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

December 27, 2018 updated by: DexCom, Inc.
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

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
        • AMCR Institute
      • Palo Alto, California, United States
        • Stanford
      • Santa Barbara, California, United States
        • Sansum
      • Walnut Creek, California, United States
        • Diablo
    • Colorado
      • Aurora, Colorado, United States
        • Barbara Davis Center
    • Georgia
      • Atlanta, Georgia, United States
        • Atlanta Diabetes
    • Massachusetts
      • Boston, Massachusetts, United States
        • Joslin Diabetes Center
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health Science University
    • Washington
      • Seattle, Washington, United States
        • Rainier

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

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CGM Users
Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement
Device: CGM
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

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 proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
Time Frame: 10 Days
10 Days

Collaborators and Investigators

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

Sponsor

DexCom, Inc.

Investigators

  • Study Director: David Price, MD, 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 (Actual)

May 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PTL-902220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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