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

NCT ID: NCT06513247

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-26
• Study Completion Date: 2029-05-31

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

2. HLA phenotyping

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

screening for Islet autoantibody

IAA, GADA, IA-2A, Zn-transporter 8 autoantibodies

Intervention Type: DIAGNOSTIC_TEST

HLA phenotype and genetic risk score

using DBS filter paper

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Reem Al Khalifah

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University Diabetes Centre at King Saud University Medial CIty

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Modi Alrashid

Role: CONTACT

ralkhalifah@ksu.edu.sa

+966555834797

Facility Contacts

Reem Al Khalifah

Role: primary

ralkhalifah@ksu.edu.sa

Iman Algadi

Role: backup

ialgadi@ksu.edu.sa

References

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.

Reference Type: DERIVED

PMID: 39930327 (View on PubMed)

Other Identifiers

NICS-2024-04-04

Identifier Type: -

Identifier Source: org_study_id