An explorative, nonrandomized, openlabel, inclinic study investigating the performance of a novel noninvasive glucose monitoring device using a new guided calibration method (RSP-26)

Aim of the study

Performance assessment of a guided calibration approach for the P0.5 prototype, using venous and capillary glucose reference values.

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Study description

Participants completed two intensive inclinic study days involving frequent device measurements, taken independently or paired with capillary and venous glucose references. The study evaluated a new guided calibration method and assessed whether a reduced calibration scheme could still deliver strong predictive performance. All participants were enrolled into the venoussampling subprotocol following interim analysis.

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Conclusions

‍A guided calibration approach achieved strong accuracy with substantially fewer calibration measurements, supporting more practical future use.

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Related peer-reviewed publication

‍Pors A, Korzeniowska B, Rasmussen MT, Lorenzen CV, Rasmussen KG, Inglev R, Philipps A, Zschornack E, Freckmann G, Weber A, Hepp KD. Calibration and performance of a Raman-based device for non-invasive glucose monitoring in type 2 diabetes. Sci Rep. 2025 Mar 25;15(1):10226. doi: https://doi.org/10.1038/s41598-025-95334-x  

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Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT05851469).