Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System|
- Effectiveness and Safety Study of the DexCom G4 System [ Time Frame: August 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
continuous glucose monitoring system
Device: DexCom™ G4 Continuous Glucose Monitoring System
Continuous Glucose Monitoring System
Other Name: Continuous Glucose Monitoring System
This will be a non-randomized, single-armed study conducted in the United States. Following screening, a minimum of 60 to a maximum of 80 subjects at up to 4 clinical sites will be enrolled. All participants will wear the G4 Sensor for one 7-day wear period (~168 hours). A subset of 20-30 subjects will wear two G4 Systems (one of which will be blinded) during the 7-day wear period for the purposes of assessing precision. During home use, subjects will be asked to use the meter provided to them to take fingersticks for calibration and diabetes management. Subjects will also be asked to confirm high and low G4 System glucose alerts/alarms by taking a comparative fingerstick immediately after receiving an alert/alarm.
All subjects will participate in one, 8-hour in-clinic session on Day 1, 4, or 7 of the study to collect accuracy information against a laboratory standard (YSI) and against SMBG. During the in-clinic session, subjects will have venous blood draws for evaluation of the YSI blood glucose measurements. Carbohydrate consumption and insulin dosing may be manipulated during the in-clinic session to ensure a wide range of glucose values. For the duration of this study, subjects will be instructed to use G4 System information as an adjunct to (and not as a replacement for) standard SMBG guidance of diabetes self-management.
Subjects will perform G4 Sensor insertions at the clinic under supervision of study staff. Sensor insertion sites will be examined after removal of the Sensor(s). Study staff will document any irritation and/or Adverse Device Effects.