UK Islet Autoantibody Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-70
SponsorUniversity of Oxford

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Ongoing subcutaneous insulin requirement

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

350 Participants
are grouped into 1 trial group
Group A: UKIAb

Trial outcomes

Primary outcomes

1

Number of individuals enrolled on the registry

Time frame
36 months

Secondary outcomes

1

Participants' perspectives and experiences

Interviews, to to understand the lived experience of being IAb positive or having a child who is IAb positive.

Time frame
28 months
2

Participants' perspectives and experiences

Interviews, to understand people's information and support needs when living with an IAb result, to improve the information and support given to people and their families who receive a positive T1D IAb result in the future and create a position statement informed by our findings.

Time frame
28 months
3

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

We will undertake data linkage with routinely collected NHS clinical datasets held by NHSE (and the equivalent for the devolved nations)

Time frame
28 months
4

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

To undertake data linkage with routinely collected NHS clinical datasets held by NHSE (and the equivalent for the devolved nations)

Time frame
28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

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