Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 25, 2024
Date Accepted: Feb 5, 2025
Date Submitted to PubMed: Feb 11, 2025
Pilot Screening Program for Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Study Design
ABSTRACT
Background:
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:
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 pre-symptomatic T1D by screening children aged 2–18 years. The primary screening method involves testing for islet autoantibodies, including insulin autoantibodies (IAA), glutamic acid decarboxylase autoantibodies (GADA), IA-2 autoantibodies (IA-2A), and Zn-transporter 8 (ZnT8) autoantibodies. Optional genetic testing, including HLA phenotyping and the Genetic Risk Score (GRS), is offered. Outcomes include the feasibility of the screening process, prevalence of early-stage T1D, psychological impacts, educational interventions effectiveness, progression rates to Stage 3 T1D, and the economic viability.
Results:
The VISION-T1D program began in May 2024. As of December 2024, 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 healthcare 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 (DKA) 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. Clinical Trial: ClinicalTrials.gov NCT06513247
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.