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NCT Number: NCT06513247

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

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University Diabetes Centre at King Saud University Medial CIty

Riyadh, Saudi Arabia

Location status: Recruiting

Location contact

Iman Algadi

CONTACT

[email protected]

Iman Algadi

PRINCIPAL_INVESTIGATOR

Khaled Aburisheh

SUB_INVESTIGATOR

Reem Al Khalifah

CONTACT

[email protected]

Reem Al Khalifah

PRINCIPAL_INVESTIGATOR

Yazed AlRuthia

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

screening for Islet autoantibody

Diagnostic Test

IAA, GADA, IA-2A, Zn-transporter 8 autoantibodies

HLA phenotype and genetic risk score

Diagnostic Test

using DBS filter paper

Primary outcomes

  1. prevalence of stage I, II and III T1D in screened participants.

    Time frame: 6 months

  2. Rates of screening refusal.

    Time frame: 6 months

    measured as number of participants that they refused to be screened.

Secondary outcomes

  1. Rate of completed screened cases

    Time frame: 12 months

    measured as number of participants who complete the screening.

  2. Adverse events associated with the screening process

    Time frame: 6 months

  3. Estimated costs for T1D screening per participant.

    Time frame: 5 years

  4. Estimated costs for DKA

    Time frame: 5 years

  5. Parental anxiety from T1D screening

    Time frame: 1 year

    measured by the generalized anxiety disorder -7 scale (GAD-7)

  6. Glycemic changes among positively screened participants

    Time frame: 5 years

    measured by oral glucose tolerance test

Study contacts

Contact information is provided by the study sponsor or research team.

Modi Alrashid

CONTACT

[email protected]

+966555834797

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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