Status:
UNKNOWN
Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy
Lead Sponsor:
Better Therapeutics
Collaborating Sponsors:
CPC Clinical Research
University of Colorado, Denver
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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, wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05266625
Start Date
February 14 2022
End Date
November 1 2025
Last Update
October 30 2023
Active Locations (3)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
2
Ascension DePaul Community Health
New Orleans, Louisiana, United States, 70118
3
VA Medical Center-Durham
Durham, North Carolina, United States, 27705