At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System
In Brief
A clinical study evaluating DexCom™ G4 Continuous Glucose Monitoring System for Diabetes Mellitus. Completed, enrolled 60 participants.
Detailed 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 subjects \>18 years-old with diabetes mellitus requiring insulin. Device performance will be primarily evaluated in terms of 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 meter glucose levels \<80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study (PTL-900360) meeting the above criteria will be compared to the proportion of such points observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL 300012). 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.
Study Details
Timeline
Interventions
Continuous Glucose Monitoring System