EDENT1FI: European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception

EDENT1FI是一个独特而及时的项目，为整个欧洲儿童/青少年1型糖尿病（T1D）的一般人群筛查建立和运营一个开放平台。这个案例是令人信服的：T1D是一种常见的慢性疾病，每300名儿童或青少年中就有1000人患病。欧洲几十年的研究表明了T1D发展的阶梯式本质，并产生了早期诊断、监测和疾病改造的工具。EDENT1FI现在将欧洲定位为t1d早期拦截的领导者。我们的目标是识别早期临床前阶段的个体，显著降低T1D诊断的临床严重程度，并提供疾病修饰疗法干预的机会，以延迟或预防临床T1D。受我们在GPPAD和INNODIA范例欧洲儿童筛查活动和临床网络成功合作的推动，edent1fi将：建立统一的胰岛自身抗体监测计划，筛查整个欧洲的20万儿童/青少年；评估筛查在不同欧洲卫生系统/人群（包括服务不足的家庭）中的社会心理、医疗和经济影响；使用最先进的代谢传感器和生物标志物来优化早期（临床前）t11的监测时间表，以最大限度地提高依从性并确定疾病进展阶段；设计SMART试验以加快对疾病改善疗法的评估；并向公众、医疗保健专业人员和监管机构通报和教育1d诊断和护理的新范式。为了实现这一目标，EDENT1FI汇集了筛查、临床护理、生物标志物、机器学习、人口推广、伦理、监管事务和政策方面的学术、临床和行业专业知识，以加速循证早期T1D筛查进入欧洲的常规医疗保健。这些活动的成功将促进其他儿童慢性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 in300 children or adolescents. Decades of European research have signposted the step-wise nature of T1D development and generatedtools for early diagnosis, monitoring and disease modification. EDENT1FI now positions Europe as the leader in early interception ofT1D. Our goals are to identify individuals at earlier, pre-clinical stages, dramatically reducing clinical severity at T1D diagnosis andproviding the opportunity for interventions with disease modifying therapies to delay or prevent clinical T1D. Spurred by the successof our collaborations in model European childhood screening activities and clinical networks in GPPAD and INNODIA, EDENT1FIwill: establish harmonised islet autoantibody surveillance programmes to screen 200,000 children/adolescents across Europe; assessthe psychosocial, medical and economic impact of screening in diverse European health systems/populations including underservedfamilies; use state of the art metabolic sensors and biomarkers to optimise monitoring schedules for early-stage (pre-clinical) T1Daligned to maximising compliance and identifying disease progression strata; design SMART trials to expedite evaluation of diseasemodifying therapies; and inform and educate the public, healthcare professionals, and regulatory authorities of the new paradigms inT1D 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 screeninginto regular healthcare in Europe. The success of these activities will promote early diagnosis and prevention pathways for other chronicchildhood diseases.