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Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C.
Diabetes Care. 2007 May; 30(5):1120-4.DC

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 > 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.

Authors+Show Affiliations

VeraLight, 800 Bradbury SE, Suite 217, Albuquerque, NM 87106, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17337498

Citation

Maynard, John D., et al. "Noninvasive Type 2 Diabetes Screening: Superior Sensitivity to Fasting Plasma Glucose and A1C." Diabetes Care, vol. 30, no. 5, 2007, pp. 1120-4.
Maynard JD, Rohrscheib M, Way JF, et al. Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. Diabetes Care. 2007;30(5):1120-4.
Maynard, J. D., Rohrscheib, M., Way, J. F., Nguyen, C. M., & Ediger, M. N. (2007). Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. Diabetes Care, 30(5), 1120-4.
Maynard JD, et al. Noninvasive Type 2 Diabetes Screening: Superior Sensitivity to Fasting Plasma Glucose and A1C. Diabetes Care. 2007;30(5):1120-4. PubMed PMID: 17337498.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. AU - Maynard,John D, AU - Rohrscheib,Mark, AU - Way,Jeffrey F, AU - Nguyen,Catriona M, AU - Ediger,Marwood N, Y1 - 2007/03/02/ PY - 2007/3/6/pubmed PY - 2007/6/15/medline PY - 2007/3/6/entrez SP - 1120 EP - 4 JF - Diabetes care JO - Diabetes Care VL - 30 IS - 5 N2 - 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 > 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. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/17337498/Noninvasive_type_2_diabetes_screening:_superior_sensitivity_to_fasting_plasma_glucose_and_A1C_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=17337498 DB - PRIME DP - Unbound Medicine ER -