Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT07039357
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07039357
Study Brief:
Protocol Section:
NCT07039357