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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: MEDIAS 2 CT; Behavioral: Current CT program

• Registration Number: NCT02748239
• Lead Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

Brief 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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2016-02
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDIAS 2 CT	MEDIAS 2 CT	The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients.
Current CT program	Current CT program	This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients.

Primary Outcome Measures

Name	Time	Method
A1c values	six months follow up after termination of the programs

Secondary Outcome Measures

Name	Time	Method
Quality of life	six months follow up	QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire.
Self-care behavior	six months follow up	The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used.
Depression	six months follow up	The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used.
Diabetes knowledge	six months follow up	A diabetes knowledge test for insulin treatment in type 2 diabetes will be used
Diabetes related emotional burden	six months follow up	Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire
Diabetes related distress	six months follow up	Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS)

Trial Locations

Locations (1)

Diabetes Centre Mergentheim; 🇩🇪 Bad Mergentheim, Germany