Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes (IM-CAPT)

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Completed

Conditions: Type1diabetes

Treatments: Behavioral: Peds QL questionnaire and diabetes modulate; Behavioral: Felt questionnaire; Behavioral: WHO-5 questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT03177096

2016-A01264-47 (Other Identifier)

GHR 866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Peds QL questionnaire and diabetes modulate

Experimental group

Description:

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.

Treatment:

Behavioral: WHO-5 questionnaire

Behavioral: Felt questionnaire

Behavioral: Peds QL questionnaire and diabetes modulate