NCT01514292

Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \>18 years-old with diabetes mellitus. The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Detailed description

The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal G4 System 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 multiple in-clinic days.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring of glucose levels (Dexcom)	Manipulation of glucose levels during multiple clinic days. Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM performance characteristics in reference to a laboratory standard.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-01-23
• Last updated: 2015-10-05
• Results posted: 2015-10-05

Locations

4 sites across 1 country: United States