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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177096
First Posted: June 6, 2017
Last Update Posted: August 1, 2017
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.
Information provided by (Responsible Party):
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
  Purpose
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.

Condition Intervention
Type1diabetes Behavioral: Peds QL questionnaire and diabetes modulate Behavioral: WHO-5 questionnaire Behavioral: Felt questionnaire

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:

Primary Outcome Measures:
  • Evolution of Peds QL questionnaire results [ Time Frame: Through study completion, an average of 10 months ]
    Questionnaire of quality of life (QL)


Secondary Outcome Measures:
  • Evolution of WHO-5 and felt questionnaire [ Time Frame: through study completion, an average of 10 months ]
    Questionnaire of quality of life


Enrollment: 14
Actual Study Start Date: September 20, 2016
Estimated Study Completion Date: August 15, 2017
Primary Completion Date: June 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
GHRMSA
Mulhouse, France, 68100
Sponsors and Collaborators
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
Principal Investigator: Fatiha GUEMAZI-KHEFFI, MD
  More Information

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

Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
ClinicalTrials.gov Identifier: NCT03177096     History of Changes
Other Study ID Numbers: GHR 866
2016-A01264-47 ( Other Identifier: Agence Nationale Sécurité du Médicament et produits de santé )
First Submitted: June 2, 2017
First Posted: June 6, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:
Type 1 diabetes children,School,Childcare facilities,Sensor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs