Type 2 Diabetes
Conditions
Keywords
diabetes self-management education, insulin therapy
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.
Interventions
BEHAVIORALMEDIAS 2 CT
The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
BEHAVIORALCurrent CT program
The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
Sponsors
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A1c values | six months follow up after termination of the programs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes knowledge | six months follow up | A diabetes knowledge test for insulin treatment in type 2 diabetes will be used |
| Diabetes related emotional burden | six months follow up | Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire |
| Quality of life | six months follow up | QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire. |
| Self-care behavior | six months follow up | The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used. |
| Depression | six months follow up | The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used. |
| Diabetes related distress | six months follow up | Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS) |
Countries
Germany
Outcome results
None listed