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

Study on Experiences of Individuals with Type 1 Diabetes (Stage 2)

Recruiting
8 years or above
All
Phase N/A
550 participants needed
1 Location

Study Overview

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

Study Details

Each participant is expected to participate in the study from the time of their enrollment through the last data delivery, which is estimated to occur five years after the first participant is enrolled.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 1 Diabetes
  • Age: 8 years or above
  • Gender: All

Inclusion Criteria:

  • History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record
  • At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment
  • Aged 8 or older at the time of enrollment
  • Aged 8 or older at the time of teplizumab infusion (if infused)
  • Receipt of medical care in the United States
  • Able to and does give written informed consent

Exclusion Criteria:

  • Failure to complete the baseline survey

This study investigates the experiences of individuals with stage 2 Type 1 diabetes in the United States. The study compares those who have received an infusion with an investigational medication and those who have not.

Participants will provide information on their quality of life, diabetes-related anxiety, and how they manage their diabetes. The study will also look at how often diabetes is misclassified, the use of glucose monitoring, insulin use, and healthcare resources over time. This is an observational study, meaning data is collected by observing participants receiving routine care, without changing their treatment.

  • Who can participate: Individuals aged 8 or older with stage 2 Type 1 diabetes, confirmed by one or more diabetes-related autoantibodies and dysglycemia in their medical record, are eligible. They must not have progressed to stage 3 Type 1 diabetes unless it occurred within the last 18 months, receive medical care in the United States, and be able to provide informed consent.
  • Study details: Participants will be observed over time to collect data on their experiences with diabetes management. They will share information about their health-related quality of life and diabetes management practices. This study involves no changes to their current treatment.
  • Study timelines: The study will last 5 years.
Updated on 03 Dec 2025. Study ID: NCT07260110

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