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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Luxembourg
Study Type
Interventional
Intervention
FLORENCED2
Sponsored by
Centre Hospitalier du Luxembourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes mellitus, children, closed loop, cross over, overnight, FLORENCED2, DANA Diabecare R pump, FreeStyle Navigator II, Dexcom G4

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DECCP Clinique Pédiatrique de Luxembourg/CHL
  • DECCP Pediatric Clinic , CHLuxembourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Starting with FLORENCED2 followed by open loop

Start open loop followed by FLORENCED2

Arm Description

Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.

Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2

Outcomes

Primary Outcome Measures

Time spent in normal glucose range ( mg/dl)
Glucose will be measured with a Continuous glucose monitoring device

Secondary Outcome Measures

glucose variability ( excursions in mg/dl)
Continuous Glucose Monitoring device
Time spent in low glucose range (< 60 mg/dl)
Continuous Glucose Monitoring
time spent in low glucose range (<70 mg/dl)
continuous glucose monitoring
time spent in high glucose range (>180mg/dl)
continuous glucose monitoring

Full Information

First Posted
March 26, 2014
Last Updated
September 15, 2014
Sponsor
Centre Hospitalier du Luxembourg
Collaborators
University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT02099409
Brief Title
Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier du Luxembourg
Collaborators
University of Cambridge

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 diabetes mellitus, children, closed loop, cross over, overnight, FLORENCED2, DANA Diabecare R pump, FreeStyle Navigator II, Dexcom G4

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starting with FLORENCED2 followed by open loop
Arm Type
Experimental
Arm Description
Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop.
Arm Title
Start open loop followed by FLORENCED2
Arm Type
Experimental
Arm Description
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
Intervention Type
Device
Intervention Name(s)
FLORENCED2
Intervention Description
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Primary Outcome Measure Information:
Title
Time spent in normal glucose range ( mg/dl)
Description
Glucose will be measured with a Continuous glucose monitoring device
Time Frame
At least 5 hours between 7 pm and 7 am
Secondary Outcome Measure Information:
Title
glucose variability ( excursions in mg/dl)
Description
Continuous Glucose Monitoring device
Time Frame
7 pm - 7 am
Title
Time spent in low glucose range (< 60 mg/dl)
Description
Continuous Glucose Monitoring
Time Frame
7 pm till 7 am
Title
time spent in low glucose range (<70 mg/dl)
Description
continuous glucose monitoring
Time Frame
7 pm till 7 am
Title
time spent in high glucose range (>180mg/dl)
Description
continuous glucose monitoring
Time Frame
7 pm - 7 am

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine deBeaufort, MD PhD
Organizational Affiliation
Centre Hospitalier du Luxembourg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roman Hovorka, Professor
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gosia Wilinska, PhD
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrike Schierloh, MD
Organizational Affiliation
Centre Hospitalier du Luxembourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
DECCP Clinique Pédiatrique de Luxembourg/CHL
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
DECCP Pediatric Clinic , CHLuxembourg
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg

12. IPD Sharing Statement

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

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