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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Type 2
• Interventions: Device: BT-001; Device: Control Mobile Application

• Registration Number: NCT05302050
• Lead Sponsor: Better Therapeutics

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

Study Timeline

• Study Start: 2022-03-07
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention BT-001 + Standard of Care	BT-001	Patients in this arm will receive the BT-001 treatment for up to 18 months.
Standard of Care	Control Mobile Application	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

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline and Day 180	Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Mass General Brigham Hospital and Clinics; 🇺🇸 Boston, Massachusetts, United States