Method and Device for Assessment of a Series of Glucose Concentration Values of a Body Fluid of a Diabetic for adjustment of Insulin Dosing

• US 20070016127A1
• Filed: 06/05/2006
• Published: 01/18/2007
• Est. Priority Date: 06/04/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: STAIB, Arnulf, Klotzer, Hans-Martin
• Granted Patent: US 10,194,839 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The invention relates to a method for assessment of a series of glucose concentration values of a body fluid of a diabetic for adjustment of the dosing of insulin administrations as well as a suitable device for carrying out the method.

Claims

1. A method for the assessment of a series of glucose concentration values of a diabetic for adjustment of the dosing of insulin administrations, the method comprising:

relating a glucose concentration values g(t1) to g(tn) to time points t1 to tn that are distributed over a period of time of at least four hours;

using the glucose concentration values g(t1) to g(tn) as input parameters;

determining a disturbance parameter based on the glucose concentration values, wherein the disturbance parameter characterizes a type and/or severity of a disturbance of the tested glucose metabolism that is manifest despite the administration of insulin;

assigning the disturbance parameter by means of predetermined parameter ranges to one of at least two predetermined classes, wherein with each of the classes recommendations for adjustment of the dosing of the insulin administrations being dedicated as output parameters;

determining the disturbance parameter, by using the glucose concentration values g(t1) to g(tn) to calculate disturbance values w(g(t1)) to w(g(tn)) as function values of a weighting function w; and

using a statistical analysis to determine the disturbance parameter from the disturbance values.

2. The method according to claim 1, wherein the weighting function has a lesser slope in a target range of the glucose concentration than in a range that is adjacent to the target range.

3. The method according to claim 1, wherein the disturbance parameter is a multi-dimensional parameter with multiple components.

4. The method according to claim 1, wherein the calculation of the disturbance parameter further comprises a step, in which a mean value of the disturbance values is calculated.

5. The method according to claim 4, wherein the calculation of the disturbance parameter comprises a step, in which a standard deviation of the disturbance values from said mean value is calculated.

6. The method according to claim 5, wherein one component of the disturbance parameter is a measure of the standard deviation of the disturbance values from the mean value.

7. The method according to claim 4 wherein one component of the disturbance parameter is a measure of the mean value of the disturbance values.

8. The method according to claim 1, wherein the calculation of the disturbance parameter comprises a step, in which the disturbance values are assigned to one each of multiple states and it is determined how long the various states persist and/or how frequently changes of states occur.

9. The method according to claim 8, wherein one component of the disturbance parameter is a measure of the period of time for which one of these states persists.

10. The method according to claim 8, wherein one component of the disturbance parameter is a measure of the frequency of the changes of states.

11. The method according to claim 1, wherein for multiple time intervals that are each included in the period of time, the disturbance values of the respective time intervals are used to calculate a characteristic disturbance number.

12. The method according to claim 11, wherein the characteristic disturbance numbers are used to determine the disturbance parameter.

13. The method according to claim 11, wherein the time intervals for which the characteristic disturbance numbers each are calculated, overlap.

14. The method according to claim 1, wherein the weighting function used to calculate the disturbance values is a function with linear section(s).

15. The method according to claim 14, wherein the weighting function is constant in the target range.

17. The device according to claim 12 wherein the device comprises an input unit by means of which relevant data in terms of the time course of the glucose concentration, can be entered or received by another device, and in that the analytical unit uses this data and the recommendations assigned to the classes to calculate required insulin doses.

18. The device according to claim 17, wherein the device comprises an output unit for output of a recommendation regarding the dosing of the insulin administration of the diabetic.

16. A device for assessment of a series of glucose concentration values of a body fluid of a diabetic for adjustment of the dosing of insulin administrations, the device comprising:

a measuring unit for determining glucose concentration values g(t1) to g(tn) for time points t1 to tn that are distributed over a period of time of at least four hours;

a memory for storing the concentration values; and

an analytical unit for analyzing the concentration values,

wherein the analytical unit is adapted to be operated to determine a disturbance parameter and assign it to one of at least two predetermined classes, to each of said classes recommendations concerning the optimal dosing of insulin administrations being dedicated such that these recommendations can be provided for adjustment of the dosing of the insulin administrations.

19. The device according to claim 16, wherein the device further comprises an insulin pump that is controlled by the analytical unit taking into consideration the recommendation of the class to which the disturbance parameter was assigned.