NCT04031300

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RSP Systems A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Detailed description

Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days. The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Prototype 0.5	Investigational Medical Device collecting spectral Raman data non-invasively from tissue

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2019-07-24
• Last updated: 2023-11-21

Locations

6 sites across 4 countries: Denmark, Germany, Sweden, United Kingdom