A new beginning in life for young adults with poorly controlled type 1 diabetes

ISRCTN ISRCTN70566290
DOI https://doi.org/10.1186/ISRCTN70566290
Secondary identifying numbers N/A
Submission date
02/12/2012
Registration date
12/12/2012
Last edited
12/12/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims:
Being young and having to face a life with a chronic condition is a great challenge. In diabetes care more than half of the patients with type 1 diabetes live with poor glycaemic control which can lead to increased risk of diabetes related complications and poor quality of life. This study investigates patients’ own judgement of their situation and the problems connected with diabetes self-management.

Who can participate?
Young adults aged 18-35 years old, who have had type 1 diabetes for at least 1 year.

What does the study involve?
Participants are randomly distributed to having GSD immediately or 18 months delayed. They choose whether the course should have an individual or a group based form. Patients fill in reflection sheets before each appointment and talk with GSD-trained nurses about the issues they have written or drawn on the sheets. Through this process the young adults discover new aspects of their own way of living with the illness and also a new potential for managing diabetes in daily life. The nurses also discover new aspects in each patient’s life and thereby become able to support patients in finding their own way in managing the situation.

What are the possible benefits and risks of participating?
Participants will benefit from the course by learning to better control their diabetes. There are no known risks associated with taking part in this study.

Where is the study run from?
Steno Diabetes Center, Denmark

When is the study starting and how long is it expected to run for?
The study started n March 2010 and is due to end in September 2013.

Who is funding the study?
Steno Diabetes Center, Denmark
Danish National Board of Health, Denmark
Novo Nordisk - Department of Global Health, Denmark

Who is the main contact?
Vibeke Zoffmann
vzof@steno.dk

Contact information

Dr Vibeke Zoffmann
Scientific

Steno Diabetes Center
Jellerød Have 32
Kokkedal
2980
Denmark

Study information

Study designRandomized controlled trial a waitlist design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleGuided self-determination tested in a flexible program for young adults with poorly controlled type 1 diabetes: a randomised controlled trial
Study objectivesIt is hypothesised that attending in a group based or individual course using Guided Self-determination (GSD) will improve the way young adults with poorly controlled type 1 diabetes live with their illness. The null hypothesis of no difference will be rejected if participants in the intervention group compared to those in a control group have decreased their HbA1c and improved their psychosocial functioning 18 months after the intervention.
Ethics approval(s)The National Committee on Health Research Ethics ref: H-D-2009-Fsp-29
The Danish Data Protection Agency ref: 2010-41-5448
Health condition(s) or problem(s) studiedType 1 diabetes in poor control
InterventionParticipants are by chance distributed 2:1 to having GSD immediately or 18 months delayed. They choose whether the course should have an individual form (eight 1-hour sessions in day time) or a group based form (eight 2½-hour sessions late afternoon). Patients fill in reflection sheets before each appointment and talk with GSD-trained nurses about the issues they have written or drawn on the sheets. Through this process the young adults discover new aspects of their own way of living with the illness and also a new potential for managing diabetes in daily life. The nurses also discover new aspects in each patient’s life and thereby become able to support patients in finding their own way in managing the situation. As part of GSD, advantages and disadvantages of different levels of HbA1c are also translated to patients in a meaningful way allowing patients to take autonomous decisions about their own goals which consequently in higher degree will be self-concordant.
Intervention typeOther
Primary outcome measureHbA1c
Secondary outcome measures1. Health Care Climate Questionnaire (HCCQ)
2. Treatment Self Regulation Questionnaire (TSRQ)
3. Problem Areas In Diabetes (PAID)
4. Perceived Competence with diabetes (PCD)
5. WHO-5
6. Rosenberg’s self-esteem scale (RSES)
7. Self-monitored blood-glucoses (SMBG) per week
8.Cancellations or failures to show-up
9. Type and amount of insulin treatment.
Overall study start date01/03/2010
Completion date30/09/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit35 Years
SexBoth
Target number of participants200
Key inclusion criteria1. Young adults, 18-35 years old with duration of type 1 diabetes at least 1 year
2. HbA1c at least 8.0% and mean HbA1c during the past 1-2 years at least 7.5%
Key exclusion criteriaYoung adults who due to mental or physical state and language barriers are unable to read and reflect on the reflection sheets used in GSD
Date of first enrolment01/03/2010
Date of final enrolment30/09/2013

Locations

Countries of recruitment

  • Denmark

Study participating centre

Steno Diabetes Center
Kokkedal
2980
Denmark

Sponsor information

Steno Diabetes Center (Denmark)
Hospital/treatment centre

Niels Steensens vej 2
Gentofte
2820
Denmark

Website http://www.steno.dk/documents/home_page/document/index.asp
ROR logo "ROR" https://ror.org/03w7awk87

Funders

Funder type

Hospital/treatment centre

Steno Diabetes Center [Kliniske udviklingsmidler] (Denmark)

No information available

Danish national Board of Health (Denmark) ref: 7-203-02-434/5

No information available

Novo Nordisk Department of Global Health (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan