NCT02748239

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	MEDIAS 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).
BEHAVIORAL	Current 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).

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2016-04-22
• Last updated: 2016-08-09

Locations

1 site across 1 country: Germany