Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes (IM-CAPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03177096|
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1diabetes||Behavioral: Peds QL questionnaire and diabetes modulate Behavioral: WHO-5 questionnaire Behavioral: Felt questionnaire||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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)|
|Actual Study Start Date :||September 20, 2016|
|Actual Primary Completion Date :||July 12, 2017|
|Actual Study Completion Date :||July 12, 2017|
Experimental: Peds QL questionnaire and diabetes modulate
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
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
- Evolution of Peds QL questionnaire results [ Time Frame: Through study completion, an average of 10 months ]Questionnaire of quality of life (QL)
- Evolution of WHO-5 and felt questionnaire [ Time Frame: through study completion, an average of 10 months ]Questionnaire of quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177096
|Mulhouse, France, 68100|
|Principal Investigator:||Fatiha GUEMAZI-KHEFFI, MD|