An explorative study of a novel noninvasive glucose monitoring device (RSP-19)

Aim of the study

Calibration model performance assessment for the P0.5 prototype, with focus on the impact of laser polarization on device performance.

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Study description

Ten participants used the P0.5 prototype during 40 homebased measurement days, completing six sessions per day while following their normal routines. They also attended two inclinic study days with controlled glucose excursions, where measurements were taken frequently to assess performance under rapid glucose changes. The study also compared two laser output configurations to understand whether polarization affected device performance.

Conclusions

‍Strong calibration performance was achieved using home-based data, and device accuracy was shown to be largely independent of laser polarization state.

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT03782441).

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