NCT01185496

Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by children and adolescent subjects (6 to \<18 years-old) with type 1 diabetes mellitus.

Detailed description

Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of the study meter reference value for glucose levels \>80 mg/dL and ±20 mg/dL at meter glucose levels \<80 mg/dL. This proportion will be compared to the proportion of such points observed in the DexCom clinical study that will be used to apply for FDA approval of the G4 System (PTL 900360) for adults. Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.

Conditions

• Diabetes Mellitus

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2010-08-20
• Last updated: 2011-06-13

Locations

1 site across 1 country: United States