(289 days)
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
BT-001 is a digital diabetes device that delivers cognitive behavioral therapy (CBT) to a patient with Type 2 Diabetes through an application on the patient's personal Android smartphone. BT-001 is prescription use only and is completely self-directed. The device is designed to allow patients to complete CBT without human support or intervention and is intended to be used in 90-day increments adjunctively to standard of care.
The cognitive behavioral therapy delivered by BT-001 is intended to aid users in making behavioral modifications to better adhere to behaviors associated with the management of diabetes. BT-001 focuses on users understanding barriers to their adhering to known diabetes management behaviors such as eating habits. nutrition, and exercise. The device also provides a way for users to self-report their meals, exercise, medications, and biometrics. When relevant, BT-001 will supply additional notifications for users to contact a healthcare provider, such as when a user logs a blood glucose reading.
This medical device has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this De Novo request, if the product has functions that are not subject to FDA premarket review. FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (from Special Controls & Labeling) | Reported Device Performance and Evidence from Clinical Study |
|---|---|
| 1. Clinical Data: Appropriately validating the model of therapy as implemented by the device using a clinically defined endpoint. | Primary Endpoint (Change in HbA1c at Day 90): |
- Intervention Group (BT-001): Mean change -0.27% (SD 1.11)
- Control Group (Standard of Care): Mean change 0.14% (SD 1.23)
- Difference: -0.41% (statistically significant, p
N/A