Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01514305|
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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;
- Absolute Relative Difference (%) to Reference Standard [ Time Frame: one time measure (day 1) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514305
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|Study Director:||David Price, MD||DexCom, Inc.|