Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

• Changes in Glycemic Control Measured by A1c [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.
  
  

• Diabetes Knowledge [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.
  
  
• Hypoglycaemia Awareness Score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
  
  
• Diabetes Empowerment Score (DES) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
  
  
• Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.
  
  
• Diabetes Distress Scale (DDS) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.
  
  
• CES-D Score [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.
  
  
• Diabetes Self-Efficacy Scale [ Time Frame: 6 Month Follow up ] [ Designated as safety issue: No ]
  A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.
  
  
• Treatment Satisfaction / Problem Areas in Dealing With Diabetes [ Time Frame: 6 Month Follow up ] [ Designated as safety issue: No ]
  Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.
  
  
• Evaluation of the Diabetes Education Course [ Time Frame: 6 month Follow up ] [ Designated as safety issue: No ]
  Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).
  
  

Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP - Treatment and education programme for intensified insulin treatment) as an active comparator.