Method and apparatus for improving clinical accuracy of analyte measurements

• US 20030108976A1
• Filed: 10/09/2002
• Published: 06/12/2003
• Est. Priority Date: 10/09/2001
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: Hercules Technology Growth Capital, Inc.
• Inventors: Braig, James R., Hartstein, Philip C., Rule, Peter, Smith, Heidi S.
• Application Number:
  US10/268,599
• Publication Number:
  US 20030108976A1
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Herein is described a system that includes a processing circuit for identifying possible zone D errors among estimated blood glucose concentration values. The system converts estimated blood glucose concentration values which are identified as possible zone D errors into adjusted blood glucose concentration values which are lower in blood glucose concentration magnitude than their corresponding estimated blood glucose concentration values, thereby decreasing the occurrence of zone D errors. Herein is also disclosed a method for improving the clinical accuracy of an analyte concentration measurement. One method includes a first act of computing an estimated analyte concentration having an associated first error that is clinically significant and a second act of processing the estimated analyte concentration to generate an adjusted analyte concentration having a second error that is clinically insignificant.

Claims

1. A blood glucose detection system comprising a processing circuit which:

identifies possible zone D errors among estimated blood glucose concentration values; and

converts those of said estimated blood glucose concentration values which are identified as possible zone D errors, into adjusted blood glucose concentration values which are lower in blood glucose concentration magnitude than their corresponding estimated blood glucose concentration values, thereby decreasing the occurrence of zone D errors.

2. The blood glucose detection system of claim 1, wherein said system has an associated error band and said processing circuit identifies said possible zone D errors as estimated blood glucose values which are greater than or equal to a threshold value of clinical significance and less than the sum of said threshold value and said error band.

3. The blood glucose detection system of claim 2, wherein said error band comprises a maximum expected deviation of said estimated blood glucose concentration values from corresponding actual blood glucose concentration values.

4. The blood glucose detection system of claim 2, wherein said error band comprises a deviation from identity which encompasses a selected percentage of measurements.

5. The blood glucose detection system of claim 4, wherein the selected percentage is at least 80%.

6. The blood glucose detection system of claim 2, wherein said threshold value of clinical significance corresponds to the lowest portion of the border between zone D and zone A of the Clarke error grid.

7. The blood glucose detection system of claim 2, wherein said threshold value of clinical significance is selected from the range of about 50 mg/dL to about 80 mg/dL.

8. The blood glucose detection system of claim 7, wherein said threshold value of clinical significance is about 70 mg/dL.

9. The blood glucose detection system of claim 1, wherein said system has an associated error band and said processing circuit converts said estimated blood glucose concentration values which are identified as possible zone D errors, by subtracting said error band from said estimated blood glucose concentration values which are identified as possible zone D errors.

10. The blood glucose detection system of claim 2, wherein said processing circuit converts said estimated blood glucose concentration values which are identified as possible zone D errors, by subtracting said error band from said estimated blood glucose concentration values which are identified as possible zone D errors.

11. A blood glucose detection system for reducing occurrences of measurement errors that exceed a threshold value of clinical significance, the system having an associated error band, the system comprising:

a processor that converts an estimated blood glucose concentration value of at least the threshold value and less than the sum of the threshold value and the error band into an adjusted blood glucose concentration value that is below the border between zones D and A of the Clarke error grid.

12. The system of claim 11, wherein the threshold value of clinical significance corresponds to the lowest portion of the border between zone D and zone A of the Clarke error grid.

13. The system of claim 11, wherein the error band comprises a maximum expected deviation from actual blood glucose concentration values.

14. The blood glucose detection system of claim 11, wherein said error band comprises a deviation from identity which encompasses a selected percentage of measurements.

15. The blood glucose detection system of claim 14, wherein the selected percentage is at least 80%.

16. An analyte detection system comprising:

a processing circuit; and

a module executable by the processing circuit whereby the processing circuit receives an estimated analyte concentration having an associated first error that is clinically significant, and the processing circuit applies a transfer function to the estimated analyte concentration to generate an adjusted analyte concentration having a second error that is clinically insignificant.

17. The system of claim 16, wherein the first error that is clinically significant comprises an error falling into any of zones C, D, and E of the Clarke error grid.

18. The system of claim 16, wherein the first error that is clinically significant comprises an error falling into any of zones D and E of the Clarke error grid.

19. The system of claim 16, wherein the estimated analyte concentration is an estimate of the concentration of glucose within blood.

20. The system of claim 17, wherein the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value from about 70 mg/dL to about 85 mg/dL.

21. The system of claim 16, wherein the system has an associated error band and the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band.

22. The system of claim 21, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 80 mg/dL.

23. The system of claim 21, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 80 mg/dL.

24. The system of claim 21, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 70 mg/dL.

25. The system of claim 21, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 70 mg/dL.

26. The system of claim 21, wherein the threshold value of clinical significance corresponds to the lowest portion of a border on the Clarke error grid below which estimated analyte concentrations are zone A errors and above which estimated analyte concentrations are zone D errors.

