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Compares everyday experiences of people with early type 1 diabetes, with or without teplizumab

Compares daily life of people with early type 1 diabetes, with or without teplizumab.

Key facts

Who runs it
Sanofi
Where
San Francisco, United StatesSee the site
Trial code
Registry 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
Status
Recruiting
People taking part
550 people, planned
Started
31 Oct 2025
Expected to end
3 Dec 2030
Type of study
Observational, 2 groups
Treatments tested
  • Teplizumab
Record updated
3 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 8 or older in the United States with a history of stage 2 type 1 diabetes. Some have had teplizumab infusions and some have not.

Age
8 years or older
Sex
All sexes can join.
Disease stage
History of stage 2 type 1 diabetes, with one or more diabetes-related autoantibodies and abnormal blood sugar confirmed in the medical record. Not yet diagnosed with stage 3 type 1 diabetes, or progressed to stage 3 in the last 18 months before enrollment.
Earlier treatment
People who had teplizumab infusions and people who did not can both join. Those who had teplizumab were aged 8 or older at the infusion.
Biomarker or test result
One or more diabetes-related autoantibodies, confirmed in the medical record.

Main reasons for not taking part

  • Did not complete the baseline survey
  • Does not receive medical care in the United States
  • Cannot give written informed consent

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Failure to complete the baseline survey

Where in United States

  • San Francisco, CaliforniaHospital not named in the registryContact: PicnicHealth For potential study participantsTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Participants with a history of teplizumab infusion

    Participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab at the time of enrollment

    Treatment: Teplizumab

  • Participants with no history of teplizumab infusion

    Participants with stage 2 type 1 diabetes who have not been infused with teplizumab at the time of enrollment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
TEPLIzumab: QUality of Life Evaluation During Stage Transition
Plain-language title
Compares everyday experiences of people with early type 1 diabetes, with or without teplizumabGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 December 2025