Screening Program for Type 1 Diabetes in a High-Risk Population
NCT Number: NCT06513247
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes
Interventions: DIAGNOSTIC_TEST: screening for Islet autoantibody|DIAGNOSTIC_TEST: HLA phenotype and genetic risk score
Sponsor: King Saud University
Collaborators: Sanofi
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-26
Completion Date: 2029-05
Locations: The University Diabetes Centre at King Saud University Medial CIty, Riyadh, Saudi Arabia

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.

Primary Outcome Measures: prevalence of stage I, II and III T1D in screened participants., 6 months|Rates of screening refusal., measured as number of participants that they refused to be screened., 6 months
Secondary Outcome Measures: Rate of completed screened cases, measured as number of participants who complete the screening., 12 months|Adverse events associated with the screening process, 6 months|Estimated costs for T1D screening per participant., 5 years|Estimated costs for DKA, 5 years|Parental anxiety from T1D screening, measured by the generalized anxiety disorder -7 scale (GAD-7), 1 year|Glycemic changes among positively screened participants, measured by oral glucose tolerance test, 5 years