No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for people with Stage 2 Type 1 Diabetes who have recently received teplizumab treatment. Participants will be monitored over time to see how well the treatment helps delay the disease's progression and improve quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have received at least 1 infusion of teplizumab in the last 6 weeks.
I have a confirmed diagnosis of Stage 2 Type 1 Diabetes.
I can provide written or electronic consent.
You may not be able to join if
I have participated in a previous clinical trial for teplizumab.
I have been enrolled in a clinical trial in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 th…
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.
Trial Locations
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Status
Eligibility Criteria
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 progre…
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.
Contacts
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