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

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Abstract

Background

We examined the accuracy of random capillary glucose (RCG) and two noninvasive screening methods, the ADA diabetes risk test (DRT) and skin fluorescence spectroscopy (SFS) as measured by Scout DS for detecting HbA1c-defined dysglycemia or type 2 diabetes in an at-risk cohort.

Methods

Subjects were recruited at two clinical sites for a single non-fasting visit. Each subject had measurements of height, weight and waist circumference. A diabetes score was calculated from skin fluorescence measured on the left forearm. A finger prick was done to measure RCG and HbA1c (A1C). Health questionnaires were completed for the DRT. Increasing dysglycemia was defined as A1C  5.7% (39 mmol/mol) or ≥6.0% (42 mmol/mol). Type 2 diabetes was defined as A1C  6.5% (47.5 mmol/mol).

Results

398 of 409 subjects had complete data for analysis with means for age, body mass index, and waist of 52 years, 27 kg/m2 and 90 cm. 51% were male. Prevalence of A1C  5.7%, ≥6.0% and ≥6.5% were 54%, 34% and 12%, respectively. Areas under the curve (AUC) for detection of increasing levels dysglycemia or diabetes for RCG were 63%, 66% and 72%, for the ADA DRT the AUCs were 75%, 76% and 81% and for SFS the AUCs were 82%, 84% and 90%, respectively. For each level of dysglycemia or diabetes, the SFS AUC was significantly higher than RCG or the ADA DRT.

Conclusions

The noninvasive skin fluorescence spectroscopy measurement outperformed both RCG and the ADA DRT for detection of A1C-defined dysglycemia or diabetes in an at-risk cohort.

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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