Method, system, and computer program product for the processing of self-monitoring blood glucose(SMBG)data to enhance diabetic self-management

• US 8,538,703 B2
• Filed: 08/08/2003
• Issued: 09/17/2013
• Est. Priority Date: 08/13/2002
• Status: Active Grant

• Current Assignee: University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Kovatchev, Boris P., Cox, Daniel J.
• Primary Examiner(s): Clow, Lori A
• Application Number:
  US10/524,094
• Publication Number:
  US 20050214892A1
• Time in Patent Office: 3,693 Days
• Field of Search: None
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A method, system, and computer program product related to the maintenance of optimal control of diabetes, and is directed to predicting the long-term exposure to hyperglycemia, and the long-term and short-term risks of severe or moderate hypoglycemia in diabetics, based on blood blucose readings collected by a self-monitoring blood glucose device. The method, system, and computer program product pertain directly to the enhancement of existing home blood glucose monitoring devices, by introducing an intelligent data interpretation component capable of predicting both HbA1c and periods of increased risk of hypoglycemia, and to the enhancement of emerging continuous monitoring devices by the same features. With these predictions the diabetic can take steps to prevent the adverse consequences associated with hyperglycemia and hypoglycemia.

Claims

1. A system for evaluating the HbA_1c of a patient based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the collected BG data to convert the collected BG data into derived BG data derived from said collected BG data, estimate HbA_1c by applying at least one predetermined formula to said derived BG data,

validate the estimate via sample selection criteria; and

output the estimate to a user.

2. The system of claim 1, wherein said first predetermined duration is about 60 days.

3. The system of claim 1, wherein said first predetermined duration ranges from about 45 days to about 75 days.

4. The system of claim 1, wherein said first predetermined duration ranges from about 45 days to about 90 days.

5. The system of claim 1, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

6. The system of claim 1, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l) via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.

7. The system of claim 6, wherein the N06, N12, N24 are percentage of SMBG readings in time intervals of about 0-6:

59 hour time period;

about 7-12;

59 hour time period, and about 18-23;

59 hour time period, respectively.

8. The system of claim 6, comprising assigning a group depending on the patient'"'"'s computed High BG Index using a predetermined mathematical formula defined as:

if (RHI1 is ≦

about 5.25 or if RHI1 is ≧

about

     16) then the assigned group=0,

if (RHI1 is >

about 5.25 and if RHI1 is <

about 7.0) then the assigned group=1,

if (RHI1 is ≧

about 7.0 and if RHI1 is <

about 8.5) then the assign group=2, and

if (RHI1 is ≧

about 8.5 and if RHI1 is <

about

     16) then the assigned group=3.

9. The system of claim 8, comprising providing estimates using a predetermined mathematical formula defined as:

E0=0.55555*BGMM1+2.95,

E1=0.50567*BGMM1+0.074*L06+2.69,

E2=0.55555*BGMM1−

0.074*L06+2.96,

E3=0.44000*BGMM1+0.035*L06+3.65; and

if (Group=1) then EST2=E1, or if (Group=2) then EST2=E2, or if (Group=3) then EST2=E3, otherwise EST2=E0.

10. The system of claim 9, comprising providing further correction of the estimates using a predetermined mathematical formula defined as:

if (missing(L06)) EST2=E0,

if (RLO1 is ≦

about 0.5 and RHI1 is le about 2.0) then EST2=E0−

0.25,

if (RLO1 is ≦

about 2.5 and RHI1 is >

about

     26) then EST2=E0−

1.5*RLO1, and

if ((RLO1/RHI1) is ≦

about 0.25 and L06 is >

about 1.3) then EST2=EST2-0.08.

