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Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial
The effect of change in diabetes treatment from multiple daily insulin injection therapy to continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life, diabetes burden, parents stress level, fear, family conflicts) in families with children and adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.
Children and adolescents currently treated with MDI and with an indication for CSII were randomized 1:1 to either starting with CSII as soon as possible or to continuing MDI while waiting six months for transmission to CSII, stratified by center. The primary outcomes were patient-reported diabetes-specific health-related quality of life , and diabetes burden of the main caregiver. We also investigated the impact of CSII on main caregiver stress, psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment satisfaction, family conflict, and HbA1c.
Age
6 - 16 years
Sex
ALL
Healthy Volunteers
No
Endokrinologikum Berlin
Berlin, Germany
Kinderklinik Charite
Berlin, Germany
Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
Bochum, Germany
Kinderkrankenhaus Kliniken der Stadt Köln GmbH
Cologne, Germany
PRIMA Kinderkliniken Darmstadt
Darmstadt, Germany
Marienhospital / Kinderklinik
Gelsenkirchen, Germany
Universitätsklinik Gießen
Giessen, Germany
Klinik am Eichert
Göppingen, Germany
Kinderkrankenhaus Wilhelmstift
Hamburg, Germany
Altonaer Kinderkrankenhaus
Hamburg, Germany
Start Date
April 1, 2011
Primary Completion Date
July 1, 2015
Completion Date
August 1, 2016
Last Updated
February 5, 2018
211
ACTUAL participants
Continuous subcutaneous insulin infusion therapy
DEVICE
Multiple daily injection therapy
DEVICE
Lead Sponsor
University Hospital Schleswig-Holstein
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04591925