- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02099409
Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
September 15, 2014 updated by: Carine de Beaufort, Centre Hospitalier du Luxembourg
Open Label Single Center Randomized Cross Over Study to Validate Current Algorithms and Evaluate Safety and Efficacy of Closed Loop Insulin Delivery (FlorenceD2 System) in Children With Type 1 Diabetes Between 6 - 12 Years of Age
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 .
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Luxembourg, Luxembourg, 1210
- DECCP Clinique Pédiatrique de Luxembourg/CHL
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Luxembourg, Luxembourg, 1210
- DECCP Pediatric Clinic , CHLuxembourg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 6 - ≤12 years
- 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:
-None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
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Experimental: Start open loop followed by FLORENCED2
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
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FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time spent in normal glucose range ( mg/dl)
Time Frame: At least 5 hours between 7 pm and 7 am
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Glucose will be measured with a Continuous glucose monitoring device
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At least 5 hours between 7 pm and 7 am
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glucose variability ( excursions in mg/dl)
Time Frame: 7 pm - 7 am
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Continuous Glucose Monitoring device
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7 pm - 7 am
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Time spent in low glucose range (< 60 mg/dl)
Time Frame: 7 pm till 7 am
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Continuous Glucose Monitoring
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7 pm till 7 am
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time spent in low glucose range (<70 mg/dl)
Time Frame: 7 pm till 7 am
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continuous glucose monitoring
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7 pm till 7 am
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time spent in high glucose range (>180mg/dl)
Time Frame: 7 pm - 7 am
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continuous glucose monitoring
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7 pm - 7 am
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carine deBeaufort, MD PhD, Centre Hospitalier du Luxembourg
- Principal Investigator: Roman Hovorka, Professor, University of Cambridge
- Principal Investigator: Gosia Wilinska, PhD, University of Cambridge
- Principal Investigator: Ulrike Schierloh, MD, Centre Hospitalier du Luxembourg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
March 27, 2014
First Posted (Estimate)
March 28, 2014
Study Record Updates
Last Update Posted (Estimate)
September 16, 2014
Last Update Submitted That Met QC Criteria
September 15, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPIDLUX 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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