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

January 31, 2018 updated by: Verena Wagner, MD, University Hospital Schleswig-Holstein

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Endokrinologikum Berlin
      • Berlin, Germany, 13353
        • Kinderklinik Charite
      • Bochum, Germany, 44791
        • Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
      • Darmstadt, Germany, 64287
        • PRIMA Kinderkliniken Darmstadt
      • Gelsenkirchen, Germany, 45138
        • Marienhospital / Kinderklinik
      • Gießen, Germany, 35392
        • Universitatsklinik Giessen
      • Göppingen, Germany, 73035
        • Klinik am Eichert
      • Hamburg, Germany, 22149
        • Kinderkrankenhaus Wilhelmstift
      • Hamburg, Germany, 22763
        • Altonaer Kinderkrankenhaus
      • Herdecke, Germany, 58313
        • Gemeinschaftskrankenhaus
      • Herford, Germany, 32052
        • Praxis fur Kinder- und Jugendmedizin
      • Karlsruhe, Germany, 76133
        • Kinderklinik Städt. Klinikum
      • Kiel, Germany, 24105
        • UK-SH, Klinik für Allg. Pädiatrie
      • Köln, Germany, 50735
        • Kinderkrankenhaus Kliniken der Stadt Köln GmbH
      • Leipzig, Germany, 04103
        • Universität Leipzig, Kinderklinik
      • Lübeck, Germany, 23538
        • UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
      • Oberhausen, Germany, 46047
        • Ev.Krankenhaus
      • Osnabrück, Germany, 49082
        • Kinderhospital Osnabrück
      • Ravensburg, Germany, 88212
        • Klinik f. Kinder- und Jugendmedizin
      • Rostock, Germany, 18057
        • Universitäts- Kinder- und Jugendklinik
      • Stolberg, Germany, 52222
        • Bethlehem Gesundheitszentrum Stolberg
      • Stuttgart, Germany, 70176
        • Olgahospital
      • Tübingen, Germany, 72706
        • Universitatsklinik Tubingen
      • Wiesbaden, Germany, 65199
        • HSK-Kinderklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
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
6 months
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
6 months
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)
6 months
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 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

German Research Foundation
University of Luebeck
Roche Diagnostics

Investigators

  • Principal Investigator: Verena Wagner, MD, University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (ESTIMATE)

April 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMPKIN
  • WA 2929/2-1/ AOBJ 582855 (OTHER_GRANT: German Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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