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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Device: BT-001
* Device: Control Mobile Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention BT-001 + Standard of Care<br>Patients in this arm will receive the BT-001 treatment for up to 18 months. | Device: BT-001<br>* 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.<br>|
| Other: Standard of Care<br>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<br>* The app asks patients brief questions about their health but does not include any behavioral therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups. | Baseline and Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |