G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

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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

Observational

Primary location

AMCR Institute, Escondido, California, United States

About this study

The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

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
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

Primary outcomes

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

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Official study title

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 2, 2016
Registry last updated: Apr 14, 2016

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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Completed