Noninvasive Type 2 Diabetes Screening: Superior Sensitivity to Fasting Plasma Glucose and Glycosylated Hemoglobin

Abstract

Objective This study compared the performance of a novel noninvasive technology to the fasting plasma glucose (FPG) and glycosylated hemoglobin (A1c) tests for detecting undiagnosed diabetes and impaired glucose tolerance (IGT).

Research Design and Methods The design was a head-to-head evaluation in a naïve population. Consented subjects received FPG, A1c and oral glucose tolerance (OGTT) tests. Subjects were also measured by a noninvasive device that detects the fluorescence of skin advanced glycation endproducts. A total of 351 subjects participated.

Results Subjects with 2-hour OGTT values equal to or exceeding 140 mg/dL defined the positive screening class. A total of 84 subjects (23.9% prevalence) screened as positive. The performances of the noninvasive device, FPG and A1c were evaluated for sensitivity and specificity against this classification. At the IFG threshold (FPG = 100 mg/dL), the FPG sensitivity was 58% and the specificity was 77.4%. At that same specificity, the sensitivity for A1c was 63.8%, while the noninvasive 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. 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 and 17.1% more than A1c. The combination of higher sensitivity and greater convenience -- rapid results with no fasting or blood draws - make the device well-suited for opportunistic screening.