Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes
brief summary
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) in patients with type 2 diabetes.
detailed description
The study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) in patients with type 2 diabetes. The screening period will consist of review of Electronic Health Record (EHR) for participants that meet inclusion criteria and telephonic outreach.
Once confirmed consented, patients will then be given access to BT-001 for 90 days with an opportunity to continue using the product for an additional 275 days.
Participants will continue their standard of care with their provider in addition to using BT-001.
official title
Long-term Effectiveness and Medication Changes After Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes Cared for in a Community Based, Clinically Integrated Network