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Observational Study of Teplizumab in Stage 2 Type 1 Diabetes

This study is looking at the real-world experiences of people with Stage 2 Type 1 Diabetes. It compares those who have received Teplizumab (a drug) with those who have not. Researchers want to understand how Teplizumab affects daily life, including how easy it is to manage diabetes, overall well-being, and anxiety. This is an observational study, meaning you won't receive any new treatment through the study; instead, researchers will gather information from your regular medical care over about five years. You may be eligible if you are 8 years or older, have Stage 2 Type 1 Diabetes (meaning you have certain antibodies and abnormal blood sugar levels), and have not yet been diagnosed with Stage 3 Type 1 Diabetes, or progressed within the last 18 months.

Study design
This is an observational study involving about 550 participants. It compares the experiences of people who have received Teplizumab with those who have not, without administering any treatment.
What's involved
You would participate in surveys every 6 months for up to approximately 5 years. These surveys will ask about your diabetes management, psychological well-being, and anxiety.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 5 years, with survey responses collected every 6 months during this period.

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NCT07260110

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

Recruiting
Not specifiedAges 8+Observational
Sanofi
~550 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Teplizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions
Measured over From baseline, repeated every 6 months up to end of study, approximately 5 years
+7 more outcomes measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questionsFrom baseline, repeated every 6 months up to end of study, approximately 5 years
  • Change in participant and caregiver-reported outcomes from survey responses: Psychological well-being World Health Organization-5 (WHO-5)From baseline, repeated every 6 months up to end of study, approximately 5 years
  • Change in participant and caregiver-reported outcomes from survey responses: State-Trait Anxiety Inventory (STAI)From baseline, repeated every 6 months up to end of study, approximately 5 years
  • Change in participant and caregiver-reported outcomes from survey responses: Type 1 Diabetes Distress Assessment System-Core Scale (T1-DDAS CORE)From baseline, repeated every 6 months, up to end of study, approximately 5 years
  • Change in participant and caregiver-reported outcomes from survey responses: Diabetes constraints scaleFrom baseline, repeated every 6 months up to end of study, approximately 5 years
  • Sociodemographic screening characteristicsAt enrollment
  • Sociodemographic medical history characteristicsAt enrollment
  • Sociodemographic diabetes management characteristicsAt enrollment