Digital Therapy for Type 2 Diabetes

(BRIGHT Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Better Therapeutics

Must be taking: Anti-diabetic

Must not be taking: Prandial insulin

Disqualifiers: Life expectancy <1 year, COVID-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 180 days

500 Participants Needed

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 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 data supports the effectiveness of the treatment Control App, PHOENIX for Type 2 Diabetes?

Research shows that digital therapeutics, like smartphone apps, have the potential to help manage type 2 diabetes by supporting lifestyle changes. 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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

Eligibility Criteria

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

I have type 2 diabetes and have been on a stable treatment plan for at least 3 months.

Your average blood sugar levels, as measured by HbA1c, are between 7.0% and 10.9% within the last thirty days.

Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.

Exclusion Criteria

The doctor thinks you may live for less than one year.

I was diagnosed with COVID-19 in the last 30 days.

I am currently using mealtime insulin injections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BT-001 treatment or control application for up to 180 days

180 days

Limited additional contacts for adverse events

Open-label extension

Participants may continue with BT-001 treatment for the remainder of the 720-day study

540 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Standard of Care Experimental Treatment 1 Intervention

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

Group II: Intervention BT-001 + Standard of Care Experimental Treatment 1 Intervention

Patients in this arm will receive the BT-001 treatment for up to 720 days.

Who Is Running the Clinical Trial?

Better Therapeutics

Lead Sponsor

Trials

5

Recruited

1,800+

Ascension Health

Collaborator

Trials

1

Recruited

500+

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

CPC Clinical Research

Collaborator

Trials

3

Recruited

8,000+

University of Colorado Health Clinics

Collaborator

Trials

1

Recruited

500+

Department of Veterans Affairs Hospital Durham, NC

Collaborator

Trials

1

Recruited

500+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Change in Glycemic Control With Use of a Digital Therapeutic in Adults With Type 2 Diabetes: Cohort Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Analysis of Use and Outcomes of the Balance Digital Disease Management Tool for Patients with Type 2 Diabetes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

In type 2 diabetes, the BT-001 smartphone app reduced HbA1c more than a control app at 90 d. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Challenges in Diabetes Care: Can Digital Health Help Address Them? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Digital Solutions in Behavior Change Interventions for Type 2 Diabetes Mellitus: A Literature Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Changing face of healthcare: digital therapeutics in the management of diabetes. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[It's a new world: Improvement of diabetes therapy through digital and technical innovations]. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The influence of diabetes distress on digital interventions for diabetes management in vulnerable people with type 2 diabetes: A qualitative study of patient perspectives. [2020]