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 of Real-World Experiences in People With Stage 2 Type 1 Diabetes

Age
8 years or above
Gender
All
Phase
N/A
Participants needed
550
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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

The purpose of this research study is to learn about and compare real-world experiences of people in the United States who have a history of stage 2 type 1 diabetes and who either have or have not received a teplizumab infusion. The study will look at topics such as quality of life, diabetes-related anxiety and burden, and how easy or hard diabetes management feels over time.

Participants will not receive a study treatment in this study. The study team will collect information over time to describe and compare the experiences of people who previously received teplizumab by infusion and people who did not. This includes looking at changes over time (such as moving to stage 3 type 1 diabetes), patterns of diabetes misclassification and correct diagnosis, and (when possible) glucose monitoring strategies, insulin use, and health care use.

Who can participate:
People with a history of stage 2 type 1 diabetes in the United States may be able to participate if they:

  • Are 8 years old or older
  • Have stage 2 type 1 diabetes in their medical record, including one or more diabetes-related autoantibodies and abnormal blood sugar (dysglycemia)
  • Have not yet been diagnosed with stage 3 type 1 diabetes, or progressed to stage 3 within the last 18 months
  • Have received medical care in the United States
  • If they previously received teplizumab, were 8 years old or older at the time of the infusion

Study timeline and visits:
Participation lasts up to 5 years (from enrollment through the last data collection for the study).

Updated on 21 Nov 2025. Study ID: NCT07260110

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