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

Study Overview
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Brief Summary
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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 .

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: FLORENCED2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Starting with FLORENCED2 followed by open loop<br>Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop. | Device: FLORENCED2<br>* FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R<br>|
| Experimental: Start open loop followed by FLORENCED2<br>Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2 | Device: FLORENCED2<br>* FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes mellitus, children, closed loop, cross over, overnight, FLORENCED2, DANA Diabecare R pump, FreeStyle Navigator II, Dexcom G4