NCT03177096

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
• Sex: All
• Age: 2 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Peds 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)
BEHAVIORAL	WHO-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
BEHAVIORAL	Felt 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

Timeline

• Start date: 2016-09-20
• Primary completion: 2017-07-12
• Completion: 2017-07-12
• First posted: 2017-06-06
• Last updated: 2019-08-21

Locations

1 site across 1 country: France