Digital Therapy for Type 2 Diabetes
(BRIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
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 requires that you have been on a stable anti-diabetic regimen for at least three months. It seems likely you can continue your current medications if they meet this condition.
How is the PHOENIX treatment for Type 2 Diabetes different from other treatments?
The PHOENIX treatment is unique because it is a digital therapy, meaning it uses high-quality software programs to help manage Type 2 Diabetes. This approach focuses on improving patient outcomes through personalized, web-based or mobile app interventions, which can enhance self-management and provide continuous monitoring, unlike traditional treatments that may not offer such digital support.12345
What data supports the effectiveness of the treatment Control App, PHOENIX for Type 2 Diabetes?
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with type 2 diabetes who have been on a stable diabetes treatment for at least three months. Participants must be fluent in English and have a smartphone that can run the study app. They should not be using prandial insulin, have had COVID-19 recently, or have a life expectancy of less than one year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the BT-001 treatment or control application for up to 180 days
Open-label extension
Participants may continue with BT-001 treatment for the remainder of the 720-day study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Control App
- PHOENIX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Better Therapeutics
Lead Sponsor
Ascension Health
Collaborator
Ascension Health
Industry Sponsor
University of Colorado, Denver
Collaborator
CPC Clinical Research
Collaborator
University of Colorado Health Clinics
Collaborator
Department of Veterans Affairs Hospital Durham, NC
Collaborator