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 type | Observational |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 1300 (estimated) |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh) |
| Status | Recruiting |
| Started | May 26, 2024 |
| Main results expected | May 2025 |
| Study ends | May 2029 |
| Registry record updated | July 22, 2024 |
| Trial ID | NCT06513247 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
- Study coordinator: Modi Alrashid
- Email: ralkhalifah@ksu.edu.sa
- Phone: +966555834797
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity
This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.
-
Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes
This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.
-
CGM-guided carb awareness education for adults with Type 1 diabetes
This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.
-
Safety and effectiveness of GLP-1 receptor agonists and SGLT inhibitors added to insulin in adults with type 1 diabetes
This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.
-
Think-Find-Solve activities for insulin self-management in children with type 1 diabetes
A behavior-change activity book is tested with children aged 8–12 with type 1 diabetes and their parents to see if it improves daily insulin self-management.
-
Near-sensor insulin delivery with CGM in people with type 1 diabetes
A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.