NCT06513247

Screening Program for Type 1 Diabetes in a High-Risk Population

Feasibility of a Pilot Screening Program for Type 1 Diabetes in a High-Risk Population

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: —

Summary

Type 1 diabetes mellitus (T1D) is a growing public health concern in Saudi Arabia, ranking ninth globally in T1D incidence and tenth in T1D prevalence in children, and the rates are expected to rise and incur greater healthcare costs. Genetic and immunological factors are believed to play a significant role in disease development, and recent clinical trials have shown promise in delaying or preventing T1D onset in high-risk individuals. Early screening for immunological or genetic markers in children is crucial to identify high-risk individuals and provide early intervention. Last year, the American diabetes association's recommended clinicians to screen first degree relatives of individual with T1D. Unfortunately, Saudi Arabia and other Arab countries lack established T1D screening programs, making early identification and intervention challenging. The benefits of screening include education for symptom awareness, monitoring to track progression to clinical T1D, a five-fold reduction in diabetic ketoacidosis (DKA) at onset, and improved glucose control for the first years following diagnosis. To address this issue, exploring effective and efficient screening methods in identifying high-risk children and the cultural acceptability, feasibility, and barriers to a broader implementation of such screening programs among Saudi families is crucial. Therefore, the investigators aim to conduct a prospective cohort study among young children and adolescents with a family history of T1D (i.e., T1D first-degree relatives). Children 2-18 years old will be screened using a 5 spots filter-dried blood sample for the following: 1. Islet autoantibodies: IAA, GADA, IA-2A, Zn-transporter autoantibodies using the antibody detection by agglutination PCR (ADAP) assay. 2. HLA phenotyping 3. Genetic risk score after the cross-sectional assessment those who are determined to be in stage I, or II of T1D will be offered prospective follow-up for 5 years.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	screening for Islet autoantibody	IAA, GADA, IA-2A, Zn-transporter 8 autoantibodies
DIAGNOSTIC_TEST	HLA phenotype and genetic risk score	using DBS filter paper

Timeline

• Start date: 2024-05-26
• Primary completion: 2025-05-01
• Completion: 2029-05-01
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: Saudi Arabia