Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: Performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy☆
Section snippets
Background
Type 2 diabetes mellitus is a debilitating chronic disease and an acknowledged global health crisis that is growing at alarming rates. Persons with diabetes are at increased risk for complications that can result in reduced quality of life, lost productivity and premature death, placing a significant burden on the health care systems of the world. In addition, the International Diabetes Federation estimated that worldwide, half of the cases of diabetes are actually undiagnosed [1], [2].
If the
Objectives
The Greece trial was a cross-sectional, two center performance comparison of noninvasive and invasive diabetes screening methods in individuals at-risk for type 2 diabetes (clinialtrials.gov, NCT 01572415). The performance of SFS, the ADA diabetes risk test (DRT) [21] and RCG were compared for detection of increasing levels of A1C-defined dysglycemia or type 2 diabetes. A single A1C measurement served as the reference method and was used to define two levels of dysglycemia, ≥5.7% (39 mmol/mol)
Data accounting
A total of 409 subjects enrolled with 209 participating at the Laiko clinic and 200 at the IKA clinic. Of the enrolled subjects, 398 had complete sets of valid SFS, RCG and A1C measurements. Of the 11 cases of incomplete or invalid data, 7 were invalid due to mismatches (>5 years) in the subject age recorded on the case report form versus the age entered into the SFS device, 1 was due to a missing RCG measurement, 1 was due to a missing A1C measurement and 2 were due to missing SFS
Discussion
While A1C is well established as a management tool for patients with known diabetes, its use as a diagnostic tool is fairly recent. In 2010, the American Diabetes Association incorporated A1C into its clinical practice guidelines for diagnosis of type 2 diabetes and identification of persons with increased risk for developing type 2 diabetes [25]. A similar set of recommendations were developed by an International Expert Committee (IEC) [26] and the World Health Organization (WHO) now
Conflict of interest
NT, SL and PL received research support for the costs of conducting the clinical study but otherwise have no competing financial interests. KT and JDM are employees of VeraLight, Inc., the manufacturer of Scout DS.
Contributions
NT, PL and JDM conceived and designed the study. JDM wrote the manuscript and analyzed data. NT, PL, SL and KT collected the data, reviewed the data analysis and reviewed/edited the manuscript.
Acknowledgement
This work was supported by a research grant from VeraLight, Inc.
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ClinialTrials.gov: NCT01572415.