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Description of Patients With Type 1 Diabetes Treated With Teplizumab

NCT06892002

CompletedN/A

Sponsor: Sanofi

Conditions: Type 1 Diabetes

Interventions: Teplizumab

Countries: United States, Israel

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (27)

Little Rock, Arkansas, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Carmel, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Morristown, New Jersey, United States
New York, New York, United States
New York, New York, United States
Staten Island, New York, United States
Syracuse, New York, United States
Fargo, North Dakota, United States
Bartlett, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
El Paso, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Petah Tikva, Israel
Ramat Gan, Israel
Tel Aviv, Israel