Overview
The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.
Description
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.
Eligibility
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 indicated for the treatment of diabetes.
- Subject is currently on any form of medication indicated for weight loss.