Title: Testing the acceptability of EarLy Surveillance for Autoimmune diabetes: The ELSA Study
Funder: Department of Health and Social Care

Abstract: Research questions Do families in the UK want their children to be tested for risk of type 1 diabetes (T1D) so that those identified at risk can participate in prevention trials? What do professional stakeholders involved in any future testing programme feel are the barriers to implementing the programme? Background T1D is the most common form of diabetes in children accounting for 96% of all diabetes and 30,000 children affected in the UK. Studies have recently identified immunotherapies that safely delay the development of T1D for up least six years. Further therapies are in development that need to be tested. Community-based surveillance programmes in other countries can now accurately identify children at risk of T1D who can be offered participation in prevention studies. The UK does not have such a system in place. PPI members tell us it is important to develop such a system to facilitate testing of new therapies but also to offer them when eventually licensed. Aims and Objectives Our overarching aim is to establish a programme for identifying children at risk of T1D so that they can be offered participation in ongoing trials for T1D prevention. The specific aim of this particular application is to explore whether parents and children in the UK would want to be part of such a programme of testing for T1D risk, how they would want to be informed and participate in such a programme, and how any barriers to recruitment and participation can be addressed. Additionally, the views of health care professionals, school staff and other stakeholders who would be involved in the testing programme will be collected and analysed. Methods We will interview parents and children age 3-13years about their views on testing for T1D risk. We will recruit purposefully to ensure representation across ethnicities and socioeconomic groups. Interviews will be transcribed, analysed and used to inform a series of iterative co-design work with further sets of families to address any issues raised. Similar qualitative work will be undertaken with professional stakeholders who would be involved in implementing any future surveillance programme. Where possible, all aspects of this study will be done remotely by phone/internet to minimise infection risk. Timelines This is a 14-month study. 1-2: study set up/website build 3-8: Interviews and transcription with 30 families 3:8: Interviews with professional stakeholders 5-8: Focus groups with parents and children at school 5-10: Analysis of qualitative interviews 7-12: Co-design work 9-12: Analysis 13-14: Write up Anticipated Impact and Dissemination This study will lay the essential groundwork with public and professional stakeholders to allow the development of a system for identifying and treating children at risk of T1D. The programme is ambitious with nothing comparable in the UK. Results of the study will be disseminated through talks and publications and through our PPI members to people with and without diabetes. We will also disseminate via our co-applicant members of the National Screening committee and Public Health England to explore the potential for developing these findings towards a national screening agenda.

Lay abstract: BACKGROUND Type 1 diabetes (T1D) is the most common form of diabetes in children. Here, the body does not make insulin. Insulin is essential for life and controls blood sugar. Therefore, to stay alive and to avoid the complications of diabetes such as blindness, children must inject insulin daily for the rest of their lives. Studies have recently shown that some medicines can safely delay children getting T1D. Many children and parents tell us that these studies are very exciting. Other countries are developing ways to tell which children in the general population are going to get T1D in the future. These children can then be offered participation in studies to delay T1D. The UK does not have such a system in place. However, very little is known about the views of UK parents and children on the introduction of a T1D testing programme. It is not clear how parents would like to be told about the study, whether they would want their children to be tested, and how they would like to receive any test results if they do. These views are important and need to be included in the design of any future testing programme. AIM We want to explore whether parents and children in the UK want to be tested for risk of T1D, and if so, how they want to be informed and tested. We also want to find out the views of doctors, nurses and school staff who would be involved in the testing programme. DESIGN Over 14-months we will interview parents (with their children if they so wish) about their views on testing for T1D risk. With their permission, we will record all the interviews for analysis. We will talk to a wide range of people, including under-served groups from the population. We will work with them to understand how best to design a testing programme. We will also interview doctors, nurses and school staff who may be involved in doing this study in the future. Where possible, the whole study will be done by phone/internet to minimise infection risk. PATIENT AND PUBLIC INVOLVEMENT We have discussed this study extensively with parents of children with T1D at local hospitals and parent group. Three parents have commented on the study and will continue to work alongside the researchers and advise on this project. All their time and costs will be covered. DISSEMINATION We will publicise the results of the study through research papers and talks to doctors, researchers, and patients. If the results demonstrate that a testing programme is acceptable to parents and children, we will use the project findings to design the most patient-friendly and accessible programme for children at risk of T1D.

Research activity codes: 4.3 INFLUENCES AND IMPACT
Health categories: METABOLIC AND ENDOCRINE