UK Islet Autoantibody Registry

NCT07125365 | Recruiting

• 3 other identifiers: PID:18612IRAS Project ID: 347853REC reference: 25/SC/0089
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of individuals enrolled on the registry

  36 months

Secondary Outcomes (15)

• Participants' perspectives and experiences

  28 months

• Participants' perspectives and experiences

  28 months

• Frequency and risk factors (e.g. antibody profile, age) associated with clinical outcomes incident diabetes as defined by start of insulin use and number of DKA episodes

  28 months

• Frequency and risk factors (e.g. antibody profile, age) associated with HbA1c mmol/l

  28 months

• Frequency of attendance in primary care

  36 months

Study Arms (1)

UKIAb

Children and adults aged 6 months - 70 years, positive for ≥ 1 islet autoantibody (IAb)

Eligibility Criteria

• Age: 6 Months - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified via: * Established research platforms e.g. BOX, INNODIA, ADDRESS-2, PoINT, SINTIA, TrialNet, ELSA, T1DRA, (this is not an exhaustive list) * Referral from clinical care * Self-referral

You may qualify if:

• Male or female, aged 6 months - 70 years
• IAb positive (≥ 1) to any of the following: insulin/GAD/IA2/ZnT8, confirmed in a reference laboratory.
• Participant is willing and able to give informed consent for participation in the study (≥ 16 years old), or for \< 16 years, parental/guardian consent (plus assent, where appropriate)
• Living in the UK
• For ADDRESS-2 participants only: have taken part in a blood draw as part of ADDRESS-2
• For the qualitative interviews: Have been living with (or is a parent/guardian of a child who has been living with) a positive IAb result for ≥ 6 months.

You may not qualify if:

• Ongoing subcutaneous insulin requirement

Sponsors & Collaborators

• University of Oxford: lead
• Cardiff University: collaborator
• University of Edinburgh: collaborator
• University of Cambridge: collaborator
• University of Dundee: collaborator
• University of Birmingham: collaborator
• Imperial College London: collaborator
• University of Bristol: collaborator
• King's College London: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• University of Exeter: collaborator

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 7BN, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperglycemia

Study Officials

• Rachel Besser

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UKIAb Registry Manager

CONTACT

+44(0)7765 932065; ukiab@ndm.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 15, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Access to data will not be considered until after the primary publication for the registry has been published
• Access Criteria: Subject to participant consent, data will be shared with other researchers for research projects that have appropriate ethical approval. Requests for access to the data will be controlled by the Data Access Committee.

Locations

GB (1)