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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Acetaminophen Challenge (G6 CGM)

• Registration Number: NCT03087877
• Lead Sponsor: DexCom, Inc.

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.

Study Timeline

• Study Start: 2017-02-03
• Study First Submitted: 2017-02-24
• Primary Completion: 2017-03-04
• Study Completion: 2017-03-04
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Ages 18 or older
• Diagnosis of diabetes

Exclusion Criteria

• Pregnancy
• Known gastroparesis
• Abnormal liver function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM Users	Acetaminophen Challenge (G6 CGM)	Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

AMCR; 🇺🇸 Escondido, California, United States

William Sansum Diabetes Center; 🇺🇸 Santa Barbara, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Rainier Clinical Research Center Inc; 🇺🇸 Renton, Washington, United States