Auto-antibody Dosage from Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease (CELDI)

February 25, 2025 updated by: Meyer Children's Hospital IRCCS
Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Florence, Italy, 50139
        • Recruiting
        • Meyer Children's Hospital IRCCS
        • Contact:
          • Chiara Azzari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 2-13 years
  • Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
  • Obtained informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Test on blood sample (diagnosis of celiac and diabetes disease)
Diagnostic test: Test on blood sample
The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.
Other: test on dried blood spot (celiac and diabetes patients)
Diagnostic test: Test on dried blood sample
A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml
Time Frame: Baseline
Baseline
Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml
Time Frame: Baseline
Baseline
Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml
Time Frame: Baseline
Baseline
Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml
Time Frame: Baseline
Baseline
Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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