Analytical method and investigation system

• US 8,734,347 B2
• Filed: 05/30/2008
• Issued: 05/27/2014
• Est. Priority Date: 12/03/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Staib, Arnulf, Kloetzer, Hans-Martin, Essenpreis, Matthias
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US12/130,091
• Publication Number:
  US 20080262333A1
• Time in Patent Office: 2,188 Days
• Field of Search: None
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Metabolism diseases are evaluated by using a sensor to measure concentration of a medically significant analyte in a human or animal body fluid. The measurement data are correlated with the concentration of a medically significant analyte in body fluid over a time period of at least eight hours. An analytical facility analyzes time intervals within the time period to determine a stability parameter that characterizes the analyte concentration dynamics of change. The analytical facility further analyzes the stability parameters to determine disease-related particularities of metabolism.

Claims

1. A system for investigation of the metabolism of a human or animal with regard to a medically significant analyte, comprising:

a sensor for determining measuring data that are correlated with a concentration of a medically significant analyte in a human or animal body fluid, and

an analytical facility for analyzing a series of the measuring data that have been determined by the sensor and are correlated with the concentration of the medically significant analyte in the human or animal body fluid for time points that are distributed over a period of time of at least eight hours, the analytical facility being free from need to obtain a reference value of the medically significant analyte to calibrate the measuring data;

whereby the analytical facility is adapted such that in operation, it selects from the period of time multiple time intervals, which each of the time intervals extend over at least one hour and the analytical facility determines a stability parameter that characterizes the analyte concentration dynamics of change in the time interval for each of the time intervals by analyzing measuring data that are from the time interval, and the analytical facility analyzes the stability parameter and assigns the stability parameter to one of a plurality of predetermined parameter ranges in order to determine disease-related particularities of metabolism.

2. The system as in claim 1 wherein the analytical facility calculates a first derivative over time of the measuring data in a calculation step in order to calculate the stability parameter.

3. The system as in claim 2 wherein the analytical facility calculates a standard deviation of the first derivative over time in a further calculation step.

4. The system as in claim 1 wherein the analytical facility performs a Fourier transformation of a derivative of the measuring data over time to calculate the stability parameter.

5. The system as in claim 1 wherein the analytical facility, performs a linear transformation when operating on the measuring data.

6. The system as in claim 5 wherein the analytical facility selects the linear transformation for each individual time interval such that the mean of the measuring data of a corresponding time interval corresponds to a pre-determined value.

7. The system as in claim 6 wherein the analytical facility selects the linear transformation for each individual time interval such that the standard deviation of the measuring data of the corresponding individual time interval corresponds to a pre-determined value.

8. The system as in claim 1 wherein the analytical facility, is a hand-held device that comprises an output unit, an input unit, and a memory.

9. The system as in claim 1 wherein the analyte is glucose.

10. The system as in claim 9 wherein the analytical facility assigns therapeutic recommendations of a dosage of insulin doses to disease-related particularities of glucose metabolism that have been determined by analysis of the stability parameters.

11. A method for analyzing a series of measuring data, comprising:

providing a sensor to determine a series of measuring data;

correlating, using a computer program product, the series of measuring data with a concentration of a medically significant analyte in a human or animal body fluid for time points that are distributed over a period of time of at least 8 hours;

selecting, using the computer program product, multiple time intervals within the period of time, each time interval extending over at least 1 hour;

determining, using the computer program product, a stability parameter through a Fourier transformation of a derivative of the measuring data over time, the stability parameter characterizing dynamics of a change of analyte concentration in each time interval by analyzing measuring data that are from that time interval,

performing, using the computer program product, a linear transformation when operating on the measuring data, the linear transformation being performed individually for each time interval; and

analyzing, using the computer program product, the stability parameter in order to determine at least one of a diabetic disease and a stage of the diabetic disease, and to further determine a treatment for the diabetic disease.

12. The method as in claim 11 wherein the computer program product can be loaded directly into the memory of a digital computer.

13. A system for investigation of the metabolism of a human or animal with regard to a medically significant analyte, comprising:

a sensor for determining measuring data that are correlated with a concentration of a medically significant analyte in a human or animal body fluid, and

means for analyzing a series of measuring data that have been determined by the sensor and are correlated with the concentration of the medically significant analyte in the human or animal body fluid for time points that are distributed over a period of time of at least eight hours by determining a stability parameter that characterizes the analyte concentration dynamics of change and analyzing the stability parameter in order to determine at least one of a diabetic disease, a stage of the diabetic disease, and a treatment for the diabetic disease, wherein the stability parameter is determined through a Fourier transformation of a derivative of the measuring data over time.

14. A method for analyzing a series of measuring data in human body fluid without calibration, comprising:

sensing a medically significant analyte in a human body to determine measuring data;

correlating a series of the measuring data with a concentration of a medically significant analyte for time points that are distributed over a period of time of at least 8 hours;

selecting multiple time intervals each extending over at least a 1 hour the period of time;

determining a stability parameter characterizing dynamics of the change of analyte concentration in said time interval for each of the time intervals by analyzing measuring data that are from said time interval,

analyzing the stability parameter free from need to obtain a reference value of the medically significant analyte to calibrate the measuring data; and

assigning the stability parameter to one of a plurality of predetermined ranges in order to determine disease-related particularities of metabolism.