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A Flexible Wearable Glucose Sensor for Noninvasive Diabetes Screening: Functional Equivalence and Model
Wenhan Xie1, Jinqi Wang1, Hao Liu1
1Beijing Key Laboratory of Environment and Aging, Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing 100069, China.
Biosensors
|April 27, 2026
Summary
Wearable noninvasive glucose monitoring (NIGM) shows functional equivalence to capillary measurements in the general population. This technology is feasible for large-scale screening of type 2 diabetes (T2DM) and prediabetes.
Area of Science:
- Biomedical Engineering
- Endocrinology
- Medical Devices
Background:
- Real-world evidence for wearable noninvasive glucose monitoring (NIGM) is limited.
- Accurate glucose monitoring is crucial for managing diabetes and prediabetes.
Purpose of the Study:
- Evaluate the functional equivalence of a wearable NIGM device.
- Assess the utility of NIGM for screening type 2 diabetes (T2DM) and prediabetes.
Main Methods:
- A multicenter study compared a reverse iontophoresis sensor with capillary glucose measurements over 12-hour daytime periods.
- Functional equivalence was assessed, and screening models for T2DM and prediabetes were developed using elastic net and logistic regression.
Main Results:
- Functional equivalence was confirmed in the general population but not in older adults or T2DM patients.
- The noninvasive T2DM screening model showed performance comparable to capillary-based models (AUC: 0.906 vs. 0.850).
- Functional principal component scores aided in prediabetes identification (AUC = 0.760).
Conclusions:
- The wearable NIGM device demonstrated acceptable accuracy and functional equivalence.
- The device is feasible as a wearable tool for large-scale screening of T2DM and early glycemic anomalies in free-living populations.
