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Noninvasive Type 2 Diabetes Screening

Superior sensitivity to fasting plasma glucose and A1C

¹ VeraLight, Albuquerque, New Mexico
² University of New Mexico School of Medicine, Albuquerque, New Mexico
³ InLight Solutions, Albuquerque, New Mexico

Address correspondence and reprint requests to M.N. Ediger, VeraLight, 800 Bradbury SE, Suite 217, Albuquerque, NM 87106. E-mail: woody.ediger{at}veralight.com

OBJECTIVE—This study compared the performance of a novel noninvasive technology to fasting plasma glucose (FPG) and A1C tests for detecting undiagnosed diabetes and impaired glucose tolerance.

RESEARCH DESIGN AND METHODS—The design was a head-to-head evaluation in a naïve population. Consented subjects received FPG and A1C tests and an oral glucose tolerance test (OGTT). Subjects were also measured by a noninvasive device that detects the fluorescence of skin advanced glycation end products. A total of 351 subjects participated.

RESULTS—Subjects with 2-h OGTT values 140 mg/dl defined the positive screening class. A total of 84 subjects (23.9% prevalence) screened positive. The performances of the noninvasive device, FPG, and A1C were evaluated for sensitivity and specificity against this classification. At the impaired fasting glucose threshold (FPG =100 mg/dl), the FPG testing sensitivity was 58% and the specificity was 77.4%. At that same specificity, the sensitivity for A1C testing was 63.8%, while the noninvasive testing sensitivity was 74.7%. The sensitivity advantage of the noninvasive device over both blood tests for detecting diabetes and precursors was statistically significant (P < 0.05).

CONCLUSIONS—The noninvasive technology showed clinical performance advantages over both FPG and A1C testing. The sensitivity differential indicated that the noninvasive device is capable of identifying 28.8% more individuals in the OGTT-defined positive screening class than FPG testing and 17.1% more than A1C testing. The combination of higher sensitivity and greater convenience—rapid results with no fasting or blood draws—makes the device well suited for opportunistic screening.

Abbreviations: AGE, advanced glycation end product • AUC, area under the curve • EER, equal error rate • FPG, fasting plasma glucose • IFG, impaired fasting glucose • IGT, impaired glucose tolerance • OGTT, oral glucose tolerance test • PCA, principal-components analysis • ROC, receiver-operator characteristic • SAGE, Spectroscopic measurement of dermal AGE

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