Performance study of a non-invasive glucose monitoring device prototype (RSP-13)

Aim of the study

‍Predictive performance assessment for real-life, home-based non-invasive glucose monitoring using the P0.1 prototype.

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Study description

‍This home-based clinical study combined intensive short-term measurements with longer-term real-life monitoring. The protocol consisted of two parts.

In Part A, participants performed frequent measurements over five days, with spectral Raman data collected every 15 minutes during 10-hour periods and paired with flash glucose monitoring and capillary blood glucose reference values.

In Part B, participants continued measurements in their own homes over 30 days, performing four daily measurement sessions in which optical Raman data were paired with capillary blood glucose values while maintaining usual diabetes management routines.

Conclusions

‍The P0.1 prototype demonstrated the ability to capture glucose-related signals during everyday home use, supporting the development of real-life predictive models.

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT03519841).

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