WO2003076893A3 - Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers - Google Patents

Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers Download PDF

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Publication number
WO2003076893A3
WO2003076893A3 PCT/US2003/006426 US0306426W WO03076893A3 WO 2003076893 A3 WO2003076893 A3 WO 2003076893A3 US 0306426 W US0306426 W US 0306426W WO 03076893 A3 WO03076893 A3 WO 03076893A3
Authority
WO
WIPO (PCT)
Prior art keywords
noninvasive
glucose
determinations
invasive
analyzer
Prior art date
Application number
PCT/US2003/006426
Other languages
French (fr)
Other versions
WO2003076893A2 (en
WO2003076893A9 (en
Inventor
Stephen L Monfre
Kevin H Hazen
Timothy L Ruchti
Thomas B Blank
James R Henderson
Original Assignee
Sensys Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sensys Medical Inc filed Critical Sensys Medical Inc
Priority to IL16353703A priority Critical patent/IL163537A0/en
Priority to EP03744151A priority patent/EP1509126A4/en
Priority to CA002476419A priority patent/CA2476419A1/en
Priority to MXPA04008714A priority patent/MXPA04008714A/en
Priority to JP2003575068A priority patent/JP2005519683A/en
Priority to AU2003225638A priority patent/AU2003225638A1/en
Publication of WO2003076893A2 publication Critical patent/WO2003076893A2/en
Publication of WO2003076893A9 publication Critical patent/WO2003076893A9/en
Priority to IL163537A priority patent/IL163537A/en
Publication of WO2003076893A3 publication Critical patent/WO2003076893A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G01N21/274Calibration, base line adjustment, drift correction
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid

Abstract

Methods for calibrating noninvasive or implantable glucose analyzers utilize either alternative invasive glucose determinations or noninvasive glucose determinations for calibrating noninvasive or implantable glucose analyzers. Use of an alternative invasive or noninvasive glucose determination in the calibration allows minimization of errors due to sampling methodology, and spatial and temporal variation that are built into the calibration model. An additional method uses statistical correlations between noninvasive and alternative invasive glucose determinations and traditional invasive glucose determinations to adjust noninvasive or alternative invasive glucose concentrations to traditional invasive glucose concentrations. The methods provide a means for calibrating on the basis of glucose determinations that reflect the matrix observed and the variable measured by the analyzer more closely. A glucose analyzer couples an invasive fingerstick meter to a noninvasive glucose analyzer for calibration, validation, adaptation, and safety check of the calibration model embodied in the noninvasive analyzer.
PCT/US2003/006426 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers WO2003076893A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
IL16353703A IL163537A0 (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable
EP03744151A EP1509126A4 (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers
CA002476419A CA2476419A1 (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers
MXPA04008714A MXPA04008714A (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers.
JP2003575068A JP2005519683A (en) 2002-03-08 2003-03-03 Method and apparatus for calibrating and maintaining non-invasive and implantable analyzers using alternative site glucose quantification
AU2003225638A AU2003225638A1 (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers
IL163537A IL163537A (en) 2002-03-08 2004-08-12 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US36289902P 2002-03-08 2002-03-08
US36288502P 2002-03-08 2002-03-08
US60/362,885 2002-03-08
US60/362,899 2002-03-08
US10/377,916 2003-02-28
US10/377,916 US6998247B2 (en) 2002-03-08 2003-02-28 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers

Publications (3)

Publication Number Publication Date
WO2003076893A2 WO2003076893A2 (en) 2003-09-18
WO2003076893A9 WO2003076893A9 (en) 2004-03-18
WO2003076893A3 true WO2003076893A3 (en) 2004-12-16

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/006426 WO2003076893A2 (en) 2002-03-08 2003-03-03 Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers

Country Status (10)

Country Link
US (4) US6998247B2 (en)
EP (1) EP1509126A4 (en)
JP (1) JP2005519683A (en)
CN (1) CN100335002C (en)
AU (1) AU2003225638A1 (en)
CA (1) CA2476419A1 (en)
IL (2) IL163537A0 (en)
MX (1) MXPA04008714A (en)
TW (1) TWI297392B (en)
WO (1) WO2003076893A2 (en)

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