Clinical trial NCT06665815: A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
Official title: A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Autoantibodies Screening
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 20000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel
timeFrame: End of screening, 3 years after obtaining the first screening test
Secondary outcomes:
measure: The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort
timeFrame: End of screening, 3 years after obtaining the first screening test
measure: Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes
timeFrame: End of screening, 3 years after obtaining the first screening test
measure: >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort
timeFrame: End of screening, 3 years after obtaining the first screening test
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof.
role: PRINCIPAL_INVESTIGATOR
References: