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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04794478
Recruitment Status : Completed
First Posted : March 12, 2021
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Dexcom Continuous Glucose Monitoring System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by subjects and/or caregivers.
Primary Purpose: Other
Official Title: Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
Actual Study Start Date : February 19, 2021
Actual Primary Completion Date : August 9, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794478


Locations
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United States, California
ProSciento
Chula Vista, California, United States, 91911
AMCR Institute
Escondido, California, United States, 92025
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Idaho
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States, 82404
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Texas
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, United States, 78229
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
United States, Utah
Advanced Research
Ogden, Utah, United States, 84405
United States, Virginia
UVA Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
DexCom, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT04794478    
Other Study ID Numbers: PTL-903880
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes