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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of stage I, II and III T1D in screened participants. | 6 months | |
| Rates of screening refusal. | measured as number of participants that they refused to be screened. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of completed screened cases | measured as number of participants who complete the screening. | 12 months |
| Adverse events associated with the screening process | 6 months |
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Inclusion Criteria:
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:
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2-18 years old health children with first-degree relatives with T1D.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Modi Alrashid | Contact | +966555834797 | ralkhalifah@ksu.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Diabetes Centre at King Saud University Medial CIty | Recruiting | Riyadh | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39930327 | Derived | 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. |
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The data is available from the PI upon reasonable request and approval by the IRB.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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HLA phenotyping and genetic risk score
| Estimated costs for T1D screening per participant. | 5 years |
| Estimated costs for DKA | 5 years |
| Parental anxiety from T1D screening | measured by the generalized anxiety disorder -7 scale (GAD-7) | 1 year |
| Glycemic changes among positively screened participants | measured by oral glucose tolerance test | 5 years |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |