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OpenTrials
Completed

NCT Number: NCT03087877

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMCR, Escondido, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 or older
  • Diagnosis of diabetes

Exclusion criteria

  • Pregnancy
  • Known gastroparesis
  • Abnormal liver function

Treatment and study plan

Acetaminophen Challenge (G6 CGM)

Device

Evaluation of acetaminophen effect on CGM glucose sensing

Primary outcomes

  1. Interference Effect for the G6 CGM

    Time frame: 6 hrs post dose

    Bias of sensor to reference measurement pre and post acetaminophen administration

Secondary outcomes

  1. Mean of sensor minus YSI values (bias) for various time periods

    Time frame: 6 hrs post dose

    Bias calculated for pre-dose, post dose and peak post dose

  2. Duration of interference effect for the G6 CGM

    Time frame: 6 hrs post dose

    Length of time the inhibition effect is more than 10 mg/dL

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2017
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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