Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes

The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC alone in patients with type 2 diabetes. The screening period will consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility. Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups: Investigational: One half of the participants will be treated with BT-001 plus SOC for 180 days; Control: One half of the participants will be treated with SOC alone for 180 days.