Screening program for early detection of Type 1 Diabetes in high-risk children
Feasibility of a Pilot Screening Program for Type 1 Diabetes in a High-Risk Population
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 type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT06513247 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children with a first-degree relative diagnosed with Type 1 Diabetes.
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.
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 performed: Other studies have shown success with similar screening approaches for Type 1 Diabetes, indicating the potential effectiveness of this program.
Eligibility criteria
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 this trial is running
Riyadh
- The University Diabetes Centre at King Saud University Medial CIty — Riyadh, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Modi Alrashid
- Email: ralkhalifah@ksu.edu.sa
- Phone: +966555834797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.