Clinical trial NCT03177096: Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Keywords: Type 1 diabetes children,School,Childcare facilities,Sensor
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of Peds QL questionnaire results
timeFrame: Through study completion, an average of 10 months
Secondary outcomes:
measure: Evolution of WHO-5 and felt questionnaire
timeFrame: through study completion, an average of 10 months
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
name: Fatiha GUEMAZI-KHEFFI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rewers MJ, Pillay K, de Beaufort C, Craig ME, Hanas R, Acerini CL, Maahs DM; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:102-14. doi: 10.1111/pedi.12190. No abstract available.
citation: Danne T, Tsioli C, Kordonouri O, Blaesig S, Remus K, Roy A, Keenan B, Lee SW, Kaufman FR. The PILGRIM study: in silico modeling of a predictive low glucose management system and feasibility in youth with type 1 diabetes during exercise. Diabetes Technol Ther. 2014 Jun;16(6):338-47. doi: 10.1089/dia.2013.0327. Epub 2014 Jan 21.
citation: Conget I, Choudhary P, Olsen BS et al. Prevention of hypoglycaemia by the predictive low glucose management feature in a user evaluation study. abstract #865
citation: Choudhary P, Olsen BS, Conget I, Welsh JB, Vorrink L, Shin JJ. Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management. Diabetes Technol Ther. 2016 May;18(5):288-91. doi: 10.1089/dia.2015.0324. Epub 2016 Feb 23.
citation: Besbes H, Hammami S et al. SFP P-024 - Etude de la qualité de vie des enfants atteints de diabète de type 1 ; Archives de Pédiatrie Volume 21, Issue 5, Supplement 1, May 2014, Pages 734
citation: Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631.
citation: Institut de Veille Sanitaire. Prévalence et incidence du diabète / Données épidémiologiques / Diabète / Maladies chroniques et traumatismes / Dossiers thématiques / Accueil