Assessment method to process a glucose concentration signal and devices thereof

• US 8,060,318 B2
• Filed: 07/29/2009
• Issued: 11/15/2011
• Est. Priority Date: 01/29/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Vering, Thomas, Kalt, Lucas, Patte, Caroline, Cris, Catalin, Kuhni, Florian
• Primary Examiner(s): Bui; Bryan
• Application Number:
  US12/511,190
• Publication Number:
  US 20100030483A1
• Time in Patent Office: 839 Days
• Field of Search: 702/19, 600/365
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Embodiments of an assessment method for processing a signal corresponding to a glucose concentration and performing a retrospective analysis comprises the steps of: a) initiating a first trigger, wherein the first trigger defines the beginning of a segment of a continuous measurement of glucose concentration or defines the first of a series of spot measurements of glucose concentration; b) collecting data of the continuous measurement or the series of spot measurements of glucose concentration to be analyzed, wherein the collected data relates to a glucose concentration excursion corresponding to a reaction to a relevant event such as a meal or physical activity; c) analyzing the collected data initiated by a second trigger, wherein the second trigger defines the end of the collected data to be analyzed, wherein a measure for a grading of the excursion is determined from the collected data, and d) displaying the results of the analysis.

Claims

1. An assessment method for processing a signal corresponding to a glucose concentration, comprising:

providing a device comprising;

a measuring device for collecting data to be analyzed,

a computing device for analyzing the collected data,

a storage device for recording the collected data and the analysis,

a display for visualizing the analyzed data, and

a communication link for transmitting data between the measuring device and the computing device, the storage device, and the display, respectively;

initiating a first trigger, wherein the first trigger defines the beginning of a segment of a continuous measurement of glucose concentration or defines the first of a series of spot measurements of glucose concentration;

collecting data of the continuous measurement or the series of spot measurements of glucose concentration to be analyzed, wherein the collected data relates to a glucose concentration excursion corresponding to a reaction to a relevant event such as a meal or physical activity;

analyzing the collected data initiated by a second trigger, wherein the second trigger defines the end of the collected data to be analyzed, wherein a measure for a grading of the excursion is determined from the collected data;

wherein a criterion for the determination of the grading of the glucose concentration excursion comprises;

a discrete number of sets of target gates, whereas each set of target gates comprises at least one first target gate of a first width and one second target gate of a second width, whereas the centers of the at least two target gates of the set show the same position in time; and

wherein the numbers of the first gates, the second gates and optionally additional gates of other widths that enclose the curve correspond to the glucose concentration excursion; and

displaying a result of the analysis.

2. The method of claim 1, wherein the first trigger and/or the second trigger corresponds to

a) user input,

b) a predetermined time,

c) a value and/or progression of glucose concentration,

d) a signal of an external device

or a combination thereof.

3. The method of claim 1 wherein the criterion for the determination of the grading of the glucose concentration excursion comprises:

a) a band of a relative target range; and

b) the relative time the band encloses the glucose concentration excursion curve.

4. The method of claim 1 wherein the criterion for the determination of the grading of the glucose concentration excursion comprises:

a) a set of bands of relative target ranges, comprising at least one first band of a first relative target range and one second band of a second relative target range; and

b) the relative time each band of relative target range respectively encloses the glucose concentration excursion curve.

5. The method of claim 1 wherein the criterion for the determination of the grading of the glucose concentration excursion are given by a range of j-indices, whereas a j-index is calculated using a mean value as well as a standard deviation of glucose concentrations wherein the determination of the grading of the glucose concentration excursion are given by a set of different ranges of j-indices indicating the grading of the glucose concentration excursion.

6. The method of claim 1 wherein the conclusions about a quality of a glucose concentration control resulting from the measured glucose concentration excursion are determined and displayed.

7. The method of claim 1 wherein a quality of a glucose concentration control is determined based on the relative time where the glucose concentration excursion curve lies within a band of relative target range, wherein the glucose concentration excursion lies within the first, second and optionally other bands of relative target ranges, respectively.

8. An assessment method for processing a signal corresponding to a glucose concentration comprising:

providing a device comprising;

a measuring device for collecting data to be analyzed,

a computing device for analyzing the collected data,

a storage device for recording the collected data and the analysis,

a display for visualizing the analyzed data, and

a communication link for transmitting data between the measuring device and the computing device, the storage device, and the display, respectively;

initiating a first trigger, wherein the first trigger defines the beginning of a segment of a continuous measurement of glucose concentration or defines the first of a series of spot measurements of glucose concentration;

collecting data of the continuous measurement or the series of spot measurements of glucose concentration to be analyzed, wherein the collected data relates to a glucose concentration excursion corresponding to a reaction to a relevant event such as a meal or physical activity;

analyzing the collected data initiated by a second trigger, wherein the second trigger defines the end of the collected data to be analyzed, wherein a measure for a grading of the excursion is determined from the collected data;

wherein a quality of a glucose concentration control is determined based on the respective numbers of glucose values, which lie within target gates of a first width, a second width and optionally other widths, respectively, whereas only the smallest gate, which encloses the respective glucose value, is considered for each set of gates, relative to the total number of sets of target gates; and

displaying a result of the analysis.

9. A device configured to perform an assessment for processing a signal corresponding to a glucose concentration, the device comprising:

a) a measuring device for collecting the data to be analyzed,

b) a computing device for analyzing the collected data,

wherein the computing device is configured to determine a measure for a grading for a glucose concentration excursion,

wherein a criterion for the determination of the grading of the glucose concentration excursion comprises;

a discrete number of sets of target gates, whereas each set of target gates comprises at least one first target gate of a first width and one second target gate of a second width, whereas the centers of the at least two target gates of the set show the same position in time;

wherein the numbers of the first gates, the second gates and optionally additional gates of other widths that enclose the curve correspond to the glucose concentration excursion;

wherein the computing device is configured such that analyzing the collected data comprises a first trigger and a second trigger, defining the beginning of a segment of continuous measurement and the end of the collected data to be analyzed, respectively; and

c) a storage device for recording the collected data and the analysis,

d) a display for visualizing the analyzed data, and

e) a communication link for transmitting data between the measuring device and the computing device, the storage device, and the display, respectively.

10. The device of claim 9 wherein the measuring device on the one hand and the computing device, storage device and display on the other hand communicate automatically, without user interaction.

11. The device of claim 9 wherein the criterion and/or method to be used can be chosen online by the user;

and wherein the criterion for the determination of the grading of the glucose concentration excursion additionally comprises at least one of;

a band of relative target ranges, whereas the width of the relative target ranges is determined as being a percentage of the appropriate value of the estimated glucose concentration excursion;

or

at least one j-index calculated using a mean value as well as a standard deviation of a number of measured glucose concentrations.