Development and Pilot Evaluation of a Wearable 12-Lead ECG System for Multilead Feature Analysis in Individuals with...

Type 2 diabetes mellitus and prediabetes often develop silently and may remain undiagnosed for years. This is particularly relevant in regions where laboratory-based screening is not always readily accessible. Against this background, the present work explores whether multilead electrocardiography can provide physiologically meaningful markers potentially associated with disturbances in glucose metabolism. We developed and tested an upgraded wearable 12-lead ECG system capable of synchronized multichannel recording under controlled conditions. ECG signals were acquired in sitting and standing positions, with a sampling frequency of 500 Hz and a recording duration of one minute per posture. The hardware architecture included a high resolution analog front-end and wireless data transmission; the accompanying software provided acquisition control, preprocessing, visualization, and data storage within a unified framework. Signal processing focused on the extraction of rhythm-related and morphological parameters, with particular attention to ventricular repolarization indices. QT interval, heart rate-corrected QT (QTc), and QT dispersion (QTd) were calculated across leads, as these parameters are known to reflect heterogeneity of repolarization and autonomic influences on myocardial electrophysiology. The analysis was structured to ensure reproducible boundary detection and systematic feature formation rather than isolated parameter measurement. The study had a pilot character and included a limited and unbalanced sample (healthy n = 10; prediabetes n = 1; T2DM n = 1). For this reason, the results are presented descriptively and should be regarded as preliminary observations. In representative cases, differences in QT-related indices were noted between categories of glycemic status; however, the potential influence of age, sex, and other confounders cannot be excluded. A pilot expert comparison of T-wave end detection demonstrated close agreement between the automated algorithm and cardiologist assessment (mean ΔTend approximately -1 to -2 ms; MAE 10-24 ms). Diagnostic performance metrics such as ROC/AUC, sensitivity, and specificity were not calculated at this stage, as validation in a larger cohort with biochemical confirmation (HbA1c, OGTT) is required. The study demonstrates the technical feasibility of combining synchronized 12-lead wearable acquisition with structured multilead repolarization analysis. The proposed system should therefore be considered a research platform intended to support further clinical validation and methodological development rather than a finished screening solution.