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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099409
• Other study ID #: SPIDLUX 4
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: September 15, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Centre Hospitalier du Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Luxembourg: Comite National d'Ethique de RechercheLuxembourg: Ministère de la Santé
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Luxembourg	DECCP Clinique Pédiatrique de Luxembourg/CHL	Luxembourg
Luxembourg	DECCP Pediatric Clinic , CHLuxembourg	Luxembourg

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier du Luxembourg	University of Cambridge

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent in normal glucose range ( mg/dl)	Glucose will be measured with a Continuous glucose monitoring device	At least 5 hours between 7 pm and 7 am	Yes
Secondary	glucose variability ( excursions in mg/dl)	Continuous Glucose Monitoring device	7 pm - 7 am	Yes
Secondary	Time spent in low glucose range (< 60 mg/dl)	Continuous Glucose Monitoring	7 pm till 7 am	Yes
Secondary	time spent in low glucose range (<70 mg/dl)	continuous glucose monitoring	7 pm till 7 am	Yes
Secondary	time spent in high glucose range (>180mg/dl)	continuous glucose monitoring	7 pm - 7 am	Yes

External Links

•   SPIDLUX 4 is a sub study of the SPIDIMAN project