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Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System

NCT01111370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-27

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects \>18 years-old with diabetes mellitus requiring insulin.

Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels \>80 mg/dL and ±20 mg/dL at meter glucose levels \<80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study (PTL-900360) meeting the above criteria will be compared to the proportion of such points observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL 300012).

Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.

Conditions

Interventions

DEVICE

DexCom™ G4 Continuous Glucose Monitoring System

Continuous Glucose Monitoring System

Sponsors & Collaborators

  • DexCom, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Balo · DexCom, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-04-30
Completion
2010-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111370 on ClinicalTrials.gov