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
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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