TY  - JOUR
AU  - Algadi, Iman S
AU  - AlRuthia, Yazed
AU  - Mujammami, Muhammad H
AU  - Aburisheh, Khaled Hani
AU  - Alotaibi, Metib
AU  - Al Issa, Sharifah
AU  - Al-Saif, Amal A
AU  - Seftel, David
AU  - Tsai, Cheng-Ting
AU  - Al Khalifah, Reem A
PY  - 2025
DA  - 2025/4/14
TI  - Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study
JO  - JMIR Res Protoc
SP  - e70575
VL  - 14
KW  - islet autoimmunity
KW  - type 1 diabetes mellitus
KW  - T1D
KW  - screening program
KW  - antibody detection by agglutination–polymerase chain reaction
KW  - PCR
KW  - ADAP
KW  - human leukocyte antigen
KW  - genetic risk score
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2025/1/e70575
UR  - https://doi.org/10.2196/70575
DO  - 10.2196/70575
ID  - info:doi/10.2196/70575
ER  -