Actively Recruiting
UK Islet Autoantibody Registry
Led by University of Oxford · Updated on 2025-08-15
350
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
C
Cardiff University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
UK Islet Autoantibody Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 6 months to 70 years
- Positive for one or more islet autoantibodies (insulin, GAD, IA2, ZnT8), confirmed in a reference laboratory
- Willing and able to give informed consent (participants 16 years and older) or parental/guardian consent with assent if under 16
- Living in the UK
- For ADDRESS-2 participants only: have taken part in a blood draw as part of ADDRESS-2
- For qualitative interviews: living with a positive islet autoantibody result for 6 months or more, or parent/guardian of such a child
You will not qualify if you...
- Currently requiring ongoing subcutaneous insulin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7BN
Actively Recruiting
Research Team
U
UKIAb Registry Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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