Clinical Trials Directory

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UnknownNCT04021251

Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

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

Summary

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects

Detailed description

Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Conditions

Interventions

TypeNameDescription
DEVICEP0.2Investigational Medical Device collecting spectral raman data from tissue.

Timeline

Start date
2018-12-20
Primary completion
2021-08-01
Completion
2021-08-01
First posted
2019-07-16
Last updated
2020-08-17

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04021251. Inclusion in this directory is not an endorsement.