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 BRIGHT - Digital therapeutic Based Randomized Investigation to improve Glycemic control in patients with type 2 diabetes and residual Hyperglycemia on stable medical Therapy

Primary Objective

To evaluate the efficacy and safety of the digital therapeutic, PHOENIX, to improve HbA1c at 90- and 180-days compared to a control group To evaluate the long-term effectiveness and impact on health care utilization and medication use between study groups in real-world clinical practice over 720 days

Study category: Diabetes & Hormone Disorders

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Description

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

Details
Age

Adult

Eligibility

Type 2 Diabetes Age 18-75 years

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 [30] 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.

Type of Study

Supportive Care

Locations

University of Colorado Hospital

Principal Investigator
Marc Bonaca,  MD

Marc Bonaca, MD

Study ID

Protocol Number: 21-4891

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