Trials / Completed
CompletedNCT03352518
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- 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 spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WM3.4NR | The investigational medical device will collect spectral raman data from tissue. |
Timeline
- Start date
- 2017-12-28
- Primary completion
- 2018-04-13
- Completion
- 2018-04-17
- First posted
- 2017-11-24
- Last updated
- 2018-10-15
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03352518. Inclusion in this directory is not an endorsement.