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

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.