Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
NCT ID: NCT04645641
Last Updated: 2020-11-27
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-10-12
2020-12-31
Brief Summary
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Detailed Description
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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 clinic sessions to assess performance of CGM compared to comparator measurement.
Continuous Glucose Monitoring System
Continuous Glucose Monitoring System
Interventions
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Continuous Glucose Monitoring System
Continuous Glucose Monitoring System
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear
Exclusion Criteria
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:
* Male: 36.0%;
* Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
2 Years
ALL
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Locations
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AMCR Institute
Escondido, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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PTL-904120
Identifier Type: -
Identifier Source: org_study_id