Abstract: A magnetic field based mechanical apparatus is disclosed. The apparatus is based on coupled attracting or opposing magnets in conjunction with the insertion or removal of a magnetic field modifier. In the preferred embodiment, two repelling magnets are drawn together with the insertion of a magnetic field modifier. The field modifier may be another magnet having an opposing pole. Removal of the field modifier returns the forces to their original states. This oscillating motion may be driven with a low energy and/or small power supply. The resulting motion of the opposing magnets can drive mechanical system such as a linear, gear, ratchet, or reciprocating drive.

Abstract: A solution for reducing interference in noninvasive spectroscopic measurements of tissue and blood analytes is provided. By applying a basis set representing various tissue components to a collected sample measurement, measurement interferences resulting from the heterogeneity of tissue, sampling site differences, patient-to-patient variation, physiological variation, and instrumental differences are reduced. Consequently, the transformed sample measurements are more suitable for developing calibrations that are robust with respect to sample-to-sample variation, variation through time, and instrument related differences. In the calibration phase, data associated with a particular tissue sample site is corrected using a selected subset of data within the same data set. This method reduces the complexity of the data and reduces the intra-subject, inter-subject, and inter-instrument variations by removing interference specific to the respective data subset.

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.

Abstract: A ceramic reference in conjunction with a spectrometer, a metallized ceramic material, and a method of utilizing a ceramic material as a reference in the ultraviolet, visible, near-infrared, or infrared spectral regions are presented. The preferred embodiments utilize a ceramic reference material to diffusely reflect incident source light toward a detector element for quantification in a reproducible fashion. Alternative embodiments metallize either the incident surface or back surface of to form a surface diffuse reflectance standard. Optional wavelength reference layers or protective layers may be added to the ceramic or to the metallized layer. The reference ceramic is used to provide a measure of optical signal of an analyzer as a function of the analyzers spatial, temporal, and environmental state.

Abstract: A novel multivariate model for analysis of absorbance spectra allows for each wavelength or spectral region to be modeled with just enough factors to fully model the analytical signal without the incorporation of noise by using excess factors. Each wavelength or spectral region is modeled utilizing its own number of factors independently of other wavelengths or spectral regions. An iterative combinative PCR algorithm allows a different number of factors to be applied to different wavelengths. In an exemplary embodiment, a three-factor model is applied over a given spectral region. The residual of the three-factor model is calculated and used as the input for an additional five-factor model. Prior to the additional five factors being applied, some of the wavelengths are removed. This leads to a three-factor model over the first region and an eight-factor model over the second region.

Abstract: Spectrometer instruments are characterized by classifying their spectra into previously defined clusters. The spectra are mapped to the clusters and a classification is made based on similarity of extracted spectral features to one of the previously defined clusters. Calibration models for each cluster are provided to compensate for instrumental variation. Calibration models are provided either by transferring a master calibration to slave calibrations or by calculating a separate calibration for each cluster. A simplified method of calibration transfer maps clusters to each other, so that a calibration transferred between clusters models only the difference between the two clusters, substantially reducing the complexity of the model.

Abstract: A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

Abstract: A magnetic field based mechanical apparatus is disclosed. The apparatus is based on coupled attracting or opposing magnets in conjunction with the insertion or removal of a magnetic field modifier. In the preferred embodiment, two repelling magnets are drawn together with the insertion of a magnetic field modifier. The field modifier may be another magnet having an opposing pole. Removal of the field modifier returns the forces to their original states. This oscillating motion may be driven with a low energy and/or small power supply. The resulting motion of the opposing magnets can drive mechanical system such as a linear, gear, ratchet, or reciprocating drive.

Abstract: Spectrometer instruments are characterized by classifying their spectra into previously defined clusters. The spectra are mapped to the clusters and a classification is made based on similarity of extracted spectral features to one of the previously defined clusters. Calibration models for each cluster are provided to compensate for instrumental variation. Calibration models are provided either by transferring a master calibration to slave calibrations or by calculating a separate calibration for each cluster. In one embodiment, a simplified method of calibration transfer maps clusters to each other, so that a calibration transferred between clusters models only the difference between the two clusters, substantially reducing the complexity of the model.

