Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
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|ClinicalTrials.gov Identifier: NCT02363907|
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
- Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device [ Time Frame: Measured during clinic session during 7 day sensor wear period ]"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363907
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|Principal Investigator:||David Liljenquist, M.D.||Rocky Mountain Diabetes and Osteoporosis Center|