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

Diabetes Type 2 Clinical Trial

— ACTION-DM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05302050
• Other study ID #: DM2-07-MGB
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 1, 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, 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Mass General Brigham Hospital and Clinics	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Better Therapeutics	Mass General Brigham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.	Baseline and Day 180
Secondary	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
Secondary	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