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

Summary

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

Eligibility

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.

Conditions3

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