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OpenTrials
Completed

NCT Number: NCT02880267

Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

Completed

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMCR Institute, Escondido, California, United States

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About this study

The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 2 or older
  • Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy
  • Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion criteria

  • Use of acetaminophen
  • Known allergy to medical-grade adhesives
  • Pregnancy
  • Hematocrit outside specification of the study-assigned blood glucose meter

Treatment and study plan

CGM

Device

Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.

Primary outcomes

  1. Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL

    Time frame: 10 Days

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2016
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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