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Digital Therapeutic

Digital Therapy for Type 2 Diabetes (BRIGHT Trial)

N/A

Waitlist Available

Research Sponsored by Better Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years, inclusive at the time of signing the informed consent

Be older than 18 years old

Must not have

COVID-19 diagnosis within thirty (30) days prior to randomization.

Current use of outpatient prandial insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an investigational digital therapeutic can help patients with type 2 diabetes improve their glycemic control, compared to a control application added to usual care, in a real-world setting.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves digital therapeutics rather than medication, traditional side effects are not expected. However, participants may experience issues related to app usability or stress from self-management of their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently using mealtime insulin injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c

Secondary study objectives

Adverse Events

Difference in HbA1c

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BT-001

2021

Completed Phase 3

~670

0 / 3Eligibility criteria met