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Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg

NCT02099409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-16

No results posted yet for this study

Summary

The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

FLORENCED2

FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R

Sponsors & Collaborators

Principal Investigators

  • Carine deBeaufort, MD PhD · Centre Hospitalier du Luxembourg

  • Roman Hovorka, Professor · University of Cambridge

  • Gosia Wilinska, PhD · University of Cambridge

  • Ulrike Schierloh, MD · Centre Hospitalier du Luxembourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Luxembourg

Study Locations

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Entities

Companies

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 NCT02099409 on ClinicalTrials.gov