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Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

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ClinicalTrials.gov Identifier: NCT01514292
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes
Intervention Device: Continuous Glucose Monitoring of glucose levels (Dexcom)
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CGM Device
Hide Arm/Group Description Dexcom CGM Device Wearing for up to 7 days
Period Title: Overall Study
Started 72
Completed 72
Not Completed 0
Arm/Group Title Real Time Continuous Glucose Monitoring System
Hide Arm/Group Description Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
Type 1 Diabetes and Type 2 Diabetes with Insulin treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<=18 years
0
   0.0%
Between 18 and 65 years
71
  98.6%
>=65 years
1
   1.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
42  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
28
  38.9%
Male
44
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Hispanic or Latino
8
  11.1%
Not Hispanic or Latino
64
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   4.2%
White
68
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
1.Primary Outcome
Title CGM Relative Differences to Laboratory Reference
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Real Time Continous Glucose Monitoring System
Hide Arm/Group Description:
Real Time Continous Glucose Monitoring System Wearing for up to 7 days
Overall Number of Participants Analyzed 72
Mean (Standard Deviation)
Unit of Measure: Percentage of difference
13  (6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Real Time Continous Glucose Monitoring System
Comments

Hence, the hypothesis is established as:

Ho: pi < 71.5% Ha: pi >71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 7 day use of continuous glucose monitoring system
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CGM Device
Hide Arm/Group Description Dexcom CGM Device Wearing for up to 7 days
All-Cause Mortality
CGM Device
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CGM Device
Affected / at Risk (%)
Total   0/72 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CGM Device
Affected / at Risk (%)
Total   0/72 (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: Andy Balo, SVP, Regulatory, Clinical and Biometrics
Organization: Dexcom, Inc
Phone: 8582000200
Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01514292     History of Changes
Other Study ID Numbers: PTL-900590
First Submitted: January 12, 2012
First Posted: January 23, 2012
Results First Submitted: February 3, 2014
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015