Status:
COMPLETED
Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Lead Sponsor:
DexCom, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Brief 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 term...
Eligibility Criteria
Inclusion
- Age 18 years or older;
- Have been diagnosed with insulin-requiring diabetes
- Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
- Insert sensors on their own and wear 2 systems simultaneously;
- Use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;
- Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
- Have an intravenous catheter inserted for 4 blood draws per hour
- Willing to perform SMBG during home use with the meter provided;
- Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
- Speak, read, and write English;
- Willing and able to be compliant with provisions laid out in this protocol.
Exclusion
- Have extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Allergy to medical-grade adhesives;
- Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
- Dialysis treatment;
- Hematocrit that is outside the range of 30-55% at screening visit;
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01514305
Start Date
November 1 2011
End Date
December 1 2011
Last Update
January 23 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404