Status:
COMPLETED
Safety and Performance of the Glyconics-SX System
Lead Sponsor:
Glyconics Ltd
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05198895
Start Date
August 1 2022
End Date
October 28 2022
Last Update
October 23 2023
Active Locations (1)
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1
Leicester Diabetes Centre
Leicester, United Kingdom