Noninvasive Type 2 Diabetes Screening
Superior sensitivity to fasting plasma glucose and A1C
- John D. Maynard, MS1,
- Mark Rohrscheib, MD2,
- Jeffrey F. Way, BS3,
- Catriona M. Nguyen, BSC3 and
- Marwood N. Ediger, PHD1
- 1VeraLight, Albuquerque, New Mexico
- 2University of New Mexico School of Medicine, Albuquerque, New Mexico
- 3InLight 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
Abstract
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.
- 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
Footnotes
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Published ahead of print at http://care.diabetesjournals.org on 2 March 2007. DOI: 10.2337/dc06-2377. Clinical trial reg. no. NCT00358254, clinicaltrials.gov.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
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- Accepted February 10, 2007.
- Received November 20, 2006.
- DIABETES CARE
