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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT05198895
Eligibility Criteria:
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
* 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
* Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05198895
Study Brief:
Protocol Section:
NCT05198895