11. The system of claim 10 for estimating the HbA_1c of a patient based on BG data collected over the first predetermined duration, wherein said estimating HbA_1c comprises :

a) HbA_1c=the EST2 defined by claim 8 or as corrected by claim 10 or

b) HbA_1c=0.809098*BGMM1+0.064540*RLO1−

0.151673*RHI1+1.873325, wherein

BGMM1 is the average BG (mmol/l) of claim 6,

RLO1 is the Low BG Index of claim 6,

RHI1 is the High BG Index of claim 6;

or

c) HbA_1c=0.682742*HBA0+0.054377*RHI1+1.553277, wherein HBA0 is a previous reference HbA_1c reading taken about a second predetermined period prior to the estimate, wherein

RHI1=is the High BG Index of claim 6;

or

d) HbA_1c=0.41046*BGMM+4.0775

wherein BGMM1is the average BG (mmol/l) of claim 6.

12. The system of claim 11, wherein said second predetermined duration is about three months.

13. The system of claim 11, wherein said second predetermined duration ranges from about 2.5 months to about 3.5 months.

14. The system of claim 11, wherein said second predetermined duration ranges from about 2.5 months to six months.

15. The system of claim 11, wherein the validation of the HbA_1c estimate using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5 to about 2.5 tests per day;

b) an alternative test frequency criterion only if the predetermined duration sample contains at least a third predetermined sample period with readings with an average frequency of about 1.8 readings/day;

c) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 6,

RHI1 is the High BG Index of claim 6;

or

d) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 6.

16. The system of claim 15, wherein said third predetermined duration is at least 35 days.

17. The system of claim 15, wherein said third predetermined duration ranges from about 35 days to about 40 days.

18. The system of claim 15, wherein said third predetermined duration ranges from about 35 days to about as long as the first predetermined duration.

19. The system of claim 11, wherein the validation of the HbA_1c estimate using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5; and

b) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 6

RHI1 is the High BG Index of claim 6;

or

c) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 6.

20. The system of claim 19, wherein said third predetermined duration is at least about 35 days.

21. A system for evaluating the HbA_1c of a patient based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a BG acquisition mechanism, said acquisition mechanism configured to acquire BG data from the patient;

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the acquired BG data to convert the acquired BG data into derived BG data derived from said acquired BG data;

estimate HbA_1c by applying at least one predetermined formula to said derived BG data;

validate the estimate via sample selection criteria; and

output the estimate to a user.

22. The system of claim 21, wherein said first predetermined duration is about 60 days.

23. The system of claim 21, wherein said first predetermined duration ranges from about 45 days to about 75 days.

24. The system of claim 21, wherein said first predetermined duration ranges from about 45 days to about 90 days.

25. The system of claim 21, wherein the pre-processing of the data comprises:

conversion of plasma data to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

26. The system of claim 21, wherein the preprocessing of the data comprises:

conversion of plasma data to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l) via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.

27. The system of claim 26, wherein the N06, N12, N24 are percentage of SMBG readings in time intervals of about 0-6:

59 hour time period;

about 7-12;

59 hour time period, and about 18-23;

59 hour time period, respectively.

28. The system of claim 26, comprising assigning a group depending on the patient'"'"'s computed High BG Index using a predetermined mathematical formula defined as:

if (RHI1 is ≦

about 5.25 or if RHI1 is ≧

about

     16) then the assigned group=0,

if (RHI1 is >

about 5.25 and if RHI1 is <

about 7.0) then the assigned group=1,

if (RHI1 is ≧

about 7.0 and if RHI1 is <

about 8.5) then the assign group=2, and

if (RHI1 is ≧

about 8.5 and if RHI1 is <

about

     16) then the assigned group=3.

29. The system of claim 28, comprising providing estimates using a predetermined mathematical formula defined as:

E0=0.55555*BGMM1+2.95,

E1=0.50567*BGMM1+0.074*L06+2.69,

E2=0.55555*BGMM1−

0.074*L06+2.96,

E3=0.44000*BGMM1+0.035*L06+3.65; and

if (Group=1) then EST2=E1, or if (Group=2) then EST2=E2, or if (Group=3) then EST2=E3, otherwise EST2=E0.

