Diabetes Mellitus Clinical Trial
Official title:
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System
The objective of the study is to establish performance of the System compared to a laboratory
reference measurement. The effectiveness of the System will be evaluated by comparison of CGM
values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous
sample measurements. Performance will be evaluated in terms of point and rate accuracy of the
System in reference to YSI.
The safety profile of the System will be characterized by the incidence of device-related
Adverse Events (AEs) experienced by study subjects.
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