Trials / Completed
CompletedNCT03519841
Performance Study of a Non-invasive Glucose Monitoring Device Prototype
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (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
Protocol consists of two parts: Part A) Subjects will collect spectral Raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributed within 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. Part B) Subjects will perform four daily measuring sessions in which optical Raman readings are paired with capillary Blood Glucose comparator. Measuring sessions are performed in subjects' own home while maintaining usual diabetes management routines. Subjects will collect data for 30 days during a 60 days' period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | P0.1 | Investigational Medical Device collecting spectral Raman data from tissue. |
Timeline
- Start date
- 2018-04-13
- Primary completion
- 2018-10-08
- Completion
- 2018-10-08
- First posted
- 2018-05-09
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03519841. Inclusion in this directory is not an endorsement.