to lower the patient'"'"'s blood glucose level by 40 mg/dL, or fifteen minutes of exercise being expected to lower the patient'"'"'s blood glucose level by 5 mg/dL, or said combinations thereof.

40. A medical device for diabetes management, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more measured blood glucose values, one or more insulin, carbohydrate intake or exercise values of a patient, along respectively with one or more insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof, for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose, carbohydrate intake or exercise actions, or combinations thereof, performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to

calculate a further value, said further value being based on said one or more optimal blood glucose values, and on said insulin, carbohydrate intake or exercise values along respectively with said one or more insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof; and

(c) a display configured to display information according to said further value.

41. The device of claim 40, wherein said microprocessor, in communication with said memory, is further programmed to determine said one or more sensitivity factors from one or more physiological parameters including body mass, metabolism rate, fitness level or hepatic or peripheral insulin sensitivity, or combinations thereof.

42. The device of claim 40, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

43. The device of claim 42, wherein said exercise values comprise durations of exercise in fifteen minute units.

44. The device of claim 40, wherein said memory comprises one or more carbohydrate intake values, wherein said microprocessor is programmed to calculate said further value based on said one or more carbohydrate intake values.

45. The device of claim 40, wherein said memory comprises one or more insulin dose values, wherein said microprocessor is programmed to calculate said further value based on said one or more insulin dose values.

46. The device of claim 40, wherein said display of said further value enables the patient to consider appropriate insulin dose action including injecting units of insulin, food intake actions including intake of grams of carbohydrates, or exercise actions including minutes of exercise or durations of exercise in 15 minute units, or combinations thereof.

47. The device of claim 40, wherein said memory further comprises one or more optimal insulin dose, food intake or exercise values, or combinations thereof, and said further value is calculated based further upon said one or more optimal insulin dose, food intake or exercise values, or combinations thereof.

48. The device of claim 40, wherein said memory comprises one or more food intake values, wherein said microprocessor is also programmed to calculate said further value based on said one or more food intake values.

49. The device of claim 48, wherein the memory comprises one or more optimal self care values including an optimal food exchange parameter value expressed in grams of carbohydrates, an optimal insulin dose parameter value expressed in units of insulin, or an optimal exercise duration parameter value expressed in fifteen minute units of exercise, or combinations thereof.

50. The device of claim 49, wherein said values are respectively determined based on one gram of carbohydrate being expected to raise the patient'"'"'s blood glucose level by 4 mg/dL, one unit of insulin being expected to lower the patient'"'"'s blood glucose level by 40 mg/dL, or fifteen minutes of exercise being expected to lower the patient'"'"'s blood glucose level by 5 mg/dL, or said combinations thereof.

51. A medical device for management by a patient of a diabetic condition of a continuous nature, comprising:

(a) a memory comprising one or more optimal blood glucose values, one or more measured blood glucose values of a patient, and one or more insulin, carbohydrate intake or exercise values of a patient, along respectively with one or more insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof, for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose, carbohydrate intake or exercise actions, or combinations thereof, performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said one or more of insulin, carbohydrate intake or exercise values of the patient, and on said one or more optimal blood glucose values, and on said one or more of insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof;

(c) a display configured to display information according to said further value; and

(d) wherein because of the continuous nature of the physiological condition, the device is configured for monitoring and controlling the blood glucose on a regular basis by the patient outside of a medical clinic.

52. The device of claim 51, further comprising a housing, wherein said memory and said microprocessor are housed within said housing, and further comprising an output port, said output port is integral with said housing, thereby providing a hand-held, readily transportable device.

53. The device of claim 52, further comprising an electronic data recording device arranged within said housing.

54. The device of claim 51, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

55. The device of claim 54, wherein said exercise values comprise minutes of exercise.

56. The device of claim 54, wherein said exercise values comprise durations of exercise in fifteen minute units.

57. The device of claim 51, wherein said memory comprises one or more carbohydrate intake values, wherein said microprocessor is programmed to calculate said further value based on said one or more carbohydrate intake values.

58. The device of claim 51, wherein said memory comprises one or more insulin dose values, wherein said microprocessor is programmed to calculate said further value based on said one or more insulin dose values.

59. The device of claim 51, further comprising an output port coupled to said processor for establishing a communication link between said device and a healthcare provider computer and for transmitting and receiving data therebetween.

60. The device of claim 59, wherein said device further comprises a modem for establishing said communication link through a communication network.

61. The device of claim 59, wherein said output port comprises an input/output port for establishing said communication link through a connection cord.

62. The device of claim 51, wherein said display is configured for displaying multiple values in graphical form.

63. The device of claim 51, further comprising an electronic data recording device including a control parameter measurement device for measuring the control parameter values, and from which the measured control parameter values are stored in the memory.

64. The device of claim 51, wherein said memory further comprises one or more optimal insulin dose, carbohydrate intake or exercise actions of a patient, or combinations thereof.

65. The device of claim 64, wherein said optimal insulin dose, carbohydrate intake or exercise values include values determined by a health care provider.

