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

University Hospital Schleswig-Holstein211 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

211

Conditions

Diabetes Mellitus, Insulin-Dependent

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.

Multiple daily injection therapyDEVICE

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (24)

Endokrinologikum Berlin

Berlin, Germany

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 6 months

Secondary Outcomes

Parental stress level

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)

Time frame: 6 months

Hypoglycemia fear (main carer)

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

Time frame: 6 months

Family conflicts

Family conflict (adolescent, main carer) will be measured by the Diabetes Family Conflict Scale (DFCS). The 19 items instrument provides a DFCS Total Score

Time frame: 6 months

HbA1c

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)

Data from ClinicalTrials.gov

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