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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention BT-001 + Standard of Care | Active Comparator | Patients in this arm will receive the BT-001 treatment for up to 18 months. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT-001 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline (enrollment) to 6 months after enrollment between groups. | Baseline and Day 180 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham Hospital and Clinics | Boston | Massachusetts | 02199 | United States |
IPD will not be shared
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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
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open label
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| Control Mobile Application | Device | The app asks patients brief questions about their health but does not include any behavioral therapy. |
|
| Baseline and Day 365 |
| D004700 | Endocrine System Diseases |