Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
This study is reviewing information from people with Type 1 diabetes who received a treatment called teplizumab through special early access programs in various countries. It's like looking back at patient records to understand how teplizumab was used in real-life situations. The main goals are to learn about the characteristics of these patients, how their Type 1 diabetes was monitored, and the treatment approaches that were taken. By gathering this information, researchers hope to quickly gain insights into who received teplizumab and how it was used in general practice. This can help improve understanding of the treatment and identify common trends among patients.
At a glance
What is this study about?
This study is called a 'Real-World Study' because it looks at how a specific treatment, teplizumab, has been used by people with Type 1 diabetes in everyday medical practice, rather than in a highly controlled research setting. Teplizumab is a treatment that some people with Type 1 diabetes have received through special early access schemes, which allow certain patients to get a new medication before it's widely available. The study is gathering information from multiple hospitals and clinics across different countries, including the UK.
The main purpose is to understand more about the patients who received teplizumab and how their Type 1 diabetes was managed. Researchers will be reviewing existing patient records to see things like the age of the patients, other health conditions they might have had, and how their diabetes progressed over time. They also want to understand the different ways doctors monitored and treated these patients.
By collecting this information, the study hopes to quickly build a picture of how teplizumab has been used in real life. This helps medical professionals and researchers learn more about the treatment's use in a broader group of people than typically seen in clinical trials, giving valuable insights into the everyday experience of patients receiving it.
Key takeaways
- This study looks at real-world data from patients who received teplizumab for Type 1 diabetes.
- It aims to understand how teplizumab was used and who received it through early access schemes.
- No new treatments, clinic visits, or tests are involved for patients.
- The study reviews existing medical records, making it a safe way to gather information.
- Findings could help improve understanding and care for people with Type 1 diabetes.
- Privacy is protected as personal identifying information is removed.
Who may be eligible?
To be included in this study, patients would have already needed to receive at least one dose of teplizumab through one of the Managed Access Programs (MAPs). These programs are specific pathways that allow some patients to access certain medicines early.
Also, a patient (or their parent/guardian if they were under 18) needed to have given their permission for their medical information to be used for this study, following local rules.
Patients would not be included if they were taking part in another active clinical trial that involved a new treatment or procedure at the time they received teplizumab. This is because participation in another trial might affect the observations in this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did you receive teplizumab for Type 1 diabetes through an early access program?
- Did you (or your parent/guardian) give permission for your medical records to be used for research?
- Were you NOT part of another active clinical trial testing a new medicine or procedure when you received teplizumab?
What does participation involve?
This study is looking back at existing medical records, so you wouldn't need to do anything extra if you were included. There are no new visits, assessments, or medications involved. It's about reviewing information that has already been collected during your routine medical care. The study period covers the time you might have received teplizumab and relevant follow-up from your medical records. You would simply have given consent (or your parent/guardian for those under 18) for your existing de-identified medical information to be used.
Potential risks and benefits
Locations (11)
- Investigational Site Number: 0560001Verified postcodeLeuven, Belgium· Recruiting
- Investigational Site Number: 2500001Verified postcodeBron, France· Recruiting
- Investigational Site Number: 2500003Verified postcodeParis, France· Recruiting
- Investigational Site Number: 2500002Verified postcodeParis, France· Recruiting
- Investigational Site Number: 3800001Verified postcodeAncona, Italy· Recruiting
- Investigational Site Number: 3800003Verified postcodePalermo, Italy· Recruiting
- Investigational Site Number: 7240001Verified postcodeMadrid, Spain· Recruiting
- Investigational Site Number: 7240002Verified postcodeMadrid, Spain· Recruiting
- Investigational Site Number: 7240003Verified postcodeZaragoza, Spain· Recruiting
- Investigational Site Number: 8260001Verified postcodeBirmingham, United Kingdom· Recruiting
- Investigational Site Number: 8260002Verified postcodeLondon, United Kingdom· Recruiting
Common questions
What is Type 1 diabetes?
Type 1 diabetes is a condition where the body's immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.
What is teplizumab?
Teplizumab is a medication that has been used to help delay the progression of Type 1 diabetes in some individuals by affecting the immune system.
What are Managed Access Programs (MAPs)?
MAPs are special schemes that allow certain patients to access a new medicine before it is widely available, usually when there is a significant medical need.
Will this study require me to visit a clinic?
No, this study is reviewing existing patient records, so you would not need to have any extra visits to a clinic or hospital.
How will my privacy be protected?
The study will use anonymised or de-identified information from your records, meaning your personal details will be removed so you cannot be identified.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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