Long-Term Outcomes of Teplizumab in Routine Clinical Care
Study of Long-Term Outcomes After Treatment for Stage 2 Type 1 Diabetes
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.
The purpose of this research study is to learn about long-term outcomes after treatment in people with Stage 2 type 1 diabetes. The study will also collect patient-reported outcomes to understand how treatment may affect quality of life, including emotional and social well-being.
Participants will receive treatment as part of their routine clinical care. The study team will follow participants over time after they have started treatment and will collect information about outcomes, including questionnaires about quality of life.
Who can participate:
People with Stage 2 type 1 diabetes may be able to participate if they:
- Have received at least one infusion of the treatment within the past 6 weeks
- Were diagnosed with Stage 2 type 1 diabetes by their treating doctor at the time of their first infusion (people who progress to Stage 3 by week six can still be eligible if they were Stage 2 at their first infusion)
- Have not been in a previous research study of this same treatment
- Have not been enrolled in another clinical trial within the past 6 months (people in other observational studies may be included)
Study timeline and visits:
Participation lasts up to 10 years, depending on when a person joins the study after starting treatment.
Find a study site near you
,
Send a message
Enter your contact details to connect with study team
Primary Contact
Please choose between Voice or SMS based delivery of verification code
or