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

NCT ID: NCT01338922

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Diabetes Mellitus, Insulin-Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin pump therapy (CSII)

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

Group Type: EXPERIMENTAL

Continuous subcutaneous insulin infusion therapy

Intervention Type: 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 (MDI)

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

Group Type: ACTIVE_COMPARATOR

Multiple daily injection therapy

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Multiple daily injection therapy

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Verena Wagner, MD

Verena Wagner MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Verena Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

Endokrinologikum Berlin

Berlin, , Germany

Kinderklinik Charite

Berlin, , Germany

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

Bochum, , Germany

Kinderkrankenhaus Kliniken der Stadt Köln GmbH

Cologne, , Germany

PRIMA Kinderkliniken Darmstadt

Darmstadt, , Germany

Marienhospital / Kinderklinik

Gelsenkirchen, , Germany

Universitätsklinik Gießen

Giessen, , Germany

Klinik am Eichert

Göppingen, , Germany

Kinderkrankenhaus Wilhelmstift

Hamburg, , Germany

Altonaer Kinderkrankenhaus

Hamburg, , Germany

Gemeinschaftskrankenhaus

Herdecke, , Germany

Praxis für Kinder- und Jugendmedizin

Herford, , Germany

Kinderklinik Städt. Klinikum

Karlsruhe, , Germany

UK-SH, Klinik für Allg. Pädiatrie

Kiel, , Germany

Universität Leipzig, Kinderklinik

Leipzig, , Germany

UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin

Lübeck, , Germany

Ev.Krankenhaus

Oberhausen, , Germany

Kinderhospital Osnabrück

Osnabrück, , Germany

Klinik f. Kinder- und Jugendmedizin

Ravensburg, , Germany

Universitäts- Kinder- und Jugendklinik

Rostock, , Germany

Bethlehem Gesundheitszentrum Stolberg

Stolberg, , Germany

Olgahospital

Stuttgart, , Germany

Universitätsklinik Tübingen

Tübingen, , Germany

HSK-Kinderklinik

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30302877 (View on PubMed)

Other Identifiers

WA 2929/2-1/ AOBJ 582855

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PUMPKIN

Identifier Type: -

Identifier Source: org_study_id