Long-Term Outcomes of Teplizumab in Routine Clinical Care

Investigating Long-Term Outcomes of Investigational Medication in Stage 2 Type 1 Diabetes

Recruiting
All
Phase N/A
1000 participants needed
4 Locations

Study Overview

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

Study Details

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

Eligibility Criteria

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

  • Conditions: Type 1 Diabetes
  • Gender: All

Inclusion Criteria -

  • Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
  • Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.

(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)

• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.

Exclusion Criteria -

  • Participants who had participated in a previous clinical trial for teplizumab.
  • Participants enrolled in a clinical trial within 6 months prior to study enrollment.

(Note: Participants enrolled in other observational studies may be included.)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates the outcomes of an investigational medication in individuals with Stage 2 Type 1 Diabetes. This study will observe the effects of the medication in delaying the onset of Stage 3 Type 1 Diabetes.

The study will focus on evaluating the impact of the medication on participants' quality of life, including emotional and psychosocial aspects. It provides insights into the long-term management of Type 1 Diabetes across diverse populations.

  • Who can participate: Participants must have received at least one infusion of the investigational medication within six weeks prior to enrollment and have a confirmed diagnosis of Stage 2 Type 1 Diabetes. Consent must be provided by participants or their legal guardians.
  • Study details: Participants will be observed over time to understand the medication's impact on their lives. The study will include assessments of quality of life and emotional well-being.
  • Study timelines: The study will last up to 10 years.
Updated on 22 May 2026. Study ID: NCT07360080

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