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Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM) (pumpkin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01338922
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : February 2, 2018
German Research Foundation
Roche Diagnostics
University of Luebeck
Information provided by (Responsible Party):
Verena Wagner, MD, University of 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Insulin-Dependent Device: Continuous subcutaneous insulin infusion therapy Device: Multiple daily injection therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial
Study Start Date : April 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin pump therapy (CSII)
Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins
Device: Continuous subcutaneous insulin infusion therapy
Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.

Active Comparator: Multiple daily injection therapy (MDI)
Multiple daily injection therapy using different devices with marketing approval and different insulin types
Device: Multiple daily injection therapy
Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.

Primary Outcome Measures :
  1. Health related quality of life (HRQOL) (patient) [ Time Frame: 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).

  2. Diabetes burden (main carer) [ Time Frame: 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 :
  1. Parental stress level [ Time Frame: 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)

  2. Hypoglycemia fear (main carer) [ Time Frame: 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

  3. Family conflicts [ Time Frame: 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

  4. HbA1c [ Time Frame: 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)

  5. Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III [ Time Frame: 6 months ]
    Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines

  6. Diabetes treatment satisfaction [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01338922

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Endokrinologikum Berlin
Berlin, Germany, 10117
Kinderklinik Charite
Berlin, Germany, 13353
Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
Bochum, Germany, 44791
PRIMA Kinderkliniken Darmstadt
Darmstadt, Germany, 64287
Marienhospital / Kinderklinik
Gelsenkirchen, Germany, 45138
Universitätsklinik Gießen
Gießen, Germany, 35392
Klinik am Eichert
Göppingen, Germany, 73035
Kinderkrankenhaus Wilhelmstift
Hamburg, Germany, 22149
Altonaer Kinderkrankenhaus
Hamburg, Germany, 22763
Herdecke, Germany, 58313
Praxis für Kinder- und Jugendmedizin
Herford, Germany, 32052
Kinderklinik Städt. Klinikum
Karlsruhe, Germany, 76133
UK-SH, Klinik für Allg. Pädiatrie
Kiel, Germany, 24105
Kinderkrankenhaus Kliniken der Stadt Köln GmbH
Köln, Germany, 50735
Universität Leipzig, Kinderklinik
Leipzig, Germany, 04103
UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
Lübeck, Germany, 23538
Oberhausen, Germany, 46047
Kinderhospital Osnabrück
Osnabrück, Germany, 49082
Klinik f. Kinder- und Jugendmedizin
Ravensburg, Germany, 88212
Universitäts- Kinder- und Jugendklinik
Rostock, Germany, 18057
Bethlehem Gesundheitszentrum Stolberg
Stolberg, Germany, 52222
Stuttgart, Germany, 70176
Universitätsklinik Tübingen
Tübingen, Germany, 72706
Wiesbaden, Germany, 65199
Sponsors and Collaborators
University of Schleswig-Holstein
German Research Foundation
Roche Diagnostics
University of Luebeck
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Principal Investigator: Verena Wagner, MD University of Schleswig-Holstein

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Verena Wagner, MD, Verena Wagner MD, University of Schleswig-Holstein Identifier: NCT01338922     History of Changes
Other Study ID Numbers: PUMPKIN
WA 2929/2-1/ AOBJ 582855 ( Other Grant/Funding Number: German Research Foundation )
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs