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

NCT06513247 | Recruiting

• 1 other identifier: NICS-2024-04-04
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Islet autoantibodies: IAA, GADA, IA-2A, Zn-transporter autoantibodies using the antibody detection by agglutination PCR (ADAP) assay.
2. 2.HLA phenotyping
3. 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.

Conditions

Type 1 Diabetes

Keywords

screening; early detection; ADAP

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Rate of completed screened cases

  12 months

• Adverse events associated with the screening process

  6 months

• Estimated costs for T1D screening per participant.

  5 years

• Estimated costs for DKA

  5 years

• Parental anxiety from T1D screening

  1 year

Interventions

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2-18 years old health children with first-degree relatives with T1D.

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• Sanofi: collaborator

Study Sites (1)

The University Diabetes Centre at King Saud University Medial CIty

Riyadh, Saudi Arabia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39930327 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

HLA phenotyping and genetic risk score

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Modi Alrashid

CONTACT

+966555834797; ralkhalifah@ksu.edu.sa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 22, 2024
• Study Start: May 26, 2024
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

SA (1)