RecruitingNCT07260110

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


Sponsor

Sanofi

Enrollment

550 participants

Start Date

Oct 31, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking real-world outcomes in people with stage 2 type 1 diabetes — meaning they have immune markers and abnormal blood sugar but have not yet developed full diabetes symptoms — to compare those who received teplizumab (an immune-modifying drug that can delay disease progression) with those who did not. **You may be eligible if...** - You are 8 years or older - You have a confirmed history of stage 2 type 1 diabetes (positive diabetes autoantibodies and abnormal blood sugar patterns) - You receive medical care in the United States - You have not yet progressed to stage 3 (full diabetes), OR you progressed within the last 18 months **You may NOT be eligible if...** - You were diagnosed with stage 3 type 1 diabetes more than 18 months ago - You are unable to participate in study visits or data collection - You do not meet the diabetes staging criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTeplizumab

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


Locations(1)

Investigational Site

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07260110


Related Trials