Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

Study Overview
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Brief Summary
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Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems. In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology in type 1 diabetic children, especially on the time spent in hypoglycemia .

Detailed Description
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Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance. However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems. In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia. The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology in type 1 diabetic children, especially on the time spent in hypoglycemia .

Official Title
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Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Continuous glucose monitoring with the stop insulin pump function


Participation Criteria
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Eligibility Criteria
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inclusion criteria : children aged between 1 and 17 years type 1 diabetes Duration of type 1 diabetes > 1 year insulin pump therapy > 3 months exclusion criteria : Other diseases predisposing to hypoglycemia Oral glycemic medications have used continuous glucose monitoring during the last 3 months HbA1c >10%

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin pump function<br>continuous glucose monitoring and then continuous glucose monitoring with the stop insulin pump function | Device: Continuous glucose monitoring with the stop insulin pump function<br>* Children with type 1 diabetes using insulin pump and continuous glucose monitoring without the stop insulin pump functionare then using the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent hypoglycemia | average daily time spent in hypoglycemia measured on a one-month data collection | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycemia | Number of glycemia less than 0.70 g/l measured on a one-month data collection | 1 month |