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Type 1 DiabetesNCT06513247

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

An observational study of Type 1 Diabetes, run by King Saud University at 1 site in Saudi Arabia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
screening for Islet autoantibody and HLA phenotype and genetic risk score
How many people
1,300 participants
Where
1 siteSaudi Arabia
Study dates
26 May 2024to May 2029
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • Child, Adult

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

Who may be able to join

  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Modi Alrashid contact

+966555834797

ralkhalifah@ksu.edu.sa

Saudi Arabia1 site, 1 recruiting

  • The University Diabetes Centre at King Saud University Medial CIty

    Riyadh

    Reem Al Khalifah, ralkhalifah@ksu.edu.sa

    Iman Algadi, ialgadi@ksu.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: 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.
Conditions
Type 1 Diabetes
Being tested
screening for Islet autoantibody, HLA phenotype and genetic risk score
Keywords
screening, early detection, ADAP
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • screening for Islet autoantibodyDiagnostic test

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

  • HLA phenotype and genetic risk scoreDiagnostic test

    using DBS filter paper

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of stage I, II and III T1D in screened participants.

    Measured: 6 months

  2. Rates of screening refusal.

    measured as number of participants that they refused to be screened.

    Measured: 6 months

Secondary outcomes (6)

  1. Rate of completed screened cases

    measured as number of participants who complete the screening.

    Measured: 12 months

  2. Adverse events associated with the screening process

    Measured: 6 months

  3. Estimated costs for T1D screening per participant.

    Measured: 5 years

  4. Estimated costs for DKA

    Measured: 5 years

  5. Parental anxiety from T1D screening

    measured by the generalized anxiety disorder -7 scale (GAD-7)

    Measured: 1 year

  6. Glycemic changes among positively screened participants

    measured by oral glucose tolerance test

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start26 May 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,300 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06513247
Sponsor's protocol ID
NICS-2024-04-04
Status last verified
Jul 2024
First submitted
7 Jul 2024
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data is available from the PI upon reasonable request and approval by the IRB.

Publications

  • 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.

    PubMed 39930327

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by King Saud University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Modi Alrashid (+966555834797, ralkhalifah@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of stage I, II and III T1D in screened participants. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06513247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.

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