Method, System, and Computer Program Product For Tracking of Blood Glucose Variability in Diabetes

التفاصيل البيبلوغرافية
العنوان: Method, System, and Computer Program Product For Tracking of Blood Glucose Variability in Diabetes
Document Number: 20110264378
تاريخ النشر: October 27, 2011
Appl. No: 13/131467
Application Filed: November 24, 2009
مستخلص: An embodiment may be in the field of glycemic analysis and control. More specifically, an embodiment or approach may provide a novel method, system, and computer program for the visual and quantitative tracking of blood glucose variability in diabetes from self-monitoring blood glucose (SMBG) data and/or continuous glucose monitoring (CGM) data. More particularly, an embodiment or aspects thereof may use glucose measurements obtained from self-monitoring data and/or CGM data of an individual or a group of individuals to track and analyze blood glucose variability.
Inventors: Breton, Marc D. (Charlottesville, VA, US); Kovatchev, Boris P. (Charlottesville, VA, US)
Assignees: UNIVERSITY OF VIRGINIA PATENT FOUNDATION (Charlottesville, VA, US)
Claim: 1. A system for visually tracking blood glucose variability in diabetes in a subject, said system comprising: an acquisition module acquiring a plurality of blood glucose data; a processor programmed to track blood glucose variability based on said blood glucose data; said tracking providing an area of optimal glucose control in a plane; and said tracking providing areas indicating risk for hyperglycemia and hypoglycemia in said plane.
Claim: 2. The system of claim 1, wherein said plane comprises: a first axis representing the risk for hypoglycemia; and a second axis representing the risk for hyperglycemia.
Claim: 3. The system of claim 1, wherein said plane comprises: a first axis representing the Low Blood Glucose Index (LBGI); and a second axis representing the Low Blood Glucose Index (HBGI).
Claim: 4. The system of claim 1, wherein said plane comprises: a first axis representing the inverse-coded lower percentile; and a second axis representing the upper percentile.
Claim: 5. The system claim 1, wherein said plane comprises at least one of: a first zone representing the optimal control of glucose variability; a second zone representing moderate deviations into hypoglycemia, but good control of hyperglycemia; a third zone representing moderate deviations into hyperglycemia, but good control of hypoglycemia; a fourth zone representing moderate deviations towards both hypoglycemia and hyperglycemia; a fifth zone representing over-correction of hyperglycemia; a sixth zone representing over-correction of hypoglycemia; a seventh zone representing failure to deal with hypoglycemia; an eighth zone representing failure to deal with hyperglycemia; and a ninth zone representing an erroneous control.
Claim: 6. The system of claim 2, wherein said first axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data and the second axis comprises about the 97.5% of a distribution of said blood glucose data.
Claim: 7. The system of claim 2, wherein said first axis comprises about the 97.5% of a distribution of said blood glucose data and the second axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data. NOTE: If you reverse the axes, all zones of the next claim would need to be redefined by reversing “first” and “second” axis in the text. This may necessitate a new claim and would be true for all claims defining the grid.
Claim: 8. The system of claim 5, wherein said plane comprises: said first zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 110-200 mg/dl; said second zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 110-200 mg/dl; said third zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 200-400 mg/dl; said fourth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 200-400 mg/dl; said fifth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 110-200 mg/dl; said sixth zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about greater than 400 mg/dl; said seventh zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 200-400 mg/dl; said eighth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about greater than 400 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about greater than 400 mg/dl.
Claim: 9. The system of claim 4, wherein said first axis comprises about the inverse-coded 25% and the second axis comprises about the 75% of said blood glucose data.
Claim: 10. The system of claim 4, wherein said second axis comprises about the inverse-coded 25% and the first axis comprises about the 75% of said blood glucose data.
Claim: 11. The system of claim 5, wherein said hypoglycemia-hyperglycemia plane comprises: said first zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 110-180 mg/dl; said second zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 110-180 mg/dl; said third zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 180-250 mg/dl; said fourth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 180-250 mg/dl; said fifth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 110-180 mg/dl; said sixth zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about greater than 250 mg/dl; said seventh zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 180-250 mg/dl; said eighth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about greater than 250 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about greater than 250 mg/dl.
Claim: 12. The system of claim 3, wherein said first axis comprises a Low Blood Glucose Index (LBGI) of said blood glucose data.
Claim: 13. The system of claim 12, wherein said Low Blood Glucose Index (LBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 14. The system of claim 3, wherein said second axis comprises a High Blood Glucose Index (HBGI) of said blood glucose data.
Claim: 15. The system of claim 14, wherein said High Blood Glucose Index (HBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 16. The system of claim 5, wherein said hypoglycemia-hyperglycemia plane comprises: said first zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about less than 5; said second zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about less than 5; said third zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about 5-10; said fourth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about 5-10; said fifth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about less than 5; said sixth zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about greater than 10; said seventh zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about 5-10; said eighth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about greater than 10; and said ninth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about greater than 10.
