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Completed No phase listed Observational

Description of Patients With Type 1 Diabetes Treated With Teplizumab

ClinicalTrials.gov ID: NCT06892002

Public ClinicalTrials.gov record NCT06892002. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Study identification

NCT ID
NCT06892002
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Sanofi
Industry
Enrollment
110 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2025
Primary completion
Aug 4, 2025
Completion
Aug 4, 2025
Last update posted
Aug 14, 2025

2025

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
22
Facility City State ZIP Site status
Arkansas Children's Hospital Research Institute Little Rock Arkansas 72202
University of California, San Francisco San Francisco California 94158
Barbara Davis Center For Childhood Diabetes Aurora Colorado 80045
Children's National Medical Center Washington D.C. District of Columbia 20010
University of Miami Medical Center Miami Florida 33136
USF Diabetes Center Tampa Florida 33612
Doctor's Clinic Vero Beach Florida 32960
Atlanta Diabetes Associates Atlanta Georgia 30318
Childrens Healthcare of Atlanta Atlanta Georgia 30329
Riley Hospital for Children Carmel Indiana 46032
University of Louisville Louisville Kentucky 40202
Boston Children's Hospital Division of Endocrinology Boston Massachusetts 02115
Atlantic Health Morristown New Jersey 07960
Hassenfeld Children's Hospital at NYU Langone New York New York 10016
Morgan Stanley Children's Hospital New York New York 10032
Ten's Medical PC Staten Island New York 10306
SUNY Upstate Medical University PARENT Syracuse New York 13210
Sanford Research/USD Fargo North Dakota 58122
AM Diabetes & Endocrinology Center Bartlett Tennessee 38133
Vanderbilt University Medical Center Nashville Tennessee 37232
University of Texas Southwestern Medical Center Dallas Texas 75390
El Paso Medical Research Institute El Paso Texas 79902-4646
University of Utah Hospitals & Clinics Salt Lake City Utah 84108
Diabetes and Endocrine Treatment Specialists Sandy City Utah 84093

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06892002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06892002 live on ClinicalTrials.gov.

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