ROME (ITALPRESS) – Sixteen recommendations aimed at developing an effective organizational model for the management of screening at the national level such as the importance of active involvement of family and hospital pediatricians for ongoing support to families, the creation of a network of qualified regional laboratories for uniform analysis of samples, and the establishment of specialized teams in regional centers for integrated care of diagnosed children. It is the White paper “Pediatric Screening for Type 1 Diabetes and Celiac Disease” promoted in accordance with Law No. 130/2023 approved just a year ago unanimously by Parliament, and presented to the Chamber of Deputies on the initiative of Vice President Giorgio Mulè. The white paper, the result of a collaboration between experts in health care, pediatric endocrinology, diabetology and representatives of patient associations, is part of the Diabetes Type 1 Vision of Screening (D1VE) project, carried out by Sanofi in collaboration with UTOPIA, which aims to foster a constructive dialogue between all the actors involved in the implementation of the law approved last fall, which places Italy as the first country in the world to introduce a national screening program regulated by a state law, focused on early diagnosis in pediatric age. “The first data on the national screening program to detect genetic predisposition to type one diabetes and celiac disease confirm the extraordinary and essential importance of Law 130 passed exactly one year ago by Parliament. The sample surveys carried out in four regions, which will be the basis for launching screening on a national basis, tell beyond reasonable doubt how, thanks to screening, a large number of cases destined otherwise to be unknown have been intercepted, with probably serious or very serious consequences for those affected. This is confirmation of the goodness of a world-first initiative that places our country at the forefront of prevention activities for two diseases that are becoming increasingly common in the pediatric population. Thanks to the work of the Istituto Superiore di Sanità, in concert with the Ministry of Health, pediatric physicians and patient associations, this first fundamental milestone has been reached. We are on the right track, now we will continue to work with the same determination to achieve new goals,” Mulè said.With an investment of 3.85 million euros per year for the biennium 2024-2025 and 2.85 million euros annually starting in 2026, the multi-year pediatric screening program is of crucial importance. This program not only prevents as-yet-incurable chronic diseases, such as type 1 diabetes, but also enables early diagnosis of growing diseases such as celiac disease, before clinical symptoms become apparent. The main goal is to avoid complications associated with late diagnosis, significantly improving the quality of life for young patients and their families. The program aims to reduce the risk of diabetic ketoacidosis-often the first clinical manifestation of type 1 diabetes-and to diagnose celiac disease at an early stage, ensuring immediate treatment to avoid complications such as growth retardation and delayed puberty. Prior to nationwide adoption, a preparatory study called D1Ce Screen 2 was conducted, sponsored by the Istituto Superiore di Sanità (ISS) in collaboration with the Ministry of Health. Four Italian regions-Lombardy, Marche, Campania, and Sardinia-were involved in this study with the aim of testing the feasibility of the program, evaluating its costs, and analyzing the benefits of systematic screening of the entire pediatric population. During this phase, free-choice pediatricians played a key role, voluntarily recruiting children aged 2, 6, and 10 years to undergo capillary blood sampling designed to determine specific autoantibodies for type 1 diabetes and celiac disease. To date, 3819 registries have been entered into the system, and the results obtained have shown high family participation, a sign of a strong awareness of the importance of early diagnosis. “The development of new therapies and the possibility of early screening are profoundly transforming the management of type 1 diabetes, and Teplizumab represents one of the most significant innovations in this context. All this opens up entirely new scenarios for prevention, providing an extraordinary opportunity to intervene before diabetes becomes clinically manifest. Alongside innovative therapies such as Teplizumab, early screening also plays a crucial role: identifying at-risk individuals allows personalizing therapeutic interventions, anticipating complications and improving the quality of life of people with type 1 diabetes,” explains Raffaella Buzzetti, President Elect of the Italian Diabetes Society (SID). Less well known than type 2 diabetes, type 1 diabetes is a still incurable autoimmune disease caused by the destruction of pancreatic islets beta cells, which are responsible for insulin production. In Italy, this disease affects about 300,000 people, and in 2021 there were 26.7 new cases per 100,000 children, including 43.2 percent with onset in diabetic ketoacidosis 3, a potentially fatal complication if not diagnosed early. Celiac disease, another chronic autoimmune disease, is also very common in Italy, with more than 200,000 people affected. Although they are distinct diseases, type 1 diabetes and celiac disease share many common elements, such as autoimmune mechanisms and a genetic predisposition associated with polymorphisms of the Human Leukocyte Antigens (HLA) complex. Up to 5% of patients may suffer from both conditions, making clinical management more complex and costly. This nationwide clinical picture further underscores the importance in moving forward with a structured prevention program starting with the very youngest. Pediatric screening for type 1 diabetes and celiac disease has already attracted the attention of leading international scientific institutions and the most prestigious journals, such as Lancet 4 and Science 5. The introduction of such an articulated and legally regulated program is unprecedented and places Italy at the forefront of preventive health care. The next steps include nationwide adoption of the program in 2025, with ongoing efforts to ensure maximum adherence and to monitor results in order to make any improvements. “Law 130/2023 has made Italy the lead country in adopting the screening tool, and this, should be a source of great pride for us. This project has fostered the meeting and close and synergistic collaboration of the main actors involved in the implementation phase of the Law, who have pooled their great expertise to achieve a common goal: that of making scientific progress such as T1D and celiac disease screening, within reach of all families in our country. It is also a significant milestone for our company, which has put immunology at the center of its research and development strategy, harnessing the expertise and vast knowledge of the immune system to understand and treat diseases, where it is out of balance, as precisely in type 1 diabetes,” stresses Alessandro Crevani, General Manager Business Unit General Medicines of Sanofi. “As Sanofi we have a history deeply linked to diabetes and we work every day to change the course of this pathology. In fact, since July last year we have set up an area dedicated to immuno-diabetology, with the ambitious goal of radically transforming the treatment of type 1 diabetes in the future, delaying its onset and with the ambition given to us by our pipeline to one day get to prevent it altogether,” he concludes.
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