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Trial record 15 of 2584 for:    ( Map: Idaho, United States )

Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02363907
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Diabetes Mellitus
Enrollment 30
Recruitment Details Subjects were recruited by one endocrinology practice in the US over a month long period, between Sep-Oct, 2012.
Pre-assignment Details  
Arm/Group Title Single Arm- Performance, Using Blood Glucose Meter Reference
Hide Arm/Group Description Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
12.1  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
2
   6.7%
Not Hispanic or Latino
28
  93.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
29
  96.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
4.3  (3.1)
Baseline A1C  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 30 participants
8.6  (1.3)
CGM Experience Level  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
0.2  (0.4)
1.Primary Outcome
Title Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device
Hide Description "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
Time Frame Measured during clinic session during 7 day sensor wear period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Subjects as their own control, comparing ISF glucose readings to capillary blood glucose readings, measured by blood glucose meters
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of matched pairs w/i %20/20
77
(75 to 79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm,Performance, Using Blood Glucose Meter Reference
Hide Arm/Group Description Subjects acting as their own control,comparing glucose values between CGM and blood glucose meters for %20/20 agreement
All-Cause Mortality
Single Arm,Performance, Using Blood Glucose Meter Reference
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm,Performance, Using Blood Glucose Meter Reference
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm,Performance, Using Blood Glucose Meter Reference
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eileen Casal, RN, MSN
Organization: Dexcom
Phone: 8588759774
Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT02363907     History of Changes
Other Study ID Numbers: PTL-900982
First Submitted: February 10, 2015
First Posted: February 16, 2015
Results First Submitted: February 7, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017