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

Sponsor
Better Therapeutics (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05302050
Collaborator
Mass General Brigham (Other)
500
1
2
32.9
15.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BT-001
  • Device: Control Mobile Application
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study population consists of approximately 500 total participants, ages 18 - 75 years old, inclusive, who have type 2 diabetes. They will be randomized to the treatment or control group at a 3:1 ratioThe study population consists of approximately 500 total participants, ages 18 - 75 years old, inclusive, who have type 2 diabetes. They will be randomized to the treatment or control group at a 3:1 ratio
Masking:
None (Open Label)
Masking Description:
open label
Primary Purpose:
Treatment
Official Title:
A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [Baseline and Day 180]

    Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.

Secondary Outcome Measures

  1. Change in HbA1c [Baseline and day 180, 365]

    Change in HbA1c from baseline (enrollment) and from 6 months, to 12 months after enrollment between groups

  2. Significant change in HbA1c [Baseline and Day 365]

    Proportion of patients with a ≥ 0.4% decrease in HbA1c at 12 months within each study group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mass General Brigham Hospital and Clinics Boston Massachusetts United States 02199

Sponsors and Collaborators

  • Better Therapeutics
  • Mass General Brigham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Better Therapeutics
ClinicalTrials.gov Identifier:
NCT05302050
Other Study ID Numbers:
  • DM2-07-MGB
First Posted:
Mar 31, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022