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.
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[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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