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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест screening for Islet autoantibody
  IAA, GADA, IA-2A, Zn-transporter 8 autoantibodies
• Диагностический тест HLA phenotype and genetic risk score
  using DBS filter paper

Первичные конечные точки

• prevalence of stage I, II and III T1D in screened participants. [Срок оценки: 6 months]
• Rates of screening refusal. [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Rate of completed screened cases [Срок оценки: 12 months]
• Adverse events associated with the screening process [Срок оценки: 6 months]
• Estimated costs for T1D screening per participant. [Срок оценки: 5 years]
• Estimated costs for DKA [Срок оценки: 5 years]
• Parental anxiety from T1D screening [Срок оценки: 1 year]
• Glycemic changes among positively screened participants [Срок оценки: 5 years]

Критерии участия

Критерии включения

• T1D diagnosis in a first-degree relative:

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%.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Саудовская Аравия · 1 центр

• The University Diabetes Centre at King Saud University Medial CIty — Riyadh

Публикации

• Algadi IS, AlRuthia Y, Mujammami MH, Aburisheh KH, Alotaibi M, Al Issa S, Al-Saif AA, Seftel D, Tsai CT, Al Khalifah RA. Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study. JMIR Res Protoc. 2025 Apr 14;14:e70575. doi: 10.2196/70575. PMID 39930327

Идентификаторы

NCT: NCT06513247 · NICS-2024-04-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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