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

Primary Purpose

Diabetes Mellitus, Insulin-Dependent

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous subcutaneous insulin infusion therapy
Multiple daily injection therapy
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Endokrinologikum Berlin
  • Kinderklinik Charite
  • Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
  • PRIMA Kinderkliniken Darmstadt
  • Marienhospital / Kinderklinik
  • Universitätsklinik Gießen
  • Klinik am Eichert
  • Kinderkrankenhaus Wilhelmstift
  • Altonaer Kinderkrankenhaus
  • Gemeinschaftskrankenhaus
  • Praxis für Kinder- und Jugendmedizin
  • Kinderklinik Städt. Klinikum
  • UK-SH, Klinik für Allg. Pädiatrie
  • Kinderkrankenhaus Kliniken der Stadt Köln GmbH
  • Universität Leipzig, Kinderklinik
  • UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
  • Ev.Krankenhaus
  • Kinderhospital Osnabrück
  • Klinik f. Kinder- und Jugendmedizin
  • Universitäts- Kinder- und Jugendklinik
  • Bethlehem Gesundheitszentrum Stolberg
  • Olgahospital
  • Universitätsklinik Tübingen
  • HSK-Kinderklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin pump therapy (CSII)

Multiple daily injection therapy (MDI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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)
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
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
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)
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
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.

Full Information

First Posted
April 7, 2011
Last Updated
January 31, 2018
Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Research Foundation, Roche Diagnostics, University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT01338922
Brief Title
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)
Acronym
pumpkin
Official Title
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 DM - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Research Foundation, Roche Diagnostics, University of Luebeck

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Insulin-Dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin pump therapy (CSII)
Arm Type
Experimental
Arm Description
Continuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins
Arm Title
Multiple daily injection therapy (MDI)
Arm Type
Active Comparator
Arm Description
Multiple daily injection therapy using different devices with marketing approval and different insulin types
Intervention Type
Device
Intervention Name(s)
Continuous subcutaneous insulin infusion therapy
Intervention Description
Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.
Intervention Type
Device
Intervention Name(s)
Multiple daily injection therapy
Intervention Description
Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.
Primary Outcome Measure Information:
Title
Health related quality of life (HRQOL) (patient)
Description
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
Title
Diabetes burden (main carer)
Description
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 Outcome Measure Information:
Title
Parental stress level
Description
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
Title
Hypoglycemia fear (main carer)
Description
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
Title
Family conflicts
Description
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
Title
HbA1c
Description
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)
Time Frame
6 months
Title
Severe Hypoglycemia International Society for Pediatric and Adolescent Diabetes (ISPAD) II/III
Description
Severe hypoglycaemia grade II and grade III will be documented according to ISPAD guidelines
Time Frame
6 months
Title
Diabetes treatment satisfaction
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verena Wagner, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endokrinologikum Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Kinderklinik Charite
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
PRIMA Kinderkliniken Darmstadt
City
Darmstadt
ZIP/Postal Code
64287
Country
Germany
Facility Name
Marienhospital / Kinderklinik
City
Gelsenkirchen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Universitätsklinik Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Klinik am Eichert
City
Göppingen
ZIP/Postal Code
73035
Country
Germany
Facility Name
Kinderkrankenhaus Wilhelmstift
City
Hamburg
ZIP/Postal Code
22149
Country
Germany
Facility Name
Altonaer Kinderkrankenhaus
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Gemeinschaftskrankenhaus
City
Herdecke
ZIP/Postal Code
58313
Country
Germany
Facility Name
Praxis für Kinder- und Jugendmedizin
City
Herford
ZIP/Postal Code
32052
Country
Germany
Facility Name
Kinderklinik Städt. Klinikum
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
UK-SH, Klinik für Allg. Pädiatrie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Kinderkrankenhaus Kliniken der Stadt Köln GmbH
City
Köln
ZIP/Postal Code
50735
Country
Germany
Facility Name
Universität Leipzig, Kinderklinik
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Ev.Krankenhaus
City
Oberhausen
ZIP/Postal Code
46047
Country
Germany
Facility Name
Kinderhospital Osnabrück
City
Osnabrück
ZIP/Postal Code
49082
Country
Germany
Facility Name
Klinik f. Kinder- und Jugendmedizin
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Universitäts- Kinder- und Jugendklinik
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Bethlehem Gesundheitszentrum Stolberg
City
Stolberg
ZIP/Postal Code
52222
Country
Germany
Facility Name
Olgahospital
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Universitätsklinik Tübingen
City
Tübingen
ZIP/Postal Code
72706
Country
Germany
Facility Name
HSK-Kinderklinik
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30302877
Citation
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. Erratum In: Pediatr Diabetes. 2020 Feb;21(1):144-145.
Results Reference
derived

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

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