27. The system of claim 16, wherein the system has an associated error band and the adjusted analyte concentration is about one error band lower than the estimated analyte concentration.

28. The system of claim 16, wherein the system has an associated error band and at least a portion of the transfer function comprises an arc having a radius equivalent to the error band and a center point having horizontal and vertical axis coordinates equal to a threshold value of clinical significance.

29. The system of claim 16, wherein at least a portion of the transfer function comprises an arc.

30. The system of claim 16, wherein the transfer function is continuous.

31. The system of claim 16, wherein the system has an associated error band and the processor adjusts the estimated analyte concentrations having a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band, to a substantially uniform adjusted value equal to the threshold value.

32. The system of claim 16, wherein the system has an associated error band and the processor adjusts the estimated analyte concentrations having a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band, to a maximum value less than the threshold value.

33. The system of claim 16, wherein the transfer function is selected to correspond to an individual user.

34. The system of claim 16, wherein the detected analyte is organic.

35. The system of claim 16, wherein the detected analyte is inorganic.

36. The system of claim 16, wherein the analyte is detected from whole blood.

37. The system of claim 16, wherein a plurality of analytes are detected.

38. The system of claim 16, wherein the analyte is detected from tissue.

39. The system of claim 16, wherein the analyte is detected from fluid.

40. The system of claim 16, wherein the analyte is detected from the group consisting of interstitial fluid, intercellular fluid, and whole blood.

41. The system of claim 16, wherein the system is for home use.

42. The system of claim 16, wherein the system is for field use.

43. An apparatus for providing an adjusted analyte concentration, wherein reporting an analyte concentration having a value below a threshold value of clinical significance causes a first course of treatment and reporting an analyte concentration having a value above the threshold value of clinical significance causes a second course of treatment, the apparatus comprising:

a processing circuit that receives an estimated analyte concentration and applies a transfer function to the estimated analyte concentration to provide an adjusted analyte concentration;

wherein the adjusted analyte concentration differs from the estimated analyte concentration when the estimated analyte concentration is in the proximity of the threshold value of clinical significance.

44. The apparatus of claim 43, wherein the estimated analyte concentration is an estimate of the concentration of glucose within blood.

45. The apparatus of claim 43, wherein the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value from about 70 mg/dL to about 85 mg/dL.

46. The apparatus of claim 43, wherein estimated analyte concentrations having a value from 70 mg/dL to 85 mg/dL are adjusted.

47. The apparatus of claim 43, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 80 mg/dL.

48. The apparatus of claim 43, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 80 mg/dL.

49. The apparatus of claim 43, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 70 mg/dL.

50. The apparatus of claim 43, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 70 mg/dL.

51. The apparatus of claim 43, wherein the apparatus has an associated error band and the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band.

52. The apparatus of claim 51, wherein the threshold value is selected from the range of about 50 mg/dL to about 80 mg/dL.

53. The apparatus of claim 51, wherein the error band is in the range of about 10 mg/dL to about 50 mg/dL.

54. The apparatus of claim 43, wherein the transfer function is continuous.

55. The apparatus of claim 43, wherein the apparatus has an associated error band and the adjusted analyte concentration differs from the estimated analyte concentration by an amount equivalent to the sum of the threshold value and the error band.

56. The apparatus of claim 43, wherein the apparatus has an associated error band and the adjusted analyte concentration differs from the estimated analyte concentration by an amount equivalent to the difference between the estimated analyte concentration and the threshold value.

57. The apparatus of claim 43, wherein the apparatus has an associated error band and the adjusted analyte concentration is selected as the greater of the threshold value and 120% of the difference between the estimated analyte concentration and the error band.

58. The apparatus of claim 43, wherein the apparatus has an associated error band and at least a portion of the transfer function comprises an arc having a radius equivalent to the error band and a center point having horizontal and vertical axis coordinates equal to a threshold value of clinical significance.

59. The apparatus of claim 43, wherein at least a portion of the transfer function comprises an arc segment.

60. The apparatus of claim 43, wherein the adjusted analyte concentration is substantially equivalent to the estimated analyte concentration value when the estimated analyte concentration value is not in the proximity of the threshold value of clinical significance.

61. The apparatus of claim 43, wherein the transfer function is selected to correspond to an individual user.

62. The apparatus of claim 43, wherein the processing circuit reduces a maximum deviation for the estimated analyte concentration.

63. An apparatus for improving the clinical accuracy of an analyte concentration measurement, the apparatus comprising:

detection means for obtaining the analyte concentration measurement;

processor means for adjusting the measurement to avoid reporting erroneous measurements that are clinically significant.

