Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01317459
Recruitment Status : Active, not recruiting
First Posted : March 17, 2011
Last Update Posted : September 10, 2015
Information provided by (Responsible Party):
Haukeland University Hospital

March 11, 2011
March 17, 2011
September 10, 2015
March 2011
December 2016   (Final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 0, 9 and 18 months ]
Same as current
Complete list of historical versions of study NCT01317459 on Archive Site
  • Who 5 [ Time Frame: 0, 9 and 18 months ]
  • TSRQ scales [ Time Frame: 0, 9 and 18 months ]
  • PAID scales [ Time Frame: 0, 9 and 18 months ]
  • Rosenberg's self-esteem scale [ Time Frame: 0, 9 and 18 months ]
  • PCD scales [ Time Frame: 0, 9 and 18 months ]
  • HCCQ scales [ Time Frame: 0, 9 and 18 months ]
  • DDS scales [ Time Frame: 0, 9 and 18 months ]
Same as current
Not Provided
Not Provided
Guided Self-determination - Promoting Self-management in Type 1 Diabetes
Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.

Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.

Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.

An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Behavioral: Guided self-determination
Group counselling
  • Experimental: Lifestyle counselling
    Intervention: Behavioral: Guided self-determination
  • Experimental: No intervention
    Care as usual
    Intervention: Behavioral: Guided self-determination
Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA(1c) ≥64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2021
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Diabetes type one, HbA1c >= 8%

Exclusion Criteria:

Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Marit Graue, RN, PhD Bergen University College
Haukeland University Hospital
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP