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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

NCT07260110

RecruitingN/A

Sponsor: Sanofi

Conditions: Type 1 Diabetes

Interventions: Teplizumab

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 8 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

San Francisco, California, United States