Trial Outcomes & Findings for Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System (NCT NCT01514292)
NCT ID: NCT01514292
Last Updated: 2015-10-05
Results Overview
The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
7 days
Results posted on
2015-10-05
Participant Flow
Participant milestones
| Measure |
CGM Device
Dexcom CGM Device Wearing for up to 7 days
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Baseline characteristics by cohort
| Measure |
Real Time Continuous Glucose Monitoring System
n=72 Participants
Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.
Outcome measures
| Measure |
Real Time Continous Glucose Monitoring System
n=72 Participants
Real Time Continous Glucose Monitoring System Wearing for up to 7 days
|
|---|---|
|
CGM Relative Differences to Laboratory Reference
|
13 Percentage of difference
Standard Deviation 6
|
Adverse Events
CGM Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andy Balo, SVP, Regulatory, Clinical and Biometrics
Dexcom, Inc
Phone: 8582000200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place