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

NCT01338922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2018-02-05

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Insulin-Dependent

Interventions

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.

DEVICE

Multiple daily injection therapy

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • University of Luebeck

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Verena Wagner, MD · University Hospital Schleswig-Holstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-07-31
Completion
2016-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338922 on ClinicalTrials.gov