Clinical trial NCT01338922: Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)
Official title: Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Insulin-Dependent
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Roche Diagnostics GmbH
name: University of Luebeck
First posted: 2011-04-20
Enrollment: 211
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 DM
* Transition to Continuous Subcutaneous Insulin Infusion (CSII)
* meeting the costs by health services
* sufficient German literacy

Exclusion Criteria:

* Remission (diabetes duration \< 6 months, insulin \< 0.5 i.E./kg)
* severe learning problems
* Investigator's children
* Waiting time not advised for medical reasons

Primary outcomes:
measure: Health related quality of life (HRQOL) (patient)
timeFrame: 6 months
measure: Diabetes burden (main carer)
timeFrame: 6 months
Secondary outcomes:
measure: Parental stress level
timeFrame: 6 months
measure: Hypoglycemia fear (main carer)
timeFrame: 6 months
measure: Family conflicts
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III
timeFrame: 6 months
measure: Diabetes treatment satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Endokrinologikum Berlin
city: Berlin
country: Germany
facility: Kinderklinik Charite
city: Bochum
country: Germany
facility: Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
city: Darmstadt
country: Germany
facility: PRIMA Kinderkliniken Darmstadt
city: Gelsenkirchen
country: Germany
facility: Marienhospital / Kinderklinik
city: Gießen
country: Germany
facility: Universitätsklinik Gießen
city: Göppingen
country: Germany
facility: Klinik am Eichert
city: Hamburg
country: Germany
facility: Kinderkrankenhaus Wilhelmstift
city: Hamburg
country: Germany
facility: Altonaer Kinderkrankenhaus
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus
city: Herford
country: Germany
facility: Praxis für Kinder- und Jugendmedizin
city: Karlsruhe
country: Germany
facility: Kinderklinik Städt. Klinikum
city: Kiel
country: Germany
facility: UK-SH, Klinik für Allg. Pädiatrie
city: Köln
country: Germany
facility: Kinderkrankenhaus Kliniken der Stadt Köln GmbH
city: Leipzig
country: Germany
facility: Universität Leipzig, Kinderklinik
city: Lübeck
country: Germany
facility: UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
city: Oberhausen
country: Germany
facility: Ev.Krankenhaus
city: Osnabrück
country: Germany
facility: Kinderhospital Osnabrück
city: Ravensburg
country: Germany
facility: Klinik f. Kinder- und Jugendmedizin
city: Rostock
country: Germany
facility: Universitäts- Kinder- und Jugendklinik
city: Stolberg
country: Germany
facility: Bethlehem Gesundheitszentrum Stolberg
city: Stuttgart
country: Germany
facility: Olgahospital
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Wiesbaden
country: Germany
facility: HSK-Kinderklinik
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Verena Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller-Godeffroy E, Vonthein R, Ludwig-Seibold C, Heidtmann B, Boettcher C, Kramer M, Hessler N, Hilgard D, Lilienthal E, Ziegler A, Wagner VM; German Working Group for Pediatric Pump Therapy (agip). Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial. Pediatr Diabetes. 2018 Dec;19(8):1471-1480. doi: 10.1111/pedi.12777. Epub 2018 Oct 10.