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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Diagnostic test: screening for Islet autoantibody; Diagnostic test: HLA phenotype and genetic risk score

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Modi Alrashid; Phone Number: +966555834797; Email: ralkhalifah@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • The University Diabetes Centre at King Saud University Medial CIty
    • Contact: Reem Al Khalifah; Email: ralkhalifah@ksu.edu.sa
    • Contact: Iman Algadi; Email: ialgadi@ksu.edu.sa
    • Principal Investigator: Reem Al Khalifah
    • Principal Investigator: Iman Algadi
    • Sub-Investigator: Khaled Aburisheh
    • Sub-Investigator: Yazed AlRuthia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: early detection; screening; ADAP
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Immunologic Factors; Autoantibodies
• Other Study ID Numbers: NICS-2024-04-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data is available from the PI upon reasonable request and approval by the IRB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No