Trials / Completed
CompletedNCT04033042
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- RSP Systems A/S · Industry
- Sex
- All
- Age
- 18 Months
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models and to evaluate the instructions for use for the device. This study will be an explorative study with 10 study subjects.
Detailed description
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Prototype 0.5 | Subjects will perform daily measurements on the IMD (Prototype 0.5) for 41 days. |
Timeline
- Start date
- 2019-09-18
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2019-07-25
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04033042. Inclusion in this directory is not an endorsement.