Introduction: A landmark report has shown that improving glycaemic control among type 1 diabetes patients markedly reduces diabetes-related complications. In clinical practice, however, many patients have problems in adhering to the treatment, and thus remain in poor glycaemic control. Research suggests a more behaviour-oriented approach to diabetes, but there is a lack of evidence on the efficacy of interventions, especially for those adult type 1 diabetes patients who are in poor glycaemic control. Diabetes-related distress has been associated with poor adherence to treatment and poor glycaemic control. There is a need for validated measures in this area, to identify patients who experience diabetes-related distress. Additionally, injection technique is crucial for the management of diabetes, and lipohypertrophy is a common side effect which deserves further attention.

Objectives: The overall aim of this thesis was to evaluate a behavioural medicine intervention among poorly controlled adult type 1 diabetes patients, and to gain a deeper knowledge in an area of diabetes self-management.

Methods: Quantitative design was used for the studies, and the clinical settings comprised two diabetes care units in Stockholm, Sweden. Study I: The Swedish version of the Problem Areas in Diabetes (Swe-PAID-20) scale was evaluated regarding its psychometric properties by type 1 diabetes patients, as well as by an expert panel of diabetes specialist nurses. Study II: A behavioural medicine intervention based on Cognitive Behaviour Therapy (CBT) was evaluated in a randomised controlled trial among poorly controlled adult type 1 diabetes patients. Study III: Using the same sample as in study II, descriptive statistics were produced, and predictive and comparative analyses performed, in order to find predictors of or associations with improvements in glycaemic control as a response to the intervention. Study IV: In a randomised crossover trial insulin absorption in lipohypertrophic injection sites was investigated in type 1 diabetes patients.

Results and conclusions: Study I: A three-factor solution of the scale was found, comprising sub-dimensions of diabetes-related emotional problems, treatment-related problems and support-related problems. Cronbach’s alpha for the total score was 0.94 and varied between 0.61 and 0.94 in the three subscales. The findings also supported the convergent and content validity. The Swe-PAID-20 seems to be a reliable and valid outcome for measuring diabetes-related distress in type 1 diabetes patients. Study II: Significant differences were observed with respect to HbA1c, well-being, diabetes-related distress, frequency of blood glucose testing, fear of hypoglycaemia, perceived stress, and depression, all of which improved more in the intervention group compared with the control group. The CBT based behavioural medicine intervention appears to be a promising approach to diabetes self-management. Study III: The participation rate in the study was 41% and attrition was 24%. Of those patients who actually participated in the intervention, 13% withdrew. From the regression models no predictors or associations were found with regard to improvement in HbA1c. The programme proved to be feasible in terms of design and methods. However, no clear pattern was found regarding predictors of or associations with improved metabolic control. Study IV: Impairment of insulin absorption from lipohypertrophic injection sites was also found with analogue insulins. It is suggested that patients should be advised to refrain from injecting insulin aspart into lipohypertrophic subcutaneous tissue.

Introduction: Individuals with type 1 diabetes require lifelong insulin supply as well as behavioral adjustments for good treatment result. Only a minority reach the goal for glycemic control set in order to reduce the risk of severe long-term complications. Interventions based on cognitive behavior therapy (CBT) have been proposed to improve diabetes-management, but evidence for its efficacy in adults with poorly controlled type 1 diabetes is sparse. One common barrier to optimal diabetes-management is fear of hypoglycemia (FOH), especially in those who have experienced severe hypoglycemic episodes. Thus there is a need for a valid and reliable instrument to assess individuals who are affected by FOH. It is also vital to identify factors associated with FOH in order to find targets for interventions to reduce fear.Aim: The overall aims of this thesis were to evaluate a CBT intervention for poorly controlled individuals with type 1 diabetes and to explore fear of hypoglycemia in an effort to gain deeper knowledge of possible targets for interventions to reduce FOH.Methods: All four studies applied quantitative designs. Study I was a randomized controlled trial in which a cognitive behavioral intervention was evaluated on poorly controlled adult persons with type 1 diabetes. Study II was a psychometric evaluation of a Swedish version of the Hypoglycemia Fear Survey (HFS) in a survey study in adult persons with type 1 diabetes. Studies III and IV were cross-sectional survey studies employed on adults with type 1 diabetes exploring disease-specific, demographic, (studies III and IV) emotional and psychosocial factors (study IV) related to FOH.Results and conclusions: Study I: The intervention group receiving CBT showed significant improvements in HbA1c, diabetes related distress, well-being, FOH, perceived stress, anxiety and depression as well as frequency in self monitoring of blood glucose. Study II: A three- factor solution was found for the Swedish version of the HFS with the dimensions Worry, Behavior and Aloneness. Cronbach’s alpha for the total scale was 0.85 and varied between 0.63 – 0.89 in the subscales. Convergent validity was also supported with moderate correlation between Swe-HFS and Swe-PAID-20. The Swe-HFS seems to be a reliable and valid instrument to measure FOH in adults with type 1 diabetes. Study III: Seven hundred and sixty- four persons (55%) responded to the questionnaire. The HFS-Worry subscale was significantly associated with frequency of severe hypoglycemia, number of symptoms during mild hypoglycemia, gender, hypoglycemic symptoms during hyperglycemia and hypoglycemic unawareness. The HFS-Aloneness subscale was significantly associated with frequency of severe hypoglycemia, number of symptoms during mild hypoglycemia, gender, frequency of mild hypoglycemia, HbA1c, hypoglycaemic unawareness and visits to the emergency room because of severe hypoglycemia. FOH proved to be more prevalent in females. Frequency of severe hypoglycemia was identified as the most important factor associated with FOH. Study IV: A total of 469 (61%) persons responded to the questionnaire. The HFS was significantly associated with The Anxiety Sensitivity Index, the Anxiety subscale of Hospital Anxiety and Depression Scale and Social Phobia Scale. Together with the disease-specific factors the regression model explained 39% of the variance. Support for a positive association between FOH and anxiety was present and previously identified gender differences were confirmed. Differences between the subgroups on factors associated with FOH were found that may have implications in developing interventions