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

NCT ID: NCT02696252

Last Updated: 2016-04-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CGM Users

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AMCR Institute

Escondido, California, United States

Site Status

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PTL-901800

Identifier Type: -

Identifier Source: org_study_id

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