Observing patients with Type 1 Diabetes treated with Teplizumab
A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab
This study is looking at how well Teplizumab works and its safety for people with Type 1 Diabetes, especially those in the later stages of the disease, by collecting real-life data from different clinics.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | teplizumab |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT06892002 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Type 1 Diabetes (T1D) who have been treated with Teplizumab, a medication that has shown promise in delaying the progression of the disease. The study aims to collect real-world data on the effectiveness and safety of Teplizumab in patients at different stages of T1D, particularly those at Stage 2 and Stage 3. By gathering information from various clinical sites, the study seeks to enhance understanding of how Teplizumab is utilized in routine practice outside of clinical trials. The findings may provide insights into the long-term outcomes of patients receiving this treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Stage 2 or Stage 3 Type 1 Diabetes who have received at least one day of Teplizumab treatment.
Not a fit: Patients currently participating in other interventional clinical studies may not benefit from this observational study.
Why it matters
Potential benefit: If successful, this study could provide valuable data on the real-world effectiveness of Teplizumab in managing Type 1 Diabetes, potentially improving treatment strategies.
How similar studies have performed: Previous studies have shown success with Teplizumab in delaying the progression of Type 1 Diabetes, indicating that this approach has potential based on earlier clinical trial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient informed consent or assent (for patients \< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity. * Patient received ≥ 1 day of teplizumab treatment. Exclusion Criteria: * Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
Where this trial is running
Atlanta, Georgia and 4 other locations
- Atlanta Diabetes Associates — Atlanta, Georgia, United States (Recruiting)
- Ten's Medical PC — Staten Island, New York, United States (Recruiting)
- AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States (Recruiting)
- El Paso Medical Research Institute — El Paso, Texas, United States (Recruiting)
- Diabetes and Endocrine Treatment Specialists — Sandy, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.