QUality of Control and slEep in Children With diabeteS, Using New Technology

Study Overview
=================
Brief Summary
-----------------
The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.

Detailed Description
-----------------
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes. In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.

Official Title
-----------------
Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Device: CGM augmented pump with PLGS ,
* Device: Insulin pump with CGM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Duration of diabetes ≥ 6 months Insulin pump treatment ≥ 6 months HbA1c ≤ 11% Parental written informed consent Exclusion Criteria: . No parental consent Physical or psychological disease likely to interfere with an appropriate conduct of the study Current drug therapy knowing to interfere with glucose metabolism Chronic sleep medication in the primary caregiver or the patient -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM augmented pump with PLGS (A)<br>Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks | Device: CGM augmented pump with PLGS ,<br>* 5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration<br>* Other names: 640G, Enlite Sensors , Freestyle Libre;|
| Active Comparator: Insulin pump with CGM (B)<br>Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks | Device: Insulin pump with CGM<br>* 5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,<br>* Other names: 640G , freestyle libre;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in glucose target | Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM | Last 6 days of treatment arm A and last 6 days of treatment arm B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time below glucose target | Percent time spent below glucose target (<3.0mmol/l and < 2,5 mmol/l) measured by blinded CGM (I-Pro 2) | Last 6 days of treatment arm A and last 6 days of treatment arm B | 
| Time above glucose target | Percent time spent above glucose target (>10.0mmol/l ) measured by blinded CGM (I-Pro 2) | Last 6 days of treatment arm A and last 6 days of treatment arm B | 
| Sleep quantity in patients and caregivers | Total sleep and wake time , number of awakenings measured by wireless actigraph | baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B | 
| perception of quality of sleep and quality of life in patients and caregivers | validated questionnaires | baseline and last week of treatment arm A and last week of treatment arm B | 
| hypoglycaemia fear in patients and caregivers | Hypoglycemia fear survey for parents and children | baseline and last week of treatment arm A and last week of treatment arm B |