Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: CGM

Detailed Description

The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States
      • AMCR Institute
    • Palo Alto, California, United States
      • Stanford
    • Santa Barbara, California, United States
      • Sansum
    • Walnut Creek, California, United States
      • Diablo
  • Colorado
    • Aurora, Colorado, United States
      • Barbara Davis Center
  • Georgia
    • Atlanta, Georgia, United States
      • Atlanta Diabetes
  • Massachusetts
    • Boston, Massachusetts, United States
      • Joslin Diabetes Center
  • Oregon
    • Portland, Oregon, United States
      • Oregon Health Science University
  • Washington
    • Seattle, Washington, United States
      • Rainier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months 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, on intensive insulin therapy
• Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

• Use of acetaminophen
• Known allergy to medical-grade adhesives
• Pregnancy
• Hematocrit outside specification of the study-assigned blood glucose meter

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
Other: CGM Users; Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement	Device: CGM; Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL	10 Days

Collaborators and Investigators

• Sponsor: DexCom, Inc.
• Investigators: Study Director: David Price, MD, DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PTL-902220

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