30. The system of claim 29, comprising providing further correction of the estimates using a predetermined mathematical formula defined as:

if (missing(L06)) EST2=E0,

if (RLO1 is ≦

about 0.5 and RHI1 is le about 2.0) then EST2=E0−

0.25,

if (RLO1 is ≦

about 2.5 and RHI1 is >

about

     26) then EST2=E0−

1.5*RLO1, and

if ((RLO1/RHI1) is ≦

about 0.25 and L06 is >

about 1.3) then EST2=EST2−

0.08.

31. The system of claim 30 for estimating the HbA_1c of a patient based on BG data collected over the first predetermined duration, said system comprising:

said estimating HbA_1c using said at least one of four predetermined mathematical formulas defined as;

a) HbA_1c=the EST2 defined by claim 28 or as corrected by claim 30 or

b) HbA_1c=0.809098*BGMM1+0.064540*RLO1-0.151673*RHI1+1.873325, wherein

BGMM1is the average BG (mmol/l) of claim 26,

RLO1 is the Low BG Index of claim 26,

RHI1 is the High BG Index of claim 26;

or

c) HbA_1c=0.682742*HBA0+0.054377*RHI1+1.553277, wherein HBA0 is a previous reference HbA_1c reading taken about a second predetermined period prior to the estimate, wherein

RHI1=is the High BG Index of claim 26;

or

d) HbA_1c=0.41046*BGMM+4.0775

wherein BGMM1is the average BG (mmol/l) of claim 26.

32. The system of claim 31, wherein said second predetermined duration is about three months.

33. The system of claim 31, wherein said second predetermined duration ranges from about 2.5 months to about 3.5 months.

34. The system of claim 31, wherein said second predetermined duration ranges from about 2.5 months to six months.

35. The system of claim 31, wherein the validation of the HbA_1c estimate using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5 to about 2.5 tests per day;

b) an alternative test frequency criterion only if the predetermined duration sample contains at least a third predetermined sample period with readings with an average frequency of about 1.8 readings/day;

c) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 26,

RHI1 is the High BG Index of claim 26;

or

d) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 26.

36. The system of claim 35, wherein said third predetermined duration is at least 35 days.

37. The system of claim 35, wherein said third predetermined duration ranges from about 35 days to about 40 days.

38. The system of claim 35, wherein said third predetermined duration ranges from about 35 days to about as long as the first predetermined duration.

39. The system of claim 31, wherein the validation of the HbA_1c estimate using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5; and

b) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 26

RHI1 is the High BG Index of claim 26;

or

c) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 26.

40. The system of claim 39, wherein said third predetermined duration is at least about 35 days.

41. A computer program product comprising a tangible computer readable medium having computer program logic for enabling at least one processor in a computer system to evaluate the HbA_1c of a patient based on blood glucose (BG) data collected over a first predetermined duration, said computer program logic comprising:

pre-processing of the collected BG data to convert the collected BG data into derived BG data derived from said collected BG data, estimating HbA_1c by applying at least one predetermined formula to said derived BG data, and

validation of the estimate via sample selection criteria; and

outputting the estimate to a user.

42. A system for evaluating the HbA_1c of a patient based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the collected BG data to convert the collected BG data into derived BG data derived from said collected BG data, validate a sample of the collected BG data via sample selection criteria, and

estimate HbA_1c from said derived BG data if the sample is valid; and

output the estimate to a user.

43. The system of claim 42, wherein said first predetermined duration is about 60 days.

44. The system of claim 42, wherein said first predetermined duration ranges from about 45 days to about 75 days.

45. The system of claim 42, wherein said first predetermined duration ranges from about 45 days to about 90 days.

46. The system of claim 42, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

47. The system of claim 42, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.

48. The system of claim 47, wherein the N06, N12, N24 are percentage of SMBG readings in time intervals of about 0-6:

59 hour time period;

about 7-12;

59 hour time period, and about 18-23;

59 hour time period, respectively.

