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

Last updated: February 17, 2022
Sponsor: DexCom, Inc.
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04794478
PTL-903880
  • Ages > 2
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Presence of extensive skin changes/diseases at sensor wear site(s) that precludewearing 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 initiatingdialysis during the study wear period
  • Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, ComputedTomography (CT) scan, or diathermy during the study wear period

Study Design

Total Participants: 482
Study Start date:
February 19, 2021
Estimated Completion Date:
October 31, 2021

Study Description

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

Connect with a study center

  • ProSciento

    Chula Vista, California 91911
    United States

    Site Not Available

  • AMCR Institute

    Escondido, California 92025
    United States

    Site Not Available

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Diablo Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Barbara Davis Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 82404
    United States

    Site Not Available

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc. (CTT)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Endeavor Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Advanced Research

    Ogden, Utah 84405
    United States

    Site Not Available

  • UVA Center for Diabetes Technology

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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