66. A computing device for use in managing a physiological condition of a continuous nature associated with glucose levels and diabetes care, comprising:

(a) a memory comprising one or more optimal control parameter values, one or more self care values of a patient, one or more measured control parameter values, and one or more scaling factors for weighting the impact on a future control parameter value and that are customizable to an individual patient to predict the effect on the control parameter of one or more self care actions performed by the individual patient;

(b) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said one or more self care values and on said one or more optimal control parameter values, and on said one or more scaling factors;

(c) a display configured to display information according to said further value; and

(d) wherein because of the continuous nature of the physiological condition associated with glucose levels and diabetes care, the device is configured for monitoring and controlling the control parameter on a regular basis by the patient outside of a medical clinic.

67. The device of claim 66, further comprising a housing, wherein said memory and said microprocessor are housed within said housing, and further comprising an output port, said output port is integral with said housing, thereby providing a hand-held, readily transportable device.

68. The device of claim 66, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

69. The device of claim 66, wherein said memory comprises one or more carbohydrate intake values, wherein said microprocessor is programmed to calculate said further value based on said one or more carbohydrate intake values.

70. The device of claim 66, wherein said memory comprises one or more insulin dose values, wherein said microprocessor is programmed to calculate said further value based on said one or more insulin dose values.

71. The device of claim 66, further comprising an output port coupled to said processor for establishing a communication link between said device and a healthcare provider computer and for transmitting and receiving data therebetween.

72. The device of claim 66, wherein said display is configured for displaying multiple values in graphical form.

73. The device of claim 66, further comprising an electronic data recording device including a control parameter measurement device for measuring the control parameter values, and from which the measured control parameter values are stored in the memory.

74. The device of claim 66, wherein said memory further comprises one or more optimal self care values.

75. The device of claim 66, wherein the physiological condition associated with glucose levels is associated with glucose levels in blood.

76. A diabetes care management system for managing blood glucose levels associated with diabetes, comprising:

(a) a computing device comprising;

(i) a memory comprising one or more optimal blood glucose values, one or more measured blood glucose values, one or more insulin, carbohydrate intake or exercise values of a patient, along respectively with one or more insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof, for weighting the impact on a future blood glucose value and that are customizable to an individual patient to predict the effect on the blood glucose of insulin dose, carbohydrate intake or exercise actions, or combinations thereof, performed by the individual patient;

(ii) a microprocessor, in communication with said memory, programmed to calculate a further value, said further value being based on said one or more optimal blood glucose values, and on said insulin, carbohydrate intake or exercise values along respectively with said one or more insulin, carbohydrate intake or exercise sensitivity factors, or combinations thereof;

(iii) a display configured to display information according to said further value; and

(iv) a housing, wherein said memory and said microprocessor are housed within said housing, thereby providing a hand-held, readily transportable computing device; and

(b) an insulin delivery device for delivering insulin in response to information associated with said further value.

77. The system of claim 76, wherein said housing further comprises an output port and said output port is integral with said housing.

78. The system of claim 77, further comprising an electronic data recording device arranged within said housing.

79. The system of claim 76, wherein said memory comprises one or more exercise values, wherein said microprocessor is programmed to calculate said further value based on said one or more exercise values.

80. The system of claim 79, wherein said exercise values comprise minutes of exercise.

81. The system of claim 79, wherein said exercise values comprise durations of exercise in fifteen minute units.

82. The device of claim 76, wherein said memory comprises one or more carbohydrate intake values, wherein said microprocessor is programmed to calculate said further value based on said one or more carbohydrate intake values.

83. The device of claim 82, wherein said carbohydrate intake values comprise grams of carbohydrates.

84. The device of claim 76, wherein said memory comprises one or more insulin dose values, wherein said microprocessor is programmed to calculate said further value based on said one or more insulin dose values.

85. The device of claim 84, wherein said insulin dose values comprise units of insulin.

86. The system of claim 76, further comprising an output port coupled to said processor for establishing a communication link between said device and a healthcare provider computer and for transmitting and receiving data therebetween.

87. The system of claim 86, further comprising a modem for establishing said communication link through a communication network.

88. The system of claim 86, wherein said output port comprises an input/output port for establishing said communication link through a connection cord.

89. The system of claim 76, wherein said display is configured for displaying multiple values in graphical form.

90. The system of claim 76, further comprising an electronic data recording device including a control parameter measurement device for measuring the control parameter values, and from which the measured control parameter values are stored in the memory.

91. The system of claim 76, further comprising an electronic data recording device configured for receiving prior control parameter values.

92. The system of claim 91, wherein said electronic data recording device is in communication with said microprocessor.

93. The system of claim 76, wherein said memory further comprises one or more optimal self care values.

94. The system of claim 93, wherein said optimal self care values include values determined by a health care provider.

95. The system of claim 93, wherein said memory further comprises one or more optimal control parameter values.

96. The system of claim 95, wherein said one or more optimal self care values and said one or more optimal control parameter values are stored in the memory, entered into the computing device by keypad or entered into the computing device by I/O port, or combinations thereof.

97. The system of claim 76, wherein said insulin delivery device includes a reservoir for storing said insulin for delivery to said patient through a tubular member.

98. The system of claim 97, wherein said reservoir for storing said insulin is a syringe barrel and said tubular member includes a needle cannula for insertion in the skin of said patient.