METHOD AND GLUCOSE MONITORING SYSTEM FOR MONITORING INDIVIDUAL METABOLIC RESPONSE AND FOR GENERATING NUTRITIONAL FEEDBACK

• US 20110053121A1
• Filed: 06/06/2008
• Published: 03/03/2011
• Est. Priority Date: 06/18/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Heaton, Kelly
• Granted Patent: US 9,675,289 B2
• Time in Patent Office: Days
• US Class Current: 434/127
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and method for monitoring individual metabolic response and for generating nutritional feedback involve monitoring of a glucose level in a qualified subject. The method comprises the step of consecutively performing a plurality of measurements of a glucose level in the qualified subject by a measuring device. In the measuring device first data corresponding to the measured glucose level is generated. This data is further transmitted to an analysis device. There, second data is generated representing at least one measure for variability of a glucose level of the subject from a time-series of glucose measurements represented by the first data. The second data is compared with reference data and a result of the comparison is further processed for generating a conclusion about nutritional quality of foodstuffs consumed by the subject and/or about a risk of long-term health complications of the subject. Finally, feedback is provided corresponding to the conclusion on an output device.

Claims

1. A method for monitoring individual metabolic response and for generating nutritional feedback, involving monitoring of a glucose level in a qualified subject, the method comprising:

a) consecutively performing a plurality of measurements of a glucose level in the qualified subject by a measuring device;

b) generating first data in the measuring device, the first data corresponding to the measured glucose level;

c) transmitting the first data to an analysis device;

d) generating second data in the analysis device, the second data representing at least one measure for variability of a glucose level of the subject from a time-series of glucose measurements represented by the first data;

e) comparing the second data with reference data and further processing a result of the comparison for generating a conclusion about nutritional quality of foodstuffs consumed by the subject and/or about a risk of long-term health complications of the subject; and

f) providing feedback corresponding to the conclusion on an output device.

2. The method of claim 1, wherein the at least one measure for variability is calculated for first data representing two different time intervals yielding a first result and a second result and in that the first result and the second result are considered for comparing the second data with the reference data and for further processing the result of the comparison for generating the conclusion.

3. The method of claim 1 further comprising providing suggestions regarding how to achieve personal metabolic goals, the suggestions including suggestions about recommended type, portion size and/or timing of food ingestion.

4. The method of claim 1, further comprising establishing a glucose reference level of the subject, the glucose reference level being used for generating the second data, for comparing the second data with the reference data, and/or for further processing the result of the comparison for generating the conclusion.

5. The method of claim 4, further comprising self-calibrating the measuring device to establish the glucose reference level, wherein the glucose reference level corresponds to a fasting glucose level of the subject.

6. The method of claim 1, wherein generating the second data comprises calculating a mean value and/or a standard deviation of glucose level measurements represented by the first data and/or of quantities derived from the first data.

7. The method of claim 6, wherein generating the second data comprises calculating a standard deviation of a slope of a function representing the time-series of glucose measurements represented by the first data.

8. The method of claim 1, wherein generating the second data comprises calculating a difference between a first glucose measurement taken in the morning and a second glucose measurement taken in the evening preceding or following said morning, wherein both glucose measurements are represented by the first data.

9. The method of claim 1, further comprising:

defining at least two glucose ranges, and

classifying the glucose measurements represented by the first data according to the range in which the glucose measurements fall, wherein the classifications of a plurality of measurements are employed for generating the second data.

10. The method of claim 1, wherein generation of the second data comprises determining values in phase space coordinates from the time-series of glucose measurements represented by the first data, wherein the phase space values are further processed and/or displayed on the output device.

11. The method of claim 1, wherein the time-series of glucose measurements is selected corresponding to a time interval specified by user input.

12. The method of claim 1, wherein the time-series of glucose measurements is selected corresponding to a time interval that is automatically determined based on the first data, the time interval corresponding to a time interval relating to a single meal, determined by detecting a rise from a glucose reference level and a return to the glucose reference level.

