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 Childrens 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 childrens diabetes association, Uppsala University, medical faculty, Jerring foundation and Groschinskys 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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24354899
Publication citations
-
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.