Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
NCT ID: NCT02880267
Last Updated: 2018-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
304 participants
INTERVENTIONAL
2016-05-31
2017-09-30
Brief Summary
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Detailed Description
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The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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CGM Users
Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement
CGM
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.
Interventions
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CGM
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification of the study-assigned blood glucose meter
2 Years
ALL
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David PRice, MD
Role: STUDY_DIRECTOR
DexCom, Inc.
Locations
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AMCR Institute
Escondido, California, United States
Stanford
Palo Alto, California, United States
Sansum
Santa Barbara, California, United States
Diablo
Walnut Creek, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Atlanta Diabetes
Atlanta, Georgia, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Oregon Health Science University
Portland, Oregon, United States
Rainier
Seattle, Washington, United States
Countries
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Other Identifiers
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PTL-902220
Identifier Type: -
Identifier Source: org_study_id