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.
Study Type
OBSERVATIONAL
Enrollment
358
Self Monitoring Blood Glucose Meter
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
Valley Research
Fresno, California, United States
CEDE (Center of Excellence in Diabetes and Endocrinology)
Sacramento, California, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Billings Clinic
Billings, Montana, United States
Impact on time above 180 mg/dL in subjects with type 2 diabetes
To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose).
Time frame: Six (6) months
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Palm Research Center
Las Vegas, Nevada, United States