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

NCT ID: NCT07039357

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-28
• Study Completion Date: 2026-05-30

Brief 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

Conditions

Diabetes Mellitus; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Apparently healthy volunteers without known diabetes

Both methods for assessment of glycaemia will be applied in this group as well

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

both interventions will be applied in both participant groups

People with known T2DM

Both methods for assessment of glycaemia will be applied in this group as well

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

both interventions will be applied in both participant groups

Interventions

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

both interventions will be applied in both participant groups

Intervention Type: DEVICE

Other Intervention Names

HbA1c analysis by point-of-care device

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: collaborator

Glyconics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barts Liver Centre

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

William Alazawi (prof)

Role: primary

BHNT.AIRS@nhs.net

+44 0207 767 3205

Other Identifiers

NIRDM-SXCIP04

Identifier Type: -

Identifier Source: org_study_id