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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Acetaminophen Challenge (G6 CGM)

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • AMCR
    • Santa Barbara, California, United States, 93105
      • William Sansum Diabetes Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 18 or older
• Diagnosis of diabetes

Exclusion Criteria:

• Pregnancy
• Known gastroparesis
• Abnormal liver function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CGM Users; Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.	Device: Acetaminophen Challenge (G6 CGM); Evaluation of acetaminophen effect on CGM glucose sensing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	6 hrs post dose

Collaborators and Investigators

• Sponsor: DexCom, Inc.
• Investigators: Study Director: David Price, MD, DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): March 4, 2017
• Study Completion (Actual): March 4, 2017

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: PTL902020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No