Quinn Lauren M, Dias Renuka P, Greenfield Sheila M, Richter Alex G, Garstang Joanna, Shukla David, Acharjee Animesh, Gkoutos Georgios, Oram Richard, Faustini Sian, Boiko Olga, Litchfield Ian, Boardman Felicity, Zakia Fatima, Burt Christine, Connop Clair, Lepley Amanda, Gardner Christine, Dayan Colin, Barrett Tim, Narendran Parth
Institute of Immunology and Immunotherapy, College of Medicine and Health, University of Birmingham, Birmingham, UK.
Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK.
Diabet Med. 2025 May;42(5):e15490. doi: 10.1111/dme.15490. Epub 2024 Dec 2.
The EarLy Surveillance for Autoimmune (ELSA) study aims to explore the feasibility and acceptability of UK paediatric general population screening for type 1 diabetes.
We aim to screen 20,000 children aged 3-13 years for islet-specific autoantibodies through dried blood spot sample collection at home, hospital or community settings. Children with two or more autoantibodies are offered metabolic staging via oral glucose challenge testing. Feasibility assessments will compare recruitment modalities and uptake according to demographic factors (age, gender, ethnicity, level of deprivation and family history of diabetes) to determine optimal approaches for general population screening. The study is powered to identify 60 children (0.3%) with type 1 diabetes (stage 1-3). Parents are invited to qualitative interviews following ELSA completion (child screened negative or positive, single autoantibody or multiple, stage 1-3) to share their screening experience, strengths of the programme and any areas for improvement (acceptability assessments). Parents who decline screening or withdraw from participation are invited to interview to explore any concerns. Finally, we will interview professional stakeholders delivering the ELSA study to explore barriers and facilitators to implementation.
Early detection of type 1 diabetes allows insulin treatment to be started sooner, avoids diagnosis as an emergency, gives families time to prepare and the opportunity to benefit from future prevention trials and treatments. ELSA will provide essential feasibility and acceptability assessments for UK general population screening to inform a future national screening programme for paediatric type 1 diabetes.
自身免疫早期监测（ELSA）研究旨在探索对英国儿科普通人群进行1型糖尿病筛查的可行性和可接受性。
我们旨在通过在家中、医院或社区环境中采集干血斑样本，对20000名3至13岁的儿童进行胰岛特异性自身抗体筛查。对有两种或更多自身抗体的儿童，通过口服葡萄糖耐量试验进行代谢分期。可行性评估将根据人口统计学因素（年龄、性别、种族、贫困程度和糖尿病家族史）比较招募方式和参与情况，以确定普通人群筛查的最佳方法。该研究有能力识别出60名1型糖尿病患儿（0.3%，1-3期）。ELSA完成后（儿童筛查结果为阴性或阳性、单一自身抗体或多种自身抗体、1-3期），邀请家长参加定性访谈，分享他们的筛查经历、该项目的优点以及任何需要改进的方面（可接受性评估）。邀请拒绝筛查或退出参与的家长参加访谈，以探讨他们的任何担忧。最后，我们将采访参与ELSA研究的专业利益相关者，以探讨实施过程中的障碍和促进因素。
1型糖尿病的早期检测能使胰岛素治疗更早开始，避免作为急症进行诊断，让家庭有时间做好准备，并使他们有机会从未来的预防试验和治疗中受益。ELSA将为英国普通人群筛查提供必要的可行性和可接受性评估，为未来全国性的儿科1型糖尿病筛查项目提供参考。
