NCT02363907

Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics

Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 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 2 to 17 years-old with diabetes mellitus.

Detailed 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.

Conditions

• Diabetes Mellitus

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2015-02-16
• Last updated: 2017-07-27
• Results posted: 2017-07-27

Locations

1 site across 1 country: United States