Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without 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.