Digital Therapy for Type 2 Diabetes
(BRIGHT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Better Therapeutics

No Placebo Group

Trial Summary

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.

I am between 18 and 75 years old.

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

See 2 more

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.

Treatment Details

Interventions

Control App (Other)
PHOENIX (Digital Therapeutic)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Standard of CareExperimental Treatment1 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 CareExperimental Treatment1 Intervention

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