Performance characteristics and safety assessment of a non-invasive glucose monitoring device (RSP-12)

Aim of the study

Calibration model performance assessment for the WM3.4NR prototype under short-term, high-frequency measurement conditions.

Study description

Across five outpatient study days, participants completed measurement sessions at 15minute intervals for approximately ten hours per day. Spectral Raman measurements collected with the WM3.4NR prototype were paired with validated glucose reference values to evaluate shortterm calibration model performance under intensive sampling conditions.

Conclusions

Short-term, high-frequency measurements confirmed glucose signal detectability but highlighted the need for longer calibration periods to support long-term prediction.

Study registration

For more information, see the study registration on ClinicalTrials.gov (NCT03352518 ).

About the study

Study period: December 2017 to April 2018

Prototype ID: WM3.4NR (XXX)

Comparator: FreeStyle Libre (CGM); HemoCue 201RT (BGM)  

Site: Department of Endocrinology, Odense University Hospital, Denmark

No of participants: 10

Profile of participants: Adults with all types of diabetes