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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 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2025-12-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

Teplizumab

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

Sponsors & Collaborators

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2030-12-03
Completion
2030-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260110 on ClinicalTrials.gov