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Completed

NCT Number: NCT02099409

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

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 .

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DECCP Clinique Pédiatrique de Luxembourg/CHL, Luxembourg

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLORENCED2

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. glucose variability ( excursions in mg/dl)

    Time frame: 7 pm - 7 am

    Continuous Glucose Monitoring device

  2. Time spent in low glucose range (< 60 mg/dl)

    Time frame: 7 pm till 7 am

    Continuous Glucose Monitoring

  3. time spent in low glucose range (<70 mg/dl)

    Time frame: 7 pm till 7 am

    continuous glucose monitoring

  4. time spent in high glucose range (>180mg/dl)

    Time frame: 7 pm - 7 am

    continuous glucose monitoring

Sponsors and collaborators

Lead sponsor

Centre Hospitalier du Luxembourg

Other

Collaborators

  • University of Cambridge

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2014
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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