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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial

Conditions
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Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
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* Device: Continuous subcutaneous insulin infusion therapy
* Device: Multiple daily injection therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin pump therapy (CSII)<br>Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins | Device: Continuous subcutaneous insulin infusion therapy<br>* Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.<br>|
| Active Comparator: Multiple daily injection therapy (MDI)<br>Multiple daily injection therapy using different devices with marketing approval and different insulin types | Device: Multiple daily injection therapy<br>* Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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) | 6 months | 
| Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III | Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines | 6 months | 
| Diabetes treatment satisfaction | Treatment Satisfaction will be measured using the Diabetes Treatment Satisfaction Scale, status version (DTSQs-teen, DTSQs-parent).The validated German version will be released by MAPI (MAPI) in April 2011. | 6 months |