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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02099409

Enrollment

Registered

2014-03-28

Start date

2014-01-31

Completion date

2014-08-31

Last updated

2014-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 .

Interventions

DEVICEFLORENCED2

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time spent in normal glucose range ( mg/dl)	At least 5 hours between 7 pm and 7 am	Glucose will be measured with a Continuous glucose monitoring device

Secondary

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

Countries

Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026