13. The method of claim 1, wherein further processing the result of the comparison comprises considering additional information, the additional information including at least one of:

timing of ingested foodstuffs, quantity of ingested foodstuffs, type of ingested foodstuffs, physical activity of the qualified subject, and values of physiological parameters of the qualified subject, wherein the additional information is received from one of;

another device and user input.

14. The method of claim 1, wherein the second data comprises a metric for glycemic variability chosen from at least one of the following:

a) M-value;

b) Pi-index;

c) coefficient of variation;

d) J-index;

e) MODD;

f) CONGA;

g) Stability parameter;

h) Low BG index (LBGI), High BG index (HBGI) and/or CGM/BG risk index; and

i) average daily risk range (ADRR).

15. The method of claim 1, further comprising:

a) generating third data representing a measure for a quantity of glycemic response of the subject from the time-series of glucose level measurements represented by the first data, the third data being an area-under-the-curve (AUC) value;

b) comparing the third data with a predetermined individual glycemic response budget for the qualified subject, the individual glycemic response budget representing a total amount of individual glycemic response allowable for a certain time period.

16. The method of claim 15, wherein a result of the comparison of the third data with the predetermined individual glycemic response budget is considered for comparing the second data with the reference data and/or for further processing the result of the comparison for generating the conclusion.

17. The method of claim 1, wherein providing feedback on the output device comprises receiving user interaction used to control interpretation of the second data.

18. The method of claim 1, further comprising correcting a raw signal corresponding to the measured glucose level against drift, signal instability, or system error.

19. A glucose monitoring system for monitoring glycemic individual metabolic response in a qualified subject and for generating nutritional feedback, comprising:

a) a measuring device comprising a sensor for consecutively performing a plurality of measurements of a glucose level in the qualified subject and comprising a data generator for generating first data corresponding to the measured glucose level;

b) an analysis device comprising a computer to generate second data representing at least one measure for variability of the glucose level of the subject from a time-series of glucose measurements represented by the first data, and to compare the second data with reference data and for further processing a result of the comparison for generating a conclusion about nutritional quality of foodstuffs consumed by the subject and/or about a risk of long-term health complications of the subject; and

c) a computer-controlled output device to provide feedback corresponding to the conclusion.

20. The system of claim 19, wherein the measuring device is an implantable glucose sensor.

21. The system of claim 20, wherein the measuring device comprises a storage for temporarily storing the first data and the measuring device and the analysis device each comprises transmission components for off-loading of the accumulated stored first data to the analysis device, in particular after the measuring device has been removed from the body of the subject.

22. The system of claim 19, wherein the measuring device and the analysis device each comprise transmission components for transmitting the first data from the measuring device to the analysis device via a wireless link and the analysis device comprises a storage for storing the received first data.

23. The system of claim 19, wherein the analysis device and the output device are incorporated in a handheld device.

24. The system of claim 19, wherein the analysis device comprises a storage for storing the reference data for the qualified subject.

25. The system of claim 19, wherein the measuring device and the analysis device each comprises an electronic circuit for correcting a raw signal corresponding to the measured glucose level against at least one of drift, signal instability, and system error.

26. The system of claim 19, wherein at least one of the analysis device and the output device comprises a user input device programmed in such a way that a user may control interpretation of the second data by using the input device.

27. The system of claim 19, wherein the analysis device comprises a storage for storing second data as well as user-specified information.

28. A tangible, machine readable medium comprising a plurality of instructions that, in response to being executed on an analysis device, result in the analysis device:

a) generating second data representing at least one measure for variability of a glucose level of a qualified subject from a time series of glucose measurements represented by first data;

b) comparing the second data with reference data;

c) generating a conclusion about nutritional quality of foodstuffs consumed by the subject and/or about a risk of long-term health complications of the subject, based on the result of the comparison.