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A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
TEPLIzumab: QUality of Life Evaluation During Stage Transition
Who can join
Ages 8 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record * At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment * Aged 8 or older at the time of enrollment * Aged 8 or older at the time of teplizumab infusion (if infused) * Receipt of medical care in the United States * Able to and does give written informed consent Exclusion Criteria: \- Failure to complete the baseline survey
About the study
This study is an observational, longitudinal, non-interventional real-world study in the United States. The study is meant to describe the experience of participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab and the experience of participants with stage 2 type 1 diabetes who have not been infused with teplizumab, and to compare descriptively the experiences of the two groups.
Primary Objective:
\- To characterize health related quality of life, diabetes-related anxiety, diabetes-related burden, and ease of diabetes management, and how participants feel, form and function in those who infused and those who did not infuse with teplizumab
Secondary Objectives:
* To show the clinical transitions experienced by those who infused and those who did not infuse with teplizumab * To describe the prevalence and timing of diabetes misclassification and the temporal patterns between misclassification, antibody testing, and the correct diagnosis of type 1 diabetes in those who infused and those who did not infuse with teplizumab * To estimate the impact of diagnostic misclassification on the timing of progression to stage 3 type 1 diabetes in those who infused and those who did not infuse with teplizumab * To characterize glucose monitoring strategies in those who infused and those who did not infuse with teplizumab where possible * To characterize insulin use in those who infused and those who did not infuse with teplizumab where possible * To characterize longitudinal health care resource utilization in those who infused and those who did not infuse with teplizumab
What is being tested
- Teplizumab (drug)
Sponsor: Sanofi · Participants: 550 · Started: Oct 31, 2025
Contact the study team
- Trial Transparency email recommended (Toll free for US & Canada) · Phone: 800-633-1610
- PicnicHealth For potential study participants · Phone: 415-680-3085
Official record on ClinicalTrials.gov — NCT07260110
Locations in the U.S.
| California | Investigational Site, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.