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

NCT06261944 | Active Not Recruiting

• 1 other identifier: NIRDM-SXCIP03
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-diabetes; Undiagnosed Diseases

Outcome Measures

Primary Outcomes (1)

• Dichotomised diabetes risk status

  YELLOW: HbA1c value \< 48 mmol/mol OR ORANGE: HbA1c value \>= 48 mmol/mol.

  10 seconds

Secondary Outcomes (1)

• Sensitivity and specificity

  10 seconds

Study Arms (1)

All participants

OTHER

All individuals will be screened for their diabetes risk / status (if previously undiagnosed)

Device: Near-infrared (NIR)

Interventions

Near-infrared (NIR) DEVICE

Near-infrared assessment of glycated keratin in middle fingernail

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Glyconics Ltd: lead

Study Sites (1)

Sant Pau Hospital

Barcelona, Spain

Location

MeSH Terms

Conditions

Glucose Intolerance; Undiagnosed Diseases

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Didac Mauricio, MD, PhD

  Sant Pau Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Mass-screening

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: March 13, 2024
• Primary Completion: May 21, 2024
• Study Completion: August 8, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

ES (1)