Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy

NAActive, not recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Diabetes Mellitus, Type 2
Interventions
BEHAVIORAL

BT-001

"Bt-001 is a software application that delivers treatment to participants with type 2 diabetes, using behavioral therapy. BT-001 is accessed via the participants' smartphone.~The behavioral intervention process involves:~Identifying maladaptive thoughts based on misinformed core beliefs that lead to disease-promoting behaviors; replacing maladaptive core beliefs with adaptive ways of thinking; and providing collaborative construction of behavioral exercises to test core beliefs.~Each week, Bt-001 asks participants to complete a new lesson, along with one skill exercise. The lessons are expected to take between 10-20 minutes to complete. In addition to completing a lesson and skill, participants will be directed to report plant-based meals consumed and minutes of exercise completed and to measure their blood sugar daily."

OTHER

Control App

The app asks patients brief questions about their health but does not include any behavioral therapy.

Trial Locations (3)

27705

VA Medical Center-Durham, Durham

70118

Ascension DePaul Community Health, New Orleans

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

CPC Clinical Research

UNKNOWN

collaborator

University of Colorado, Denver

OTHER

collaborator

Ascension Health

INDUSTRY

collaborator

Department of Veterans Affairs Hospital Durham, NC

UNKNOWN

collaborator

University of Colorado Health Clinics

UNKNOWN

lead

Better Therapeutics

INDUSTRY