🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07039357
Active, not recruiting

Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes

NCT07039357 · tracked via the Priya Life Science UK tracker
Sponsor
Glyconics Ltd
Phase
N/A
Started
2026-01-28
Last updated
2026-09-15

Condition(s) studied

Diabetes MellitusHealthy

Investigational drug(s) / intervention(s)

Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail

Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail: both interventions will be applied in both participant groups

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: * Apparently healthy adults (≥18 years of age) with known (n=50) or unknown T2DM status (n=50) willing to participate in and provide a written consent for the study * willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test * Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail Exclusion Criteria: * Individuals with any known medical conditions impacting the PoC device assessment methodology for glycaemia, such as * Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar) * haemoglobinopathies or atypical haemoglobin subtypes not detectable by the assay * severe renal impairment (CKD stage III-IV) or decompensated hepatic disease * severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 \< 25 nmol/ml) * known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia * eating disorders (as per clinical assessment) * recent (within 28 days) blood donation * known / diagnosed other diabetes such as T1DM, GDM, MODY, etc. * For the Glyconics-DS device / targeted nail: * Mechanical damage or marks on the surface of the nail after removal of nail polish, or * Use of acrylic or gel nail decoration and polish, which cannot be removed.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street Ashton-under-Lyne England
Barts Liver Centre London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039357 on ClinicalTrials.gov ↗ ← All trials in the UK