Type1diabetes
Conditions
Keywords
Type 1 diabetes children,School,Childcare facilities,Sensor
Brief summary
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
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.
Interventions
BEHAVIORALPeds QL questionnaire and diabetes modulate
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)
BEHAVIORALWHO-5 questionnaire
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
BEHAVIORALFelt questionnaire
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
Sponsors
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Peds QL questionnaire results | Through study completion, an average of 10 months | Questionnaire of quality of life (QL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of WHO-5 and felt questionnaire | through study completion, an average of 10 months | Questionnaire of quality of life |
Countries
France
Outcome results
None listed