Effectiveness and Safety of the Dexcom™ G6 Continuous Glu... | NCT02880267

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

NCT02880267

Sponsor

DexCom, Inc.

Status

Completed

Last Update Posted

Dec 31, 2018Actual

Enrollment

304Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Aug 23, 2016

First Submission Date that Met QC Criteria

Aug 23, 2016

First Posted Date

Aug 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2018

Last Update Posted Date

Dec 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGM Users	Other	Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement	Device: CGM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGM	Device	Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.	CGM Users

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David PRice, MD	DexCom, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AMCR Institute		Escondido	California		United States
Stanford

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided