Method and device for assessment of a series of glucose concentration values of a body fluid of a diabetic for adjustment of insulin dosing

Patent metadata

Field	Value
Publication number	US-10194839-B2
Application number	US-42212606-A
Country	US
Kind code	B2
Filing date	Jun 5, 2006
Priority date	Jun 4, 2005
Publication date	Feb 5, 2019
Grant date	Feb 5, 2019

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.

First claim

What is claimed is:

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(t 1 ) to g(t n ) to time points t 1 to t n that are distributed over a period of time of at least four hours;
using the glucose concentration values g(t 1 ) 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(t 1 ) 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.

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(t 1 ) to g(t n ) to time points t 1 to t n that are distributed over a period of time of at least four hours;
using the glucose concentration values g(t 1 ) 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(t 1 ) to g(t n ) and a target range of glucose concentration values than a small deviation between the glucose concentration values g(t 1 ) 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.

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.

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(t 1 ) to g(t n ) for time points t 1 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(t 1 ) 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(t 1 ) 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 o

Assignees

• Staib Arnulf
• Kloetzer Hans Martin
• Roche Diabetes Care Inc

Inventors

• Staib Arnulf
• Klötzer Hans-Martin

Classifications

• G01N2800/042

  Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism · CPC title

• G01N33/66

  involving blood sugars, e.g. galactose · CPC title

• A61M5/1723

  using feedback of body parameters, e.g. blood-sugar, pressure (measurement of body parameters A61B5/00) · CPC title

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61M2005/14208

  with a programmable infusion control system, characterised by the infusion program · CPC title