A Flexible Wearable Glucose Sensor for Noninvasive Diabetes Screening: Functional Equivalence and Model...

Real-world evidence for wearable noninvasive glucose monitoring (NIGM) remains limited. To evaluate the functional equivalence of a wearable NIGM device and explore its utility for T2DM and prediabetes screening. In this multicenter study, 12-h daytime glucose profiles obtained by a flexible reverse iontophoresis-based electrochemical sensor were compared with capillary glucose using functional equivalence. Subgroup analyses were conducted. Screening models of T2DM and prediabetes were developed using elastic net and Logistic regression. A total of 135 participants (mean age 35.3 years; 60.0% female) were included, and no serious device-related adverse events were reported. Compared to the capillary measurements, functional equivalence was confirmed (T = -6.537 < threshold = -2.081) in the general population but not in older adults or T2DM patients. The T2DM noninvasive screening model demonstrated discrimination and reclassification performance comparable to those of the capillary-based model (AUC: 0.906 vs. 0.850, NRI: 0.044, IDI: -0.078, p > 0.05). Functional principal component scores facilitated the identification of prediabetes (AUC = 0.760). The device demonstrated acceptable accuracy and functional equivalence with reference methods. Its capability to detect T2DM and early glycemic anomalies supports its feasibility as a wearable, interpretative adjunct tool for large-scale screening in free-living populations.