Evaluation of the Dexcom G6 Continuous Glucose Monitoring... | NCT03087877

Studies
Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

NCT03087877

Sponsor

DexCom, Inc.

Status

Completed

Last Update Posted

Dec 31, 2018Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Acetaminophen Challenge (G6 CGM)

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

Feb 3, 2017Actual

Primary Completion Date

Mar 4, 2017Actual

Completion Date

Mar 4, 2017Actual

First Submitted Date

Feb 24, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 23, 2017Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Detailed Description

The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGM Users	Other	Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.	Device: Acetaminophen Challenge (G6 CGM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetaminophen Challenge (G6 CGM)	Device	Evaluation of acetaminophen effect on CGM glucose sensing	CGM Users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interference Effect for the G6 CGM	Bias of sensor to reference measurement pre and post acetaminophen administration	6 hrs post dose

Secondary Outcomes

Measure	Description	Time Frame
Mean of sensor minus YSI values (bias) for various time periods	Bias calculated for pre-dose, post dose and peak post dose	6 hrs post dose
Duration of interference effect for the G6 CGM	Length of time the inhibition effect is more than 10 mg/dL

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18 or older
Diagnosis of diabetes

Exclusion Criteria:

Pregnancy
Known gastroparesis
Abnormal liver function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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		Escondido	California	92025	United States
William Sansum Diabetes Center

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

Masking Info

Masking

None (Open Label)

Masking Description

The system will be blinded to the user, i.e. no glucose values will be displayed to the subject during the study duration.

Who Masked

Not provided