Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/10/2012
Date assigned
25/01/2013
Last edited
08/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In children, type 1 diabetes is the most predominant form of diabetes and it is increasing in Sweden. The most common treatment is insulin injections (multiple daily injections, MDI), but treatment with insulin pump (continuous subcutaneous insulin infusion, CSII) is an alternative. In 2011, 42 % of the children with type 1 diabetes in Sweden were treated with insulin pump. When looking on glycemic (blood glucose level) control in children using insulin pump, studies are showing different results. One reason for poor glycemic control among adolescents treated with insulin pump is omitted insulin injections before meals. The reason for missed doses is mainly explained by lost focus, the children forget the doses. The distribution of the responsibility for diabetes self-management between children and parents is often unclear and needs to be clarified.
In general, children with chronic diseases and their parents report significant lower perceived health and quality of life (QOL) compared with healthy children. Adolescence is the transitional phase of development from childhood towards adulthood. It imposes challenges on the individuals with diabetes, their families and the diabetes care team.
There is great support for continued parental involvement and shared diabetes management during adolescence. There are five categories important for decision making competence; cognitive maturity, personal qualities, experience, social network and parent involvement. Teenagers describe that parental involvement can be constructive or destructive. The challenge is to find a level that is comfortable for all involved.
Person-centred care highlights the importance of knowing the person behind the patient in order to engage the person as an active partner in his/her cares and treatment. Guided self-determination (GSD) is a person-centred reflection model that intends to guide the patient to become self-determined and develop life skills to manage difficulties in the diabetes self-management by using structured worksheet. It has been effective both in individual and group training in adults with type 1 diabetes and there is an on-going study in Denmark on youth with type 1 diabetes using a version adapted to adolescents and parents (Guided self-determination-Young, GSD-Y). The goal with our study is to evaluate if an intervention (treatment) with GSD-Y leads to less diabetes related family conflicts, increased perceived health and quality of life and improved glycemic control.

Who can participate?
The study intends to involve 80 youths between 12 and 17 years who are planned to start insulin pump.

What does the study involve?
The participants will be randomly allocated to either intervention or control group.
All youth will receive standard insulin pump start training, including technical skills and how to use carbohydrate counting with insulin pump. The parents will simulate diabetes by wearing pump and test blood glucose before the child will start insulin pump treatment. The intervention group will be divided in groups of four adolescents and their parents. The education intervention will be performed by diabetes nurses during four opportunities the first four month after starting on insulin pump. The GSD-Y method will be used.

What are the possible benefits and risks of participating?
All youth will receive standard insulin pump start training, including technical skills and how to use carbohydrate counting with insulin pump. The GSD-Y (Guided self-determination-Young, GSD-Y) education will hopefully lead to increased parental support and clarified responsibility distribution, may decrease negative impact of diabetes, improve perceived health, quality of life and glycemic control.
By taking part in this study there are no risks of physical injury or harm.

Where is the study run from?
The study will take place at Astrid Lindgren Children’s Hospital, Karolinska University hospital and Sachs’ children and youth hospital, Södersjukhuset, Stockholm, Sweden.

When is the study starting and how long is it expected to run for?
The plan is to include the first patient in January 2013 and will run until the required number of 80 participants has been recruited.

Who is funding the study?
Funding has been provided by the Swedish Diabetes association, The Swedish children’s diabetes association, Uppsala University, medical faculty, Jerring foundation and Groschinsky’s foundation.

Who is the main contact?
Anna Lena Brorsson, reg nurse anna-lena.brorsson@karolinska.se
Anna Lindholm Olinder, PhD, anna.lindholm-olinder@sodersjukhuset.se
Gunnel Viklund, PhD, gunnel.viklund@karolinska.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Lindholm Olinder

ORCID ID

Contact details

Sachs Children and Youth Hospital
Södersjukhuset
Stockholm
11883
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Constructive parental support and clarified responsibility to youth with type 1 diabetes starting continuous subcutaneous insulin infusion: a randomized controlled study

Acronym

Study hypothesis

Increased parental support and clarified responsibility distribution may decrease negative impact of diabetes, improve perceived health, quality of life and glycemic control among young treated with continuous subcutaneous insulin infusion.

