CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Peds QL questionnaire and diabetes modulate +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03177096
NCT03177096N/ACompleted

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)

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace·interventional·Posted Jun 6, 2017·Updated Aug 21, 2019

In Brief

A clinical study evaluating Peds QL questionnaire and diabetes modulate, WHO-5 questionnaire, and 1 other intervention for Type1diabetes. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1diabetes
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 6, 2017
Enrollment StartSep 20, 2016
Primary CompletionJul 12, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.1 years ago

Interventions

Peds QL questionnaire and diabetes modulatebehavioral

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 questionnairebehavioral

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 questionnairebehavioral

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