Clinical Trials Directory

Trials / Completed

CompletedNCT03530644

Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device

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

Summary

This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.

Detailed description

Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered. Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples will be collected.

Conditions

Interventions

TypeNameDescription
DEVICEWM3.4NRThe investigational medical device will collect spectral Raman data from tissue.
DEVICEP0.1The investigational medical device will collect spectral Raman data from tissue.

Timeline

Start date
2018-08-28
Primary completion
2018-12-14
Completion
2018-12-14
First posted
2018-05-21
Last updated
2018-12-19

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03530644. Inclusion in this directory is not an endorsement.