US 6,998,247 B2 · Method and apparatus using alternative site glucose determinations to calibrate and maintain noninvasive and implantable analyzers

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.

Claims37

Dependent claims

A method of controlling sample site disparity error in calibration of a noninvasive glucose analyzer comprising:

collecting one or more noninvasive signals from a subject's body at an alternative sampling site, said alternative sampling site having a location that is among those sites that are selected when performing an alternative invasive glucose determination, said alternative sampling site being located at a region other than said subject's fingertips or toes;
invasively determining an alternative reference glucose measurement corresponding in time to each noninvasive signal from said body at an alternative reference measurement site, said alternative reference measurement site located at a region of the body having a tissue matrix substantially identical or equivalent to a tissue matrix at said alternative sampling site so that error due to a discrepancy between glucose concentration at said alternative sampling site and said alternative reference measurement site is reduced or eliminated, and;
any of the steps of:
calibrating said glucose analyzer utilizing a calibration model calculated from said one or more noninvasive signals and said alternative reference glucose measurements;
and
maintaining calibration of said glucose analyzer by utilizing said one or more noninvasive signals and said alternative reference glucose measurements to select, adjust and/or correct a calibration model.

3 more elements

A method of controlling sample site disparity error in calibration of an implantable glucose analyzer, comprising the steps of:

collecting one or more signals at a first site from a subject's body using said implantable glucose analyzer, said first site being located at a region other than said subject's fingertips or toes;
determining an alternative reference glucose measurement corresponding in time to each of said one or more signals from said body at an alternative reference measurement site, said alternative reference measurement site located at a region of the body having a tissue matrix substantially identical or equivalent to a tissue matrix at said first site so that error due to a discrepancy between glucose concentration at said first site and said alternative reference measurement site is reduced or eliminated, and:
any of the steps of:
calibrating said glucose analyzer utilizing a calibration model calculated from said one or more signals and said alternative reference glucose measurements;
and
maintaining calibration of said glucose analyzer by utilizing said one or more signals and reference glucose measurements to select, adjust and/or correct a calibration model.

3 more elements

Dependencies are inferred from the claim text.

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

Life of this patent

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

Life of this patent

Abstract

Claims37