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

April 13, 2016 updated by: DexCom, Inc.

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults and pediatrics with diabetes mellitus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CGM Users

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DexCom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PTL-901800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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