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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07039357

Acronym

ANODE04

Enrollment

100

Registered

2025-06-26

Start date

2026-01-28

Completion date

2026-09-30

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Healthy

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

Interventions

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

both interventions will be applied in both participant groups

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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%

Secondary

Measure	Time frame	Description
Secondary performance measure and accuracy: False positive / negative rates for the screening test result	10 minutes	Assessment of sensitivity and specificity -derived false positive / false negative rates in % for chemometric model outcomes for HbA1c cut-off value of 48 mmol/mol (6.5%) in the study cohort n=100, in individuals with and without known T2DM.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026