Glucose level control method and system

• US 7,266,400 B2
• Filed: 05/06/2003
• Issued: 09/04/2007
• Est. Priority Date: 05/06/2003
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Fine, Ilya, Ma'Ayan, Lior
• Primary Examiner(s): Winakur; Eric F.
• Application Number:
  US10/429,969
• Publication Number:
  US 20040225205A1
• Time in Patent Office: 1,582 Days
• Field of Search: 600/310, 600/316, 600/322, 600/323, 600/324, 600/326, 600/331, 600/483, 600/485
• 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:

collecting measured data during a predetermined time period while taking a sequence of measurements of the blood glucose level during a day and repeating the sequence of measurements from several days to several weeks, said sequence of measurements including non-invasive-measurements utilizing application of pressure to the patient'"'"'s blood perfused fleshy medium, said application of pressure including application of over-systolic pressure thereby causing a state of temporarily blood flow cessation in the medium, the measured data being in the form of time variations of light responses of the medium to incident light for at least two different wavelenghts of the incident light, respectively;

analyzing the measured data to determine a relation between changes in the two time variations indicative of the glucose concentration in the patient'"'"'s blood, and determine a distribution of average glucose values within said predetermined time period, and

presenting results of the determined distribution of the average glucose values in a visual or auto format to 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, 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.

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

a measurement unit configured to be operable for carrying out non-invasive-measurements by applying over-systolic pressure to patient'"'"'s blood perfused fleshy medium thereby causing a state of temporarily blood flow cessation in the medium, 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 time variation of a light response of the medium for each of said at least two wavelenghts, and generating measurable data indicative thereof; and

a control unit connectable to the measurement unit, the control unit being configured for operating the measurement unit during a predetermined time period for taking a sequence of measurements, including said non-invasive measurements, during a day and repeating the sequence of measurements from several days to several weeks, and being configured and operable for collecting the measured data, analyzing the collected measured data to determine a relation between changes in the two time variations indicative of the glucose concentration in the patient'"'"'s blood, determine a distribution of average glucose values within the predetermined time period, and presenting results of the determine a distribution of the average glucose values in a visual or audio format the patient or an authorized person, said presented results being indicative about a long-term effect of the patient'"'"'s behavior on his blood glucose level.

9. 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 pressurizing 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.

10. 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 to the patient'"'"'s blood perfused fleshy medium a gradually increasing pressure, and concurrently taking optical measurements of the blood glucose level on the medium and collecting measured data during a predetermined time period including a sequence of measurements taken during a day and repeated sequence of measurements taken during a period from several days to several weeks, the measured data being in the form of a time variation of a light response of the medium as a function of the applied pressure;

analyzing 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, and 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;

presenting results of the determined distribution of the average glucose values and the diastolic and systolic pressures, in a visual or audio format to the patient or an authorized person.