Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes

Study Overview
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Brief Summary
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The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure of the glycemia is visible in real time on the pump and then the rate can be normalized. The study will evaluate the impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes aged 2 to 13 years old.

Detailed Description
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The French High Health Authority recommends, for patient with type1 diabetes, a supervision of at least 4 tests a day in pre and post prandial with additional controls in circumstances of meal or of unusual physical activities. Du to age, this control need supervision of an adult, in each place of children life (school, nursery, out-of-school center ...), according to their autonomy. During several years, all the actors of educational care tried to improve the welcome of the children affected by handicap or by chronic disease. Since 10 years, the team of pediatric diabetology of Mulhouse Hospital has developed a partnership with the department of Education by setting up every year in September of a training courses for voluntary teachers and all staff nursery. These sessions are consisted of a formal time bringing knowledge on the disease, followed by exchanges and finally a practical time around manipulation of the readers of glycemia and pumps. Alerts can be scheduled to warm an increase or an important reduction of blood glucose. The study will evaluate the child quality of life, and also parents and staffs in preschool, school or in out-of-school center felt too.

Official Title
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Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes. A French Monocentric Prospective Study (IM-CAPT)

Conditions
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Type1diabetes

Intervention / Treatment
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* Behavioral: Peds QL questionnaire and diabetes modulate
* Behavioral: WHO-5 questionnaire
* Behavioral: Felt questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment between September 15 to November 15, 2016 Insulin-dependent Type 1 Diabetes with insulin pump From 2 to 13 years old Schooled to the nursery or primary school, seeing frequently a day-nursery or in an out-of-school center Treated at the hospital of Mulhouse, France Exclusion Criteria: Opposition to study participation Patients who don't need sensor of measure of the continuous glycemia

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 13 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peds QL questionnaire and diabetes modulate<br>Routine practice of a continuous measure sensor of the glycemia with insulin pump for children aged 2 to 13 years followed at Mulhouse Hospital for type 1 diabetes : 5 sessions after enrollment visit(V1) (1 session 2 months, 4 months, 6 months, 8 months and 10 months) This study will be proposed to patients treated for type 1 diabetes enrolled in kindergarten, primary school, attending a nursery or a childcare center (patient's participation = 10 months) and will evaluate the child quality of life and the parents and staffs in preschool and school felt too. | Behavioral: Peds QL questionnaire and diabetes modulate<br>* Peds QL questionnaire and diabetes modulate is a pediatric questionnaire about quality of life - children's version and parents version : assessed in the 1st visit (enrollment visit) and after ten months ( V6 End of study)<br>Behavioral: WHO-5 questionnaire<br>* WHO-5 questionnaire is a questionnaire about quality of life : assessed in the 1st visit (enrollment visit) and after ten months (V6 End of Study) by the children<br>Behavioral: Felt questionnaire<br>* Felt questionnaire completed by parents with regard to the welcome of their child in community and by the staffs in preschool, school or in out-of school center : assessed 2 months (V2) and ten months (V6 End of study) after enrollment visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Peds QL questionnaire results | Questionnaire of quality of life (QL) | Through study completion, an average of 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of WHO-5 and felt questionnaire | Questionnaire of quality of life | through study completion, an average of 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes children,School,Childcare facilities,Sensor