The IHI EDENT1FI project was set up with one goal: to improve screening for type 1 diabetes in children and adolescents throughout Europe. By the time the project ends, more than 200 000 children and teenagers in the general population across Europe will be screened for this disease.
The scientific work behind the EDENT1FI screening programme is substantial; EDENT1FI researchers are comparing different protocols for screening, evaluating the ethics of screening, considering cost-effectiveness strategies and examining best practices for follow-up.
Around the same time as EDENT1FI started, the Italian government passed a law announcing that national screening programmes for type 1 diabetes in children and teenagers would start. Although it’s still early days for EDENT1FI, which kicked off in 2023, Italian researchers active in the project were called on to assist the government with the national plan, and so a dialogue began between the two screening initiatives.
Working together for better results
The type of approach taken by the Italian government is different to that taken by EDENT1FI, but the researchers have opened a channel of communication where best practices and learnings are shared liberally.
“We feed them, they feed us. It’s a very good form of collaboration,” says Chantal Mathieu, the project coordinator of EDENT1FI.
“The Italian government have achieved nice results and they have their pilot study going. It’s great to see that it can be done in this way,” says Jurgen Vercauteren, who is both a researcher and a patient advocate involved in the EDENT1FI project.
The Italian government has already implemented EDENT1FI’s master protocol as part of an ongoing pilot screening programme. A method using capillary tests to screen for multiple auto-antibodies – indicators of type 1 diabetes – which proved efficient and non-invasive was also developed by EDENT1FI and taken on board by the Italian government.
The main hub of contact between EDENT1FI and the national screening programme is in Milan at the Ospedale San Raffaele, where EDENT1FI screening and national screening are ongoing simultaneously. The Ospedale transmits EDENT1FI’s findings to the rest of the country and also communicates learnings from the national programme to EDENT1FI.
“It is a continuous ping-pong between EDENT1FI through Milan to the rest of Italy,” says Mathieu. “All of the screening in the Milan region (about 20 000 children) is following the EDENT1FI protocol directly, including monitoring the children that are found to be positive.”
For EDENT1FI, knowledge gained through the Italian initiative can be used to hone best practices, protocols and guidelines that are generated by the project. All of the children screened in the greater Milan region will be registered in the EDENT1FI registry, and an effort will be made to mirror all the children diagnosed with early stage T1D throughout Italy into a bigger pre-T1D registry that EDENT1FI also has access to. Developing these large registries is essential so that patterns can be more easily detected and so that diabetes researchers can learn more about how the disease can be identified in children and young adults.
The domino effect: rolling out screening programmes in other countries
EDENT1FI has set up T1D screening programmes in four EU regions (Czech Republic, Italy, Poland, Portugal). In places where screening programmes were already underway (such as Germany, the Öresund Region in Denmark and Sweden, UK), EDENT1FI is helping to optimise them. To date, 38 742 children have been screened using the EDENT1FI Master Protocol.
This progress was highlighted in December at an event at the European Parliament which also celebrated the success of the Italian government in rolling out the national programme.
Other EU countries are starting to show their interest – France and Belgium have indicated that they will soon roll out screening for the family members of people diagnosed with type 1 diabetes, while Greece has been in touch with EDENT1FI for advice on how to implement a national screening programme. That's great news for the EDENT1FI researchers.
“We want to rapidly move the learnings from the pilots in the countries where EDENT1FI is screening to help implement this in all countries in Europe,” says Mathieu.
“What we hope to learn is what works, what doesn’t work in specific healthcare systems and what are the tips and tricks that we can give other countries.”
EDENT1FI didn't start from scratch, however: it builds on the solid foundations already put in place by the IMI INNODIA and IMI2 INNODIA HARVEST projects. Thanks to the work of those projects, EDENT1FI has had a ‘flying start’ according to Mathieu.
“It gave us insights into how to collaborate efficiently throughout Europe in a public private partnership on type 1 diabetes,” she says.
The INNODIA and INNODIA HARVEST projects are supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry. EDENT1FI is supported by the Innovative Health Initiative.
Type 1 diabetes happens when your body can’t produce insulin effectively, caused by an autoimmune reaction. Up until relatively recently, it hasn’t been possible to tell whether people are diabetic unless they experience blood sugar problems – a dip or rise in blood sugar that can cause a range of symptoms from dizziness and confusion to extreme thirst or even seizures.
For some people these events go unnoticed, meaning that their diabetes continues to progress unknown to them and they run the risk of developing ketoacidosis. This life-threatening condition occurs when the body can’t produce insulin and begins to break down fat as fuel, causing a buildup of acids in the bloodstream.
Screening programmes can help to dramatically reduce the number of children and teenagers who experience ketoacidosis or organ damage because of undiagnosed diabetes. If a person knows that they have diabetes, even asymptomatic diabetes, then steps can be taken to keep their blood sugar levels under control and minimise damage.