UK Islet Autoantibody Registry

NCT07125365 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-08-15

No results posted yet for this study

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
  • University of Cambridge

    collaborator OTHER
  • University of Dundee

    collaborator OTHER
  • University of Birmingham

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • University of Bristol

    collaborator OTHER
  • King's College London

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125365 on ClinicalTrials.gov