Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C.
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.


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 > or = 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.
Maynard
John D
JD
VeraLight, 800 Bradbury SE, Suite 217, Albuquerque, NM 87106, USA.
Rohrscheib
Mark
M
Way
Jeffrey F
JF
Nguyen
Catriona M
CM
Ediger
Marwood N
MN
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000175:diagnosis* / Q000453:epidemiology; D005006:Ethnicity; D005260:Female; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000032:analysis*; D017127:Glycation End Products, Advanced / Q000032:analysis; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D044469:Racial Groups; D012680:Sensitivity and Specificity; D014481:United States / Q000453:epidemiology
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D017127:Glycation End Products, Advanced