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Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System 482

Completed
Clinical Trial NCT04794478 was an interventional study for Diabetes Mellitus that is now completed. The study started on 19 February 2021, with plans to enroll 482 participants. Led by DexCom, Inc., the expected completion date was 31 October 2021. The latest data from ClinicalTrials.gov was last updated on 18 February 2022.
Brief Summary
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
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.
Official Title

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

Conditions
Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • PTL-903880
NCT ID Number
NCT04794478
Start Date (Actual)
2021-02-19
Last Update Posted
2022-02-18
Completion Date (Estimated)
2021-10-31
Enrollment (Estimated)
482
Study Type
Interventional
PHASE
N/A
Status
Completed
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorCGM Users
Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.
Dexcom Continuous Glucose Monitoring System
Dexcom Continuous Glucose Monitoring System
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dexcom Continuous Glucose Monitoring System Performance
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 MeasureMeasure DescriptionTime Frame
System Related Adverse Device Effects
The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants
10 days
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
  • 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

  • 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

DexCom, Inc. logoDexCom, Inc.
No contact data.
12 Study Locations in 1 Countries

California

ProSciento, Chula Vista, California, 91911, United States
AMCR Institute, Escondido, California, 92025, United States
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States

Colorado

Barbara Davis Center, Aurora, Colorado, 80045, United States

Idaho

Rocky Mountain Clinical Research, Idaho Falls, Idaho, 82404, United States

Massachusetts

Joslin Diabetes Center, Boston, Massachusetts, 02215, United States

Texas

Clinical Trials of Texas, Inc. (CTT), San Antonio, Texas, 78229, United States
Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
Endeavor Clinical Trials, San Antonio, Texas, 78229, United States

Utah

Advanced Research, Ogden, Utah, 84405, United States

Virginia

UVA Center for Diabetes Technology, Charlottesville, Virginia, 22903, United States