Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study

BackgroundType 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....

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Main Authors: Iman S Algadi, Yazed AlRuthia, Muhammad H Mujammami, Khaled Hani Aburisheh, Metib Alotaibi, Sharifah Al Issa, Amal A Al-Saif, David Seftel, Cheng-Ting Tsai, Reem A Al Khalifah
Format: Article
Language:English
Published: JMIR Publications 2025-04-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e70575
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Summary:BackgroundType 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. ObjectiveThis 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. MethodsThe 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. ResultsThe 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT06513247; https://clinicaltrials.gov/study/NCT06513247 International Registered Report Identifier (IRRID)DERR1-10.2196/70575
ISSN:1929-0748