Diabetes Clinical Trial
Official title:
Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4
System when used as an adjuvant to blood glucose testing.
Device performance will be primarily evaluated in terms of the proportion of glucose values
within a pre-specified range compared to reference values.
Safety data of the G4 System will also be collected vis-a-vis adverse event reporting
characterized by the incidence and severity of Serious Adverse Device Events, and Adverse
Device Events experienced by study participants.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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