Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT01627210
- Lead Sponsor
- DexCom, Inc.
- Brief Summary
This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI.
- Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion.
- Have extensive skin changes/ diseases that preclude wearing the device.
- Dialysis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the Dexcom G4 system utility and usability during home use. One year The primary object of the study is to evaluate the Dexcom G4 system utility and usability during home use. Variables to be evaluated are sensor used, length of use, and data capture during use.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Catalina Research Institute
🇺🇸Chino, California, United States
Desert Endocrinology Clinical Research Center
🇺🇸Henderson, Nevada, United States
Diabetes and Endocrine Associate
🇺🇸La Mesa, California, United States
Infosphere
🇺🇸West Hills, California, United States