EDENT1FI: European action for the Diagnosis of Early Non-symptomatic Type 1 diabetes For Intervention

EDENT1FI是一个独特和及时的项目，它建立并运行了一个开放平台，用于在整个欧洲范围内对儿童/青少年进行1型糖尿病(T1D)的一般人群筛查。这个案例令人信服：T1D是一种常见的慢性疾病，在300名儿童或青少年中有1人受到影响。数十年的欧洲研究表明，T1D的发展是循序渐进的，并产生了早期诊断、监测和疾病修改的工具。EDENT1FI现在将欧洲定位为早期拦截T1D的领导者。我们的目标是在更早的临床前阶段识别个体，极大地降低T1D诊断的临床严重性，并提供通过疾病修改疗法进行干预的机会，以延迟或预防临床T1D。受我们在模拟欧洲儿童筛查活动以及GPPAD和INNODIA临床网络方面的成功合作的鼓舞，EDENT1FI将：建立统一的胰岛自身抗体监测计划，对欧洲各地200,000名儿童/青少年进行筛查；评估在欧洲不同卫生系统/人群(包括服务不足的家庭)进行筛查的心理、医疗和经济影响；使用最先进的代谢传感器和生物标记物来优化早期(临床前)T1D的监测计划，以最大限度地遵守规定并确定疾病进展层次；设计智能试验以加快对疾病修改疗法的评估；以及向公众、医疗专业人员和监管当局通报和教育T1D诊断和护理方面的新范式。为了实现这一目标，EDENT1FI汇集了筛查、临床护理、生物标记物、机器学习、人口拓展、伦理、监管事务和政策方面的学术、临床和行业专业知识，以加快欧洲常规医疗保健的循证早期T1D筛查。这些活动的成功将促进其他慢性儿童疾病的早期诊断和预防途径。

EDENT1FI is a unique and timely project building and operationalising an open platform for general population screening of children/ adolescents for type 1 diabetes (T1D) throughout Europe. The case is compelling: T1D is a common chronic disease affecting >1 in 300 children or adolescents. Decades of European research have signposted the step-wise nature of T1D development and generated tools for early diagnosis, monitoring and disease modification. EDENT1FI now positions Europe as the leader in early interception of T1D. Our goals are to identify individuals at earlier, pre-clinical stages, dramatically reducing clinical severity at T1D diagnosis and providing the opportunity for interventions with disease modifying therapies to delay or prevent clinical T1D. Spurred by the success of our collaborations in model European childhood screening activities and clinical networks in GPPAD and INNODIA, EDENT1FI will: establish harmonised islet autoantibody surveillance programmes to screen 200,000 children/adolescents across Europe; assess the psychosocial, medical and economic impact of screening in diverse European health systems/populations including underserved families; use state of the art metabolic sensors and biomarkers to optimise monitoring schedules for early-stage (pre-clinical) T1D aligned to maximising compliance and identifying disease progression strata; design SMART trials to expedite evaluation of disease modifying therapies; and inform and educate the public, healthcare professionals, and regulatory authorities of the new paradigms in T1D diagnosis and care. To achieve this, EDENT1FI assembles academic, clinical and industry expertise in screening, clinical care, biomarkers, machine learning, population outreach, ethics, regulatory affairs and policy to accelerate evidence-based early T1D screening into regular healthcare in Europe. The success of these activities will promote early diagnosis and prevention pathways for other chronic childhood diseases.