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

Status

Completed

Intervention / Treatment

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

      • Luxembourg, Luxembourg, 1210
        • DECCP Clinique Pédiatrique de Luxembourg/CHL
      • Luxembourg, Luxembourg, 1210
        • DECCP Pediatric Clinic , CHLuxembourg

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.
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Experimental: Start open loop followed by FLORENCED2
Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2
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
Glucose will be measured with a Continuous glucose monitoring device
At least 5 hours between 7 pm and 7 am

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose variability ( excursions in mg/dl)
Time Frame: 7 pm - 7 am
Continuous Glucose Monitoring device
7 pm - 7 am
Time spent in low glucose range (< 60 mg/dl)
Time Frame: 7 pm till 7 am
Continuous Glucose Monitoring
7 pm till 7 am
time spent in low glucose range (<70 mg/dl)
Time Frame: 7 pm till 7 am
continuous glucose monitoring
7 pm till 7 am
time spent in high glucose range (>180mg/dl)
Time Frame: 7 pm - 7 am
continuous glucose monitoring
7 pm - 7 am

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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.

Clinical Trials on Type 1 Diabetes Mellitus

3
Subscribe