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.

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

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.