Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Interventions
- Device: Continuous subcutaneous insulin infusion therapyDevice: Multiple daily injection therapy
- Registration Number
- NCT01338922
- Lead Sponsor
- University Hospital Schleswig-Holstein
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- Type 1 DM
- Transition to Continuous Subcutaneous Insulin Infusion (CSII)
- meeting the costs by health services
- sufficient German literacy
- Remission (diabetes duration < 6 months, insulin < 0.5 i.E./kg)
- severe learning problems
- Investigator's children
- Waiting time not advised for medical reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin pump therapy (CSII) Continuous subcutaneous insulin infusion therapy Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins Multiple daily injection therapy (MDI) Multiple daily injection therapy Multiple daily injection therapy using different devices with marketing approval and different insulin types
- Primary Outcome Measures
Name Time Method Health related quality of life (HRQOL) (patient) 6 months Child's HRQOL will be measured using the well-known standardized KINDL-R (KINDL) modular questionnaire. The widely used instrument provides a generic age-appropriate core-measure (24 items) and a diabetes-specific module (21 items).
Diabetes burden (main carer) 6 months The main carer (parent) will report on the Overall Diabetes Burden using a one-dimensional 5-point intensity scale which was used in the pilot-study and showed sensitivity to change.
Comment: Two primary measures are used because independent information from the child (patient) and the main carer is requested
- Secondary Outcome Measures
Name Time Method Parental stress level 6 months Parental stress will be measured using the Paediatric Inventory for Parents (PIP). The 42-items instrument provides a Total Frequency Score (PIP-F), and a Total Difficulty Score (PIP-D)
Hypoglycemia fear (main carer) 6 months Hypoglycemia fear will be measured using the Hypoglycaemia Fear Survey, parent version (HFS-P, Clarke et al. 1998). The 25-items instrument provides two scales: Behaviour and Worry
Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III 6 months Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines
Family conflicts 6 months Family conflict (adolescent, main carer) will be measured by the Diabetes Family Conflict Scale (DFCS). The 19 items instrument provides a DFCS Total Score
HbA1c 6 months Blood samples will be collected locally with standardised equipment.The mean HbA1c value will be calculated for each patient from the last 3 measurements taken during the past six months. HbA1c values will be mathematically standardized to the Diabetes Control and Complications Trial (DCCT) -equivalent in agreement with published guidelines (Marshall\& Barth 2000)
Diabetes treatment satisfaction 6 months Treatment Satisfaction will be measured using the Diabetes Treatment Satisfaction Scale, status version (DTSQs-teen, DTSQs-parent).The validated German version will be released by MAPI (MAPI) in April 2011.
Trial Locations
- Locations (24)
Endokrinologikum Berlin
🇩🇪Berlin, Germany
Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
🇩🇪Bochum, Germany
Kinderkrankenhaus Wilhelmstift
🇩🇪Hamburg, Germany
Gemeinschaftskrankenhaus
🇩🇪Herdecke, Germany
Kinderhospital Osnabrück
🇩🇪Osnabrück, Germany
Universitäts- Kinder- und Jugendklinik
🇩🇪Rostock, Germany
Universität Leipzig, Kinderklinik
🇩🇪Leipzig, Germany
Universitätsklinik Tübingen
🇩🇪Tübingen, Germany
HSK-Kinderklinik
🇩🇪Wiesbaden, Germany
Kinderklinik Charite
🇩🇪Berlin, Germany
PRIMA Kinderkliniken Darmstadt
🇩🇪Darmstadt, Germany
Marienhospital / Kinderklinik
🇩🇪Gelsenkirchen, Germany
Universitätsklinik Gießen
🇩🇪Gießen, Germany
Klinik am Eichert
🇩🇪Göppingen, Germany
Kinderklinik Städt. Klinikum
🇩🇪Karlsruhe, Germany
UK-SH, Klinik für Allg. Pädiatrie
🇩🇪Kiel, Germany
Praxis für Kinder- und Jugendmedizin
🇩🇪Herford, Germany
Kinderkrankenhaus Kliniken der Stadt Köln GmbH
🇩🇪Köln, Germany
Klinik f. Kinder- und Jugendmedizin
🇩🇪Ravensburg, Germany
Bethlehem Gesundheitszentrum Stolberg
🇩🇪Stolberg, Germany
Olgahospital
🇩🇪Stuttgart, Germany
Altonaer Kinderkrankenhaus
🇩🇪Hamburg, Germany
Ev.Krankenhaus
🇩🇪Oberhausen, Germany
UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
🇩🇪Lübeck, Germany