An observational study in Diabete Type 1, sponsored by University of Bari. Recruiting at 1 site in Italy. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Bari · Observational
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.
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 600 is above the median of 160 across 126 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →University of Bari is the lead sponsor of 75 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with biopbsy-confirmed CD
Exclusion Criteria:
Known diagnosis of type 1 diabetes.
600 pediatric subjects will be enrolled, all with a confirmed diagnosis of celiac disease according to the 2020 ESOPGHAN criteria.
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)
Time frame: baseline
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.
Time frame: 12 months
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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