A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients

NCT06665815 | Recruiting

• 1 other identifier: 0483-24RMC
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 \& 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA. A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA. Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.

Conditions

Type 1 Diabetes; Autoantibodies Screening

Outcome Measures

Primary Outcomes (1)

• The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel

  End of screening, 3 years after obtaining the first screening test

Secondary Outcomes (3)

• The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort

  End of screening, 3 years after obtaining the first screening test

• Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes

  End of screening, 3 years after obtaining the first screening test

• >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort

  End of screening, 3 years after obtaining the first screening test

Study Arms (2)

Negative result at the autoantibodies screening test

1. Participants without positive autoantibodies will not be confirmed or referred to follow up 2. Participants with only one positive autoantibody, will be referred to perform regular follow up as part of routine medical care according to the international consensus guidelines published in July 2024

Positive result at the autoantibodies screening test

Participants with two or more positive autoantibodies: 1. will be invited to perform a confirmation test as part of the study 2. If confirmed as having pre-symptomatic type 1 diabetes (T1D) (stages 1 / 2), participants will be referred to complete an educational program emphasizing on DKA prevention and to perform regular follow-up according to the international consensus guidelines published in July 2024, as part of routine medical care

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old

You may qualify if:

• Age 2-45 years
• First-degree relatives of Type 1 Diabetes probands
• Signing an informed consent

You may not qualify if:

• Known diabetes of any kind (type 1, type 2, MODY)
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children Medical Center of Israel

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Prof.

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Phillip, Prof.

CONTACT

972-544-795995; moshe.phillip@phillipmd.com

Alona Hamou, Msc

CONTACT

972-545-950277; alonah@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)