NCT02880267

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2016

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

August 23, 2016

Last Update Submit

December 27, 2018

Conditions

Diabetes Mellitus

Outcome Measures

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

    10 Days

Study Arms (1)

CGM Users

OTHER

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

Device: CGM

Interventions

CGMDEVICE

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

CGM Users

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

AMCR Institute

Escondido, California, United States

Location

Stanford

Palo Alto, California, United States

Location

Sansum

Santa Barbara, California, United States

Location

Diablo

Walnut Creek, California, United States

Location

Barbara Davis Center

Aurora, Colorado, United States

Location

Atlanta Diabetes

Atlanta, Georgia, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, United States

Location

Oregon Health Science University

Portland, Oregon, United States

Location

Rainier

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David PRice, MD

    DexCom, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

December 31, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(9)