Clinical trial Recruiting at 1 site Observational Ages 2 to 18

Screening program for early detection of Type 1 Diabetes in high-risk children

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

Run by King Saud University · NCT06513247 · Data updated 2026-11-12

This study is testing a new screening program to find early signs of Type 1 Diabetes in children who have a family member with the condition, so they can get help sooner.

Quick facts

Study typeObservational
Ages2 Years to 18 Years
SexAll
Enrollment1300 (estimated)
SponsorKing Saud University
Academic / other
Locations1 site (Riyadh)
StatusRecruiting
StartedMay 26, 2024
Main results expectedMay 2025
Study endsMay 2029
Registry record updatedJuly 22, 2024
Trial IDNCT06513247 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children with a first-degree relative diagnosed with Type 1 Diabetes.

Probably not a fit

Patients who may not benefit from this study include those with Maturity-Onset Diabetes of the Young (MODY) or Type 2 Diabetes Mellitus (T2DM), as well as non-Saudi children.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to implement a screening program for Type 1 Diabetes (T1D) in children who have a first-degree relative diagnosed with the condition. The program focuses on identifying genetic and immunological markers that indicate a high risk for developing T1D, allowing for early intervention and education on symptom awareness. By screening for islet autoantibodies, HLA phenotypes, and genetic risk scores, the study seeks to improve early detection and potentially delay the onset of T1D in this vulnerable population. The initiative addresses the lack of established screening programs in Saudi Arabia, where T1D incidence is notably high.

Why it matters

Potential benefit: If successful, this program could significantly reduce the incidence of Type 1 Diabetes in high-risk children through early detection and intervention.

How similar studies have gone: Other studies have shown success with similar screening approaches for Type 1 Diabetes, indicating the potential effectiveness of this program.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The University Diabetes Centre at King Saud University Medial CIty
    Riyadh, Saudi Arabia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.