← Back to all trials
Active Not Recruiting
NCT07039357
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
Conditions: Diabetes Mellitus, Healthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: Glyconics Ltd
Location: Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street Ashton-under-Lyne England
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 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.
Source: ClinicalTrials.gov (NCT07039357). StuddyBuddy aggregates publicly available trial information.