Trial Outcomes & Findings for Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics (NCT NCT02363907)
NCT ID: NCT02363907
Last Updated: 2017-07-27
Results Overview
"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels \>80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels \<80 mg/dL
COMPLETED
30 participants
Measured during clinic session during 7 day sensor wear period
2017-07-27
Participant Flow
Subjects were recruited by one endocrinology practice in the US over a month long period, between Sep-Oct, 2012.
Participant milestones
| Measure |
Single Arm- Performance, Using Blood Glucose Meter Reference
Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
Baseline characteristics by cohort
| Measure |
Single Arm
n=30 Participants
Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
|
|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Duration of diabetes
|
4.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Baseline A1C
|
8.6 percent
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
CGM Experience Level
|
0.2 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured during clinic session during 7 day sensor wear period"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels \>80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels \<80 mg/dL
Outcome measures
| Measure |
Single Arm
n=30 Participants
Subjects as their own control, comparing ISF glucose readings to capillary blood glucose readings, measured by blood glucose meters
|
|---|---|
|
Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device
|
77 Percentage of matched pairs w/i %20/20
Interval 75.0 to 79.0
|
Adverse Events
Single Arm,Performance, Using Blood Glucose Meter Reference
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place