Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/12/2012
Date assigned
12/12/2012
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vibeke Zoffmann

ORCID ID

Contact details

Steno Diabetes Center
Jellerød Have 32
Kokkedal
2980
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Guided self-determination tested in a flexible program for young adults with poorly controlled type 1 diabetes: a randomised controlled trial

Acronym

Study hypothesis

It 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

The National Committee on Health Research Ethics ref: H-D-2009-Fsp-29
The Danish Data Protection Agency ref: 2010-41-5448

Study design

Randomized controlled trial a waitlist design

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 below to request a patient information sheet

Condition

Type 1 diabetes in poor control

Intervention

Participants 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c

Secondary outcome measures

1. 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 trial start date

01/03/2010

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Young adults who due to mental or physical state and language barriers are unable to read and reflect on the reflection sheets used in GSD

Recruitment start date

01/03/2010

Recruitment end date

30/09/2013

Locations

Countries of recruitment

Denmark

Trial participating centre

Steno Diabetes Center
Kokkedal
2980
Denmark

Sponsor information

Organisation

Steno Diabetes Center (Denmark)

Sponsor details

Niels Steensens vej 2
Gentofte
2820
Denmark

Sponsor type

Hospital/treatment centre

Website

http://www.steno.dk/documents/home_page/document/index.asp

Funders

Funder type

Hospital/treatment centre

Funder name

Steno Diabetes Center [Kliniske udviklingsmidler] (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novo Nordisk Department of Global Health (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes