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)
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol) — 10 minutes Acceptance criteria for specificity is to demonstrate a result being at least or above 75%
Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol) — 10 minutes Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%
Trial sites (2)
Facility
City
Region
Status
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.
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