G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator



Status:Completed
Healthy:No
Age Range:2 - Any
Updated:4/21/2016
Start Date:January 2016
End Date:April 2016

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Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an
Automated Applicator vs. a Manual Sensor Applicator

The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x
System with the automated applicator is no worse than that of the commercial Dexcom G4 TM
PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

Inclusion Criteria:

- Ages 2 or older

- Diagnosis of Type 1 diabetes or Type 2 diabetes

- Willing to participate in a clinic session involving venous sampling for evaluation
of study end point

Exclusion Criteria:

- Use of acetaminophen

- Known allergy to medical-grade adhesives

- Pregnancy

- Hematocrit outside specification of the study-assigned blood glucose meter
We found this trial at
4
sites
Idaho Falls, Idaho 83404
Principal Investigator: David R. Liljenquist, MD
Phone: 208-522-6005
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Idaho Falls, ID
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Douglas S. Denham, DO, CPI
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San Antonio, TX
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Lori Laffel, MD, MPH
Phone: 617-309-4523
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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Escondido, California 92026
Principal Investigator: Timothy Bailey, MD
Phone: 760-466-1523
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Escondido, CA
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