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NCT Number: NCT06665815

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

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.

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Key information

Conditions

Type 1 Diabetes Autoantibodies Screening Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schneider Children Medical Center of Israel

Petah Tikva, Israel

Location status: Recruiting

Location contact

Alona Hamou, MSc

CONTACT

[email protected]

972-545-950-277

Moshe Phillip, Prof

PRINCIPAL_INVESTIGATOR

Tal Oron, Dr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

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

    Time frame: End of screening, 3 years after obtaining the first screening test

Secondary outcomes

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

    Time frame: End of screening, 3 years after obtaining the first screening test

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

    Time frame: End of screening, 3 years after obtaining the first screening test

  3. >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort

    Time frame: End of screening, 3 years after obtaining the first screening test

Study contacts

Contact information is provided by the study sponsor or research team.

Alona Hamou, Msc

CONTACT

[email protected]

972-545-950277

Moshe Phillip, Prof.

CONTACT

[email protected]

972-544-795995

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Acronym: ADIR Families

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 30, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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