Clinical trial NCT05266625: Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy
Official title: Randomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Better Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: CPC Clinical Research
name: University of Colorado, Denver
name: Ascension Health
name: Department of Veterans Affairs Hospital Durham, NC
name: University of Colorado Health Clinics
First posted: 2022-03-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 90 days
measure: Adverse Events
timeFrame: 90 days
Secondary outcomes:
measure: Difference in HbA1c
timeFrame: 180 days
measure: Adverse Events
timeFrame: 180 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Orleans
country: United States
facility: Ascension DePaul Community Health
state: Louisiana
city: Durham
country: United States
facility: VA Medical Center-Durham
state: North Carolina
Study officials:
References: