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 10,194,839 B2
• Filed: 06/05/2006
• Issued: 02/05/2019
• 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
• Primary Examiner(s): Sims, Jason M
• Application Number:
  US11/422,126
• Publication Number:
  US 20070016127A1
• Time in Patent Office: 4,628 Days
• Field of Search: None
• 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 determining a disturbance parameter characterizing a disturbance of a tested glucose metabolism that is manifest despite the administration of insulin to adjust dosing of insulin administration, the method comprising:

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

using the glucose concentration values g(t₁) to g(t_n) as input parameters to a processor to calculate disturbance values w(g(t1)) to w(g(tn)) as function values of a weight function w, wherein the weight function w has a lesser slope in a target range of the glucose concentration values g(t₁) to g(t_n) than in a range that is adjacent to the target range;

determining the disturbance parameter on a processor from the disturbance 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 on a processor by use of predetermined parameter ranges to one of at least two predetermined classes, wherein with each of the classes corresponding to recommendations for adjustment of the dosing of the insulin administrations are generated as output parameters;

signaling an output unit to output a recommendation for adjustment of the dosing of the insulin administrations corresponding to the assigned class; and

controlling an insulin administration device to adjust the dosing of the insulin administration in response to the recommendation.

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

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

4. The method according to claim 3, wherein determining the disturbance parameter comprises a step, in which a standard deviation of the disturbance values from said mean value is calculated.

5. The method according to claim 4, wherein one component of the disturbance parameter is a measure of the standard deviation of the disturbance values from the mean value.

6. The method according to claim 3 wherein one component of the disturbance parameter is a measure of the mean value of the disturbance values.

7. 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.

8. The method according to claim 7, wherein one component of the disturbance parameter is a measure of the period of time for which one of these states persists.

9. The method according to claim 7, wherein one component of the disturbance parameter is a measure of the frequency of the changes of states.

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

14. The method according to claim 13, wherein the weight function is constant in the target range.

19. The method according to claim 1, wherein a recommendation for one of the at least two predetermined classes is to adjust a basal rate, a recommendation of another of the at least two predetermined classes is to adjust bolus doses, and a recommendation of yet another of the at least two predetermined classes is to adjust both a basal rate and a bolus doses.

10. A method for determining a disturbance parameter characterizing a disturbance of a tested glucose metabolism that is manifest despite the administration of insulin to adjust dosing of insulin administration, the method comprising:

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

using the glucose concentration values g(t₁) to g(t_n) as input parameters to a processor to calculate disturbance values w(g(t1)) to w(g(tn)) as function values of a weight function w, the weight function w being configured to give more weight to a large deviation between the glucose concentration values g(t₁) to g(t_n) and a target range of glucose concentration values than a small deviation between the glucose concentration values g(t₁) to g(t_n) and the target range;

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 respective characteristic disturbance numbers;

using the characteristic disturbance numbers to determine the disturbance parameter on a processor, 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;

signaling an output unit to output a recommendation for adjustment of a dosing of the insulin administrations corresponding to the type and/or severity of the disturbance; and

controlling an insulin administration device to adjust the dosing of the insulin administration in response to the recommendation.

11. The method according to claim 10, further comprising assigning the disturbance parameter on a processor by use of predetermined parameter ranges to one of at least two predetermined classes, wherein with each of the classes correspond to recommendations for adjustment of the dosing of the insulin administrations and are generated as output parameters.

12. The method according to claim 10, wherein the time intervals, for which the characteristic disturbance numbers each are calculated, overlap.

15. A system 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 system comprising:

a measuring unit comprising a sensor configured to measure glucose concentration values g(t₁) to g(t_n) for time points t₁ to t_n that are distributed over a period of time of at least four hours;

a memory for storing the concentration values;

an analytical unit for analyzing the concentration values;

a receiver in communication with the measuring unit and the analytical unit;

the receiver being configured to transfer the measured glucose concentration values from the measuring unit to the analytical unit;

wherein the analytical unit is adapted to use the glucose concentration values g(t₁) to g(t_n) as input parameters to calculate disturbance values w(g(t1)) to w(g(tn)) as function values of a weight function w, determine a disturbance parameter from the disturbance values, and assign the disturbance parameter to one of at least two predetermined classes, each of said classes corresponding to 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;

wherein the weight function w has a lesser slope in a target range of the glucose concentration values g(t₁) to g(t_n) than in a range that is adjacent to the target range; and

an insulin administration device coupled to the analytical unit, the insulin administration device being controlled by the analytical unit to adjust the dosing of the insulin administration in response to the recommendation corresponding to the assigned predetermined class.

16. The system according to claim 15 wherein the system 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.

17. The system according to claim 16, wherein the system comprises an output unit for output of a recommendation regarding the dosing of the insulin administration of the diabetic.

18. The system according to claim 15, wherein the insulin administration device is 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.