Trials / Completed
CompletedNCT01514305
Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- DexCom, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2012-01-23
- Last updated
- 2012-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01514305. Inclusion in this directory is not an endorsement.