A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.
Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes. The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
350
FreeStyle Libre Flash Glucose Monitoring System
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Boston Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, United States
UMPC
Pittsburgh, Pennsylvania, United States
Impact on time above 180 mg/dL
To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL
Time frame: Three (3) months
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