Overview
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
Eligibility
Inclusion Criteria -
- Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
- Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.
(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)
• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
Exclusion Criteria -
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment.
(Note: Participants enrolled in other observational studies may be included.)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.