Clinical Performance Evaluation of Type 1 Diabetes (T1D) SNP Array
Research type
Research Study
Full title
Clinical Performance Evaluation of Type 1 Diabetes (T1D) SNP Array (EV4489A/B)
IRAS ID
357706
Contact name
Kristopher Pentland
Contact email
Sponsor organisation
Randox Laboratories Limited
Duration of Study in the UK
0 years, 0 months, 10 days
Research summary
There are several forms of diabetes including Type 1 Diabetes and Type 2 Diabetes. It is not always easy for a doctor to be certain what type of diabetes a person has. It is important that the correct type is confirmed as the patient treatment and care pathways are very different. This observational study, sponsored by Randox Laboratories Ltd, aims to evaluate the performance of a test which provides a genetic risk profile for Type 1 Diabetes. The genetic component of Type 1 Diabetes is well known and remains unchanged throughout life offering a means to identify individuals who are at a higher genetic risk for this condition helping with disease identification before symptoms arise and improving patient care, treatment and potential outcomes. The study will involve testing leftover pre-characterised clinical samples originating from NIHR Exeter Clinical Research Facility including non-diabetics, individuals with early onset Type 1 Diabetes, adult-onset Type 1 Diabetes or Type 2 Diabetes. All samples have fully informed consent for research use. The study will be conducted within Randox Clinical Laboratory Services (RCLS), a UKAS ISO 15189 accredited laboratory and will be completed within 10 working days. Study outcomes will show discrimination between Type Diabetes and non-diabetes or Type 2 Diabetes as per the intended use of the test.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0091
Date of REC Opinion
27 May 2025
REC opinion
Favourable Opinion