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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02363907
Study type Observational
Source DexCom, Inc.
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date October 2012

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