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Diabetes Mellitus, Insulin-DependentpumpkinNCT01338922

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

A study testing Continuous subcutaneous insulin infusion therapy and Multiple daily injection therapy in people with Diabetes Mellitus, Insulin-Dependent, run by University Hospital Schleswig-Holstein at 24 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Diabetes Mellitus, Insulin-Dependent
What is being tested?
Continuous subcutaneous insulin infusion therapy and Multiple daily injection therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
24 sitesGermany
Study dates
Apr 2011to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Type 1 DM
  • Transition to Continuous Subcutaneous Insulin Infusion (CSII)
  • meeting the costs by health services
  • sufficient German literacy

Who cannot join

  • 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 locations and contacts

24 sites in 1 country.

24 sites in 1 country

Germany24 sites

  • Endokrinologikum Berlin

    Berlin, 10117

  • Kinderklinik Charite

    Berlin, 13353

  • Klinik für Kinder- und Jugendmedizin, Ruhr-Universität-Bochum

    Bochum, 44791

  • Kinderkrankenhaus Kliniken der Stadt Köln GmbH

    Cologne, 50735

  • PRIMA Kinderkliniken Darmstadt

    Darmstadt, 64287

  • Marienhospital / Kinderklinik

    Gelsenkirchen, 45138

  • Universitätsklinik Gießen

    Giessen, 35392

  • Klinik am Eichert

    Göppingen, 73035

  • Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149

  • Altonaer Kinderkrankenhaus

    Hamburg, 22763

  • Gemeinschaftskrankenhaus

    Herdecke, 58313

  • Praxis für Kinder- und Jugendmedizin

    Herford, 32052

  • Kinderklinik Städt. Klinikum

    Karlsruhe, 76133

  • UK-SH, Klinik für Allg. Pädiatrie

    Kiel, 24105

  • Universität Leipzig, Kinderklinik

    Leipzig, 04103

  • UK SH Campus Lübeck, Klinik für Kinder- und Jugendmedizin

    Lübeck, 23538

  • Ev.Krankenhaus

    Oberhausen, 46047

  • Kinderhospital Osnabrück

    Osnabrück, 49082

  • Klinik f. Kinder- und Jugendmedizin

    Ravensburg, 88212

  • Universitäts- Kinder- und Jugendklinik

    Rostock, 18057

  • Bethlehem Gesundheitszentrum Stolberg

    Stolberg, 52222

  • Olgahospital

    Stuttgart, 70176

  • Universitätsklinik Tübingen

    Tübingen, 72706

  • HSK-Kinderklinik

    Wiesbaden, 65199

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Continuous subcutaneous insulin infusion therapy, Multiple daily injection therapy
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01338922
Study groupRoleWhat they receive
Insulin pump therapy (CSII)ExperimentalContinuous subcutaneous insulin infusion therapy using different devices with marketing approval and different insulins
Receives: Device: Continuous subcutaneous insulin infusion therapy
Multiple daily injection therapy (MDI)Active comparatorMultiple daily injection therapy using different devices with marketing approval and different insulin types
Receives: Device: Multiple daily injection therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (6)

  1. 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)

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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)

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338922
Sponsor's protocol ID
PUMPKIN
Other IDs
WA 2929/2-1/ AOBJ 582855
Acronym
pumpkin
Status last verified
Jan 2018
First submitted
7 Apr 2011
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30302877

Questions about this trial

What is this clinical trial studying?

A study testing Continuous subcutaneous insulin infusion therapy and Multiple daily injection therapy in people with Diabetes Mellitus, Insulin-Dependent, run by University Hospital Schleswig-Holstein at 24 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life (HRQOL) (patient) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338922, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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