Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System|
- CGM Relative Differences to Laboratory Reference [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.
|Study Start Date:||December 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Real Time Continuous Glucose Monitoring System
7 day use of real time continuous glucose monitoring system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514292
|United States, California|
|Profil Institute for Clinical Research|
|Chula Vista, California, United States, 91911|
|AMCR Institute, Inc.|
|Escondido, California, United States, 92026|
|Diablo Clinical Research|
|Walnut Creek, California, United States, 94598|
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|Study Director:||David Price, MD||DexCom, Inc.|