Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- A1c values
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
A new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) was developed.
In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.
Detailed Description
The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment. The active comparator condition (ACC-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons, which were conducted as group sessions.
Investigators
Norbert Hermanns
Prof. Dr.
Forschungsinstitut der Diabetes Akademie Mergentheim
Eligibility Criteria
Inclusion Criteria
- •type 2 diabetes
- •two years diabetes duration with oral treatment
- •BMI \> 20 and \< 40 kg/m²
- •written informed consent
Exclusion Criteria
- •current psychiatric disease
- •dementia or other severe cognitive impairment
- •severe complications
- •severe conditions (e.g., cancer)
- •gestational diabetes.
Outcomes
Primary Outcomes
A1c values
Time Frame: six months follow up after termination of the programs
Secondary Outcomes
- Quality of life(six months follow up)
- Self-care behavior(six months follow up)
- Depression(six months follow up)
- Diabetes knowledge(six months follow up)
- Diabetes related emotional burden(six months follow up)
- Diabetes related distress(six months follow up)