EZSCAN as a Screening Tool for Prediabetes and Diabetes in a Large Mexican Population

Abstract

Objective: Autonomic neuropathy especially small C-Fibers innervating sweat glands is common in diabetes and occurs in pre-diabetes. EZSCAN, a new and non-invasive device that precisely assesses sudomotor function was evaluated as a screening tool for pre-diabetes and diabetes in a large Mexican population. Methods: The study was performed in Hospital Regional “Lic. Adolfo Lopez Mateos” ISSSTE center. Subjects were classified as pre-diabetic or diabetic according to ADA criteria for fasting plasma glucose (FPG) and HbA1C. EZSCAN test was performed and subjects were classified as no risk, moderate risk or high risk and its performance as a screening tool was assessed through ROC curve analysis. Results: Among the 1414 subjects involved in the study 357 had pre-diabetes and 64 had diabetes according to FPG confirmed by HbA1C for 52 of them. Area under the Curve for EZSCAN to detect pre-diabetes or diabetes using FPG as reference were 0.65 and 0.73 respectively. Using 27 and 34 as threshold values for EZSCAN risk score for detection of pre-diabetes and diabetes sensitivity was 69% and 73%, specificity 56% and 70% and negative predictive value 82% and 98% respectively. The Odds Ratio (OR) for a patient classified as moderate risk with EZSCAN test was 2.06 (1.59-2.67) to have pre-diabetes and 15.8 (3.8-65.5) to have diabetes as compared to a subject with no risk. The OR was 4.32 (2.49-7.50) for pre-diabetes and 18.3 (3.3-102.5) for diabetes for a subject with high risk as compared to a subject with no risk. No adverse events during and after measurement with EZSCAN were reported. Conclusion: EZSCAN allowing quick and quantitative assessment of sudomotor function could be used as an early screening tool for pre-diabetes and diabetes in a large population before performance of more sophisticated and specific, but time-consuming and expensive tests.