Description of Patients With Type 1 Diabetes Treated With Teplizumab

Study on Medication Use for Type 1 Diabetes

Recruiting
All
Phase N/A
100 participants needed
4 Locations

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
  • 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.

Updated on 25 Mar 2025. Study ID: NCT06892002

This study investigates the use of an investigational medication in people with Type 1 diabetes, a condition where the body's immune system attacks the cells in the pancreas that produce insulin. Type 1 diabetes is 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.

Participants in this study will have received at least one day of treatment with the investigational medication. The study will collect information on how patients were managed after receiving this treatment. This will help researchers understand the effects of the investigational medication in routine care.

  • Who can participate: Individuals, including those under 18 with consent, who have received at least one day of treatment with the investigational medication can participate. Those currently in another interventional study are not eligible.
  • Study details: Participants will provide information about their experience with the investigational medication. This will involve sharing details about their treatment and management after receiving the medication.

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