Randomized, sham-controlled, multicenter, pragmatic, trial with open-label extension of PHOENIX to improve glycemic control in adults with type 2 diabetes in a real-world setting
Randomized, sham-controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that PHOENIX, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a sham application added to usual care across a broad range of patients in a real-world setting
Major inclusion criteria 1. Age 18-75 years, inclusive at the time of signing the informed consent 2. Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months 3. HbA1c 7.0% to 10.9% (within thirty  days of signing the informed consent form [ICF]) 4. Able to use PHOENIX e.g., English fluent, smartphone is capable of running the study intervention. Major exclusion criteria 1. Current use of outpatient prandial insulin 2. In the opinion of the investigator, life expectancy < one (1) year 3. Any other reason that in the opinion of the investigator, the participant would be unable to comply with the protocol, or that participation would expose the patient to increased risk, including unstable psychiatric disease, current or planned pregnancy 4. COVID-19 diagnosis within thirty (30) days prior to randomization.
Medical Center of the Rockies
Benjamin Leon, MD
Protocol Number: 22-0325
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