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

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Device: Continuous subcutaneous insulin infusion therapy; Device: Multiple daily injection therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01338922

WA 2929/2-1/ AOBJ 582855 (Other Grant/Funding Number)

PUMPKIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

Insulin pump therapy (CSII)

Experimental group

Description:

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

Treatment:

Device: Continuous subcutaneous insulin infusion therapy

Multiple daily injection therapy (MDI)

Active Comparator group

Description:

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

Treatment:

Device: Multiple daily injection therapy