Claim: 17. (canceled)
Claim: 18. (canceled)
Claim: 19. The system of claim 1, wherein said tracking determines extreme glucose events.
Claim: 20. The system of claim 1, wherein said tracking determines the extent of glycemic fluctuations over a specified time interval.
Claim: 21. (canceled)
Claim: 22. (canceled)
Claim: 23. (canceled)
Claim: 24. The system of claim 1, wherein said tracking comprises plotting a trajectory of data points from said blood glucose data on a specified time interval.
Claim: 25. (canceled)
Claim: 26. (canceled)
Claim: 27. (canceled)
Claim: 28. The system of claim 1, wherein said blood glucose data is acquired from continuous glucose monitoring (CGM) or self-monitoring blood glucose (SMBG) or both.
Claim: 29. A method for visually tracking blood glucose variability in diabetes in a subject, said method comprising: acquiring a plurality of blood glucose data; tracking blood glucose variability based on said blood glucose data; said tracking providing an area of optimal glucose control in a plane; and said tracking providing areas indicating risk for hyperglycemia and hypoglycemia in said plane.
Claim: 30. The method of claim 29, wherein said plane comprises: a first axis representing the risk for hypoglycemia; and a second axis representing the risk for hyperglycemia.
Claim: 31. The method of claim 29, wherein said plane comprises: a first axis representing the Low Blood Glucose Index (LBGI); and a second axis representing the Low Blood Glucose Index (HBGI).
Claim: 32. The method of claim 29, wherein said plane comprises: a first axis representing the inverse-coded lower percentile; and a second axis representing the upper percentile.
Claim: 33. The method claim 29, wherein said plane comprises at least one of: a first zone representing the optimal control of glucose variability; a second zone representing moderate deviations into hypoglycemia, but good control of hyperglycemia; a third zone representing moderate deviations into hyperglycemia, but good control of hypoglycemia; a fourth zone representing moderate deviations towards both hypoglycemia and hyperglycemia; a fifth zone representing over-correction of hyperglycemia; a sixth zone representing over-correction of hypoglycemia; a seventh zone representing failure to deal with hypoglycemia; an eighth zone representing failure to deal with hyperglycemia; and a ninth zone representing an erroneous control.
Claim: 34. The method of claim 30, wherein said first axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data and the second axis comprises about the 97.5% of a distribution of said blood glucose data.
Claim: 35. The method of claim 30, wherein said first axis comprises about the 97.5% of a distribution of said blood glucose data and the second axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data.
Claim: 36. The method of claim 33, wherein said plane comprises: said first zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 110-200 mg/dl; said second zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 110-200 mg/dl; said third zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 200-400 mg/dl; said fourth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 200-400 mg/dl; said fifth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 110-200 mg/dl; said sixth zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about greater than 400 mg/dl; said seventh zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 200-400 mg/dl; said eighth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about greater than 400 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about greater than 400 mg/dl.
Claim: 37. The method of claim 32, wherein said first axis comprises about the inverse-coded 25% and the second axis comprises about the 75% of said blood glucose data.
Claim: 38. The method of claim 32, wherein said second axis comprises about the inverse-coded 25% and the first axis comprises about the 75% of said blood glucose data.
Claim: 39. The method of claim 33, wherein said hypoglycemia-hyperglycemia plane comprises: said first zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 110-180 mg/dl; said second zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 110-180 mg/dl; said third zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 180-250 mg/dl; said fourth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 180-250 mg/dl; said fifth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 110-180 mg/dl; said sixth zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about greater than 250 mg/dl; said seventh zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 180-250 mg/dl; said eighth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about greater than 250 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about greater than 250 mg/dl.
Claim: 40. The method of claim 31, wherein said first axis comprises a Low Blood Glucose Index (LBGI) of said blood glucose data.
Claim: 41. The method of claim 40, wherein said Low Blood Glucose Index (LBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 42. The method of claim 31, wherein said second axis comprises a High Blood Glucose Index (HBGI) of said blood glucose data.
Claim: 43. The method of claim 42, wherein said High Blood Glucose Index (HBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 44. The method of claim 33, wherein said hypoglycemia-hyperglycemia plane comprises: said first zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about less than 5; said second zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about less than 5; said third zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about 5-10; said fourth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about 5-10; said fifth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about less than 5; said sixth zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about greater than 10; said seventh zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about 5-10; said eighth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about greater than 10; and said ninth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about greater than 10.
Claim: 45. (canceled)
Claim: 46. (canceled)
Claim: 47. The method of claim 29, wherein said tracking determines extreme glucose events.
