Safety and Performance of the Glyconics-SX System (ANODE02)

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

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