Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes

Study 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.

Official Title
-----------------
Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Non-Intensive Insulin Therapy in Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: MEDIAS 2 CT
* Behavioral: Current CT program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MEDIAS 2 CT<br>The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. | Behavioral: MEDIAS 2 CT<br>* 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).<br>|
| Placebo Comparator: Current CT program<br>This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. | Behavioral: Current CT program<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c values |  | six months follow up after termination of the programs | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes self-management education, insulin therapy