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New study tracks 300 people at risk for type 1 diabetes over 10 years

NCT ID NCT07503366

Knowledge-focused Sponsor: Società Italiana di Endocrinologia e Diabetologia Pediatrica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

The SIRENA study will follow 300 children and adults who have tested positive for islet autoantibodies, which are early markers of type 1 diabetes. Over up to 10 years, researchers will track how their blood sugar, immune system, and metabolism change. The goal is to better predict who will develop diabetes and to reduce dangerous complications at diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could improve how doctors predict and detect type 1 diabetes early, potentially reducing severe complications at diagnosis.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and results depend on long-term follow-up over 10 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes children, adolescents, and adults who have tested positive for at least one islet cell autoantibody through population-based screening, family screening, routine clinical evaluation, or targeted screening of individuals with autoimmune conditions or incidental dysglycemia. Eligible participants are in the pre-symptomatic stages of T1D, without clinical signs of disease and not meeting diagnostic criteria for diabetes at enrollment. Recruitment occurs at pediatric and adult diabetes centers participating in the national study network. The resulting dataset also provides a resource for future analyses of the clinical and psychological outcomes associated with pre-symptomatic T1D.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Individuals of any age who test positive for at least one islet autoantibody. * Absence of clinical symptoms of diabetes. * Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia). * Ability to comply with follow-up procedures according to clinical practice. * Written informed consent obtained from the participant or, for minors, from a parent or legal guardian. Exclusion Criteria: * Prior diagnosis of type 1 or type 2 diabetes. * Fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg/dL. * Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration). * Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability. * Inability or unwillingness to provide informed consent.

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Conditions

The condition(s) this trial relates to.

autoimmune disease disease Disease Progression glucose intolerance hyperglycemia prediabetes syndrome Stress, Psychological type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoantibodies Hyperglycemia Impaired glucose tolerance (prediabetes) Type 1 diabetes (T1D)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo

    Bari, Italy

  • Azienda Ospedale-Università Padova

    Padova, Italy

  • Azienda Ospedaliero Integrata di Verona

    Verona, Italy

  • Centro Provinciale di Diabetologia Pediatrica - SOC di Pediatria - Ospedale "S. Giovanni di Dio"

    Crotone, Italy

  • Centro Regionale di Diabetologia Pediatrica, UOC Pediatria Specialistica, Dipartimento ad Attività Integrata Materno Infantile, AOU Federico II

    Naples, Italy

  • Centro di Diabetologia Pediatrica Grande Ospedale Metropolitano

    Reggio Calabria, Italy

  • Centro diabetologico aziendale - UOS Diabetologia pediatrica; ASL Viterbo

    Viterbo, Italy

  • Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University

    Bolzano, Italy

  • IRCCS "Ospedale Infantile" Burlo Garofolo

    Trieste, Italy

  • IRCCS Policlinico San Matteo, SS Pediatria 2 - Malattie Endocrine / Ambulatorio di Diabetologia Pediatrica

    Pavia, Italy

  • Ospedale G.Di Cristina - ARNAS Civico di Cristina Benfratelli

    Palermo, Italy

  • Ospedale Maggiore della Carità di Novara

    Novara, Italy

  • Ospedale Pediatrico Bambino Gesù

    Roma, Italy

  • Ospedale S. Raffaele

    Milan, Italy

  • Ospedale S.M. del Ca' Foncello, Treviso, AULSS2 Marca Trevigiana

    Treviso, Italy

  • Ospedale di Santa Chiara Azienda USL

    Trento, Italy

  • S.C. Pediatria, P.O.C SS. Annunziata

    Taranto, Italy

  • SOC Diabetologia ed Endocrinologia, AOU Meyer IRCCS

    Florence, Italy

  • SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche

    Ancona, Italy

  • UOC Endocrinologia e Malattie del Metabolismo AOU di Parma

    Parma, Italy

  • UOC Pediatria, Azienza Ospedaliero-Universitaria "Renato Dulbecco"

    Catanzaro, Italy

  • UOC Pediatria, Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano

    Caserta, Italy

  • Università degli Studi dell'Aquila - UO Pediatria e PSP, Ospedale San Salvatore

    L’Aquila, Italy

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