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

August 20, 2019 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Mulhouse, France, 68100
        • GHRMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of Peds QL questionnaire results
Time Frame: Through study completion, an average of 10 months
Questionnaire of quality of life (QL)
Through study completion, an average of 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of WHO-5 and felt questionnaire
Time Frame: through study completion, an average of 10 months
Questionnaire of quality of life
through study completion, an average of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Investigators

  • Principal Investigator: Fatiha GUEMAZI-KHEFFI, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

July 12, 2017

Study Completion (Actual)

July 12, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHR 866
  • 2016-A01264-47 (Other Identifier: Agence Nationale Sécurité du Médicament et produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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