An observational study in Type 1 Diabetes, sponsored by King Saud University. Recruiting at 1 site in Saudi Arabia. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by King Saud University · Observational
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:
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →King Saud University is the lead sponsor of 168 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
2-18 years old health children with first-degree relatives with T1D.
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Diabetes is defined based on the American diabetes association (ADA) definition: Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL), or Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 h, or Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an OGTT, or HbA1c >6.5%.
Exclusion Criteria:
IAA, GADA, IA-2A, Zn-transporter 8 autoantibodies
using DBS filter paper
prevalence of stage I, II and III T1D in screened participants.
Time frame: 6 months
Rates of screening refusal.
measured as number of participants that they refused to be screened.
Time frame: 6 months
Rate of completed screened cases
measured as number of participants who complete the screening.
Time frame: 12 months
Adverse events associated with the screening process
Time frame: 6 months
Estimated costs for T1D screening per participant.
Time frame: 5 years
Estimated costs for DKA
Time frame: 5 years
Parental anxiety from T1D screening
measured by the generalized anxiety disorder -7 scale (GAD-7)
Time frame: 1 year
Glycemic changes among positively screened participants
measured by oral glucose tolerance test
Time frame: 5 years
Plan to share: Undecided — The data is available from the PI upon reasonable request and approval by the IRB.
Started May 2024 (actual). Primary completion is estimated for May 2025, 12 months after the start.
Of 239 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 12 months is below that.
Counting every sponsor, half of 288 studies reached it within 27 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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