Abbott Diabetes Care
The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.
This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.
Inclusion Criteria: * Subject must be at least 18 years of age. * Subject must be willing and able to provide written signed and dated informed consent. Exclusion Criteria: * Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes. * Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment. * Subject is known to be pregnant at the time of enrollment. * Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin. * Subject is currently on any form of treatment…
Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)
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