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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitoring System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stayce Beck, PhD, MPH; Phone Number: 858-203-6454; Email: stayce.beck@dexcom.com

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • Recruiting
      • AMCR Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Barbara Davis Center
  • Idaho
    • Idaho Falls, Idaho, United States, 82404
      • Recruiting
      • Rocky Mountain Clinical Research
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Endeavor Clinical Trials

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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: Continuous Glucose Monitoring System; Continuous Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Performance	System Performance will be characterized with respect to comparator venous plasma measurements.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Related Adverse Device Effects	System will be characterized by Adverse Device Effects experienced by study participants	10 days

Collaborators and Investigators

• Sponsor: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PTL-904120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes