About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
first-degree relative case with Maturity-Onset Diabetes of the Young (MODY) or Type 2 Diabetes Mellitus (T2DM).
Non-Saudi children.
first-degree relative not following at our centre.
Trial population
2-18 years old health children with first-degree relatives with T1D.
Trial design
Cohort
Prospective
Treatments tested in this trial
screening for Islet autoantibody
Diagnostic testIAA, GADA, IA-2A, Zn-transporter 8 autoantibodies
HLA phenotype and genetic risk score
Diagnostic testusing DBS filter paper
Treatment groups
Trial outcomes
Primary outcomes
prevalence of stage I, II and III T1D in screened participants.
Rates of screening refusal.
measured as number of participants that they refused to be screened.
Secondary outcomes
Rate of completed screened cases
measured as number of participants who complete the screening.
Adverse events associated with the screening process
Estimated costs for T1D screening per participant.
Estimated costs for DKA
Sponsors and contacts
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King Saud University
Lead sponsor
Sanofi
Collaborator