Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
482
Dexcom Continuous Glucose Monitoring System
ProSciento
Chula Vista, California, United States
AMCR Institute
Escondido, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Dexcom Continuous Glucose Monitoring System Performance
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements
Time frame: 10 days
System Related Adverse Device Effects
The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants
Time frame: 10 days
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