NCT07038473

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

June 6, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

December 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

June 6, 2025

Last Update Submit

February 17, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D

    Stage 1 is defined by the presence of two or more diabetes-related autoantibodies with normoglycemia. Stage 2 is characterized by the presence of two or more diabetes-related autoantibodies with dysglycemia (impaired fasting glucose or impaired glucose tolerance) but without clinical symptoms of diabetes

    At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)

Secondary Outcomes (3)

  • Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis

    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

    At Baseline (screening visit)

  • Acceptance rate - ratio of patients proposed for screening who accepted autoantibody testing and follow-up monitoring

    At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)

Study Arms (1)

Children, adolescents and first-degree relatives of T1D probands

OTHER

Blood samples will be collected from the participants and autoantibody testing will be performed. For participants who test positive for any autoantibodies, another autoantibody test and HbA1C test and Oral Glucose Tolerance Test (OGTT) or CGM (Continuous Glucose Monitoring) will be performed

Procedure: Investigational Procedure

Interventions

Investigational ProcedurePROCEDURE

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.

Children, adolescents and first-degree relatives of T1D probands

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and adolescents, age 1.5 years to 18 years
  • First degree relatives of T1D probands
  • Parent or legal guardian signing an informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Abdulaziz Medical City, National Guard Hospital, Jeddah - Site Number: 01

Jeddah, Mecca Region, Saudi Arabia

RECRUITING

Sheikh Shakhbout Medical City - Site Number: 06

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610Contact-US@sanofi.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 26, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

SA(1)AE(1)