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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04031300
Study type Interventional
Source RSP Systems A/S
Contact
Status Withdrawn
Phase N/A
Start date June 1, 2019
Completion date June 1, 2019
View Details
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