Observational Study to Evaluate the 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.
Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.
Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System|
- Absolute Relative Difference (%) to Reference Standard [ Time Frame: one time measure (day 1) ] [ Designated as safety issue: No ]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. The point accuracy is measured as 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 YSI glucose levels <80 mg/dL.
|Study Start Date:||November 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Type 1 Diabetes Mellitus (TIDM)Type 2 Diabetes Mellitus (T2DM)
Adults that have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514305
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|Study Director:||David Price, MD||DexCom, Inc.|