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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: MEDIAS 2 CT; