NCT06261944

A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package

A Pivotal Multi-centre, Open-label, Two-part Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Results

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Glyconics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.

Conditions

• Pre-diabetes
• Undiagnosed Diseases

Interventions

Type	Name	Description
DEVICE	Near-infrared (NIR)	Near-infrared assessment of glycated keratin in middle fingernail

Timeline

• Start date: 2024-03-13
• Primary completion: 2024-05-21
• Completion: 2024-08-08
• First posted: 2024-02-15
• Last updated: 2024-05-24

Locations

1 site across 1 country: Spain