Clinical Validation on Healthy Humans of a Portable Non-invasive Continuous Glucose Monitor Based on Transdermal Band-Pass Raman Spectroscopy

基于经皮带通拉曼光谱的便携式无创连续血糖监测仪在健康人体中的临床验证

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Abstract

BACKGROUND: Accurate and painless glucose monitoring remains a major challenge in diabetes management. To address this need, we developed a compact, portable, and non-invasive continuous glucose monitoring (CGM) device based on transdermal band-pass Raman (BPR) spectroscopy intended for benchtop point-of-care use. METHODS: The BPR-CGM optically probes the molecular vibrations of glucose in the interstitial fluid targeting only three ultra-narrow Raman bands to extract glucose concentration trends while compensating for background variations through intra-spectrum referencing. By refraining from collecting redundant full-spectrum information as in standard Raman spectroscopy, our technology overcomes the need for bulky and expensive components while maintaining high sensitivity, making point-of-care non-invasive CGM a reality. RESULTS: A six-participant clinical study compared the non-invasive BPR-CGM with a standard blood glucometer and two commercial needle-based CGMs during a standard oral glucose tolerance test, inducing dynamic postprandial glucose variations. Glucose trends inferred by the BPR-CGM closely matched reference blood glucose values without algorithmic lag compensation. Across participants, the device achieved a mean absolute relative difference of 11.34 ± 1.96%, statistically indistinguishable from needle-based CGM sensors performance (10.42 ± 2.46% and 12.93 ± 4.69%). All BPR-CGM readings fell within clinically acceptable zones A and B of the Parkes (consensus) error grid. No adverse skin reactions were observed following the trial. CONCLUSIONS: These results demonstrate that the BPR-CGM technology can achieve clinical-grade accuracy comparable to invasive systems, paving the way for wearable, needle-free, and miniaturized glucose monitoring solutions.

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