Trial Status: Open
Type 1 diabetes (T1D) is an autoimmune condition, and one of the most common, chronic conditions of childhood. Three stages of T1D are recognised, with stage 1 and 2 T1D characterised by autoimmunity (presence of two or more diabetes antibodies) where individuals are pre-symptomatic. Stage 3 T1D is the classical symptomatic presentation, when insulin commencement is necessary. Almost all children with two or more T1D antibodies, will develop T1D in their lifetime. Earlier detection of T1D will identify individuals who can be offered novel therapies for T1D prevention and allow insulin treatment to be started sooner, reducing the risk of long-term complications and avoid T1D being diagnosed as an emergency.
We propose to explore the feasibility and acceptability of a system for identifying children in the general population at risk of type 1 diabetes (T1D).
We aim to recruit 20,000 children aged 3-13 years, over a 3 year study period, and will compare the feasibility of different community recruitment strategies including online and social media, general practices, childhood immunisation programmes, and schools.
We will undertake fingerstick antibody testing of 20,000 children aged 3-13years. Children at risk will be further risk stratified with oral glucose challenge testing.
All children testing positive for diabetes antibodies will be invited to an education session with their family, to be informed about the signs and symptoms of T1D, monitoring programmes available for long-term follow-up, and trials their child may be eligible for to delay the onset of T1D.
Mixed-methods qualitative work including distress questionnaires and interviews with parents of children testing positive or negative for antibodies will be performed to assess acceptability.
The ELSA Study is a stand-alone application because we have now designed a screening programme that we are rolling out and recruiting 20,000 children for. This is to test feasibility. This significantly differs from ELSA 1 where we were seeking thoughts and ideas on screening and to identify preferences from 30 families and 20 stakeholders. The ELSA study qualitative work is to gain feedback from participants who have been screened to identify what went well and areas for improvement.
An important consideration for screening relates to the cost-effectiveness. Costs for the study advertising, recruitment, study procedures, staff time, and screening programme interventions will be calculated to e