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

a glucose analyzer and alternative site technology, applied in the field of calibration and maintenance of glucose analyzers, can solve the problems of inability to accurately calibrate the device, affecting the accuracy of the calibration, and introducing errors into the noninvasive analyzer that are associated with sampling the reference glucose concentration, so as to achieve the effect of negative effect on accuracy and precision and indirect calibration

Inactive Publication Date: 2005-09-15
MONFRE STEPHEN L +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0061] The invention provides a method and apparatus for using either alternative invasive glucose determinations or alternative site noninvasive glucose determinations to calibrate noninvasive or implantable glucose analyzers. Use of an alternative invasive or alternative site noninvasive glucose determination in the calibration allows for minimization of errors built into the glucose analyzer model, including errors due to sampling, methodology, and errors due to temporal and spatial variations of glucose concentration within the subject's body. In addition, the invention provides conversion of glucose concentrations determined from noninvasive or alternative reference determinations into traditional invasive glucose determinations. As described herein, the use of an alternative invasive or noninvasive glucose determination for calibration is also understood to include their use for glucose determination, prediction, calibration transfer, calibration maintenance, quality control, and quality assurance.

Problems solved by technology

Meters with increased percentage error such as 10 percent may also be acceptable, though the error of the device being calibrated may increase.
Calibration of a noninvasive glucose analyzer entails some complications not observed in traditional invasive glucose analyzers.
This approach, however, introduces errors into the noninvasive analyzer that are associated with sampling the reference glucose concentration.
One key source of error is the difference between glucose concentrations at the site tested by the noninvasive glucose analyzer and the reference site sampled with an invasive technology.

Method used

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

Examples

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example 1

[0082] In a first example, variation of glucose concentration at locations in the body is demonstrated at fixed points in time. A total of twenty diabetic subjects were run through one of two glucose profiles each having two peaks so that the resulting curves formed the shape of an ‘M,’ shown in part in FIG. 1, over a period of eight hours. Thus, glucose concentration started low at around 80 mg / dL, was increased to approximately 350 mg / dL, and was brought back to about 80 mg / dL in a period of about four hours. The cycle was immediately repeated to form an ‘M’-shaped glucose concentration profile. These profiles were alternately generated with intake of a liquid form of carbohydrate (50-100 g) or intake of a solid form of carbohydrate (50-100 g) in combination with insulin to generate the two excursions of the ‘M’ profile. Traditional invasive fingertip capillary glucose concentrations were determined every 15 minutes throughout the 8-hour period. Each fingertip determination was im...

example

[0142] A single calibration model was applied to 4,980 noninvasive spectra collected from the volar aspect of the forearm of twenty-six subjects covering 233 unique visits utilizing nine instruments collected over a period of eight months. Each subject was tested every fifteen minutes for a period of approximately eight hours. The resulting glucose predictions were compared to both traditional invasive reference fingertip and alternative invasive reference forearm glucose concentrations.

[0143] A concentration correlation plot of the predicted glucose concentrations versus the forearm reference glucose concentrations is presented in FIG. 8. A Clarke error grid analysis for this data demonstrates that 81.9 and 17.9 percent of the data falls into the A and B region, respectively. Thus, 99.8 percent of the data are predicted clinically accurately versus the alternative invasive reference forearm glucose concentrations. However, as shown in FIG. 9, accuracy diminishes when plotted again...

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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. 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.

Description

CROSS REFERENCE TO RELATED APPLICATION [0001] This Application is a divisional application of U.S. patent application Ser. No. 10 / 377,916, filed Feb. 28, 2003, which claims benefit of U.S. provisional patent application Ser. No. 60 / 362,899, filed Mar. 8, 2002 and U.S. provisional patent application Ser. No. 60 / 362,885, filed Mar. 8, 2002, each of which is incorporated herein in its entirety by this reference thereto.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention relates generally to the calibration and maintenance of glucose analyzers. More particularly, the invention relates to the use of alternative site glucose determinations to improve algorithm development, calibration, and / or quality control of noninvasive or implantable glucose analyzers. [0004] 2. Background Information [0005] Diabetes is a chronic disease that results in improper production and utilization of insulin, a hormone that facilitates glucose uptake into cells. While a precise ca...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B5/00A61B5/1455A61B5/145A61B5/1495G01N21/27G01N21/35G01N21/49
CPCA61B5/14532A61B5/1455G01N21/49G01N21/274G01N21/359A61B5/1495
Inventor MONFRE, STEPHEN L.HAZEN, KEVIN H.RUCHTI, TIMOTHY L.BLANK, THOMAS B.HENDERSON, JAMES R.
Owner MONFRE STEPHEN L
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