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CompletedNCT02880267Updated Dec 31, 2018

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

An interventional study of CGM in Diabetes Mellitus, sponsored by DexCom, Inc.. Completed at 9 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2018-12-31.

Sponsored by DexCom, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2017, 9 years 3 months ago, and no results have been posted to the registry.
  • Registered 3 months after the study started (first participant enrolled May 2016, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
304
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus
03

In context

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Use of acetaminophen
  • Known allergy to medical-grade adhesives
  • Pregnancy
  • Hematocrit outside specification of the study-assigned blood glucose meter
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
304 participants (actual)

Study arms

  • Other
    CGM Users

    Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement

    Device: CGM

Interventions

  • DeviceCGM

    Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 Days

07

Study locations

9 sites
  • AMCR Institute
    Escondido, California, United States
  • Stanford
    Palo Alto, California, United States
  • Sansum
    Santa Barbara, California, United States
  • Diablo
    Walnut Creek, California, United States
  • Barbara Davis Center
    Aurora, Colorado, United States
  • Atlanta Diabetes
    Atlanta, Georgia, United States
  • Joslin Diabetes Center
    Boston, Massachusetts, United States
  • Oregon Health Science University
    Portland, Oregon, United States
  • Rainier
    Seattle, Washington, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02880267
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
May 2016
Primary completion
Jul 2017
Completion
Sep 2017
Last update
Dec 31, 2018

Study contacts

David PRice, MD
study director · DexCom, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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DexCom, Inc.

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