Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
NCT ID: NCT02099409
Last Updated: 2014-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Starting with FLORENCED2 followed by open loop
Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.
FLORENCED2
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Start open loop followed by FLORENCED2
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
FLORENCED2
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Interventions
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FLORENCED2
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Eligibility Criteria
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Inclusion Criteria
* With type 1 diabetes for 6 months or more and
* Pump user for at least 6 months.
* HbAc1 should be \<11 %.
* No medication or physical or psychological disease should be present, which could interfere with the study.
Exclusion Criteria
6 Years
12 Years
ALL
No
Sponsors
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University of Cambridge
OTHER
Centre Hospitalier du Luxembourg
OTHER
Responsible Party
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Carine de Beaufort
MD , PhD
Principal Investigators
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Carine deBeaufort, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier du Luxembourg
Roman Hovorka, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Gosia Wilinska, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Ulrike Schierloh, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier du Luxembourg
Locations
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DECCP Clinique Pédiatrique de Luxembourg/CHL
Luxembourg, , Luxembourg
DECCP Pediatric Clinic , CHLuxembourg
Luxembourg, , Luxembourg
Countries
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Other Identifiers
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SPIDLUX 4
Identifier Type: -
Identifier Source: org_study_id
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