Description of Patients With Type 1 Diabetes Treated With Teplizumab (TEPLI-REAL)
Investigation of Type 1 Diabetes Management with Investigational Treatment for Type 1 Diabetes
Study Overview
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes
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Gender: All
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.
This study investigates the management of Type 1 diabetes, a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels. The study focuses on patients who have received an investigational medication, aiming to understand how these patients are managed after treatment.
The study will collect data on patients who have received the investigational medication as part of their routine care. This involves observing how the treatment is administered and managed in real-world settings, without altering the standard treatment procedures. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
- Who can participate: Participants must have received at least one day of the investigational medication treatment and provided informed consent or assent if under 18. They should not be involved in any interventional clinical study at the time of participation.
- Study details: Participants will be observed as they receive routine care with the investigational medication, without any changes to their standard treatment procedures.
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