49. The system of claim 47, comprising assigning a group depending on the patient'"'"'s computed High BG Index using a predetermined mathematical formula defined as:

if (RHI1 is ≦

about 5.25 or if RHI1 is ≧

about

     16) then the assigned group=0,

if (RHI1 is >

about 5.25 and if RHI1 is <

about 7.0) then the assigned group=1,

if (RHI1 is ≧

about 7.0 and if RHI1 is <

about 8.5) then the assign group=2, and

if (RHI1 is ≧

about 8.5 and if RHI1 is <

about

     16) then the assigned group=3.

50. The system of claim 49, comprising providing estimates using a predetermined mathematical formula defined as:

E0=0.55555*BGMM1+2.95,

E1=0.50567*BGMM1+0.074*L06+2.69,

E2=0.55555*BGMM1−

0.074*L06+2.96,

E3=0.44000*BGMM1+0.035*L06+3.65; and

if (Group=1) then EST2=E1, or if (Group=2) then EST2=E2, or if (Group=3) then EST2=E3, otherwise EST2=E0.

51. The system of claim 50, comprising providing further correction of the estimates using a predetermined mathematical formula defined as:

if (missing(L06)) EST2=E0,

if (RLO1 is ≦

about 0.5 and RHI1 is le about 2.0) then EST2=E0−

0.25,

if (RLO1 is ≦

about 2.5 and RHI1 is >

about

     26) then EST2=E0−

1.5*RLO1, and

if ((RLO1/RHI1) is ≦

about 0.25 and L06 is >

about 1.3) then EST2=EST2-0.08.

52. The system of claim 51 for estimating the HbA_1c of a patient based on BG data collected over the first predetermined duration, said system comprising:

estimating HbA_1c using at least one of four predetermined mathematical formulas defined as;

a) HbA_1c=the EST2 defined by claim 49 or as corrected by claim 51 or

b) HbA_1c=0.809098*BGMM1+0.064540*RLO1-0.151673*RHI1+1.873325, wherein

BGMM1is the average BG (mmol/l) of claim 47,

RLO1 is the Low BG Index of claim 47,

RHI1 is the High BG Index of claim 47;

or

c) HbA_1c=0.682742*HBA0+0.054377*RHI1+1.553277, wherein HBA0 is a previous reference HbA_1c reading taken about a second predetermined period prior to the estimate, wherein

RHI1=is the High BG Index of claim 47;

or

d) HbA_1c=0.41046*BGMM+4.0775

wherein BGMM1is the average BG (mmol/l) of claim 47.

53. The system of claim 52, wherein said second predetermined duration is about three months.

54. The system of claim 52, wherein said second predetermined duration ranges from about 2.5 months to about 3.5 months.

55. The system of claim 52, wherein said second predetermined duration ranges from about 2.5 months to six months.

56. The system of claim 52, wherein the validation of the sample using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5to about 2.5 tests per day;

b) an alternative test frequency criterion only if the predetermined duration sample contains at least a third predetermined sample period with readings with an average frequency of about 1.8 readings/day;

c) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 47,

RHI1 is the High BG Index of claim 47;

or

d) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 47.

57. The system of claim 56, wherein said third predetermined duration is at least 35 days.

58. The system of claim 56, wherein said third predetermined duration ranges from about 35 days to about 40 days.

59. The system of claim 56, wherein said third predetermined duration ranges from about 35 days to about as long as the first predetermined duration.

60. The system of claim 52, wherein the validation of the sample using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5; and

b) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 47

RHI1 is the High BG Index of claim 47;

or

c) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 47.

