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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDIAS 2 CT | Active Comparator | The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. |
|
| Current CT program | Placebo Comparator | This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDIAS 2 CT | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| A1c values | six months follow up after termination of the programs |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire. | six months follow up |
| Diabetes knowledge | A diabetes knowledge test for insulin treatment in type 2 diabetes will be used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Hermanns, PHD | Forschungsinstitut der Diabetes Akademie Mergentheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Centre Mergentheim | Bad Mergentheim | 97980 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Current CT program | Behavioral | 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). |
|
| six months follow up |
| Diabetes related emotional burden | Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire | six months follow up |
| Diabetes related distress | Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS) | six months follow up |
| Self-care behavior | The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used. | six months follow up |
| Depression | The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used. | six months follow up |
| D004700 | Endocrine System Diseases |