Early diagnosis program for the identification of type 1 diabetes

The law will make it possible, from 2024, to prevent the occurrence of the most dangerous complications, such as diabetic ketoacidosis, in Italian children between 1 and 17 years old, who are destined to develop type 1 diabetes. As a matter of fact, screening programmes based on the measurement of circulating diabetes-associated autoantibodies have demonstrated that individuals that will progress toward disease development can be identified also in the general population. The law also makes it possible to collect more information to better understand the disease and to introduce pharmacological strategies to slow and possibly stop the disease. To this regard, it should be underlined that, after decades of insulin treatment as the unique therapy for patients with type 1 diabetes, the first immunomodulatory antibody (Teplizumab – an anti-CD3 monoclonal antibody), i.e. a “disease-modifying” drug, has been approved by the FDA in the USA and the approval procedure is ongoing at the EMA.

National observatory on type 1 diabetes

Based on the provisions of the law, the Italian Ministry of Health will establish a National Observatory on type 1 diabetes composed of a representative of the Ministry of Health, representatives of the National Health Institute (ISS), doctors and representatives of the main associations of people suffering from type 1 diabetes.

Awareness campaigns

Finally, the Ministry of Health allocates resources to create awareness campaigns on the importance of early diagnosis in paediatric age. These campaigns will increase the knowledge of the screening program and will underline for the general population the importance of preventive screening. 

Resources and budget allocation

The total government funding for the first three years of screening amounts to more than 10 million euros. This is the first time in Italy that a national law specifically targets type 1 diabetes, making Italy one of the first countries in the world to have a law for the systematic screening of diabetes in the paediatric population.