Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational Procedure.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 18 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia, United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Islet Autoantibody Early Detection in At-risk Children/Adolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries
Overview
The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).
Interventions
- Procedure Investigational Procedure
It consists of prospective blood sample collection from children, adolescents and first-degree relatives of T1D probands. Study without any Investigational Medicinal Product (IMP) administration.
Primary outcome measures
- Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D [Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)]
Secondary outcome measures (3)
- Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis [Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)]
- Refusal rate - ratio of patients proposed for screening who did not accept autoantibody testing and follow-up monitoring [Time frame: At Baseline (screening visit)]
- Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring [Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)]
Eligibility criteria
Inclusion criteria
- Children and adolescents, age 1.5 years to 18 years
- First degree relatives of T1D probands
- Parent or legal guardian signing an informed consent
Exclusion criteria
- Already developed clinical overt T1D
- Known diabetes of any kind (type 1, type 2, Maturity Onset Diabetes of the Young - MODY)
- Have a previous history of being treated with insulin
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Saudi Arabia · 1 center
- King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01 — Jeddah
United Arab Emirates · 1 center
- Sheikh Shakhbout Medical City - Site Number: 06 — Abu Dhabi
Identifiers
NCT: NCT07038473 · PIR18651 · U1111-1319-5409