| NCT ID | NCT07125365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2025-07-11 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Rachel Besser
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT07125365 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 70 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07125365 currently recruiting?
Yes, NCT07125365 is actively recruiting participants. Contact the research team at ukiab@ndm.ox.ac.uk for enrollment information.
Where is the NCT07125365 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07125365 clinical trial?
NCT07125365 is sponsored by University of Oxford. The principal investigator is Rachel Besser at University of Oxford. The trial plans to enroll 350 participants.
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