An explorative study of a novel noninvasive glucose measuring device in outpatient settings (RSP-24)

Aim of the study

Calibration requirements and long-term calibration stability for the P0.5 prototype, with evaluation of performance, safety, and selected hardware configurations during extended use.

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Study description

Participants used the P0.5 prototype across several outpatient subprotocols designed to evaluate calibration needs, longterm stability, and hardware robustness. Depending on the subprotocol, participants completed between 41 and 150 homebased measurement days, with multiple calibration sessions per day. Additional substudies compared two image sensors and assessed performance under different spectrometer slit widths. All measurements were paired with validated capillary glucose references.

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Conclusions

‍The study demonstrated that the P0.5 prototype is safe, userfriendly, and suitable for calibration in everyday use. It identified reduced calibration requirements while maintaining long-term performance stability and confirmed robust performance across key hardware configurations.

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Related peer-reviewed publication

‍Pors A, Rasmussen KG, Inglev R, Jendrike N, Philipps A, Ranjan AG, Vestergaard V, Henriksen JE, Nørgaard K, Freckmann G, Hepp KD, Gerstenberg MC, Weber A. Accurate Post-Calibration Predictions for Noninvasive Glucose Measurements in People Using Confocal Raman Spectroscopy. ACS Sens. 2023 Mar 24;8(3):1272-1279. Doi: https://pubs.acs.org/doi/10.1021/acssensors.2c02756  

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Study registration‍

For more information, see the study registration on ClinicalTrials.gov (NCT04518813).

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