UK islet autoantibody registry for early Type 1 diabetes
UK Islet Autoantibody Registry
This UK registry collects health and antibody information from people with one or more islet autoantibodies to track who develops Type 1 diabetes and to connect them with monitoring or prevention options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 6 Months to 70 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT07125365 on ClinicalTrials.gov |
What this trial studies
This is an observational registry that enrolls people aged 6 months to 70 years living in the UK who have at least one confirmed islet autoantibody (insulin, GAD, IA-2, or ZnT8). Participants' clinical data and antibody results are recorded and followed over time to document progression between preclinical stages and clinical Type 1 diabetes. The registry links with existing cohort initiatives (such as ADDRESS-2) and includes opportunities for qualitative interviews about living with a positive antibody result. No investigational treatments are given as part of the registry, but the collected data support earlier detection of progression and help identify candidates for future prevention trials.
Who should consider this trial
Good fit: Ideal candidates are UK residents aged 6 months to 70 years with at least one laboratory-confirmed islet autoantibody and who are not currently insulin-dependent.
Not a fit: People who already require ongoing subcutaneous insulin (established clinical Type 1 diabetes), those outside the age range, or those living outside the UK are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could enable earlier identification and monitoring of people at high risk of Type 1 diabetes, reduce emergency presentations like diabetic ketoacidosis, and speed recruitment into prevention studies.
How similar studies have performed: Large longitudinal cohorts have already shown that having two or more islet autoantibodies strongly predicts progression to clinical Type 1 diabetes (over 80% within 15 years), so this registry builds on established predictive findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Ongoing subcutaneous insulin requirement
Where this trial is running
Oxford, Oxfordshire
- University of Oxford — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rachel Besser — University of Oxford
- Study coordinator: UKIAb Registry Manager
- Email: ukiab@ndm.ox.ac.uk
- Phone: +44(0)7765 932065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.