Journal of diabetes science and technology
Real-World Evaluation of a Near-Infrared Spectroscopy-based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes
By Amuedo S, Macías ME, Fornés JM and 8 others.
Abstract
Background
Self-monitoring of blood glucose remains widely used in many individuals with type 2 diabetes (T2D), although the burden of capillary testing often limits the frequency of measurements. Noninvasive technologies may improve glucose monitoring. This study evaluated the analytical performance and applicability of a near-infrared spectroscopy-based noninvasive glucose monitoring device.
Methods
In this prospective, open-label clinical investigation, 52 adults with T2D performed 4 daily paired glucose measurements for more than 21 days using the investigational device and a reference capillary glucometer (Ascensia Contour Next). Following individualized calibration (10 paired measurements), post-calibration measurements within the 70 to 400 mg/dL range were included in the primary analysis. Accuracy was assessed using a combined mean absolute difference/mean absolute relative difference (MAD/MARD) metric, Parkes consensus error grid (CEG), and DTS error grid analyses.