Digital Therapy for Type 2 Diabetes
(ACTION-DM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain types of insulin. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment BT-001 for Type 2 Diabetes?
Research shows that digital therapies can help people with Type 2 Diabetes manage their condition by encouraging healthy lifestyle changes and regular monitoring of blood sugar levels. These digital solutions have been found to improve metabolic outcomes, which means they help control blood sugar and reduce complications.12345
Is the digital therapy for type 2 diabetes, including BT-001, safe for humans?
The research articles reviewed do not provide specific safety data for the digital therapy BT-001 or similar treatments. However, they suggest that incretin-based therapies, which are used for type 2 diabetes, are generally well-tolerated and have a low risk profile compared to existing therapies.678910
How is the digital therapy BT-001 for type 2 diabetes different from other treatments?
BT-001 is a digital therapy that uses high-quality software to manage type 2 diabetes, offering a novel approach compared to traditional treatments. Unlike standard medications, it provides a patient-centric, software-driven intervention that can improve outcomes by integrating digital tools for precise glucose monitoring and facilitating communication between patients and healthcare providers.511121314
What is the purpose of this trial?
Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.
Eligibility Criteria
This trial is for adults with type 2 diabetes who can use an Android or iPhone, speak and read English, are willing to check their blood sugar regularly using the app, and have a recent HbA1c level over 7.01%. It's not for those with severe memory loss conditions, terminal illnesses with less than a year of life expectancy, or those on certain insulin treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the BT-001 digital therapeutic for glycemic control in type 2 diabetes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into additional treatment cycles of BT-001
Treatment Details
Interventions
- BT-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Better Therapeutics
Lead Sponsor
Mass General Brigham
Collaborator