Diabete Type 1CARES-T1DNCT07862101
Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients
An observational study of Diabete Type 1, run by University of Bari at 1 site in Italy.
Trial summary
Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diabete Type 1
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with biopbsy-confirmed CD
Who may be able to join
- Children aged 1-18 years with biopsy-confirmed CD.
- Informed consent from parents/legal guardians and assent from the child (as applicable).
Who cannot join
- • Known diagnosis of type 1 diabetes.
- Other autoimmune endocrinopathies or immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Of Bari Aldo Moro-Pediatric Gastroenterology Section
Bari, BA, 70121
Fernanda Cristofori, 3384176598, fernandacristofori@gmail.com
About this study
Official title: Celiac Autoimmunity and Risk Evaluation Strategies for Type 1 Diabetes in Pediatric Patients
Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset. International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet.
In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families.
Read the detailed description
Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset.
Current guidelines recommend screening for celiac disease with tissue transglutaminase autoantibody (TGA) testing in both symptomatic individuals and asymptomatic individuals with high-risk features. These include a family history of CD, coexisting autoimmune disorders such as T1D, and specific genetic syndromes. While gastrointestinal symptoms like diarrhea, abdominal distension, vomiting, and malabsorption often prompt CD evaluation, many patients-more than half-are asymptomatic at diagnosis. This highlights a significant limitation in symptom-based screening approaches.
International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet.
In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families. This initiative seeks to identify early serological markers of T1D in a high-risk population and to inform preventive strategies aimed at reducing the burden of severe complications such as DKA.
- Conditions
- Diabete Type 1
- Keywords
- diabete type 1, celiac disease, paediatric patients
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiac paediatric patients | 600 pediatric subjects will be enrolled, all with a confirmed diagnosis of celiac disease according to the 2020 ESOPGHAN criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening of celiac paediatric patients
The aim of the CARES-T1D project is to determine the prevalence of type 1 diabetes-associated autoantibodies (T1D) in pediatric subjects with CD to assess the frequency with which these immunologic biomarkers occur in this specific population. The plan is to screen all children in follow-up at our out-patient celiac clinic for diabetes specific autoantibodies. The parents will be informed about the study and invited to take part in the study during the scheduled appointment; a written informed consent will be signed by parents. The screening activity will be carried out over a 1-year period. It is expected that at least 80% of the parents will give their informed consent to participation in the study. Accordingly, about 480 celiac patients will be screened for the four biochemical autoantibodies predicting T1D, i.e. insulin autoantibodies (IAA)
Measured: baseline
Secondary outcomes (1)
TD1 in CD
Secondary aims are a) to assess the frequency of multiple autoantibody positivity and classify children according to TrialNet T1D staging; b) to identify predictors of antibody positivity; c) to evaluate progression rates to clinical T1D in the follow-up phase; d) to reduce the incidence of DKA by promoting early detection; d) to validate a scalable screening protocol for T1D risk in pediatric CD populations.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862101
- Sponsor's protocol ID
- CARES-T1D
- Acronym
- CARES-T1D
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Autoimmunity and Risk Evaluation Strategies for Type 1 Diabetes in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07862101
- Acronym / sponsor ID
- CARES-T1D / CARES-T1D
- Conditions
- Diabete Type 1
- Keywords
- diabete type 1, celiac disease, paediatric patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset. International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet.
In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families.
Detailed description
Celiac disease (CD) and type 1 diabetes mellitus (T1D) are chronic autoimmune disorders that frequently co-occur, largely due to shared genetic susceptibility, particularly HLA-DQ2 and HLA-DQ8 alleles. In Italy, approximately 300,000 individuals are affected by T1D, with a prevalence of 0.5% in the general population and 0.22% in the pediatric population. The annual incidence among children is 12.26 per 100,000, with boys affected more frequently than girls (13.13 vs. 11.35 per 100,000). Alarmingly, 25-40% of pediatric patients present with diabetic ketoacidosis (DKA) at disease onset.
Current guidelines recommend screening for celiac disease with tissue transglutaminase autoantibody (TGA) testing in both symptomatic individuals and asymptomatic individuals with high-risk features. These include a family history of CD, coexisting autoimmune disorders such as T1D, and specific genetic syndromes. While gastrointestinal symptoms like diarrhea, abdominal distension, vomiting, and malabsorption often prompt CD evaluation, many patients-more than half-are asymptomatic at diagnosis. This highlights a significant limitation in symptom-based screening approaches.
International prospective studies, such as the Environmental Determinants of Diabetes in the Young (TEDDY) study, have demonstrated that symptoms are poor predictors of CD autoimmunity, emphasizing the need for structured population-based screening strategies. Similarly, in T1D, the appearance of disease-specific autoantibodies-such as anti-GAD, insulin autoantibodies (IAA), IA-2A, and ZnT8A-can precede the onset of clinical disease by years. Identifying these markers enables early risk stratification, timely monitoring, and potential enrollment in immunomodulatory prevention trials, including those organized by TrialNet.
In this context, an observational study is being conducted at the Pediatric Department of the University of Bari. It involves the prospective screening of children (ages 1 to 18 years) with a confirmed diagnosis of celiac disease for T1D-associated autoantibodies. The study aims to enroll 600 CD patients over one year, with an anticipated 80% participation rate among eligible families. This initiative seeks to identify early serological markers of T1D in a high-risk population and to inform preventive strategies aimed at reducing the burden of severe complications such as DKA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celiac paediatric patients | – | –600 pediatric subjects will be enrolled, all with a confirmed diagnosis of celiac disease according to the 2020 ESOPGHAN criteria. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with biopbsy-confirmed CD
Key inclusion criteria (2 listed)
- Children aged 1-18 years with biopsy-confirmed CD.
- Informed consent from parents/legal guardians and assent from the child (as applicable).
Key exclusion criteria (2 listed)
- • Known diagnosis of type 1 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening of celiac paediatric patients
Time frame: baseline
The aim of the CARES-T1D project is to determine the prevalence of type 1 diabetes-associated autoantibodies (T1D) in pediatric subjects with CD to assess the frequency with which these immunologic biomarkers occur in this specific population. The plan is to screen all children in follow-up at our out-patient celiac clinic for diabetes specific autoantibodies. The parents will be informed about the study and invited to take part in the study during the scheduled appointment; a written informed consent will be signed by parents. The screening activity will be carried out over a 1-year period. It is expected that at least 80% of the parents will give their informed consent to participation in the study. Accordingly, about 480 celiac patients will be screened for the four biochemical autoantibodies predicting T1D, i.e. insulin autoantibodies (IAA)
1 secondary outcome
TD1 in CD
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 1, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruggiero Francavilla, Prof (00390805592063, rfrancavilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening of celiac paediatric patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.