Completed

TEPLI-REALTeplizumab Use in Type 1 Diabetes Patients

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Autoimmune Diseases+9

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 11, 2025

Actual date on which the first participant was enrolled.

This study focuses on Type 1 Diabetes Mellitus (T1D), a chronic condition where the immune system attacks the pancreas' beta cells, leading to insulin deficiency. T1D progresses in three stages, from the presence of autoantibodies without symptoms, to dysglycemia, and finally to overt hyperglycemia and symptoms, typically requiring insulin treatment. Teplizumab, a drug approved in the USA, has shown to delay progression to the final stage in patients at stage 2. This observational study aims to gather data on the use of Teplizumab in routine care, helping to understand which patients receive the drug and how they are managed post-treatment, especially for patients outside the USA who receive it through special programs. Participants in this study will have their blood glucose levels monitored using Continuous Glucose Monitoring (CGM) systems. The study will also record participant demographics at the start of Teplizumab treatment, including age, sex at birth, height, weight, and Body Mass Index (BMI). Additionally, it will document the participants' family history of T1D and other autoimmune diseases, their medical history related to T1D, and the presence of T1D susceptibility genes. The study will evaluate these factors to better understand the effects and outcomes of Teplizumab treatment in real-world scenarios.

Official TitleA Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab
NCT06892002
Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease ProgressionDisease AttributesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Patient informed consent or assent (for patients < 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.

Patient received ≥ 1 day of teplizumab treatment.

1 exclusion criteria prevent from participating
Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Suspended

Arkansas Children's Hospital Research Institute

Little Rock, United StatesOpen Arkansas Children's Hospital Research Institute in Google Maps
Suspended

University of California, San Francisco

San Francisco, United States
Suspended

Barbara Davis Center For Childhood Diabetes

Aurora, United States
Suspended

Children's National Medical Center

Washington D.C., United States
Completed27 Study Centers
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