Summary

Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

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

Keywords

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

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Diabetes and Endocrine Treatment Specialists accepting new patients
    Sandy Utah 84093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT06892002
Study Type
Observational
Participants
Expecting 100 study participants
Last Updated