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

NCT ID: NCT03087877

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2017-03-04

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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

Study Groups

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CGM Users

Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.

Group Type OTHER

Acetaminophen Challenge (G6 CGM)

Intervention Type DEVICE

Evaluation of acetaminophen effect on CGM glucose sensing

Interventions

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Acetaminophen Challenge (G6 CGM)

Evaluation of acetaminophen effect on CGM glucose sensing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ages 18 or older
* Diagnosis of diabetes

Exclusion Criteria

* Pregnancy
* Known gastroparesis
* Abnormal liver function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Price, MD

Role: STUDY_DIRECTOR

DexCom, Inc.

Locations

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AMCR

Escondido, California, United States

Site Status

William Sansum Diabetes Center

Santa Barbara, California, United States

Site Status

Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Rainier Clinical Research Center Inc

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PTL902020

Identifier Type: -

Identifier Source: org_study_id