Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07039357). StuddyBuddy aggregates publicly available trial information.