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

Type 2 Diabetes Clinical Trial

— MEDIAS-2-CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748239
• Other study ID #: FIDAM-02-10
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: August 8, 2016
• Start date: February 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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).
• 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).

Locations

Country	Name	City	State
Germany	Diabetes Centre Mergentheim	Bad Mergentheim

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c values		six months follow up after termination of the programs	No
Secondary	Quality of life	QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire.	six months follow up	No
Secondary	Diabetes knowledge	A diabetes knowledge test for insulin treatment in type 2 diabetes will be used	six months follow up	No
Secondary	Diabetes related emotional burden	Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire	six months follow up	No
Secondary	Diabetes related distress	Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS)	six months follow up	No
Secondary	Self-care behavior	The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used.	six months follow up	No
Secondary	Depression	The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used.	six months follow up	No