Abstract: The invention provides a method of determining an individual's glucose metabolism sensitivity based upon the shape of a glucose profile in response to a stimulus, such as a caloric challenge. The sensitivity of an individual may be used to project a glucose response profile or to achieve a targeted response in the individual's blood glucose concentrations in response to a stimulus, such as medication, exercise, or caloric intake. An actual glucose response to a stimulus is determined using parameters that measure the shape of a glucose profile resulting from the stimulus. The glucose response provides rapid feedback of an individual's diabetic state.

Abstract: A ceramic reference in conjunction with a spectrometer, a metallized ceramic material, and a method of utilizing a ceramic material as a reference in the ultraviolet, visible, near-infrared, or infrared spectral regions are presented. The preferred embodiments utilize a ceramic reference material to diffusely reflect incident source light toward a detector element for quantification in a reproducible fashion. Alternative embodiments metallize either the incident surface or back surface of to form a surface diffuse reflectance standard. Optional wavelength reference layers or protective layers may be added to the ceramic or to the metallized layer. The reference ceramic is used to provide a measure of optical signal of an analyzer as a function of the analyzers spatial, temporal, and environmental state.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

Abstract: The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na+, K+and Cl−. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analyte's concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, &mgr;'s and &mgr;a. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.

Abstract: Methods and system for noninvasive determination of tissue analytes utilize tissue properties as reflected in key features of an analytical signal to improve measurement accuracy and precision. Physiological conditions such as changes in water distribution among tissue compartments lead to complex alterations in the measured analytical signal of skin, leading to a biased noninvasive analyte measurement. Changes in the tissue properties are detected by identifying key features in the analytical signal responsive to physiological variations. Conditions not conducive to the noninvasive measurement are detected. Noninvasive measurements that are biased by physiological changes in tissue are compensated. In an alternate embodiment, the analyte is measured indirectly based on natural physiological response of tissue to changes in analyte concentration. A system capable of such measurements is provided.

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.

Abstract: A solution for reducing interference in noninvasive spectroscopic measurements of tissue and blood analytes is provided. By applying a basis set representing various tissue components to a collected sample measurement, measurement interferences resulting from the heterogeneity of tissue, sampling site differences, patient-to-patient variation, physiological variation, and instrumental differences are reduced. Consequently, the transformed sample measurements are more suitable for developing calibrations that are robust with respect to sample-to-sample variation, variation through time, and instrument related differences. In the calibration phase, data associated with a particular tissue sample site is corrected using a selected subset of data within the same data set. This method reduces the complexity of the data and reduces the intra-subject, inter-subject, and inter-instrument variations by removing interference specific to the respective data subset.

Abstract: A non-invasive system for characterizing and classifying the state and structure of a tissue sample operates on a near infrared absorbance spectrum of in vivo tissue. A method that uses near-infrared spectral measurements to characterize and classify the state and structure of tissue sampled based on absorbance features related to fat in adipose tissue is provided. Also provided is a method of estimating skin fold thickness. The approach provides information about sources of tissue variability and is therefore useful for establishing the general category of the tissue structure. Categorization of subjects on the basis of the determination is suitable for further spectral analysis and the measurement of biological and chemical compounds, such as blood analytes. The invention further provides a method of estimating percent body fat based on a skin fold thickness estimate.

Abstract: The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na+, K+ and Cl−. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analyte's concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, &mgr;′s and &mgr;a. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body.

Abstract: A method of screening for disorders of glucose metabolism such as impaired glucose tolerance and diabetes allows prevention, or early detection and treatment of diabetic complications such as cardiovascular disease, retinopathy, and other disorders of the major organs and systems. A mathematical algorithm evaluates the shape of a subject's glucose profile and classifies the profile into one of several predefined clusters, each cluster corresponding either to a normal condition or one of several abnormal conditions. The series of blood glucose values making up the glucose tolerance curve may be measured using any glucose analyzer including: invasive, minimally invasive and noninvasive types. The method is executed on a processing device programmed to perform the steps of the method. Depending on the outcome of the screening, a subject may be provided with additional information concerning their condition and/or counseled to consult further with their health care provider.