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

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02696252
• Lead Sponsor: DexCom, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	7 days

Trial Locations

Locations (4)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

AMCR Institute; 🇺🇸 Escondido, California, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States

Rocky Mountain Diabetes and Osteoporosis Center; 🇺🇸 Idaho Falls, Idaho, United States