A preliminary investigation of EZSCAN™ screening for impaired glucose tolerance and diabetes in a patient population.

Abstract

EZSCAN™ is a non-invasive technology that evaluates sweat gland dysfunction using electrochemical skin conductance measurements, providing an opportunity to determine the risk of impaired glucose tolerance (IGT) and diabetes mellitus (DM). This study was conducted with the aims of detecting IGT and DM and investigating the efficacy and cut-off points of the EZSCAN test in a patient population. The traditional serum and plasma glucose tests were used as comparators. In this cross-sectional study, 270 previously undiagnosed patients (180 women and 90 men) with a high risk of glucose metabolism disorders (≥45 years old) were enrolled. All patients underwent an oral glucose tolerance test (OGTT) and hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and EZSCAN tests. Forty (14.8%) patients had newly diagnosed DM (NDM), 79 (29.3%) had IGT and 151 (55.9%) had normal glucose tolerance. The EZSCAN values of these groups were 48±11, 47±11 and 34±13%, respectively. For all patients, the correlation coefficient of EZSCAN was 0.462 with the OGTT (P<0.001), 0.182 with the FPG test (P<0.001) and 0.379 with the HbA1c test (P<0.001). The EZSCAN cut-off point for the detection of IGT was 37% [sensitivity, 82%; specificity, 62%; area under the curve (AUC), 0.778], and the cut-off point for NDM was 50% (sensitivity, 53%; specificity, 59%; AUC, 0.528). This study demonstrated that the non-invasive EZSCAN system is an effective screening tool for the detection of glucose dysfunction in the population tested, and that its performance in detecting previously undiagnosed IGT is superior to its performance in detecting DM.