Diabetes Mellitus, Type 2
Conditions
Brief summary
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting
Detailed description
This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.
Interventions
BEHAVIORALBT-001
Bt-001 is 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.
OTHERControl App
The app asks patients brief questions about their health but does not include any behavioral therapy.
Sponsors
CPC Clinical Research
University of Colorado, Denver
Ascension Health
Department of Veterans Affairs Hospital Durham, NC
University of Colorado Health Clinics
Better Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
While patients and providers will not be told which arm they are in, it will be obvious when they complete the installation of the mobile application which arm they are in.
Intervention model description
Patients will be randomized to an intervention arm or control arm. After 6 months, patients in the control arm will be able to cross over to using the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years, inclusive at the time of signing the informed consent * Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months * HbA1c 7.0% to 10.9% (within thirty \[30\] days of signing the informed consent form \[ICF\]) * Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.
Exclusion criteria
* Current use of outpatient prandial insulin * In the opinion of the investigator, life expectancy \< one (1) year * COVID-19 diagnosis within thirty (30) days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 90 days | Difference in the mean change from baseline in HbA1c between treatment groups. |
| Adverse Events | 90 days | Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in HbA1c | 180 days | Difference in mean change from baseline in HbA1c between treatment groups. |
| Adverse Events | 180 days | Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups |
Countries
United States
Outcome results
None listed