A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

NCT ID: NCT05302050

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: 2022-03-07
• Study Completion Date: 2025-12-01

Brief Summary

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.

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

Conditions

Diabetes 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 18 months.

Group Type: ACTIVE_COMPARATOR

BT-001

Intervention Type: DEVICE

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.

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

Group Type: OTHER

Control Mobile Application

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Control Mobile Application

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Better Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mass General Brigham Hospital and Clinics

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

DM2-07-MGB

Identifier Type: -

Identifier Source: org_study_id