Method, System and Computer Program Product for Evaluation of Blood Glucose Variability In Diabetes From Self-Monitoring Data
First Claim
1. A method for measuring blood glucose variability, said method comprising:
- acquiring a plurality of blood glucose data points;
transforming the plurality of blood glucose data points according to a transforming function;
calculating at least one risk value for at least some of each of the transformed plurality of blood glucose data points;
calculating at least one risk range based on at least two of the calculated risk values within a period of time with a predetermined duration; and
calculating at least one composite risk range based on at least one of the calculated risk ranges.
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Accused Products
Abstract
A system, computer program product, method and algorithm for evaluation of blood glucose variability—one of the most important parameters of diabetes management. An embodiment of the method may use routine self-monitoring blood glucose (SMBG) data collected over a period of 2-6 weeks, for example, based on a theory of risk analysis of blood glucose data. One aspect may include a method, system and computer program product for computing the Average Daily Risk Range (ADRR)—a measure of overall glucose variability. Another aspect may include a method, system, and computer program product for estimating separately the glucose variability in the hypoglycemic range via a Low BG Index (LBGI) and the glucose variability in the high BG range via High BG Index (HBGI) followed by a combination of the two indices into a single variability display.
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Citations
101 Claims
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1. A method for measuring blood glucose variability, said method comprising:
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acquiring a plurality of blood glucose data points; transforming the plurality of blood glucose data points according to a transforming function; calculating at least one risk value for at least some of each of the transformed plurality of blood glucose data points; calculating at least one risk range based on at least two of the calculated risk values within a period of time with a predetermined duration; and calculating at least one composite risk range based on at least one of the calculated risk ranges. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A system for determining blood glucose variability, said system comprising:
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an acquisition module acquiring a plurality of blood glucose data points; and a processor programmed to; transform the plurality of blood glucose data points from a blood glucose range to a transformed range according to a transforming function, calculate at least one risk value for at least some of each of the transformed plurality of blood glucose data points, calculate at least one risk range based on at least two of the calculated risk values within a period of time with a predetermined duration, and calculate at least one composite risk range based on at least one of the calculated risk ranges. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
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61. A computer program product comprising a computer useable medium having computer program logic for enabling at least one processor in a computer system to measure blood glucose variability, said computer program logic comprising:
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acquiring a plurality of blood glucose data points; transforming the plurality of blood glucose data points from a blood glucose range to a transformed range according to a transforming function; calculating at least one risk value for at least some of each of the transformed plurality of blood glucose data points; calculating at least one risk range based on at least two of the calculated risk values within a period of time with a predetermined duration; and calculating at least composite one risk range based on at least one of the calculated risk ranges. - View Dependent Claims (62, 63, 64, 65, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89)
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- 66. The computer program product of claim 66, wherein the plurality of blood glucose data points includes at least three blood glucose data point readings per period of time with predetermined duration.
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90. A method for measuring blood glucose variability, said method comprising:
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acquiring a plurality of self-monitored blood glucose data points, wherein the plurality of self-monitored blood glucose data points span a period of at least one day; transforming the plurality of self-monitored blood glucose data points according to a transforming function, wherein the transforming function is;
f(BG,α
,β
,γ
)=γ
·
[(ln(BG))α
−
β
],where BG is a blood glucose value, (α
, β
, γ
)=(1.026, 1.861, 1.794) if BG is measured in mM, and (α
, β
, γ
)=(1.084, 5.381, 1.509) if BG is measured in mg/dl;defining a BG risk space, wherein the BG risk space is;
r(BG)=10·
f(BG)2;defining a left branch of the BG risk space representing a risk of hypoglycemia as;
rl(BG)=r(BG) if f(BG)<
0 and 0 otherwise;defining a right branch of the BG risk space representing a risk of hyperglycemia as;
rh(BG)=r(BG) if f(BG)>
0 and 0 otherwise;calculating a maximal hypoglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
LRi=max(rl(x1i),rl(x2i), . . . , rl(xni i)),where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i;calculating a maximal hyperglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
HRi=max(rh(x1i),rh(x2i), . . . , rh(xni i))where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i;calculating an average daily risk range as; where the plurality of self-monitored blood glucose data points are collected on days i=1, 2, . . . , M; classifying the average daily risk range into one of at least four categories, wherein said at least four categories includes “
Low”
, “
Low-Moderate”
, “
Moderate-High”
, and “
High, wherein the “
Low Risk”
category corresponds to a risk range between about 0 and about 20, the “
Low-Moderate Risk”
category corresponds to a risk range between about 20 and about 30, the “
Moderate-High Risk”
category corresponds to a risk range between about 30 and about 40, and the “
High Risk”
category corresponds to a risk range greater than about 40; anddisplaying the average daily risk range and the one of the at least four categories into which the average daily risk range is classified.