Claim: 48. The method of claim 29, wherein said tracking determines the extent of glycemic fluctuations over a specified time interval.
Claim: 49. (canceled)
Claim: 50. (canceled)
Claim: 51. (canceled)
Claim: 52. The method of claim 29, wherein said tracking comprises plotting a trajectory of data points from said blood glucose data on a specified time interval.
Claim: 53. (canceled)
Claim: 54. (canceled)
Claim: 55. (canceled)
Claim: 56. The method of claim 29, wherein said blood glucose data is acquired from continuous glucose monitoring (CGM) or self-monitoring blood glucose (SMBG) or both.
Claim: 57. (canceled)
Claim: 58. (canceled)
Claim: 59. A computer program product comprising a computer useable medium having a computer program logic for enabling at least one processor in a computer system to track blood glucose variability in diabetes in a subject, or in a group of subjects, said computer program logic comprising: acquiring a plurality of blood glucose data; tracking blood glucose variability based on said blood glucose data; said tracking providing an area of optimal glucose control intended for a plane format: and said tracking providing areas indicating risk for hyperglycemia and hypoglycemia in said plane format.
Claim: 60. The computer program product of claim 59, wherein said plane format is transmitted to an interface.
Claim: 61. (canceled)
Claim: 62. The computer program product of claim 59, wherein said plane format comprises: a first axis representing the risk for hypoglycemia; and a second axis representing the risk for hyperglycemia.
Claim: 63. The computer program product of claim 59, wherein said plane format comprises: a first axis representing the Low Blood Glucose Index (LBGI); and a second axis representing the Low Blood Glucose Index (HBGI).
Claim: 64. The computer program product of claim 59, wherein said plane format comprises: a first axis representing the inverse-coded lower percentile; and a second axis representing the upper percentile.
Claim: 65. The computer program product of claim 59, wherein said plane format comprises at least one of: a first zone representing the optimal control of glucose variability; a second zone representing moderate deviations into hypoglycemia, but good control of hyperglycemia; a third zone representing moderate deviations into hyperglycemia, but good control of hypoglycemia; a fourth zone representing moderate deviations towards both hypoglycemia and hyperglycemia; a fifth zone representing over-correction of hyperglycemia; a sixth zone representing over-correction of hypoglycemia; a seventh zone representing failure to deal with hypoglycemia; an eighth zone representing failure to deal with hyperglycemia; and a ninth zone representing an erroneous control.
Claim: 66. The computer program product of claim 62, wherein said first axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data and the second axis comprises about the 97.5% of a distribution of said blood glucose data.
Claim: 67. The computer program product of claim 62, wherein said first axis comprises about the 97.5% of a distribution of said blood glucose data and the second axis comprises about the inverse-coded 2.5% of a distribution of said blood glucose data.
Claim: 68. The computer program product of claim 65, wherein said plane format comprises: said first zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 110-200 mg/dl; said second zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 110-200 mg/dl; said third zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about 200-400 mg/dl; said fourth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about 200-400 mg/dl; said fifth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about 110-200 mg/dl; said sixth zone further comprises said first axis ranging from about 110-80 mg/dl and said second axis ranging from about greater than 400 mg/dl; said seventh zone further comprises said first axis ranging from about less than 50, mg/dl and said second axis ranging from about 200-400 mg/dl; said eighth zone further comprises said first axis ranging from about 80-50 mg/dl and said second axis ranging from about greater than 400 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 50 mg/dl and said second axis ranging from about greater than 400 mg/dl.
Claim: 69. The computer program product of claim 64, wherein said first axis comprises about the inverse-coded 25% and the second axis comprises about the 75% of said blood glucose data.
Claim: 70. The computer program product of claim 64, wherein said second axis comprises about the inverse-coded 25% and the first axis comprises about the 75% of said blood glucose data.
Claim: 71. The computer program product of claim 64, wherein said hypoglycemia-hyperglycemia plane format comprises: said first zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 110-180 mg/dl; said second zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 110-180 mg/dl; said third zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about 180-250 mg/dl; said fourth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about 180-250 mg/dl; said fifth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 110-180 mg/dl; said sixth zone further comprises said first axis ranging from about 110-90 mg/dl and said second axis ranging from about greater than 250 mg/dl; said seventh zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about 180-250 mg/dl; said eighth zone further comprises said first axis ranging from about 90-70 mg/dl and said second axis ranging from about greater than 250 mg/dl; and said ninth zone further comprises said first axis ranging from about less than 70 mg/dl and said second axis ranging from about greater than 250 mg/dl.
Claim: 72. The computer program product of claim 63, wherein said first axis comprises a Low Blood Glucose Index (LBGI) of said blood glucose data.