Ethics approval

Ethical Review Board in Stockholm, 8 June 2011, ref: 2011/762-31/4

Study design

Open randomized intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Type 1 diabetes

Intervention

Participants will be randomized to either intervention (n=40) or control group (n=40) when they have decided to start on CSII. All youth will receive standard start training, including technical skills and how to use carbohydrate counting with CSII. The parents will simulate diabetes by wearing pump and test blood glucose before the child will start insulin pump treatment. The intervention group will be divided in groups of four adolescents and their parents.

The intervention will be performed by diabetes nurses during start of CSII and four opportunities the first four month after starting on CSII. Person-centred care highlights the importance of knowing the person behind the patient in order to engage the person as an active partner in his/her cares and treatment. Guided self-determination (GSD) is a person-centred reflection model that intends to guide the patient to become self-determined and develop life skills to manage difficulties in the diabetes self-management by using structured worksheet. It has been effective both in individual and group training in adults with type 1 diabetes. In an on-going Danish study GSD has been adopted to adolescents and parents (Guided self-determination-Young, GSD-Y). The GSD-Y method will be used in the intervention group.

The participants in the control group are followed according to normal routine.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured before start of CSII:
1. HbA1c
2. Length and weight
3. Mean frequency of self-monitoring of blood glucose (SMBG)
4. Check your health measure perceived physical and emotional health, social relations, general quality of life and impact of diabetes
5. Disabkids is measuring generic health in children with chronic illness and have a specific diabetes module
6. DFCS (Diabetes family conflict scale) is the most widely used measure of diabetes-specific family conflict
7. Swe-DES 23 measures the psychosocial self-efficacy of people with diabetes
8. Treatment satisfaction

Measure 6 and 12 month after start CSII:
1. Same measures as before start CSII
2. Frequency of missed bolus doses
3. Usage of carbohydrate counting

Secondary outcome measures

Two weeks after completing the program 20 adolescents will be interviewed. This qualitative interview study will evaluate how adolescents perceive their parent support after taking part in the education program. The questions will be designed especially for this study. The interviews will be taped and transcribed and the analysis method will be qualitative content analysis.

Overall trial start date

01/03/2011

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children between the ages 12 and 17 years who are planned to start on Continuous Subcutaneous Insulin Infusion (CSII)
2. A diagnosis of type 1 diabetes for at least 1 year

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80 youth and their parents

Participant exclusion criteria

1. If the teenager or the parent has difficulties to understand Swedish
2. Usage of continuous glucose monitoring (CGM) during study period

Recruitment start date

01/01/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Sachs Children and Youth Hospital
Stockholm
11883
Sweden

Sponsor information

Organisation

Uppsala University (Sweden)

Sponsor details

c/o Anna Lindholm Olinder
PhD
Karolinska Institute Södersjukhuset
Sachs Children and Youth Hospital
Södersjukhuset
Stockholm
11883
Sweden

Sponsor type

University/education

Website

http://www.uu.se/en

Funders

Funder type

University/education

Funder name

Uppsala University (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Diabetes Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Child Diabetes Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Jerring Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Clas Groschinsky Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All data will be used as a part of Anna-Lena Brorsson's thesis. A manuscript including the qualitative interview-study is planned to be submitted for publication in a peer reviewed journal in January 2017. A manuscript including the quantitative data is planned to be submitted Spring 2018.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to ethical reasons.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24354899

Publication citations

  1. Protocol

    Brorsson AL, Leksell J, Viklund G, Lindholm Olinder A, A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion--a study protocol., BMC Pediatr, 2013, 13, 212, doi: 10.1186/1471-2431-13-212.

Additional files

Editorial Notes

08/12/2016: The overall trial dates have been updated from 01/01/2013 - 31/12/2015 to 01/03/2011 - 31/12/2017. In addition, the publication and dissemination plan and availability of participant level data have been added.