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

DexCom, Inc.97 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (4)

AMCR Institute

Escondido, California, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Outcomes

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

Data from ClinicalTrials.gov

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