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

Diabetes Mellitus, Type 2 Clinical Trial

— BRIGHT  

Official title:

Randomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05266625
• Other study ID #: DM2-07-CPC
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Better Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

• Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months

• HbA1c 7.0% to 10.9% (within thirty [30] days of signing the informed consent form [ICF])

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

Exclusion Criteria:

• Current use of outpatient prandial insulin

• In the opinion of the investigator, life expectancy < one (1) year

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	VA Medical Center-Durham	Durham	North Carolina
United States	Ascension DePaul Community Health	New Orleans	Louisiana

Sponsors (6)

Lead Sponsor	Collaborator
Better Therapeutics	Ascension Health, CPC Clinical Research, Department of Veterans Affairs Hospital Durham, NC, University of Colorado Health Clinics, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Difference in the mean change from baseline in HbA1c between treatment groups.	90 days
Primary	Adverse Events	Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups	90 days
Secondary	Difference in HbA1c	Difference in mean change from baseline in HbA1c between treatment groups.	180 days
Secondary	Adverse Events	Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups	180 days