Performance evaluation of a novel non-invasive glucometer, calibrated against validated interstitial glucose references (RSP-08)

Aim of the study

‍Predictive performance assessment of non-invasive glucose monitoring using multiple validated glucose reference methods.

‍

Study description

‍Spectral Raman measurements were collected using the WM3.4NR prototype and paired with validated glucose reference values. Reference sampling included capillary blood, venous blood, microdialysis, and commercially available continuous glucose monitoring (CGM) systems. Ten participants completed two inclinic study visits, each lasting approximately six hours, during which measurements were obtained in both fasting conditions and following oral glucose administration. The study design enabled evaluation of glucoserelated spectral features across multiple reference methods and supported the development and comparison of calibration models for noninvasive glucose measurement.

‍

Conclusions

‍The WM3.4NR prototype proved safe and feasible for noninvasive glucose monitoring. The strongest calibration results were achieved when using microdialysis as the reference, supporting the device’s ability to track glucose changes accurately. (OR)

‍

Concusions 2

‍Using multiple validated reference methods confirmed the device’s ability to track glucose dynamics, with strongest performance observed against high-accuracy interstitial references.

‍

Study registration

For more information, see the study registration on ClinicalTrials.gov (NCT03782649)

‍