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

NCT ID: NCT05266625

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2025-11-30

Brief 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

Detailed 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention BT-001 + Standard of Care

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

Group Type: EXPERIMENTAL

BT-001

Intervention Type: BEHAVIORAL

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.

Standard of Care

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 Type: OTHER

Control App

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Control App

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CPC Clinical Research

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Ascension Health

INDUSTRY

Sponsor Role: collaborator

Department of Veterans Affairs Hospital Durham, NC

UNKNOWN

Sponsor Role: collaborator

University of Colorado Health Clinics

UNKNOWN

Sponsor Role: collaborator

Better Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Ascension DePaul Community Health

New Orleans, Louisiana, United States

VA Medical Center-Durham

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DM2-07-CPC

Identifier Type: -

Identifier Source: org_study_id