To evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels using continuous glucose monitoring.
This is a non-pivotal , non-randomized, single-arm, multi-center, prospective, non-significant risk study to evaluate the relationship between glycated hemoglobin (HbA1c) and average glucose levels. Up to approximately 600 subjects will be enrolled who will have fourteen (14) study visits over the course of approximately six (6) months. During each visit the subject will have blood samples drawn for documentation of their HbA1c level. Subjects will also be required to wear Professional FreeStyle Libre Flash Glucose Monitoring System(s) to record blood glucose levels through the duration of the study. During Visits 1 and 14, Venous sample for CBC, biochemistry, haemoglobinopathy screen, hematology, liver function and iron panels will be collected.
Study Type
OBSERVATIONAL
Enrollment
488
All subjects will wear the professional FreeStyle Libre Pro for glucose data and HbA1c data will be collected at different time points over the participation period.
Excellence Research and Medical
Miami Gardens, Florida, United States
Establish a relationship between laboratory-derived HbA1c and average glucose levels
This is an observational data collection study, where the goal is to gather data to establish the relationship between laboratory-derived HbA1c and average glucose levels.
Time frame: six (6) months
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