Method, system and computer program product for evaluation of blood glucose variability in diabetes from self-monitoring data

Patent metadata

Field	Value
Publication number	US-11355238-B2
Application number	US-15989107-A
Country	US
Kind code	B2
Filing date	Jan 5, 2007
Priority date	Jan 5, 2006
Publication date	Jun 7, 2022
Grant date	Jun 7, 2022

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.

First claim

I claim:

1. A system for enabling a diabetes patient to maintain accurate control over their blood glucose level by determining blood glucose variability, said system comprising:
an acquisition module acquiring a plurality of blood glucose data points representing glucose concentration levels in blood of said patient;
a processor programmed to:
transform the plurality of blood glucose data points received from said acquisition module from a blood glucose range to a transformed range according to a transforming function,
calculate a risk value for one or more of a plurality of the transformed plurality of blood glucose data points,
calculate one or more risk ranges each based on a respective one of the calculated risk values within a period of time with a predetermined duration, and
calculate at least one composite risk range based on one or more of the calculated risk ranges;

a display module displaying said at least one composite risk range to said patient to prompt said patient, in response to visualization by said patient of said at least one composite risk range, to take a non-hypoglycemia or a non-hyperglycemia action to maintain their blood glucose level within a euglycemic range based on the value of said at least one composite risk range; and
an audio module to transmit to said patient an audible tone corresponding to a risk of deviation from said euglycemic range based on the value of said at least one composite risk range,
wherein at least said processor is configured for communication with an insulin delivery device of said patient, and based on the value of said at least one composite risk range indicating hyperglycemia, said processor causes the administration of insulin to said patient via said insulin delivery device.

2. The system of claim 1 , wherein the calculation of said at least one
composite risk range comprises computing an average risk range.

3. The system of claim 2 , wherein the average risk range is computed as:

A
⁢

⁢
D
⁢

⁢
R
⁢

⁢
R

=

1
M

⁢

∑

i
=
1

M

⁢

[

LR
i

+

HR
i

]

,

where LR i represents a maximal hypoglycemic risk value for period of time with a predetermined duration i, HR i represents a maximal hyperglycemic risk value for period of time with a predetermined duration i, LR i +HR i represents a calculated risk range for period of time with predetermined duration i, and the plurality of blood glucose data points are collected on periods of time with predetermined duration i=1, 2, . . . , M.

4. The system of claim 1 , wherein the calculation of said composite risk range comprises computing a standard deviation risk range.

5. The system of claim 4 , wherein the standard deviation risk range is computed as:

S
⁢

⁢
D
⁢

⁢
R
⁢

⁢

R
2

=

1

M
-
1

⁢

∑

i
=
1

M

⁢

[

(

LR
i

+

HR
i

)

-

mean
(

LR
i

+

HR
i

)

]

2

,

where LR i represents a maximal hypoglycemic risk value for period of time with a predetermined duration i, HR i represents a maximal hyperglycemic risk value for period of time with a predetermined duration i, LR i +HR i represents a calculated risk range for period of time with predetermined duration i, and the plurality of blood glucose data points are collected on periods of time with predetermined duration i=1, 2, . . . , M.

6. The system of claim 1 , wherein the plurality of blood glucose data points includes at least three blood glucose data point readings per period of time with predetermined duration.

7. The system of claim 1 , wherein the plurality of blood glucose data points includes blood glucose data points from about one to about two weeks of self-monitoring.

8. The system of claim 1 , wherein the plurality of blood glucose data points includes blood glucose data points from about two to about six weeks of self-monitoring.

9. The system of claim 8 , wherein the plurality of blood glucose data points includes blood glucose data points from about four weeks of self-monitoring.

10. The system of claim 1 , wherein the plurality of blood glucose data points includes blood gluco

Assignees

• Kovatchev Boris P
• Univ Virginia Patent Foundation

Inventors

• Kovatchev Boris P

Classifications

• G16H50/20 Primary

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title