Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.
Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.
Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
Pediatric Subjects With Diabetes Mellitus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.|
- System Performance Effectiveness [ Time Frame: 7 days ] [ Designated as safety issue: No ]The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
- System Performance at Alternate Wear Site [ Time Frame: 7 days ] [ Designated as safety issue: No ]An additional objective is to evaluate System performance at an alternate wear site. The System performance will be assessed, using the same statistical methodology as the primary wear site.
|Study Start Date:||July 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Pediatric subjects with diabetes mellitus|
|United States, California|
|Advanced Metabolic Care and Research|
|Escondido, California, United States, 92026|
|Orange, California, United States, 92868|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Barbara Davis Center|
|Aurora, Colorado, United States, 80045|
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center, PA|
|Idaho Falls, Idaho, United States, 83404|
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|