TEPLI-REALTeplizumab Use in Type 1 Diabetes Patients
Data Collection
Collected from past medical records and data - RetrospectiveAutoimmune Diseases+9
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 11, 2025
Actual date on which the first participant was enrolled.This study focuses on Type 1 Diabetes Mellitus (T1D), a chronic condition where the immune system attacks the pancreas' beta cells, leading to insulin deficiency. T1D progresses in three stages, from the presence of autoantibodies without symptoms, to dysglycemia, and finally to overt hyperglycemia and symptoms, typically requiring insulin treatment. Teplizumab, a drug approved in the USA, has shown to delay progression to the final stage in patients at stage 2. This observational study aims to gather data on the use of Teplizumab in routine care, helping to understand which patients receive the drug and how they are managed post-treatment, especially for patients outside the USA who receive it through special programs. Participants in this study will have their blood glucose levels monitored using Continuous Glucose Monitoring (CGM) systems. The study will also record participant demographics at the start of Teplizumab treatment, including age, sex at birth, height, weight, and Body Mass Index (BMI). Additionally, it will document the participants' family history of T1D and other autoimmune diseases, their medical history related to T1D, and the presence of T1D susceptibility genes. The study will evaluate these factors to better understand the effects and outcomes of Teplizumab treatment in real-world scenarios.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.110 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 27 locations
Arkansas Children's Hospital Research Institute
Little Rock, United StatesOpen Arkansas Children's Hospital Research Institute in Google MapsUniversity of California, San Francisco
San Francisco, United StatesBarbara Davis Center For Childhood Diabetes
Aurora, United StatesChildren's National Medical Center
Washington D.C., United States