NCT07039357

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2026May 2026

First Submitted

Initial submission to the registry

June 10, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

June 10, 2025

Last Update Submit

March 26, 2026

Conditions

Diabetes MellitusHealthy

Outcome Measures

Primary Outcomes (2)

  • Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)

    Acceptance criteria for specificity is to demonstrate a result being at least or above 75%

    10 minutes

  • Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)

    Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%

    10 minutes

Secondary Outcomes (1)

  • Secondary performance measure and accuracy: False positive / negative rates for the screening test result

    10 minutes

Other Outcomes (1)

  • Patient reported outcomes: test preference

    2 minutes

Study Arms (2)

Apparently healthy volunteers without known diabetes

EXPERIMENTAL

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

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

People with known T2DM

EXPERIMENTAL

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

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

Interventions

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

both interventions will be applied in both participant groups

Also known as: HbA1c analysis by point-of-care device
Apparently healthy volunteers without known diabetesPeople with known T2DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street

Ashton-under-Lyne, England, OL6 9RW, United Kingdom

Location

Barts Liver Centre

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 26, 2025

Study Start

January 28, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

GB(2)