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Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
Sponsor: Glyconics Ltd
Summary
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
Official title: A Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01-28
Completion Date
2026-05-30
Last Updated
2026-03-27
Healthy Volunteers
Yes
Conditions
Interventions
Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail
both interventions will be applied in both participant groups
Locations (2)
Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street
Ashton-under-Lyne, England, United Kingdom
Barts Liver Centre
London, United Kingdom