Type 2 Diabetes Clinical Trial
Official title:
Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients
A new diabetes education program for the initiation of intensive insulin therapy in type 2
diabetic patients (MEDIAS 2 ICT) 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 ICT) can demonstrate non-inferiority with regard to the main outcome variable
glycemic control. If non-inferiority can be demonstrated superiority of this programs will
be tested.
The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will
be separately analyzed and published.
The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted
as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to
help patients perform multiple-injection insulin therapy and adjust their insulin doses
depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels.
In addition, MEDIAS 2 ICT focuses 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) consist of a combination of two previously established
and evaluated education programs - a diabetes education program to initiate mealtime insulin
and a hypertension education program for the treatment of hypertension. These education
programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing
primarily on the acquisition of knowledge, skills, and information about the correct
treatment of diabetes and hypertension.
Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 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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