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NCT07260110 · ClinicalTrials.gov registry record

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

A clinical trial of Type 1 Diabetes, sponsored by Sanofi.

Recruiting
Registry status
550
Enrollment target
1
Study location

NCT07260110: Recruiting study of Type 1 Diabetes, sponsored by Sanofi.

NCT07260110 is a study of Type 1 Diabetes that is actively recruiting participants, run by Sanofi. The registered enrollment target is 550 participants, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07260110, a study of Type 1 Diabetes, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
550 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Teplizumab

Study Locations (1)

California

  • Investigational Site - San Francisco

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2025-10-31
Est. Completion 2030-12-03
Sanofi

713 total trials

What NCT07260110 shows while recruiting

NCT07260110 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (28% lower).

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Teplizumab is the first listed.

NCT07260110 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT07260110 about?

NCT07260110 is a clinical study titled "A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the 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...

What is the current status of trial NCT07260110?

This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2025-10-31. Estimated completion is 2030-12-03.

What conditions does trial NCT07260110 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT07260110?

The interventions under investigation include: Teplizumab (DRUG).

Who is sponsoring clinical trial NCT07260110?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07260110 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 1 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07260110's enrollment target sits among peer trials

550 15th of 198 higher than 184 of 198 other Type 1 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07260110, the US trial registry maintained by the National Library of Medicine. NCT07260110 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.