%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70575 %T Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study %A Algadi,Iman S %A AlRuthia,Yazed %A Mujammami,Muhammad H %A Aburisheh,Khaled Hani %A Alotaibi,Metib %A Al Issa,Sharifah %A Al-Saif,Amal A %A Seftel,David %A Tsai,Cheng-Ting %A Al Khalifah,Reem A %+ Department of Pediatrics, College of Medicine, King Saud University, PO Box 800, Riyadh, 11421, Saudi Arabia, 966 0557100303, reem_ah@yahoo.com %K islet autoimmunity %K type 1 diabetes mellitus %K T1D %K screening program %K antibody detection by agglutination–polymerase chain reaction %K PCR %K ADAP %K human leukocyte antigen %K genetic risk score %D 2025 %7 14.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X 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 %R 10.2196/70575 %U https://www.researchprotocols.org/2025/1/e70575 %U https://doi.org/10.2196/70575