Mar 16, 2026
100,000 Participants Screened for Early-Stage Type 1 Diabetes in the EDENT1FI Project
The EDENT1FI project (“European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception”), with screening activities led by researchers at Helmholtz Munich, has reached an important milestone toward its goal, having screened 100,000 of the more than 200,000 children and adolescents planned across Europe for early-stage type 1 diabetes, with 7,536 of those in Saxony alone, involving researchers from TU Dresden and the University Hospital Carl Gustav Carus.
Establishing Screening Programs for Early-Stage Type 1 Diabetes Across Europe
Type 1 diabetes is a chronic condition in which the immune system attacks the insulin-producing cells of the pancreas, leading to lifelong dependence on insulin therapy. The autoimmune process that ultimately results in the onset of the disease often begins early in life yet is typically detected only when symptoms appear. When diagnosis and treatment are delayed, this can escalate into a life-threatening medical emergency. A simple blood test can detect type 1 diabetes in its early stages, by identifying islet autoantibodies, thereby revealing the autoimmune activity associated with type 1 diabetes long before symptoms develop. Early detection offers a critical opportunity for monitoring, timely intervention, and improved patient outcomes.
In 2023, EDENT1FI was launched, with the aim of bringing type 1 diabetes screening and monitoring to Europe. Building on the foundation and success of the Fr1da study which pioneered early-stage type 1 diabetes screening in Bavaria, Germany, EDENT1FI has established screening programs in Czechia, Poland, and Portugal and has strengthened existing initiatives in Germany, Italy, the UK, Denmark and Sweden. Dresden is one of the clinical sites for the EDENT1FI study. A study team at the Center for Regenerative Therapies Dresden (CRTD) of TU Dresden together with the University Hospital Carl Gustav Carus is led by Prof. Reinhard Berner and Prof. Ezio Bonifacio.
“Although it was initially uncertain whether the screening principles developed in Germany through the Fr1da study could be successfully applied in regions with entirely different healthcare systems, these programs have already proven highly successful. EDENT1FI’s success demonstrates that early-stage type 1 diabetes screening can be effectively implemented throughout Europe,” says Prof. Anette-Gabriele Ziegler, Co-Lead Coordinator of EDENT1FI, Work Package 1 (Screening) Lead, Investigator for Fr1da and Director of the Institute of Diabetes Research at Helmholtz Munich and Chair of Diabetes and Gestational Diabetes at the TUM University Hospital.
Screening settings varied across countries, with programs conducted in primary care, hospitals, schools, and homes. Despite these differences, EDENT1FI successfully harmonized islet autoantibody detection and standardized data collection and processing across countries. The initiative also introduced central laboratories and robust quality control processes throughout Europe, enabling the screening of more than 100,000 children and adolescents at a rate of approximately 6,500 participants per month.
“Early detection of children with type 1 diabetes in its early stages can largely prevent serious metabolic disorders and enable new therapeutic approaches to be developed jointly in Europe.,” says Dr. Gita Gemulla, pediatric diabetologist and functional senior physician at the University Hospital Carl Gustav Carus Dresden and Principal Investigator for Fr1da and EDENT1FI in Saxony.
Supporting Children and Adolescents with Early-Stage Type 1 Diabetes
Participation in the EDENT1FI screening program requires only a few drops of blood. Families receive counseling and ongoing support throughout the process. Children and adolescents identified with early-stage type 1 diabetes are closely monitored and informed about opportunities for early intervention. By equipping families with knowledge and resources, EDENT1FI aims to reduce the burden of an unexpected onset of clinical diabetes and empower them to manage life with type 1 diabetes effectively. EDENT1FI’s goal is to screen 220,000 children and adolescents from the general population across Europe to identify those with presymptomatic type 1 diabetes.
"Reaching 100,000 screened children is a major step for early-stage diagnosis of type 1 diabetes. With recently approved and future disease modifying therapies, diagnosing children earlier becomes even more meaningful. This milestone shows how collaboration is reshaping the future of type 1 diabetes care," explains Prof. Chantal Mathieu, Lead Coordinator of EDENT1FI.
New Therapy Highlights Importance of Early Detection
In January 2026, the immunomodulatory drug teplizumab was approved in Europe for use in children aged eight years and older with presymptomatic type 1 diabetes (Stage 2). This approval underscores the importance of early detection programs like EDENT1FI. Through early detection, families and clinicians can consider interventions such as teplizumab to delay the onset of the disease. Additional therapies that may prevent or delay the onset of type 1 diabetes are currently being studied in clinical trials.
About EDENT1FI
EDENT1FI is a collaborative initiative involving 27 partners from academia, industry, and charitable organizations across 13 European countries. The project is funded by the Innovative Health Initiative (IHI) through Horizon Europe, with additional support from the Helmsley Charitable Trust, BreakthroughT1D, and other stakeholders. Launched in 2023, EDENT1FI focuses on detecting type 1 diabetes in children and adolescents before clinical symptoms appear, with the goal of improving early intervention, refining risk stratification, and enabling the development of innovative therapies.
www.edent1fi.eu
About the Center for Regenerative Therapies Dresden (CRTD)
The Center for Regenerative Therapies Dresden (CRTD) of TUD Dresden University of Technology is an academic home for scientists from more than 30 nations. Their mission is to discover the principles of cell and tissue regeneration and leverage this for the recognition, treatment, and reversal of diseases. The CRTD links the bench to the clinic, scientists to clinicians to pool expertise in stem cells, developmental biology, gene-editing, and regeneration towards innovative therapies for neurodegenerative diseases such as Alzheimer's and Parkinson's disease, hematological diseases such as leukemia, metabolic diseases such as diabetes, bone and retina diseases. The CRTD was founded in 2006 as a research center of the German Research Foundation (DFG) and funded until 2018 as a DFG Research Center, as well as a Cluster of Excellence. Since 2019, the CRTD is funded by the TU Dresden and the Free State of Saxony.
The CRTD is one of three institutes of the central scientific facility Center for Molecular and Cellular Bioengineering (CMCB) of the TU Dresden.
http://www.tud.de/crtd
http://www.tud/de/cmcb