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

NCT05266625 | Unknown DMC FDA Device

• 1 other identifier: DM2-07-CPC
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c

  Difference in the mean change from baseline in HbA1c between treatment groups.

  90 days

• Adverse Events

  Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups

  90 days

Secondary Outcomes (2)

• Difference in HbA1c

  180 days

• Adverse Events

  180 days

Study Arms (2)

Intervention BT-001 + Standard of Care

EXPERIMENTAL

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

Behavioral: BT-001

Standard of Care

OTHER

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

Other: Control App

Interventions

BT-001 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.

Intervention BT-001 + Standard of Care

Control App OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Better Therapeutics: lead
• CPC Clinical Research: collaborator
• University of Colorado, Denver: collaborator
• Ascension Health: collaborator
• Department of Veterans Affairs Hospital Durham, NC: collaborator
• University of Colorado Health Clinics: collaborator

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Ascension DePaul Community Health

New Orleans, Louisiana, 70118, United States

Location

VA Medical Center-Durham

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While patients and providers will not be told which arm they are in, it will be obvious when they complete the installation of the mobile application which arm they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to an intervention arm or control arm. After 6 months, patients in the control arm will be able to cross over to using the intervention.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: February 14, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)