Method and system for investigating glucose metabolism

• US 8,131,474 B2
• Filed: 03/15/2006
• Issued: 03/06/2012
• Est. Priority Date: 03/15/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Staib, Arnulf, Pill, Johannes, Kotulla, Reinhard, Hegger, Reiner
• Primary Examiner(s): Smith, Carolyn L.
• Application Number:
  US11/276,816
• Publication Number:
  US 20060253067A1
• Time in Patent Office: 2,183 Days
• Field of Search: None
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The invention relates to a method for investigating the glucose metabolism of a human being for disease-relevant and/or disease-related particularities. The glucose concentration g(t1) to g(tn) of a body fluid is measured at time points t1 to tn that are distributed over a period of at least six hours. The data points are then determined in phase space coordinates from the glucose concentration measuring values g(t1) to g(tn). The data points are then processed to highlight disease-relevant and/or disease-related particularities of the glucose metabolism of the investigated human being. The processing of the data points can be implemented by plotting them in a phase space representation or by determining from the data points a disturbance parameter that is correlated to the severity of a disturbance of glucose metabolism.

Claims

1. A method for investigating a glucose metabolism of a human being for particularities, the method comprising:

measuring, using a sensor, a glucose concentration g(t1) to g(tn) of a body fluid at time points t1 to tn that are distributed over a period of at least six hours and are consecutive with time intervals of less than 10 minutes;

determining, using a microprocessor, data points in phase space coordinates from the glucose concentration g(t1) to g(tn); and

processing, using the microprocessor, the data points to identify particularities of the glucose metabolism of the investigated human being;

wherein the processing step includes performing a statistical analysis of the data points situated within a phase space boundary of a predetermined size having at least two dimensions to determine a disturbance parameter that indicates a severity of a disturbance of glucose metabolism and indicates a stage of a disease of glucose metabolism.

2. The method according to claim 1, wherein the body fluid is blood.

3. The method according to claim 1, wherein the time points t1 to tn are consecutive with time intervals of less than 5 minutes.

4. The method according to claim 1, wherein the determining step includes the step of determining data points in a two dimensional phase space coordinate system from the glucose concentration.

5. The method according to claim 1, wherein the data points are processed by plotting in a graphic phase space representation.

6. The method according to claim 5, wherein an increased density of data points in the graphic phase space representation is highlighted by coloring.

7. The method according to claim 6, wherein the data points are shown in a color that depends on the number of data points that are present in a pre-determined vicinity U of a first data point.

8. The method according to claim 6, wherein different symbols are used in areas of increased data point density as compared to regions of lower density.

9. The method according to claim 5, wherein a trajectory described by the data points is displayed.

10. The method according to claim 1, wherein delay coordinates are used as phase space coordinates.

11. The method according to claim 10, wherein a delay time of between 10 minutes and 90 minutes, preferably between 15 minutes and 30 minutes, is selected for the delay coordinates.

12. The method according to claim 1, wherein the disturbance parameter is determined from the fraction of data points situated within a pre-determined vicinity U of a regulation point.

13. The method according to claim 1, wherein the disturbance parameter is determined from the ratio of the main axes of an ellipsoid of variance of the data points.

14. The method according to claim 1, wherein a trajectory in phase space described by a sequence of data points is analyzed in order to determine the disturbance parameter.

15. The method according to claim 14, wherein the disturbance parameter is determined from a curvature of a loop of the trajectory.

16. The method according to claim 15, wherein the loop of the trajectory is approximated by an ellipse and the disturbance parameter is determined from a ratio of main axes of the ellipse.

17. The method according to claim 1, wherein the disturbance parameter is determined by means of a cross-prediction.

18. The method according to claim 1, wherein the disturbance parameter is correlated to a probability of a diabetic disease.

26. The method of claim 1, wherein the phase space is a volume having three dimensions.

27. The method of claim 7, wherein the first point is a regulation point.

28. The method according to claim 1, wherein a function of the blood glucose concentration and/or at least one of its derivatives with respect to time are used as phase space coordinates.

29. The method according to claim 28, wherein the glucose concentration is one of the phase space coordinates.

30. The method according to claim 28, wherein a rate of change of the glucose concentration is one of the phase space coordinates.

19. A system for investigating a glucose metabolism of a human being for particularities, the system comprising:

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

means for determining data points in phase space coordinates from the glucose concentration g(t1) to g(tn);

wherein the determining means is used to process the data points to identify a boundary having at least two dimensions in phase space having the data points therein which corresponds to a particularity of the glucose metabolism of the investigated human being and indicates a stage of a disease of glucose metabolism.

20. The system of claim 19, wherein the time points t1 to tn are distributed over a period of at least six hours.

21. The system according to claim 19, wherein the system further comprises a display facility for displaying the data points thus determined in a phase space representation.

22. The system according to claim 19, wherein the determining means is used to determine from the data points a disturbance parameter that is correlated to a severity of a disturbance of glucose metabolism.

23. The system according to claim 22, wherein the disturbance parameter is used in conjunction with therapy data stored in a database to prepare and output a therapy recommendation.

24. The system according to claim 19, wherein the system comprises an implant with a storage reservoir for insulin and a micropump for the controlled release of insulin into the bloodstream of a patient, whereby the determining means triggers an alarm signal as soon as the disturbance parameter deviates by more than a pre-determined tolerance from a pre-determined nominal value.

25. A method for investigating a glucose metabolism of a human being for particularities, the method comprising:

measuring, using a sensor, a glucose concentration g(t1) to g(tn) of a body fluid at time points t1 to tn that are distributed over a period of at least six hours and are consecutive with time intervals of less than 10 minutes;

determining, using a microprocessor, data points in phase space coordinates from the glucose concentration g(t1) to g(tn); and

processing, using the microprocessor, the data points to identify particularities of the glucose metabolism of the investigated human being;

wherein the processing step includes performing a statistical analysis of the data points to determine a disturbance parameter that indicates a severity of a disturbance of glucose metabolism, the disturbance parameter being determined from a curvature of a loop of a trajectory in phase space described by a sequence of data points, the loop being approximated by an ellipse having main axes, and

wherein the disturbance parameter is determined from the curvature of the loop by determining a ratio of the axes.