A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
← catalyst calendarNCT07260110 · readout in 1,566 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
550estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-31 | actual | When the study began enrolling |
| Primary completion | 2030-12-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-12-03 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Type 1 Diabetes
Intervention
- Drug: Teplizumab — also filed as TZIELD
Primary outcomes
what the primary-completion date above is the date OFChange in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions
measured From baseline, repeated every 6 months up to end of study, approximately 5 years
Change in participant and caregiver-reported outcomes from survey responses: Psychological well-being World Health Organization-5 (WHO-5)
measured From baseline, repeated every 6 months up to end of study, approximately 5 years
Change in participant and caregiver-reported outcomes from survey responses: State-Trait Anxiety Inventory (STAI)
measured From baseline, repeated every 6 months up to end of study, approximately 5 years
Change in participant and caregiver-reported outcomes from survey responses: Type 1 Diabetes Distress Assessment System-Core Scale (T1-DDAS CORE)
measured From baseline, repeated every 6 months, up to end of study, approximately 5 years
Change in participant and caregiver-reported outcomes from survey responses: Diabetes constraints scale
measured From baseline, repeated every 6 months up to end of study, approximately 5 years
Sociodemographic screening characteristics
measured At enrollment
Sociodemographic medical history characteristics
measured At enrollment
Sociodemographic diabetes management characteristics
measured At enrollment
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