Comparative study between two models of a non-invasive glucose monitoring device (RSP-14)

Aim of the study

Comparative performance assessment of two non-invasive glucose monitoring prototypes (WM3.4NR and P0.1) during controlled glucose excursions.  

Study description

This in-clinic study included two visits per participant. At each visit, participants arrived fasting and received an oral glucose bolus to induce glucose excursions. During each study day, optical measurements were performed using two non-invasive device prototypes. Spectral Raman data were collected at regular intervals and paired with flash glucose monitoring, capillary blood glucose, and arterialized venous blood glucose reference measurements. Each visit lasted approximately 7–8 hours, with measurements every eight minutes.

Conclusions

The newer P0.1 prototype outperformed the earlier WM3.4NR model, confirming clear technological progress between device generations.

Study registration

For more information, see the study registration on ClinicalTrials.gov (NCT03530644).

About the study

Study period: September 2018 to November 2019

Prototype ID: WM3.4NR and P0.1  

Comparator: FreeStyle Libre (CGM)  

Site: Steno Diabetes Center Odense, Denmark  

No of participants: 3

Profile of participants: Adults with diabetes type 1