An interventional study of Investigational Procedure in Type 1 Diabetes, sponsored by Sanofi. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Sanofi · Not applicable, Interventional, and Diagnostic
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).
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
Time frame: At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)
Proportion of participants who meet the criteria for Stage 3 Type 1 Diabetes (T1D) diagnosis
Stage 3 is defined by the presence of two or more diabetes-related autoantibodies, abnormal blood glucose levels, and clinical symptoms of T1D, such as polyuria, polydipsia, weight loss, and fatigue
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)
Plan to share: Yes — 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
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jun 2027, 18 months after the start.
Of 105 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 18 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Dec 2026 → Jun 2027 and completion Dec 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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