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

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Completed

CT.gov ID

NCT01338922

Collaborator

German Research Foundation (Other), Roche Diagnostics (Industry), University of Luebeck (Other)

211

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Device: Continuous subcutaneous insulin infusion therapy Device: Multiple daily injection therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

open multicentre parallel randomised controlled intervention trial with waiting-list-control-groupopen multicentre parallel randomised controlled intervention trial with waiting-list-control-group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin pump therapy (CSII) Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins	Device: 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.
Active Comparator: Multiple daily injection therapy (MDI) Multiple daily injection therapy using different devices with marketing approval and different insulin types	Device: Multiple daily injection therapy Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.

Arm

Intervention/Treatment

Experimental: Insulin pump therapy (CSII)

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

Device: 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.

Active Comparator: Multiple daily injection therapy (MDI)

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

Device: Multiple daily injection therapy

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

Outcome Measures

Primary Outcome Measures

Health related quality of life (HRQOL) (patient) [6 months]
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).
Diabetes burden (main carer) [6 months]
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

Secondary Outcome Measures

Parental stress level [6 months]
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)
Hypoglycemia fear (main carer) [6 months]
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
Family conflicts [6 months]
Family conflict (adolescent, main carer) will be measured by the Diabetes Family Conflict Scale (DFCS). The 19 items instrument provides a DFCS Total Score
HbA1c [6 months]
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)
Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III [6 months]
Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines
Diabetes treatment satisfaction [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Endokrinologikum Berlin	Berlin	Germany	10117
2	Kinderklinik Charite	Berlin	Germany	13353
3	Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum	Bochum	Germany	44791
4	PRIMA Kinderkliniken Darmstadt	Darmstadt	Germany	64287
5	Marienhospital / Kinderklinik	Gelsenkirchen	Germany	45138
6	Universitätsklinik Gießen	Gießen	Germany	35392
7	Klinik am Eichert	Göppingen	Germany	73035
8	Kinderkrankenhaus Wilhelmstift	Hamburg	Germany	22149
9	Altonaer Kinderkrankenhaus	Hamburg	Germany	22763
10	Gemeinschaftskrankenhaus	Herdecke	Germany	58313
11	Praxis für Kinder- und Jugendmedizin	Herford	Germany	32052
12	Kinderklinik Städt. Klinikum	Karlsruhe	Germany	76133
13	UK-SH, Klinik für Allg. Pädiatrie	Kiel	Germany	24105
14	Kinderkrankenhaus Kliniken der Stadt Köln GmbH	Köln	Germany	50735
15	Universität Leipzig, Kinderklinik	Leipzig	Germany	04103
16	UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin	Lübeck	Germany	23538
17	Ev.Krankenhaus	Oberhausen	Germany	46047
18	Kinderhospital Osnabrück	Osnabrück	Germany	49082
19	Klinik f. Kinder- und Jugendmedizin	Ravensburg	Germany	88212
20	Universitäts- Kinder- und Jugendklinik	Rostock	Germany	18057
21	Bethlehem Gesundheitszentrum Stolberg	Stolberg	Germany	52222
22	Olgahospital	Stuttgart	Germany	70176
23	Universitätsklinik Tübingen	Tübingen	Germany	72706
24	HSK-Kinderklinik	Wiesbaden	Germany	65199

Sponsors and Collaborators

University Hospital Schleswig-Holstein
German Research Foundation
Roche Diagnostics
University of Luebeck

Investigators

Principal Investigator: Verena Wagner, MD, University Hospital Schleswig-Holstein

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Verena Wagner, MD, Verena Wagner MD, University Hospital Schleswig-Holstein

ClinicalTrials.gov Identifier:

NCT01338922

Other Study ID Numbers:

PUMPKIN
WA 2929/2-1/ AOBJ 582855

First Posted:

Apr 20, 2011

Last Update Posted:

Feb 5, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Insulin

Study Results

No Results Posted as of Feb 5, 2018