Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes (MEDIAS-2-ICT)

Forschungsinstitut der Diabetes Akademie Mergentheim

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Current ICT program (ACC-ICT); Behavioral: MEDIAS 2 ICT

Study type: Interventional

Funder types: Other

Identifiers

NCT00901992

FIDAM-02-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes
• age < 75 and age > 17 years
• two years diabetes duration with oral treatment
• BMI > 20 nad BMI < 40 kg/m²
• 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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186 participants in 2 patient groups

MEDIAS 2 ICT

Experimental group

Description:

MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients

Treatment:

Behavioral: MEDIAS 2 ICT

Current ICT program (ACC)

Active Comparator group

Description:

This education program consists of 10 lessons combining an insulin education program with an hypertension program

Treatment:

Behavioral: Current ICT program (ACC-ICT)