A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

Part of paid clinical trials in San Francisco, California.

Sponsor
Sanofi
Study ID
NCT07260110
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teplizumab — DRUG
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study Details

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

Key Dates

Start date
Oct 31, 2025
Status verified
Nov 2025
Primary completion
Dec 3, 2030
Completion
Dec 3, 2030

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Participants with a history of teplizumab infusion
    Participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab at the time of enrollment
  • Arm: Participants with no history of teplizumab infusion
    Participants with stage 2 type 1 diabetes who have not been infused with teplizumab at the time of enrollment

Primary Outcome Measure

Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions [ Time Frame: From baseline, repeated every 6 months up to end of study, approximately 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational SiteSan FranciscoCalifornia94107-

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Investigational Site· San Francisco, CA

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