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