Diabetes Mellitus Clinical Trial
Official title:
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4
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 over a 7-day period in people 2 to 17 years-old with diabetes mellitus.
Performance of the system will be primarily evaluated by comparing the blood glucose
measurements from the reference device, a blood glucose meter, to the CGM System values
collected during the study. Specifically, performance will be primarily evaluated in terms of
the proportion of G4 System values that are within ±20% of glucose meter reference value for
glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values <80 mg/dL. These
G4-meter matched pairs will be analyzed across the 7 days of wear.
Safety data of the CGM System will also be collected and safety will be characterized by the
incidence of anticipated device-related adverse events (ADEs) of subjects who participate in
the study.
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