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Completed

NCT Number: NCT03177096

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

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.

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Key information

Conditions

Age range

2 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHRMSA

Mulhouse, 68100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

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

Primary outcomes

  1. Evolution of Peds QL questionnaire results

    Time frame: Through study completion, an average of 10 months

    Questionnaire of quality of life (QL)

Secondary outcomes

  1. Evolution of WHO-5 and felt questionnaire

    Time frame: through study completion, an average of 10 months

    Questionnaire of quality of life

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study 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)

Acronym: IM-CAPT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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