NCT06849622

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 20, 2025

Last Update Submit

February 25, 2025

Conditions

Celiac Disease in ChildrenDiabetes Mellitus, Type IScreening

Outcome Measures

Primary Outcomes (1)

  • Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml

    Baseline

Secondary Outcomes (5)

  • Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml

    Baseline

  • Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml

    Baseline

  • Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml

    Baseline

  • Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml

    Baseline

  • Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes

    Baseline

Study Arms (2)

Test on blood sample (diagnosis of celiac and diabetes disease)

OTHER
Diagnostic Test: Test on blood sample

test on dried blood spot (celiac and diabetes patients)

OTHER
Diagnostic Test: Test on dried blood sample

Interventions

Test on blood sampleDIAGNOSTIC_TEST

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.

Test on blood sample (diagnosis of celiac and diabetes disease)
Test on dried blood sampleDIAGNOSTIC_TEST

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)

test on dried blood spot (celiac and diabetes patients)

Eligibility Criteria

Age2 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Italy, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Chiara Azzari

CONTACT

+3905556621chiara.azzari@meyer.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 27, 2025

Study Start

November 4, 2024

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)