An interventional study of BT-001 and Control App in Diabetes Mellitus, Type 2, sponsored by Better Therapeutics. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Better Therapeutics · Not applicable, Interventional, and Treatment
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
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 500 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Better Therapeutics is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive the BT-001 treatment for up to 720 days.
Behavioral: BT-001
Patients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study
Other: Control App
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.
The app asks patients brief questions about their health but does not include any behavioral therapy.
Change in HbA1c
Difference in the mean change from baseline in HbA1c between treatment groups.
Time frame: 90 days
Adverse Events
Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups
Time frame: 90 days
Difference in HbA1c
Difference in mean change from baseline in HbA1c between treatment groups.
Time frame: 180 days
Adverse Events
Occurrence, relatedness and severity of adverse device effects and adverse events between treatment groups
Time frame: 180 days
Plan to share: No — no plan to share IPD
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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