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 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.
Xie et al. (Fri,) studied this question.