Glucose level control method and system

• US 20040225205A1
• Filed: 05/06/2003
• Published: 11/11/2004
• Est. Priority Date: 05/06/2003
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: MaʼAyan, Lior, Fine, Ilya
• Granted Patent: US 7,266,400 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 5/02255 the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A method and device are provided for self-monitoring a patient'"'"'s blood glucose condition to determine a long-term effect of the patient'"'"'s behavior on his blood glucose level. A sequence of measurements of the blood glucose level is applied during a day, the sequential measurements are repeated during a predetermined time period from several days to several weeks, and measured data are collected. The measured data is analyzed to determine a distribution of the average glucose values within said predetermined time period, thereby providing a feedback for the patient or an authorized person.

Claims

1. A method of self-monitoring a patient'"'"'s blood glucose condition to determine a long-term effect of the patient'"'"'s behavior on his blood glucose level, the method comprising:

applying a sequence of measurements of the blood glucose level during a day, repeating the sequence of measurements during a predetermined time period from several days to several weeks and collecting measured data;

analyzing the measured data to determine a distribution of the average glucose values within said predetermined time period, thereby providing a feedback for the patient or an authorized person.

2. The method of claim 1, comprising calibrating a non-invasive measurement device used for carrying out said sequence of measurements.

3. The method of claim 2, wherein said calibrating comprising using a first measurement device, of a kind different from said non-invasive measurement device, to perform at least one first reference measurement and obtain first measured data of blood glucose concentration for a specific patient;

applying said non-invasive measurement device to said patient to perform at least one of the non-invasive measurements either prior to or after said first measurement, and determining second measured data indicative of the glucose concentration in the patient'"'"'s blood while utilizing a certain calculation model; and

determining a correlation between said first measured data and said second measured data, and applying a statistic algorithm to thereby optimize coefficients used in said model to obtain the best fitting between the first and second measured data.

4. The method of claim 3, wherein said first measurement device is designed to carry out invasive measurements.

5. The method of claim 3, comprising carrying out a plurality of the reference measurements and calculating a calibration function.

6. The method of claim 5, comprising utilizing data obtained during further measurements with the first and second measurement devices and updating the calibration function.

7. The method of claim 1, wherein said non-invasive-measurements utilize application of pressure to the patient'"'"'s blood perfused fleshy medium.

8. The method of claim 7, wherein said non-invasive measurements comprises:

applying over-systolic pressure to the medium thereby causing a state of temporarily blood flow cessation in the medium; and

applying optical measurements with at least two different wavelengths of incident light to the medium while at the state of blood flow cessation to detect the time variation of a light response of the medium for each of said at least two wavelengths, a relation between changes in the two time variations being indicative of the glucose concentration in the patient'"'"'s blood.

9. The method of claim 7, comprising measuring a patient'"'"'s blood pressure, the method comprising:

applying to the patient'"'"'s blood perfused fleshy medium a gradually increasing pressure, and concurrently applying optical measurements to the medium to determine a time variation of a light response of the medium as a function of the applied pressure;

analyzing the measured time variations of the light response as the function of the applied pressure to determine a diastolic pressure as the pressure corresponding to an appearance of a changed form of the time variation of the light response while having pulsatile components and determine a systolic pressure as the pressure corresponding to substantial disappearance of the pulsatile components in the time variation of the light response.

10. A method of calibrating a non-invasive measurement device for use in self-monitoring a patient'"'"'s blood glucose condition, the method comprising:

using a first measurement device, of a kind different from said non-invasive measurement device, to obtain first measured data indicative of glucose concentration in blood of a specific patient;

applying said non-invasive measurement device to said patient either prior to or after said first measurement, said non-invasive measurement device utilizing a certain calculation model to determine second measured data indicative of the glucose concentration in the patient'"'"'s blood;

determining a correlation between said first measured data and said second measured data, and applying a medical statistic algorithm to thereby optimize coefficients used in said model to obtain the best fitting between the first and second measured data.

11. A method for measuring a patient'"'"'s blood pressure, the method comprising:

applying to the patient'"'"'s blood perfused fleshy medium a gradually increasing pressure, and concurrently applying optical measurements to the medium to determine a time variation of a light response of the medium as a function of the applied pressure;

analyzing the measured time variations of the light response as the function of the applied pressure to determine a diastolic pressure as the pressure corresponding to an appearance of a changed form of the time variation of the light response while having pulsatile components and determine a systolic pressure as the pressure corresponding to substantial disappearance of the pulsatile components in the time variation of the light response.

12. A measurement device for use in self-monitoring a patient'"'"'s blood glucose condition, the device comprising:

a measurement unit operable for detecting data indicative of a blood glucose level, and a control unit (processor unit) connectable to the measurement unit for collecting and analyzing the measured data to determine a distribution of the average glucose values within a predetermined time period, thereby providing a feedback for the patient or an authorized person about a long-term effect of the patient'"'"'s behavior on his blood glucose level.

13. An integrated measurement system for self-monitoring a patient'"'"'s blood glucose condition, the system comprising:

a first measurement device configured to provide first reference data indicative of a glucose concentration in patient'"'"'s blood;

a second measurement device configured differently to said first measurement device and operable to apply non-invasive measurements to the patient'"'"'s blood perfused fleshy medium and provide second measured data indicative of the glucose concentration in the patient'"'"'s blood; and

a control unit operating the first measurement device and operating the second measurement device to carry out at least one non-invasive measurement either prior to after the first measurement device with a certain interval between these measurements, and then sequentially operating the second measurement device to carry out a sequence of said non-invasive measurements, the control unit being preprogrammed to be response to the first and second measured data to correlate between them, and apply a medical statistic algorithm to thereby optimize coefficients used in calculating the second measured data.

14. A non-invasive measurement device comprising:

an optical measurement system for applying to a patient'"'"'s blood perfused fleshy medium, said system including an illuminator producing light of at least two different wavelengths, and a light detector for detecting light responses of the medium at the different wavelengths and generating measured data indicative thereof;

a pressurizing assembly operable to apply pressure to the medium; and

a control unit configured for operating the pressing assembly to apply gradually increasing pressure to the medium, and maintaining the application of pressure during a certain time period upon reaching certain over-systolic pressure, and for operating the measurement system to apply measurements and generate the measured data during the application of pressure, the control unit having a data processing and analyzing utility operable to analyze the light responses and determine a diastolic pressure as the pressure corresponding to an appearance of a changed form of the light response profile while having pulsatile components, determine a systolic pressure as the pressure corresponding to substantial disappearance of the pulsatile components in the light response profile, and determine the glucose concentration from a relation between the light response profiles at the different wavelengths measured during the application of said certain over-systolic pressure.