NCT02099409

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Centre Hospitalier du Luxembourg · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FLORENCED2	FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-03-28
• Last updated: 2014-09-16

Locations

2 sites across 1 country: Luxembourg