D1Ce Screen / Italy national screening (Law 130/2023)

What Italy actually did

In September 2023 the Italian Parliament unanimously approved Law 130/2023 (Legge 15 settembre 2023, n. 130), which makes screening for presymptomatic type 1 diabetes (T1D) — and for coeliac disease — a legal entitlement for every child in the national health service.¹ That is the world first: other countries run screening as a research programme (Germany's Fr1da, the UK's ELSA, the US ASK and T1Detect, Type1Screen in Australia), funded for a period and dependent on renewal. Italy wrote it into statute, with standing money attached: €3.85 million for each of 2024 and 2025, and €2.85 million a year from 2026 onwards.¹

The law covers ages 1 to 17 and creates a Ministry of Health Observatory to collect and evaluate the results.¹ It does not, on its own, deliver a single test — a national programme still has to be built. That is what D1Ce Screen is.

The D1Ce Screen pilot

D1Ce Screen is the pilot of the national programme, run by the Ministry of Health with the Istituto Superiore di Sanità (ISS), Italy's national public health institute.²³ It ran from May 2024 to March 2025 across four regions chosen to represent the whole country — Lombardy (north), Marche (centre), Campania (south) and Sardinia (islands), the last having one of the highest T1D incidences in the world.³

Rather than screen every age, D1Ce Screen tests three narrow age windows — 2.0-2.9, 6.0-6.9 and 10.0-10.9 years — chosen because they sit at the peaks of seroconversion, when children are most likely to have just developed islet autoantibodies.³ The pilot was designed around a target sample of 5,363 children across those three cohorts.³ Note what that number is and is not: it is a feasibility sample, not a census. Italy has millions of children in the covered age range, and the pilot was powered to test whether the model works — acceptability, logistics, assay performance — not to measure national outcomes.

What the test is

The sample is a capillary finger-prick, 25 µL minimum — no venous draw for the first-line test.³ From that one stick the lab runs:

• Islet autoantibodies: a combined ELISA for GAD65, IA-2 and ZnT8, with positives confirmed by luciferase immunoprecipitation (LIPS), plus insulin autoantibodies (IAA).³
• Coeliac disease: anti-transglutaminase (tTG) IgA and IgG antibodies.³
• Genetic risk: HLA DQ2/DQ8 typing by real-time PCR on a dried blood spot.³

Two or more confirmed islet autoantibodies define presymptomatic T1D — stage 1 if blood glucose is still normal, stage 2 once it is not, stage 3 when clinical diabetes arrives.³ Screening for two diseases in the same finger-prick is a genuinely elegant piece of programme design: the marginal burden on a child of adding coeliac serology to a T1D screen is zero.

What a positive result unlocks

A confirmed positive routes the family to a regional paediatric specialist centre for metabolic staging (glucose testing) and ongoing monitoring.³ That monitoring is the point. Across screening programmes internationally, knowing in advance is what prevents children arriving at diagnosis in diabetic ketoacidosis (DKA) — a dangerous, sometimes fatal metabolic crisis that is the way T1D otherwise announces itself in a large minority of children. Italian investigators have published initial observations on DKA frequency following the pilot, but that report is a short Letter and we are not able to verify a specific Italian figure, so we quote none.⁴

The other door screening opens is disease-modifying therapy. Teplizumab (Teizeild in Europe) was approved by the European Commission in January 2026 to delay progression from stage 2 to clinical T1D — but only for people aged 8 and over. Two of D1Ce Screen's three cohorts (the 2-year-olds and the 6-year-olds) are below that age, so for them screening buys monitoring, education and DKA prevention, not a drug. That is still a great deal; it is just not the same deal.

Honest limits

• The law is not yet the service. The entitlement exists nationally; the delivery does not. The pilot covered four regions, and the nationwide rollout is scheduled to begin in 2026 — it has not been demonstrated across all twenty regions, and regional health systems in Italy vary considerably in capacity.
• The pilot was a feasibility study. D1Ce Screen was designed to show the model works, not to hit a DKA-reduction endpoint. Italy's own yield, progression and DKA outcome data are still to come.³
• Age windows, not continuous cover. Screening three single-year cohorts catches seroconversion at its peaks, but a child who seroconverts between windows is found late — or, if the child is past 10.9, not found by this design at all. Rescreening strategy matters, and other programmes have shown repeat testing finds nearly as many cases as first testing.

None of that diminishes the significance. Every other national screening effort in the world is a study that has to justify its existence each funding round. Italy's has to be delivered because it is the law.

References

1. Screening type 1 diabetes and celiac disease by law. The Lancet Diabetes & Endocrinology (2023). https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00354-6/abstract ↩ ↩² ↩³

2. Istituto Superiore di Sanità. The D1Ce Screen project (accessed 2026). https://www.iss.it/en/-/il-progetto-d1ce ↩

3. Study protocol of D1Ce Screen: a pilot project of the Italian national screening program for type 1 diabetes and coeliac disease in the paediatric population. PLOS One (2025). https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0328624 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

4. Initial observations on the frequency of diabetic ketoacidosis following pilot screening for type 1 diabetes in the general Italian population. Diabetes, Obesity and Metabolism (2025). https://doi.org/10.1111/dom.16611 ↩