Digital Therapy for Type 2 Diabetes
(BRIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a digital therapy called PHOENIX to determine its effectiveness in helping people with type 2 diabetes manage their blood sugar levels. It compares this new digital tool to a standard diabetes management app. Participants will either use the PHOENIX tool alongside their usual care or start with a standard app, with the option to switch later. Ideal participants have managed type 2 diabetes with stable medication for at least three months and have access to a smartphone. As an unphased trial, this study allows participants to contribute to innovative research that could improve diabetes management for many.
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.
What prior data suggests that this digital therapy is safe for type 2 diabetes patients?
Research has shown that BT-001, a digital therapy for type 2 diabetes, has been tested in earlier studies. These studies examined its effectiveness in managing blood sugar levels. While specific information on side effects is not available, the nature of the treatment offers some insights. BT-001 is an app utilizing cognitive behavioral therapy (CBT), a well-known and safe form of talk therapy, suggesting that its use through an app is likely low-risk.
In other studies, this app lowered blood sugar more effectively than a different app used for comparison. Although detailed safety information is not provided, the absence of reported side effects suggests it is well-tolerated. Digital therapies typically have fewer side effects than medications, making them a promising option for managing conditions like type 2 diabetes.12345Why are researchers excited about this trial?
Unlike traditional treatments for type 2 diabetes, which often rely on medication or insulin therapy, the PHOENIX digital therapy uses the BT-001 treatment, a digital platform designed to support lifestyle and behavioral changes. This innovative approach leverages technology, potentially enhancing patient engagement and adherence through personalized, interactive content. Researchers are excited because digital therapy can offer continuous, real-time support and monitoring, which could lead to more sustainable lifestyle changes and better long-term outcomes for managing diabetes.
What evidence suggests that this digital therapy is effective for type 2 diabetes?
Research has shown that the BT-001 digital therapy, which participants in this trial may receive, can help lower blood sugar levels in people with type 2 diabetes. One study found that patients using BT-001 had significantly lower levels of hemoglobin A1c, a measure of long-term blood sugar control, after 90 days compared to those using a different app. Another study also found that BT-001 was more effective at reducing blood sugar than the other app. This digital therapy employs cognitive behavioral therapy (CBT) to encourage healthier lifestyle choices, such as improved diet and increased exercise. Evidence suggests that BT-001 is a promising tool for managing type 2 diabetes.23678
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
Trial Overview
The trial is testing BT-001, an investigational digital therapeutic designed to help manage blood sugar levels in people with type 2 diabetes. It's being compared to a control application as part of usual care in various real-world settings.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study
Patients in this arm will receive the BT-001 treatment for up to 720 days.
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
Citations
Randomized, Controlled Trial of a Digital Behavioral ...
Conclusions: Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital ...
Digital Therapy for Type 2 Diabetes (BRIGHT Trial)
A study found that a similar app, BT-001, reduced blood sugar levels more effectively than a control app in people with type 2 diabetes.
Cost-Effectiveness Analysis of a Prescription Digital ...
The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer ...
Cognitive behavioral therapy delivered via digital mobile ...
BT-001 is a digital therapeutic application (app) providing CBT via smartphone supporting dietary change, physical activity, and medication ...
5.
prnewswire.com
prnewswire.com/news-releases/creative-medical-technology-announces-positive-top-line-results-for-type-2-diabetes-study-301795119.htmlCreative Medical Technology Announces Positive Top ...
At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement. The ...
Cognitive behavioral therapy delivered via digital mobile ...
This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable ...
DE Novo CLASSIFICATION REQUEST FOR BT-001
BT-001 is a digital diabetes device that delivers cognitive behavioral therapy (CBT) to a patient with Type 2 Diabetes through an application on ...
Digital Therapy for Type 2 Diabetes (ACTION-DM Trial)
The research articles reviewed do not provide specific safety data for the digital therapy BT-001 or similar treatments. However, they suggest that ...
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