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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06665815

Acronym

ADIR Families

Enrollment

20000

Registered

2024-10-30

Start date

2024-12-15

Completion date

2028-02-15

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoantibodies Screening, Type 1 Diabetes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Israel

Contacts

Primary ContactMoshe Phillip, Prof.

moshe.phillip@phillipmd.com972-544-795995

Backup ContactAlona Hamou, Msc

alonah@clalit.org.il972-545-950277

Outcome results