NCT04886388

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

Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: Better Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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) compared to standard medical care in patients with type 2 diabetes.

Detailed description

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	BT-001	BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
OTHER	Physician-guided Standard of Care for type 2 diabetes	Current ADA Standard of Care Guidelines for type 2 diabetes

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-03-09
• Completion: 2022-09-27
• First posted: 2021-05-14
• Last updated: 2023-09-28

Locations

6 sites across 1 country: United States