A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package

Pre-diabetes Clinical Trial

— ANODE03  

Official title:

A Pivotal Multi-centre, Open-label, Two-part Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261944
• Other study ID #: NIRDM-SXCIP03
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: August 8, 2024

Study information

• Verified date: March 2024
• Source: Glyconics Ltd
• Contact: Paivi M Paldanius, MD, PhD
• Phone: +358407667819
• Email: paivi.paldanius[@]glyconics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: August 8, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Apparently healthy adults (=18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study
• Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample)
• Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail.

Exclusion Criteria:

• Individuals with any known medical conditions impacting either of the 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 regular (local) laboratory assays for HbA1c.
• 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
• Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.)
• Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra

measurement, including:

• nail dystrophy or deformity
• severe nail infections (onychomycosis causing visual changes in the appearance of the nail).
• rare hereditable conditions impacting the structure of keratin.
• mechanical damage or marks on the surface of the nail after removal of nail polish.
• use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time)
• Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre-diabetes
• Prediabetic State
• Undiagnosed Diseases

Intervention

Device:
• Near-infrared (NIR)
Near-infrared assessment of glycated keratin in middle fingernail

Locations

Country	Name	City	State
Spain	Sant Pau Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Glyconics Ltd

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichotomised diabetes risk status	YELLOW: HbA1c value < 48 mmol/mol OR ORANGE: HbA1c value >= 48 mmol/mol.	10 seconds
Secondary	Sensitivity and specificity	HbA1c cut-off value of 48 mmol/mol (6.5%) and HbA1c cut-off value of 42 mmol/mol (6.0%)	10 seconds