Claim: 73. The computer program product of claim 72, wherein said Low Blood Glucose Index (LBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 74. The computer program product of claim 73, wherein said second axis comprises a High Blood Glucose Index (HBGI) of said blood glucose data.
Claim: 75. The computer program product of claim 64, wherein said High Blood Glucose Index (HBGI) is provided by: [mathematical expression included] where k is the subject and t is the time period.
Claim: 76. The computer program product of claim 65, wherein said hypoglycemia-hyperglycemia plane format comprises: said first zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about less than 5; said second zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about less than 5; said third zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about 5-10; said fourth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about 5-10; said fifth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about less than 5; said sixth zone further comprises said first axis ranging from about less than 2.5 and said second axis ranging from about greater than 10; said seventh zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about 5-10; said eighth zone further comprises said first axis ranging from about 2.5-5 and said second axis ranging from about greater than 10; and said ninth zone further comprises said first axis ranging from about greater than 5 and said second axis ranging from about greater than 10.
Claim: 77. (canceled)
Claim: 78. (canceled)
Claim: 79. The computer program product of claim 59, wherein said tracking determines extreme glucose events.
Claim: 80. The computer program product of claim 59, wherein said tracking determines the extent of glycemic fluctuations over a specified time interval.
Claim: 81. (canceled)
Claim: 82. (canceled)
Claim: 83. (canceled)
Claim: 84. The computer program product of claim 59, wherein said tracking comprises plotting a trajectory of data points from said blood glucose data on a specified time interval.
Claim: 85. (canceled)
Claim: 86. (canceled)
Claim: 87. (canceled)
Claim: 88. The computer program product of claim 59, wherein said blood glucose data is acquired from continuous glucose monitoring (CGM) or self-monitoring blood glucose (SMBG) or both.
Claim: 89. (canceled)
Claim: 90. (canceled)
Claim: 91. A system for audibly tracking blood glucose variability in diabetes in a subject, said system comprising: an acquisition module acquiring a plurality of blood glucose data; a processor programmed to track blood glucose variability based on said blood glucose data; said tracking providing a signal for optimal glucose control; and said tracking providing signals indicating risk for hyperglycemia and hypoglycemia.
Claim: 92. A method for audibly tracking blood glucose variability in diabetes in a subject, said method comprising: acquiring a plurality of blood glucose data; tracking blood glucose variability based on said blood glucose data; said tracking providing a signal of optimal glucose control; and said tracking providing signals indicating risk for hyperglycemia and hypoglycemia.
Claim: 93. The system of claim 20, wherein said specified time interval is approximately two or more days.
Claim: 94. The system of claim 20, wherein said specified time interval is approximately a daily basis.
Claim: 95. The system of claim 20, wherein said specified time interval is less than a daily basis.
Claim: 96. The system of claim 20, wherein said specified time interval is approximately half a day.
Claim: 97. The system of claim 20, wherein said specified time interval is approximately two or more hours.
Claim: 98. The system of claim 20, wherein said specified time interval is approximately an hour.
Claim: 99. The system of claim 20, wherein said specified time interval is less than an hour.
Claim: 100. The system of claim 20, wherein said specified time interval is approximately fifteen minutes.
Claim: 101. The method of claim 48, wherein said specified time interval is approximately two or more days.
Claim: 102. The method of claim 48, wherein said specified time interval is approximately a daily basis.
Claim: 103. The method of claim 48, wherein said specified time interval is less than a daily basis.
Claim: 104. The method of claim 48, wherein said specified time interval is approximately half a day.
Claim: 105. The method of claim 48, wherein said specified time interval is approximately two or more hours.
Claim: 106. The method of claim 48, wherein said specified time interval is approximately an hour.
Claim: 107. The method of claim 48, wherein said specified time interval is less than an hour.
Claim: 108. The method of claim 48, wherein said specified time interval is approximately fifteen minutes.
Claim: 109. The computer program product of claim 80, wherein said specified time interval is approximately two or more days.
Claim: 110. The computer program product of claim 80, wherein said specified time interval is approximately a daily basis.
Claim: 111. The computer program product of claim 80, wherein said specified time interval is less than a daily basis.
Claim: 112. The computer program product of claim 80, wherein said specified time interval is approximately half a day.
Claim: 113. The computer program product of claim 80, wherein said specified time interval is approximately two or more hours.
Claim: 114. The computer program product of claim 80, wherein said specified time interval is approximately an hour.
Claim: 115. The computer program product of claim 80, wherein said specified time interval is less than an hour.
Claim: 116. The computer program product of claim 80, wherein said specified time interval is approximately fifteen minutes.
Current U.S. Class: 702/19
Current International Class: 06; 01
رقم الانضمام: edspap.20110264378
قاعدة البيانات: USPTO Patent Applications