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

Sponsor
DexCom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04794478
Collaborator
(none)
482
Enrollment
12
Locations
1
Arm
8.3
Actual Duration (Months)
40.2
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Dexcom Continuous Glucose Monitoring System
 N/A

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 Design

Study Type:
Interventional
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 :
Feb 19, 2021
Actual Primary Completion Date :
Aug 9, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dexcom Continuous Glucose Monitoring System Performance [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 [10 days]

    The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProSciento Chula Vista California United States 91911
2 AMCR Institute Escondido California United States 92025
3 Sansum Diabetes Research Institute Santa Barbara California United States 93105
4 Diablo Clinical Research Walnut Creek California United States 94598
5 Barbara Davis Center Aurora Colorado United States 80045
6 Rocky Mountain Clinical Research Idaho Falls Idaho United States 82404
7 Joslin Diabetes Center Boston Massachusetts United States 02215
8 Clinical Trials of Texas, Inc. (CTT) San Antonio Texas United States 78229
9 Diabetes & Glandular Disease Clinic, P.A. San Antonio Texas United States 78229
10 Endeavor Clinical Trials San Antonio Texas United States 78229
11 Advanced Research Ogden Utah United States 84405
12 UVA Center for Diabetes Technology Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • DexCom, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT04794478
Other Study ID Numbers:
  • PTL-903880
First Posted:
Mar 12, 2021
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Feb 18, 2022