61. The system of claim 60, wherein said third predetermined duration is at least about 35 days.

62. A system for evaluating the HbA_1c of a patient based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a BG acquisition mechanism, said acquisition mechanism configured to acquire BG data from the patient;

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the acquired BG data to convert the acquired BG data into derived BG data derived from said acquired BG data;

validate a sample of the acquired BG data via sample selection criteria;

estimate HbA_1c from said derived BG data if the sample is valid; and

output the HbA_1c estimate to a user.

63. The system of claim 62, wherein said first predetermined duration is about 60 days.

64. The system of claim 62, wherein said first predetermined duration ranges from about 45 days to about 75 days.

65. The system of claim 62, wherein said first predetermined duration ranges from about 45 days to about 90 days.

66. The system of claim 62, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

67. The system of claim 62, wherein the pre-processing of the data comprises:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l) via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.

68. The system of claim 67, wherein the N06, N12, N24 are percentage of SMBG readings in time intervals of about 0-6:

59 hour time period;

about 7-12;

59 hour time period, and about 18-23;

59 hour time period, respectively.

69. The system of claim 67, comprising assigning a group depending on the patient'"'"'s computed High BG Index using a predetermined mathematical formula defined as:

if (RHI1 is ≦

about 5.25 or if RHI1 is ≧

about

     16) then the assigned group=0,

if (RHI1 is >

about 5.25 and if RHI1 is <

about 7.0) then the assigned group=1,

if (RHI1 is ≦

about 7.0 and if RHI1 is <

about 8.5) then the assign group=2, and

if (RHI1 is ≦

about 8.5 and if RHI1 is <

about

     16) then the assigned group=3.

70. The system of claim 69, comprising providing estimates using a predetermined mathematical formula defined as:

E0=0.55555*BGMM1+2.95,

E1=0.50567*BGMM1+0.074*L06+2.69,

E2=0.55555*BGMM1−

0.074*L06+2.96,

E3=0.44000*BGMM1+0.035*L06+3.65; and

if (Group=1) then EST2=E1, or if (Group=2) then EST2=E2, or if (Group=3) then EST2=E3, otherwise EST2=E0.

71. The system of claim 70, comprising providing further correction of the estimates using a predetermined mathematical formula defined as:

if (missing(L06)) EST2=E0,

if (RLO1 is ≦

about 0.5 and RHI1 is le about 2.0) then EST2=E0−

0.25,

if (RLO1 is ≦

about 2.5 and RHI1 is >

about

     26) then EST2=E0−

1.5*RLO1, and

if ((RLO1/RHI1) is ≦

about 0.25 and L06 is >

about 1.3) then EST2=EST2-0.08.

72. The system of claim 71 for estimating the HbA_1c of a patient based on BG data collected over the first predetermined duration, said system comprising:

estimating HbA_1c using at least one of four predetermined mathematical formulas defined as;

a) HbA_1c=the EST2 defined by claim 69 or as corrected by claim 71 or

b) HbA_1c=0.809098*BGMM1+0.064540*RLO1-0.151673*RHI1+1.873325, wherein

BGMM1is the average BG (mmol/l) of claim 67,

RLO1 is the Low BG Index of claim 67,

RHI1 is the High BG Index of claim 67;

or

c) HbA_1c=0.682742*HBA0+0.054377*RHI1+1.553277, wherein HBA0is a previous reference HbA_1c reading taken about a second predetermined period prior to the estimate, wherein

RHI1=is the High BG Index of claim 67;

or

d) HbA_1c=0.41046*BGMM+4.0775

wherein BGMM1is the average BG (mmol/l) of claim 67.

73. The system of claim 72, wherein said second predetermined duration is about three months.

74. The system of claim 72, wherein said second predetermined duration ranges from about 2.5 months to about 3.5 months.

75. The system of claim 72, wherein said second predetermined duration ranges from about 2.5 months to six months.

76. The system of claim 72, wherein the validation of the sample using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5to about 2.5 tests per day;

b) an alternative test frequency criterion only if the predetermined duration sample contains at least a third predetermined sample period with readings with an average frequency of about 1.8 readings/day;

c) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 67,

RHI1 is the High BG Index of claim 67;

or

d) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 67.

