Actively Recruiting

Age: 6Months - 70Years
All Genders
NCT07125365

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

Age: 6Months - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Oxford

Oxford, Oxfordshire, United Kingdom, OX3 7BN

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here