@Article{info:doi/10.2196/70575,
author="Algadi, Iman S
and AlRuthia, Yazed
and Mujammami, Muhammad H
and Aburisheh, Khaled Hani
and Alotaibi, Metib
and Al Issa, Sharifah
and Al-Saif, Amal A
and Seftel, David
and Tsai, Cheng-Ting
and Al Khalifah, Reem A",
title="Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study",
journal="JMIR Res Protoc",
year="2025",
month="Apr",
day="14",
volume="14",
pages="e70575",
keywords="islet autoimmunity; type 1 diabetes mellitus; T1D; screening program; antibody detection by agglutination--polymerase chain reaction; PCR; ADAP; human leukocyte antigen; genetic risk score",
abstract="Background: Type 1 diabetes (T1D) is a growing global health concern, with a notable rise in incidence in Saudi Arabia. Despite the potential benefits of early detection through screening programs, such initiatives are currently lacking in Saudi Arabia and other Arab countries. Objective: This study aims to evaluate the feasibility, acceptability, and cost-effectiveness of a T1D-screening program targeting high-risk individuals, specifically children with a first-degree relative diagnosed with T1D. Methods: The VISION-T1D program is a prospective cohort study focused on the early detection of presymptomatic T1D by screening children aged 2-18 years. The primary screening method involves testing for islet autoantibodies, including insulin autoantibodies, glutamic acid decarboxylase autoantibodies, insulinoma associated-2 autoantibodies, and zinc transporter-8 autoantibodies. Optional genetic testing, including human leukocyte antigen phenotyping and the genetic risk score, is offered. Outcomes include the feasibility of the screening process, prevalence of early-stage T1D, psychological impacts, educational intervention effectiveness, progression rates to stage-3 T1D, and economic viability. Results: The VISION-T1D program began in May 2024. As of December 2024, a total of 176 families have been enrolled. Data collection will continue until April 2025, with final data analysis projected for mid-2025. Conclusions: The VISION-T1D study provides a practical approach to T1D screening tailored to the health care landscape of Saudi Arabia. The insights gained from this pilot program will inform the development of a national, population-based screening initiative designed to reduce diabetic ketoacidosis at diagnosis, improve long-term outcomes, and alleviate the economic burden of T1D. The VISION-T1D initiative could also serve as a scalable and sustainable model that can be adopted internationally, contributing to global efforts to manage and prevent T1D. Trial Registration: ClinicalTrials.gov NCT06513247; https://clinicaltrials.gov/study/NCT06513247 International Registered Report Identifier (IRRID): DERR1-10.2196/70575 ",
issn="1929-0748",
doi="10.2196/70575",
url="https://www.researchprotocols.org/2025/1/e70575",
url="https://doi.org/10.2196/70575"
}