Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes (ANODE04)

Glyconics

Status: Not yet enrolling

Conditions: Healthy; Diabetes Mellitus

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07039357

NIRDM-SXCIP04

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Apparently healthy volunteers without known diabetes

Experimental group

Description:

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

Treatment:

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

People with known T2DM

Experimental group

Description:

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

Treatment:

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