Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

February 17, 2022 updated by: DexCom, Inc.
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Study Type

Interventional

Enrollment (Actual)

482

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
      • Chula Vista, California, United States, 91911
        • Prosciento
      • Escondido, California, United States, 92025
        • AMCR Institute
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center
    • Idaho
      • Idaho Falls, Idaho, United States, 82404
        • Rocky Mountain Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc. (CTT)
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A.
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Center for Diabetes Technology

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

Description

Inclusion Criteria:

  • Ages 2 or older
  • 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:

  • Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
  • 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

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
Active Comparator: CGM Users
Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.
Device: Dexcom Continuous Glucose Monitoring System
Dexcom Continuous Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dexcom Continuous Glucose Monitoring System Performance
Time Frame: 10 days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Related Adverse Device Effects
Time Frame: 10 days
The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants
10 days

Collaborators and Investigators

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

Sponsor

DexCom, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 19, 2021

Primary Completion (Actual)

August 9, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PTL-903880

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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