Diabetes Mellitus Clinical Trial
Official title:
Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) 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.
Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed. Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. ;
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