Randomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting

This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.