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

EDENT 1FI是一个独特而及时的项目，为整个欧洲的儿童/青少年进行1型糖尿病（T1 D）筛查建立并运营一个开放平台。这一案例令人信服：T1 D是一种常见的慢性疾病，每300名儿童或青少年中就有1人患病。几十年的欧洲研究已经标志着T1 D发展的逐步性质，并产生了早期诊断，监测和疾病修改的工具。EDENT 1FI现在将欧洲定位为T1 D早期拦截的领导者。我们的目标是在早期、临床前阶段识别个体，显著降低T1 D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T1 D。受我们在欧洲儿童筛查活动模型和GPPAD和INNODIA临床网络中合作成功的鼓舞，EDENT 1FI将：建立协调的胰岛自身抗体监测计划，以筛查欧洲各地的200，000名儿童/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、医学和经济影响;使用最先进的代谢传感器和生物标志物，以优化早期阶段的监测时间表（临床前）T1 D与最大限度地提高依从性和确定疾病进展分层相一致;设计SMART试验，以加快疾病调节治疗的评价;并告知和教育公众、医疗保健专业人员和监管机构T1 D诊断和护理的新范例。为了实现这一目标，EDENT 1FI汇集了筛查、临床护理、生物标志物、机器学习、人口外展、伦理、法规事务和政策方面的学术、临床和行业专业知识，以加速欧洲常规医疗保健中基于证据的早期T1 D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 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.