Abstract: The invention relates generally to the extraction and/or presentation of glucose concentrations estimated as a function of time into a format that facilitates conveyance of the underlying information. More particularly, glucose concentration histories are presented in terms of risk of behavior, in a video format, and/or in an audio format. The reduction of data into video format, selected by time period, cluster, or glucose concentration response, into an animated or video presentation allows diagnosis and treatment information to be more readily determined and used. Alternatively, glucose concentrations are output through a voice synthesizer or an earcon. These information presentations are useful for both the medical professional and the end user. The information presentation is preferably used with a noninvasive, implantable, semi-continuous, and/or continuous analyte analyzer, such as a glucose concentration analyzer.

Abstract: A method and apparatus for calibrating noninvasive or implantable glucose analyzers uses 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 variations that are built into the calibration model. An additional embodiment 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 invention provides 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: An optical sampling interface system is disclosed that minimizes and compensates for errors that result from sampling variations and measurement site state fluctuations. Embodiments of the invention use a guide that does at least one of, induce the formation of a tissue meniscus, minimize interference due to surface irregularities, control variation in the volume of tissue sampled, use a two-part guide system, use a guide that controls rotation of a sample probe and allows z-axis movement of the probe, use a separate base module and sample module in conjunction with a guide, and use a guide that controls rotation. Optional components include an occlusive element and a coupling fluid.

Abstract: A method and apparatus for calibrating noninvasive or implantable glucose analyzers that uses either alternative invasive glucose determinations or noninvasive glucose determinations to calibrate 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 variations that are built into the calibration model. An additional embodiment 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 invention provides 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 method and apparatus for calibrating noninvasive or implantable glucose analyzers uses 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 variations that are built into the calibration model. An additional embodiment 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 invention provides 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: Sampling is controlled to enhance analyte concentration estimation derived from noninvasive sampling. Means of assuring that the same tissue sample volume is repeatably sampled are presented, thus minimizing sampling errors due to mechanical tissue distortion, specular reflectance, and probe placement. In a first embodiment of the invention, sampling is controlled using automated delivery of a coupling fluid to a region between a tip of a sample probe and a tissue measurement site in a manner requiring minimal user interaction. In a second embodiment of the invention, sampling is controlled by controlling temperature variations, preferably with a coupling fluid, at a region about the tip of a sample probe and a sample site. In a third embodiment, sampling is procedurally controlled via timing and location of coupling fluid delivery to a sample site.

Abstract: The invention relates to the extraction and/or presentation of glucose concentrations estimated as a function of time into a format that facilitates conveyance of the underlying information. More particularly, short term actions, such as exercise, diabetes drug treatment, and/or food intake, are correlated to glucose response profiles. Optionally, glucose concentration responses are back correlated to parameters, such as time, exercise, diabetes drug treatment and/or food intake. The resulting correlated data are output to the user in a time compressed format, in video format, and/or as a cluster allowing diagnosis and treatment information to be more readily determined and used. These information presentations are useful for both the medical professional and the end user. The information presentation is preferably used with a noninvasive, implantable, semi-continuous, and/or continuous analyte analyzer, such as a glucose concentration analyzer.

Abstract: The invention provides for transformation of a section of a data block independently of the transformation of separate or overlapping data blocks to determine a property related to the original matrix, where each of the separate or overlapping data blocks are derived from an original data matrix. The transformation enhances parameters of a first data block over a given region of an axis of the data matrix, such as signal-to-noise, without affecting analysis of a second data block derived from the data matrix. This allows for enhancement of analysis of an analyte property, such as concentration, represented within the original data matrix. In a first embodiment of the invention, a separate decomposition and factor selection for each selected data matrix is performed with subsequent score matrix concatenization. The combined score matrix is used to generate a model that is subsequently used to estimate a property, such as concentration represented in the original data matrix.

Abstract: A near-infrared spectrometer-based analyzer attaches continuously or semi-continuously to a human subject and is used to collect spectral measurements of a tissue sample. The spectral readings are used to estimate a biological parameter in the sampled tissue noninvasively, such as glucose concentration. The preferred apparatus is a near-infrared analyzer that includes a base module and a sample module connected together with a communication bundle. The base module contains the bulk of the analyzer, such as a spectrograph and a central processing unit with an algorithm used for converting the optical signal into a glucose concentration. The sample module is typically in a smaller module that interfaces to a tissue sample. The sample module is preferably handheld and provides minimal sampling distortion due to heat or pressure.

Abstract: A method and apparatus using photo-stimulation to treat or pretreat a sample site prior to analyte concentration determination is presented. More particularly, photo-stimulation at or near at least one sample site is used to enhance perfusion of the sample site leading to reduced errors associated with sampling. Increased perfusion of the sample site leads to increased volume percentages of the target analyte and/or allows the blood or tissue constituent concentrations to more accurately and/or precisely track corresponding sample constituents in more well perfused body compartments or sites such as arteries, veins, or fingertips. In one embodiment, analysis of the photo-stimulated site is used in conjunction with glucose analyzers to determine the analyte concentration with greater ease, accuracy, or precision and may allow determination of the analyte concentration of another non-sampled body part or compartment.

Abstract: A near IR spectrometer-based analyzer attaches continuously or semi-continuously to a human subject and collects spectral measurements for determining a biological parameter in the sampled tissue, such as glucose concentration. The analyzer includes an optical system optimized to target the cutaneous layer of the sampled tissue so that interference from the adipose layer is minimized. The optical system includes at least one optical probe. Spacing between optical paths and detection fibers of each probe and between probes is optimized to minimize sampling of the adipose subcutaneous layer and to maximize collection of light backscattered from the cutaneous layer. Penetration depth is optimized by limiting range of distances between paths and detection fibers. Minimizing sampling of the adipose layer greatly reduces interference contributed by the fat band in the sample spectrum, increasing signal-to-noise ratio.

Abstract: A method and apparatus for easing the use of an optically based noninvasive analyzer is presented. More particularly, a simplified algorithm is used that removes the daily requirement of collecting and using a noninvasive spectrum to update a calibration model. In another embodiment, a guide is used to substantially reduce variation in sample probe placement in relation to a skin tissue sampling site, resulting in the ability to maintain calibration performance with the use of a reference analyte concentration, with or without the use of a reference spectrum collected nearby in time.

Abstract: The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyze is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.