77. The system of claim 76, wherein said third predetermined duration is at least 35 days.

78. The system of claim 76, wherein said third predetermined duration ranges from about 35 days to about 40 days.

79. The system of claim 76, wherein said third predetermined duration ranges from about 35 days to about as long as the first predetermined duration.

80. The system of claim 72, wherein the validation of the sample using sample selection criteria of HbA_1c estimate only if the first predetermined duration sample meets at least one of the following four criteria:

a) a test frequency criterion wherein if the first predetermined duration sample contains an average of at least about 1.5; and

b) a randomness of data criterion-1 wherein the HbA_1c estimate is validated or displayed only if the ratio (RLO1/RHI1>

=about 0.005),

wherein

RLO1 is the Low BG Index of claim 67

RHI1 is the High BG Index of claim 67;

or

c) a randomness of data criterion-2 wherein HbA_1c estimate is validated or displayed only if the ratio (NO6>

=about 3%),

wherein

N06 is the percentage of readings during the night of claim 67.

81. The system of claim 80, wherein said third predetermined duration is at least about 35 days.

82. A system for evaluating the HbA_1c of a patient without the need for prior HbA_1c information based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the collected BG data to convert the collected BG data into derived BG data derived from said collected BG data,

validate a sample of the collected BG data via sample selection criteria, and

estimate HbA_1c from said derived BG data if the sample is valid; and

output the estimate to a user.

83. The system of claim 82, wherein said first predetermined duration is about 60 days.

84. The system of claim 82, wherein said first predetermined duration ranges from about 45 days to about 75 days.

85. The system of claim 82, wherein said first predetermined duration ranges from about 45 days to about 90 days.

86. The system of claim 82, wherein the preprocessing of the data comprises:

conversion of plasma data to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

87. The system of claim 82, wherein the preprocessing of the data comprises:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.

88. A system for evaluating the HbA_1c of a patient without the need for prior HbA_1c information based on blood glucose (BG) data collected over a first predetermined duration, said system comprising:

a BG acquisition mechanism, said acquisition mechanism configured to acquire BG data from the patient;

a database component operative to maintain a database identifying said BG data; and

a processor programmed to;

pre-process the collected BG data to convert the collected BG data into derived BG data derived from said collected BG data;

validate a sample of the collected BG data via sample selection criteria;

estimate HbA_1c from said derived BG data if the sample is valid; and

output the HbA_1c estimate to a user.

89. The system of claim 88, wherein said first predetermined duration is about 60 days.

90. The system of claim 88, wherein said first predetermined duration ranges from about 45 days to about 75 days.

91. The system of claim 88, wherein said first predetermined duration ranges from about 45 days to about 90 days.

92. The system of claim 88, wherein the preprocessing of the data comprises:

conversion of plasma data to whole blood BG mg/dl;

conversion of BG measured in mg/dl to units of mmol/l; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1).

93. The system of claim 88, wherein the preprocessing of the data is defined as:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG (mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/l via BGMM=BG/18; and

computing Low Blood Glucose Index (RLO1) and High Blood Glucose Index (RHI1) using a predetermined mathematical formula defined as;

Scale=[ln(BG)]^1.0845−

5.381, wherein BG is measured in units of mg/dl,

Risk1=22.765(Scale)², wherein

RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of LBGI exists, otherwise RiskLO=0, and

RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of HBGI exists, otherwise RiskHI=0,

BGMM1=average of BGMM per patient,

RLO1=average of RiskLO per patient,

RHI1=average of RiskHI per patient,

L06=average of RiskLO computed only for readings during the night, otherwise missing if there are no readings at night,

N06, N12, N24 are percentage of SMBG readings in time intervals,

NC1=total number of SMBG readings in the first predetermined duration; and

NDAYS=number of days with SMBG readings in the first predetermined duration.