Long-term outcomes of teplizumab for type 1 diabetes in routine care
Follows people with early type 1 diabetes who receive teplizumab in routine care.
Plain-language title generated from the registry record
Registry title: Long-Term Outcomes of Teplizumab in Routine Clinical Care
Key facts
- Where
- Atlanta, New York, Sandy City, Syosset, and Washington D.C., United StatesSee the 6 sites
Where in United States
- AtlantaAtlanta, United StatesTaking people
- AtlantaAtlanta, United StatesTaking people
- New YorkNew York, United StatesTaking people
- Sandy CitySandy City, United StatesTaking people
- SyossetSyosset, United StatesTaking people
- Washington D.C.Washington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07360080
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
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.
Inclusion: 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: 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.