Calibration and performance of a Raman-based device for non-invasive glucose monitoring in type 2 diabetes

Abstract

Abstract Raman spectroscopy has been demonstrated as a viable technique for non-invasive glucose monitoring (NIGM). However, its clinical utility is limited by an extended calibration period lasting several weeks. In this study, we address this limitation by employing a pre-trained calibration model, which is individualized through a brief calibration phase consisting of 10 measurements. The performance of the Raman-based NIGM device was evaluated in a clinical trial involving 50 individuals with type 2 diabetes over a 2-day study period. The protocol included a 4-h calibration phase on the first day, followed by validation phases of 4 h and 8 h on days 1 and 2, respectively. NIGM glucose readings were compared with capillary blood glucose measurements, with glucose fluctuations induced by standardized meal challenges. The numerical and clinical accuracy of the NIGM device was evaluated on 1918 paired points and expressed by mean absolute relative difference of 12.8% (95% CI 12.4, 13.2) and consensus error grid analysis showing 100% of NIGM readings in zones A and B. These results highlight the ability to reliably track blood glucose levels in people with type 2 diabetes. The successful introduction of a practical calibration scheme underlines Raman spectroscopy as a promising technology for NIGM and constitutes an important step towards factory calibration.