Database and calibration of a non-invasive glucose monitoring device (RSP-10)

Aim of the study

‍Long-term calibration stability assessment for non-invasive glucose monitoring using the WM3.4NR prototype during real-life home use.

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Study description

‍Spectral Raman measurements were collected using the WM3.NR prototype and paired with validated glucose reference values during participants’ normal daily routines. In the first part of the study, ten participants completed thirty outpatient days, each consisting of four measurement sessions. In the second part, six participants took part in a sixmonth investigation comprising two months with thirty active outpatient days (four sessions per day), followed by four months with sixty active outpatient days (two sessions per day). This study design enabled evaluation of longterm calibration model performance under reallife conditions and supported assessment of the prototype’s ability to measure interstitial fluid glucose without the need for recalibration over extended periods.

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Conclusions

‍The study demonstrated that calibration performance could remain stable over extended periods of real-life home use without frequent recalibration.

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT03362528 ).

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