Type 2 Diabetes Clinical Trial
Official title:
Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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