Trials / Completed
CompletedNCT05476016
Safety and Performance of the Glyconics-SX System (ANODE02)
A Single-Centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Glyconics Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with a validated comparator device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Near-infrared (NIR) | NIR spectral assessment of glycated nail keratin vs HbA1c |
Timeline
- Start date
- 2022-08-29
- Primary completion
- 2022-11-30
- Completion
- 2022-12-08
- First posted
- 2022-07-27
- Last updated
- 2022-12-16
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05476016. Inclusion in this directory is not an endorsement.