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91. A system for measuring blood glucose variability, said system comprising:
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an acquisition module acquiring a plurality of self-monitored blood glucose data points, wherein the plurality of self-monitored blood glucose data points span a period of at least one day; a processor programmed to; transform the plurality of self-monitored blood glucose data points from a blood glucose range to a transformed range according to a transforming function, wherein the minimal and maximal values of the transformed range are −
√
10 and ·
10, respectively, wherein the transforming function is;
f(BG,α
,β
,γ
)=γ
·
[(ln(BG))α
−
β
],where BG is a blood glucose value, (α
, β
, γ
)=(1.026, 1.861, 1.794) if BG is measured in mM, and (α
, β
, γ
)=(1.084, 5.381, 1.509) if BG is measured in mg/dl;define a BG risk space, wherein the BG risk space is;
r(BG)=10·
f(BG)2;define a left branch of the BG risk space representing a risk of hypoglycemia as;
rl(BG)=r(BG) if f(BG)<
0 and 0 otherwise;define a right branch of the BG risk space representing a risk of hyperglycemia as;
rh(BG)=r(BG) if f(BG)>
0 and 0 otherwise;calculate a maximal hypoglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
LRi=max(rl(x1i),rl(x2i), . . . , rl(xni i)),where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i;calculate a maximal hyperglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
HRi=max(rh(x1i),rh(x2i), . . . , rh(xni i))where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i; andcalculate an average daily risk range as; where the plurality of self-monitored blood glucose data points are collected on days i=1, 2, . . . , M; classifying the average daily risk range into one of at least four categories, wherein said at least four categories includes “
Low”
, “
Low-Moderate”
, “
Moderate-High”
, and “
High, wherein the “
Low Risk”
category corresponds to a risk range between about 0 and about 20, the “
Low-Moderate Risk”
category corresponds to a risk range between about 20 and about 30, the “
Moderate-High Risk”
category corresponds to a risk range between about 30 and about 40, and the “
High Risk”
category corresponds to a risk range greater than about 40; anda display module displaying the average daily risk range and the one of the at least four categories into which the average daily risk range is classified.
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92. A computer program product comprising a computer useable medium having computer program logic for enabling at least one processor in a computer system to measure blood glucose variability, said computer program logic comprising:
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acquiring a plurality of self-monitored blood glucose data points, wherein the plurality of self-monitored blood glucose data points span a period of at least one day; transforming the plurality of self-monitored blood glucose data points from a blood glucose range to a transformed range according to a transforming function, wherein the minimal and maximal values of the transformed range are −
√
10 and √
10, respectively, wherein the transforming function is;
f(BG,α
,β
,γ
)=γ
·
[(ln(BG))α
−
β
],where BG is a blood glucose value, (α
, β
, γ
)=(1.026, 1.861, 1.794) if BG is measured in mM, and (α
, β
, γ
)=(1.084, 5.381, 1.509) if BG is measured in mg/dl;defining a BG risk space, wherein the BG risk space is;
r(BG)=10·
f(BG)2;defining a left branch of the BG risk space representing a risk of hypoglycemia as;
rl(BG)=r(BG) if f(BG)<
0 and 0 otherwise;defining a right branch of the BG risk space representing a risk of hyperglycemia as;
rh(BG)=r(BG) if f(BG)>
0 and 0 otherwise;calculating a maximal hypoglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
LRi=max(rl(x1i),rl(x2i), . . . , rl(xni i))where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i;calculating a maximal hyperglycemic risk value for the plurality of self-monitored blood glucose data points for each day as;
HRi=max(rh(x1i),rh(x2i), . . . , rh(xni i)),where ni is the number of readings for each day i and x1i, x2i, . . . , xn i i are the ni self-monitored blood glucose data points for each day i;calculating an average daily risk range as; where the plurality of self-monitored blood glucose data points are collected on days i=1, 2, . . . M; classifying the average daily risk range into one of at least four categories, wherein said at least four categories includes “
Low”
, “
Low-Moderate”
, “
Moderate-High”
, and “
High, wherein the “
Low Risk”
category corresponds to a risk range between about 0 and about 20, the “
Low-Moderate Risk”
category corresponds to a risk range between about 20 and about 30, the “
Moderate-High Risk”
category corresponds to a risk range between about 30 and about 40, and the “
High Risk”
category corresponds to a risk range greater than about 40; anddisplaying the average daily risk range and the one of the at least four categories into which the average daily risk range is classified.
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93. A method for measuring blood glucose variability, said method comprising:
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acquiring a plurality of blood glucose data points; calculating at least one risk range based on at least two of the plurality of blood glucose data points within a period of time with a predetermined duration; and calculating at least one average predetermined duration blood glucose risk range based on at least one of the calculated risk ranges. - View Dependent Claims (94, 95)
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96. A system for measuring blood glucose variability, said system comprising:
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an acquisition module acquiring a plurality of blood glucose data points; and a processor programmed to; calculate at least one risk range based on at least two of the plurality of blood glucose data points within a period of time with a predetermined duration, and calculate at least one average predetermined duration blood glucose risk range based on at least one of the calculated risk ranges. - View Dependent Claims (97, 98)
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99. A computer program product comprising a computer useable medium having computer program logic for enabling at least one processor in a computer system to measure blood glucose variability, said computer program logic comprising:
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acquiring a plurality of blood glucose data points; calculating at least one risk range based on at least two of the plurality of blood glucose data points; and calculating at least one average daily blood glucose risk range based on at least one of the calculated daily risk ranges. - View Dependent Claims (100, 101)
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Specification