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

NCT03177096 | Completed

• 2 other identifiers: GHR 8662016-A01264-47
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

Type 1 diabetes children,School,Childcare facilities,Sensor

Outcome Measures

Primary Outcomes (1)

• Evolution of Peds QL questionnaire results

  Questionnaire of quality of life (QL)

  Through study completion, an average of 10 months

Secondary Outcomes (1)

• Evolution of WHO-5 and felt questionnaire

  through study completion, an average of 10 months

Study Arms (1)

Peds QL questionnaire and diabetes modulate

EXPERIMENTAL

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; Behavioral: WHO-5 questionnaire; Behavioral: Felt questionnaire

Interventions

Peds QL questionnaire and diabetes modulate BEHAVIORAL

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)

Peds QL questionnaire and diabetes modulate

WHO-5 questionnaire BEHAVIORAL

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

Peds QL questionnaire and diabetes modulate

Felt questionnaire BEHAVIORAL

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

Peds QL questionnaire and diabetes modulate

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Opposition to study participation
• Patients who don't need sensor of measure of the continuous glycemia

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

GHRMSA

Mulhouse, 68100, France

Location

Related Publications (7)

• 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.

  PMID: 25182311 BACKGROUND

• 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.

  PMID: 24447074 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26907513 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12610013 BACKGROUND

• Institut de Veille Sanitaire. Prévalence et incidence du diabète / Données épidémiologiques / Diabète / Maladies chroniques et traumatismes / Dossiers thématiques / Accueil

  BACKGROUND

Study Officials

• Fatiha GUEMAZI-KHEFFI, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: September 20, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: August 21, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)