Method of adapting in-vitro models to aid in noninvasive glucose determination
First Claim
1. A method for noninvasively estimating an analyte concentration with an in-vivo instrument system, comprising the steps of:
- providing a first model;
removing at least one interference from said first model to form a second model;
standardizing said in-vivo instrument system to said second model to generate a third model;
providing an in-vivo test set, comprising;
at least one in-vivo test signal; and
a reference analyte concentration corresponding with said in-vivo test signal;
applying said third model to said in-vivo test signal to generate a test value;
determining a correction to said third model using said test value and said reference analyte concentration;
providing an in-vivo measurement signal; and
estimating said analyte concentration using said third model and said in-vivo measurement signal.
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Abstract
The invention relates to a noninvasive analyzer and a method of using information determined at least in part from in-vitro spectra of tissue phantoms or analyte solutions to aid in the development of a noninvasive glucose concentration analyzer and/or in the analysis of noninvasive spectra resulting in glucose concentration estimations in the body. The preferred apparatus is a spectrometer that includes a base module and a sample module that is semi-continuously in contact with a human subject and that collects spectral measurements which are used to determine a biological parameter in the sampled tissue, such as glucose concentration. Collection of in-vitro samples is, optionally, performed on a separate instrument from the production model allowing the measurement technology to be developed on a research grade instrument and used or transferred to a target product platform or production analyzer for noninvasive glucose concentration estimation.
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Citations
70 Claims
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1. A method for noninvasively estimating an analyte concentration with an in-vivo instrument system, comprising the steps of:
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providing a first model;
removing at least one interference from said first model to form a second model;
standardizing said in-vivo instrument system to said second model to generate a third model;
providing an in-vivo test set, comprising;
at least one in-vivo test signal; and
a reference analyte concentration corresponding with said in-vivo test signal;
applying said third model to said in-vivo test signal to generate a test value;
determining a correction to said third model using said test value and said reference analyte concentration;
providing an in-vivo measurement signal; and
estimating said analyte concentration using said third model and said in-vivo measurement signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method for noninvasive estimation of a sample constituent property, comprising the steps of:
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providing a first model, wherein said first model comprises coefficients that are generated at least in part with an in-vitro data set;
standardizing an in-vivo instrument system to said first model, wherein a second model is generated;
providing a noninvasive signal; and
estimating said sample property by applying said second model to said noninvasive signal. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29)
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30. An apparatus for noninvasive estimation of a sample constituent property from a noninvasive spectrum, comprising:
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an analyzer comprising a base module, a sample module, and a model residing in said analyzer;
wherein said model comprises coefficients generated by standardizing an in-vivo system to an in-vitro data set;
and wherein said model is applied to said noninvasive spectrum for estimation of said sample constituent property. - View Dependent Claims (31)
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32. A method for noninvasive estimation of a sample constituent property, comprising the steps of:
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providing a first model, wherein said first model comprises coefficients that are generated at least in part with an in-vitro data set;
standardizing an in-vivo instrument system to said first model to generate a second model, wherein said second model comprises a second set of coefficients;
providing an in-vivo test set, comprising;
at least one in-vivo test signal; and
a reference sample concentration that is correlated with said in-vivo test signal;
applying said second model to said in-vivo test set to generate a test value;
determining a correction to said second model using said test value and said reference sample concentration;
providing an in-vivo measurement signal; and
estimating said sample constituent property using said second model and said in-vivo measurement signal. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. A method for noninvasively estimating an analyte concentration, comprising the steps of:
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providing a first calibration model;
removing at least one interference from said first model to form a second model;
providing an in-vivo signal; and
estimating said analyte concentration using said second model and said in-vivo signal. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. An apparatus for noninvasive estimation of a sample constituent property from a noninvasive spectrum, comprising:
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an analyzer, comprising;
a base module;
a sample module; and
a model residing in said analyzer;
wherein said model comprises coefficients generated by standardizing an in-vivo system to a model of coefficients derived at least in part from an in-vitro data set; and
wherein said model is applied to said noninvasive spectrum to generate said sample constituent property. - View Dependent Claims (54, 55, 56, 57)
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58. A method for noninvasively estimating a blood/tissue glucose concentration, comprising the steps of:
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providing a calibration model;
supplementing said calibration model with an in-vitro signal;
providing a noninvasive near-infrared signal; and
estimating said blood glucose concentration using said model and said noninvasive signal. - View Dependent Claims (59, 60, 61)
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62. A method for noninvasive estimation of a sample constituent property from an in-vivo instrument system, comprising the steps of:
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providing a model, comprising coefficients generated at least in part with an in-vitro data set;
standardizing said model to said in-vivo instrument system;
providing a noninvasive signal; and
estimating said sample property by applying said model to said noninvasive signal. - View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70)
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Specification