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Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab
  • Drug: Teplizumab
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Recruiting Locations

Investigational Site Number: 8400003
Atlanta, Georgia 30318-2538

Investigative Site Number: 8400004
Atlanta, Georgia 30329-3102

Investigative Site Number: 8400002
Syosset, New York 11791

Investigational Site Number: 8400005
Sandy City, Utah 84093

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.