NCT05302050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

3.7 years

First QC Date

March 21, 2022

Last Update Submit

October 27, 2023

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

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

    Baseline and Day 180

Secondary Outcomes (2)

  • Change in HbA1c

    Baseline and day 180, 365

  • Significant change in HbA1c

    Baseline and Day 365

Study Arms (2)

Intervention BT-001 + Standard of Care

ACTIVE COMPARATOR

Patients in this arm will receive the BT-001 treatment for up to 18 months.

Device: BT-001

Standard of Care

OTHER

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

Interventions

BT-001DEVICE

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 BT-001 + Standard of Care
Control Mobile ApplicationDEVICE

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

Standard of Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham Hospital and Clinics

Boston, Massachusetts, 02199, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 ratio
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

March 7, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

US(1)