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

Forschungsinstitut der Diabetes Akademie Mergentheim

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Current CT program; Behavioral: MEDIAS 2 CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02748239

FIDAM-02-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups, including a placebo group

MEDIAS 2 CT

Active Comparator group

Description:

The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients.

Treatment:

Behavioral: MEDIAS 2 CT

Current CT program

Placebo Comparator group

Description:

This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients.

Treatment:

Behavioral: Current CT program