BRIGHTBT-001 para un mejor control glucémico en adultos con diabetes tipo 2

This study is a large, multi-center trial focusing on adults with type 2 diabetes. The main goal is to test if a new treatment called BT-001, when used alongside usual care, can improve blood sugar control in real-world settings. The importance of this study lies in its potential to enhance diabetes management, addressing the need for better glycemic control strategies. Approximately 500 adults with type 2 diabetes will participate, randomly assigned to either BT-001 or a control group. During the trial, most clinical data will be gathered from electronic medical records, with limited additional contacts for safety monitoring. The primary outcomes include changes in HbA1c levels, a key indicator of blood sugar control, and occurrences of adverse events. For HbA1c assessment, a lab requisition form will be provided if the data is not available from the records. In the extension phase, biomarker data will only be collected from the records. Clinical and healthcare utilization data will be extracted from the records, covering the period from 180 days before enrollment to 720 days after enrollment.