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Determination of a Measure of a Glycation End-Product or Disease State Using Tissue Fluorescence of Various Sites

A noninvasive fluorescence spectroscopy method for detecting diabetes and pre-diabetes through skin AGE measurement addresses the inadequacies of current screening methods by enhancing sensitivity and convenience, enabling earlier detection and intervention.

Inactive Publication Date: 2012-07-12
VERALIGHT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The method significantly improves the sensitivity of diabetes detection, identifying approximately 29% more individuals with undiagnosed abnormal glucose tolerance compared to traditional methods, while being more convenient and providing rapid results, facilitating early intervention and prevention of diabetes-related complications.

Problems solved by technology

However, current screening methods for type 2 diabetes and pre-diabetes are inadequate due to their inconvenience and inaccuracy.
FPG also suffers from poor sensitivity (40-60%) contributing to late diagnoses.

Method used

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  • Determination of a Measure of a Glycation End-Product or Disease State Using Tissue Fluorescence of Various Sites
  • Determination of a Measure of a Glycation End-Product or Disease State Using Tissue Fluorescence of Various Sites
  • Determination of a Measure of a Glycation End-Product or Disease State Using Tissue Fluorescence of Various Sites

Examples

Experimental program
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Embodiment Construction

Clinical Study Research Design and Methods

[0057]Embodiments of the present invention have been tested in a large clinical study, conducted to compare SAGE with the fasting plasma glucose (FPG) and glycosylated hemoglobin (A1c), using the 2-hour oral glucose tolerance test (OGTT) to determine truth (i.e., the “gold standard”). The threshold for impaired glucose tolerance (IGT)—a 2-hour OGTT value of 140 mg / dL or greater—delineated the screening threshold for “abnormal glucose tolerance.” A subject was classified as having abnormal glucose tolerance if they screen positive for either IGT (OGTT: 140-199 mg / dL) or type 2 diabetes (OGTT: 200 mg / dL). The abnormal glucose tolerance group encompasses all subjects needing follow-up and diagnostic confirmation. The study was conducted in a naïve population—subjects who have not been previously diagnosed with either type 1 or 2 diabetes.

[0058]In order to demonstrate superior sensitivity at 80% power with 95% confidence, an abnormality in 80 su...

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PUM

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Abstract

Embodiments of the present invention provide an apparatus suitable for determining properties of in vivo tissue. An illumination system communicates light at a plurality of broadband ranges to an optical probe, which can comprise a flexible probe. Light homogenizers and mode scramblers can be employed in some embodiments. The optical probe can physically contact the tissue, or can be maintained separate from the tissue. The optical probe receives light from the illumination system and transmits it to tissue, and receives light diffusely reflected in response to the broadband light, emitted from the in vivo tissue by fluorescence thereof in response to the broadband light, or a combination thereof. The optical probe can communicate the light to a spectrograph which produces a signal representative of the spectral properties of the light. An analysis system determines a property of the in vivo tissue from the spectral properties.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority as a continuation of U.S. application Ser. No. 11 / 675,524, filed Feb. 15, 2007; and to the applications which said Ser. No. 11 / 675,524 claims priority. Said Ser. No. 11 / 675,524 application (1) claims priority to U.S. provisional application 60 / 781,638, filed Mar. 10, 2006; and (2) claims priority as a continuation in part of U.S. application Ser. No. 11 / 350,916, filed Feb. 9, 2006, which application claimed priority to U.S. provisional application 60 / 651,679, filed Feb. 9, 2005; and (3) claims priority as a continuation in part of U.S. application Ser. No. 11 / 624,214, filed Jan. 17, 2007, which application claims priority as a continuation-in-part of U.S. application Ser. No. 11 / 561,380, filed Nov. 17, 2006, which was a continuation of U.S. application Ser. No. 10 / 972,173, filed Oct. 22, 2004, which was a continuation in part of U.S. application Ser. No. 10 / 116,272, filed Apr. 4, 2002, and claimed the ben...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B5/00
CPCA61B5/0071A61B5/1455A61B5/14532
Inventor MAYNARD, JOHN D.EDIGER, MARWOOD NEALJOHNSON, ROBERT D.ROBINSON, M. RIES
Owner VERALIGHT INC
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