NCT01338922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4.3 years

First QC Date

April 7, 2011

Last Update Submit

January 31, 2018

Conditions

Diabetes Mellitus, Insulin-Dependent

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life (HRQOL) (patient)

    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)

    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 Outcomes (6)

  • Parental stress level

    6 months

  • Hypoglycemia fear (main carer)

    6 months

  • Family conflicts

    6 months

  • HbA1c

    6 months

  • Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Insulin pump therapy (CSII)

EXPERIMENTAL

Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins

Device: Continuous subcutaneous insulin infusion therapy

Multiple daily injection therapy (MDI)

ACTIVE COMPARATOR

Multiple daily injection therapy using different devices with marketing approval and different insulin types

Device: Multiple daily injection therapy

Interventions

Continuous subcutaneous insulin infusion therapyDEVICE

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

Insulin pump therapy (CSII)
Multiple daily injection therapyDEVICE

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

Multiple daily injection therapy (MDI)

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Type 1 DM
  • Transition to Continuous Subcutaneous Insulin Infusion (CSII)
  • meeting the costs by health services
  • sufficient German literacy

You may not qualify if:

  • Remission (diabetes duration \< 6 months, insulin \< 0.5 i.E./kg)
  • severe learning problems
  • Investigator's children
  • Waiting time not advised for medical reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Endokrinologikum Berlin

Berlin, 10117, Germany

Location

Kinderklinik Charite

Berlin, 13353, Germany

Location

Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum

Bochum, 44791, Germany

Location

Kinderkrankenhaus Kliniken der Stadt Köln GmbH

Cologne, 50735, Germany

Location

PRIMA Kinderkliniken Darmstadt

Darmstadt, 64287, Germany

Location

Marienhospital / Kinderklinik

Gelsenkirchen, 45138, Germany

Location

Universitätsklinik Gießen

Giessen, 35392, Germany

Location

Klinik am Eichert

Göppingen, 73035, Germany

Location

Kinderkrankenhaus Wilhelmstift

Hamburg, 22149, Germany

Location

Altonaer Kinderkrankenhaus

Hamburg, 22763, Germany

Location

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

Location

Praxis für Kinder- und Jugendmedizin

Herford, 32052, Germany

Location

Kinderklinik Städt. Klinikum

Karlsruhe, 76133, Germany

Location

UK-SH, Klinik für Allg. Pädiatrie

Kiel, 24105, Germany

Location

Universität Leipzig, Kinderklinik

Leipzig, 04103, Germany

Location

UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin

Lübeck, 23538, Germany

Location

Ev.Krankenhaus

Oberhausen, 46047, Germany

Location

Kinderhospital Osnabrück

Osnabrück, 49082, Germany

Location

Klinik f. Kinder- und Jugendmedizin

Ravensburg, 88212, Germany

Location

Universitäts- Kinder- und Jugendklinik

Rostock, 18057, Germany

Location

Bethlehem Gesundheitszentrum Stolberg

Stolberg, 52222, Germany

Location

Olgahospital

Stuttgart, 70176, Germany

Location

Universitätsklinik Tübingen

Tübingen, 72706, Germany

Location

HSK-Kinderklinik

Wiesbaden, 65199, Germany

Location

Related Publications (1)

  • Mueller-Godeffroy E, Vonthein R, Ludwig-Seibold C, Heidtmann B, Boettcher C, Kramer M, Hessler N, Hilgard D, Lilienthal E, Ziegler A, Wagner VM; German Working Group for Pediatric Pump Therapy (agip). Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial. Pediatr Diabetes. 2018 Dec;19(8):1471-1480. doi: 10.1111/pedi.12777. Epub 2018 Oct 10.

    PMID: 30302877DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Verena Wagner, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Verena Wagner MD

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 20, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(24)