To compare the impact of the FreeStyle Libre (FSL) 2 Flash Glucose Monitoring System to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes.
This is a non-pivotal, randomized, two-arm, multi-center, prospective, non-significant risk study to evaluate the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System compared to the current Diabetes Monitoring standard of care (SOC) on weight reduction in subjects with type 2 diabetes. Subjects who have been diagnosed with type 2 diabetes will be randomized to use FreeStyle Libre 2 sensor (intervention arm) or their current standard of care (control arm) to manage their diabetes for a period of 6 months. Subjects will be asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline (visit 1) and during visit 6. Subjects will also complete a separate subject questionnaire during visit 6. All subjects will wear a FreeStyle Libre Pro sensor for enrollment (Screening) purposes and to collect baseline glycemic data prior to randomization. In addition, all subjects in both the intervention and control arms will wear an FSL Pro at days 75 and 165 for collection of glycemic endpoint data.
Study Type
OBSERVATIONAL
Enrollment
43
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.
Rainier Clinical Research Center
Renton, Washington, United States
Difference in bodyweight from the control arm at 6 months
Subjects' bodyweight will be measured during Visits 1, 3, 5 and 7. At the end of the 6 months period the bodyweight change, if any, will be assessed between the two Arms of the study.
Time frame: six (6) months
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