Standardized Procedure for the Assessment of New-to-market Continuous Glucose Monitoring Systems

NCT01751932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-12-16

No results posted yet for this study

Summary

The purpose of this study is to assess the accuracy of two continuous glucose monitoring devices (the Dexcom G4 Platinum and Medtronic Enlite systems) in patients with type 1 diabetes mellitus.

Conditions

Interventions

DEVICE

CGM Monitoring

All patients will be fitted with the two study CGM systems. Paradigm Veo will be configured to use the CGM part only if another pump is used.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • J. Hans DeVries, MD, PhD · Academic Medical Center - Department of Internal Medicine, Amsterdam, The Netherlands

  • Eric Renard, PhD · Medical University Montpellier, France

  • Angelo Avogaro, PhD · Medical University Padova, Italy

  • Julia Mader, MD · Medical University Graz, Austria

  • Thomas Pieber, MD · Medical University Graz, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Netherlands

Study Locations

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Entities

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 NCT01751932 on ClinicalTrials.gov