Safety and Performance of the Glyconics-SX System (ANODE01)

Glyconics

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Near-infrared (NIR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05198895

NIRDM-SXCIP01

Details and patient eligibility

About

The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apparently healthy adults (≥18 years of age) with known or unknown T2DM status 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 two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers

Exclusion criteria

• Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as

  • anaemia (iron deficiency sickle cell anaemia or similar)
  • haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
  • severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
  • severe Vitamin D deficiency
  • 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 structural, deviating and visually detectable deviations in the appearance of the nails 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

• Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Open-label, single arm with identical assessment of both biomarkers for all participants

Experimental group

Description:

All participants will have their glycated nail keratin assessed by infrared and blood HbA1c levels measured via an assay (based on finger prick blood drop sample)

Treatment:

Device: Near-infrared (NIR)