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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights

BRIGHT Trial 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.Check my eligibility
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.See study design
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.

BRIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

BRIGHT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c
Secondary outcome measures
Adverse Events
Difference in HbA1c

BRIGHT 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

Find a Location

Who is running the clinical trial?

Ascension HealthUNKNOWN
24 Previous Clinical Trials
2,536 Total Patients Enrolled
Better TherapeuticsLead Sponsor
4 Previous Clinical Trials
1,266 Total Patients Enrolled
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,048 Total Patients Enrolled

Media Library

Type 2 Diabetes Clinical Trial 2023: PHOENIX Highlights & Side Effects. Trial Name: NCT05266625 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to individuals aged 35 and over?

"The age range for eligibility in this trial is 18 to 75 years old."

Answered by AI

Who meets the eligibility requirements to partake in this research project?

"In order to be considered for this clinical trial, individuals must have type 2 diabetes mellitus and be 18-75 years of age. The team is expecting 500 total patients in the study."

Answered by AI

Is there still opportunity for individuals to participate in the clinical experiment?

"As indicated on clinicaltrials.gov, this trial is currently not recruiting new candidates. It was first announced in mid-February and revised for the last time at the end of June 2022. However, there are 1,392 other trials that are actively seeking participants right now."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of Colorado Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy
2022. "Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266625.
All > Diabetes Type 2
~205 spots leftby Nov 2025
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