UK Islet Autoantibody Registry
NCT07125365 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350
Last updated 2025-08-15
Summary
Type 1 diabetes (T1D) is a life-long condition where the immune system destroys part of the body (the pancreas) which makes the chemical, insulin. Insulin is needed to control blood sugar levels. Treatment involves life-long insulin replacement by injection or insulin pump.
Previous research has shown that the development of T1D occurs through different stages. This starts with a phase where there are no symptoms, which can last months or years, before symptoms of T1D develop and a person becomes unwell. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies (IAb). Children with two or more IAb have an 80-90% chance of developing T1D within 15 years. It is almost certain that they will develop the condition in their lifetime. Children with only one IAb have a much lower risk of developing T1D (around 15%). Less is understood about the natural history of being IAb positive in adults, and the investigators hope this study will help them understand more.
The aim of the research is to understand what it is like to live with being at risk of T1D, what information and support people need, and whether they use NHS services more than others, for example due to being anxious about developing T1D. The investigators will work with the public and patient involvement group using information from the research and, with the charity Diabetes UK, to create a policy statement about the type of care that is needed to support these individuals.
To be able to do this research, tbhe investigators need first to recruit these rare individuals into one single registry of children, young people and adults who have islet autoantibodies in their blood. This will also allow the invetigators to collect data from individuals in the registry to compare this to data from other countries, to help understand why people progress from being islet autoantibody positive to requiring insulin in the UK.
People entering the registry will also be told if a drug is licensed in the UK to help delay T1D onset. Participants can also consent to be contacted about any research studies, which are testing drugs or interventions to prevent or delay the start of T1D.
Conditions
- Type 1 Diabetes (T1D)
- Registry
- Pre-diabetes
- Screening
Sponsors & Collaborators
-
Cardiff University
collaborator OTHER -
University of Edinburgh
collaborator OTHER - collaborator OTHER
-
University of Dundee
collaborator OTHER -
University of Birmingham
collaborator OTHER -
Imperial College London
collaborator OTHER -
University of Bristol
collaborator OTHER - collaborator OTHER
-
Oxford University Hospitals NHS Trust
collaborator OTHER -
University of Exeter
collaborator OTHER -
University of Oxford
lead OTHER
Principal Investigators
-
Rachel Besser · University of Oxford
Eligibility
- Min Age
- 6 Months
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-11
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- United Kingdom
Study Locations
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