COMPLETED

Description of Patients With Type 1 Diabetes Treated With Teplizumab

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-11
Study Completion:2025-08-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06892002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patient received ≥ 1 day of teplizumab treatment.
  1. * 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.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11
Study Completion Date2025-08-05

Study Record Updates

Study Start Date2025-02-11
Study Completion Date2025-08-05

Terms related to this study

Keywords Provided by Researchers

  • Teplizumab
  • Type 1 Diabetes
  • Real-world study
  • Stage 2 Type 1 Diabetes
  • Stage 3 Type 1 Diabetes
  • Disease progression
  • Treatment patterns
  • Patient monitoring

Additional Relevant MeSH Terms

  • Type 1 Diabetes