Trials / Completed
CompletedNCT04126759
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- RSP Systems A/S · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | P0.3 | Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2020-01-31
- Completion
- 2020-01-31
- First posted
- 2019-10-15
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04126759. Inclusion in this directory is not an endorsement.