Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:2 - Any
Updated:1/2/2019
Start Date:May 2016
End Date:September 2017

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Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

The objective of the study is to establish performance of the System compared to a laboratory
reference measurement. The effectiveness of the System will be evaluated by comparison of CGM
values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous
sample measurements. Performance will be evaluated in terms of point and rate accuracy of the
System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related
Adverse Events (AEs) experienced by study subjects.

Inclusion Criteria:

- Ages 2 or older

- Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy

- 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
9
sites
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Atlanta, Georgia 30318
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Atlanta, GA
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Aurora, Colorado 80010
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Aurora, CO
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Escondido, California 92026
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Escondido, CA
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Palo Alto, California 94304
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Palo Alto, CA
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317 West Pueblo Street
Santa Barbara, California 93105
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Santa Barbara, CA
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Seattle, Washington
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Seattle, WA
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Walnut Creek, California
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Walnut Creek, CA
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