Skip to main content
OpenTrials
Completed

NCT Number: NCT01338922

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Insulin-dependent Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endokrinologikum Berlin, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous subcutaneous insulin infusion therapy

Device

Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.

Multiple daily injection therapy

Device

Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • German Research Foundation
  • Roche Diagnostics GmbH
  • University of Luebeck

Registry information

Official study title

Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial

Acronym: pumpkin

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 20, 2011
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.