64. A system for determining an analyte concentration, said system comprising a processing circuit which:

computes a first analyte concentration measurement value accurate within a first error band of said system;

determines whether said first analyte concentration measurement value is greater than or equal to a threshold value of clinical significance and less than the sum of said threshold value and said first error band; and

computes a second analyte concentration measurement value when said first analyte concentration measurement value is greater than or equal to said threshold value of clinical significance and less than the sum of said threshold value and said first error band, wherein said second analyte concentration is accurate within a second error band of said system.

65. The system of claim 64, wherein said processor applies a transfer function to obtain an adjusted analyte concentration measurement value when the second analyte concentration measurement value is greater than or equal to said threshold value of clinical significance and less than the sum of said threshold value and said second error band.

66. The system of claim 64, wherein said processor computes said second analyte concentration measurement value by increased sampling of the analyte concentration.

67. The system of claim 64, wherein said processor computes said second analyte concentration measurement value by increasing a sampling time period.

68. A method for improving the clinical accuracy of an analyte concentration measurement, the method comprising:

computing an estimated analyte concentration having an associated first error that is clinically significant; and

processing the estimated analyte concentration to generate an adjusted analyte concentration having a second error that is clinically insignificant.

69. The method of claim 68, wherein the first error that is clinically significant comprises an error falling into any of zones C, D, and E of the Clarke error grid.

70. The method of claim 68, wherein the first error that is clinically significant comprises an error falling into any of zones D and E of the Clarke error grid.

71. The method of claim 68, further comprising determining zones of clinical significance.

72. The method of claim 68, wherein the estimated analyte concentration is an estimate of the concentration of glucose within blood.

73. The method of claim 71, wherein the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value from about 70 mg/dL to about 85 mg/dL.

74. The method of claim 68, further comprising determining an error band, wherein the adjusted analyte concentration differs from the estimated analyte concentration where the estimated analyte concentration has a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band.

75. The method of claim 74, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 80 mg/dL.

76. The method of claim 74, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 80 mg/dL.

77. The method of claim 74, wherein the threshold value of clinical significance is selected from the range of about 50 mg/dL to about 70 mg/dL.

78. The method of claim 74, wherein the threshold value of clinical significance is selected from the range of about 60 mg/dL to about 70 mg/dL.

79. The method of claim 74, wherein the threshold value of clinical significance corresponds to the lowest portion of a border on the Clarke error grid below which estimated analyte concentrations are zone A errors and above which estimated analyte concentrations are zone D errors.

80. The method of claim 68, further comprising determining an associated error band, wherein the adjusted analyte concentration is about one error band lower than the estimated analyte concentration.

81. The method of claim 68, further comprising determining an associated error band, wherein the processing adjusts the estimated analyte concentrations having a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band, to a substantially uniform adjusted value equal to the threshold value.

82. The method of claim 68, further comprising determining an associated error band, wherein the processing adjusts the estimated analyte concentrations having a value greater than or equal to a threshold value of clinical significance and less than or equal to the sum of the threshold value and the error band, to a maximum value less than the threshold value.

83. The method of claim 68, wherein the processing is performed using a transfer function.

84. The method of claim 83, wherein the transfer function is derived from a flow chart.

85. The method of claim 83, wherein the transfer function is derived from a procedural checklist.

86. The method of claim 83, wherein the transfer function is derived from a graph.

87. The method of claim 83, wherein the transfer function is derived from a lookup table.

88. The method of claim 83, further comprising determining an associated error band, wherein at least a portion of the transfer function comprises an arc having a radius equivalent to the error band and a center point having horizontal and vertical axis coordinates equal to a threshold value of clinical significance.

89. The method of claim 83, wherein at least a portion of the transfer function comprises an arc.

90. The method of claim 83, wherein the transfer function is continuous.

91. The method of claim 83, wherein the transfer function is selected to correspond to an individual user.

92. The method of claim 68, wherein the processing is performed using a filter.

93. The method of claim 92, wherein the estimated analyte concentration is a filter input.

94. The method of claim 92, wherein the adjusted analyte concentration provides feedback to the filter.

95. The method of claim 92, wherein the filter is digital.

96. The method of claim 95, wherein a sample period is less than one second.

97. The method of claim 95, wherein a sample period is between one second and one minute.

98. The method of claim 95, wherein a sample period is between one minute and one hour.

99. The method of claim 95, wherein a sample period is greater than one hour.

100. The method of claim 68, wherein the detected analyte is organic.

101. The method of claim 68, wherein the detected analyte is inorganic.

102. The method of claim 68, wherein the analyte is detected from whole blood.

103. The method of claim 68, wherein a plurality of analytes are detected.

104. The method of claim 68, wherein the analyte is detected from tissue.

105. The method of claim 68, wherein the analyte is detected from fluid.

106. The method of claim 68, wherein the analyte is detected from the group consisting of interstitial fluid, intercellular fluid, and whole blood.