Actively Recruiting

Age: 8Years +
All Genders
NCT07260110

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

Led by Sanofi · Updated on 2025-12-03

550

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of stage 2 type 1 diabetes with one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record
  • At enrollment, not yet diagnosed with stage 3 type 1 diabetes or diagnosed within the last 18 months
  • Aged 8 years or older at enrollment
  • Aged 8 years or older at time of teplizumab infusion (if applicable)
  • Receiving medical care in the United States
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Failure to complete the baseline survey

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Investigational Site

San Francisco, California, United States, 94107

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

P

PicnicHealth For potential study participants

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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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 | DecenTrialz