A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus (ACTION-DM)

Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Type 2
• Intervention / Treatment: Device: BT-001; Device: Control Mobile Application

Detailed Description

The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02199
      • Mass General Brigham Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current (within 3 months prior to enrollment) HbA1c >=7.01%
• Possession of and ability to use Android or iPhone mobile phone
• Speaks and reads in English
• Willing to measure frequent fasting finger glucose measurements as part of the App utilization

Exclusion Criteria:

• Current use of insulin other than a long-acting insulin analogue or human NPH insulin
• HbA1c >=11%
• Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
• Any terminal medical condition with life expectancy of < 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention BT-001 + Standard of Care; Patients in this arm will receive the BT-001 treatment for up to 18 months.	Device: BT-001; BT-001is 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: Standard of Care; Patients will have access to a control mobile application for 6 months and then will have the option to use the treatment for the remainder of the 18 month study	Device: Control Mobile Application; The app asks patients brief questions about their health but does not include any behavioral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.	Baseline and Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change in HbA1c from baseline (enrollment) and from 6 months, to 12 months after enrollment between groups	Baseline and day 180, 365
Significant change in HbA1c	Proportion of patients with a ≥ 0.4% decrease in HbA1c at 12 months within each study group	Baseline and Day 365

Collaborators and Investigators

• Sponsor: Better Therapeutics
• Collaborators: Mass General Brigham

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DM2-07-MGB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No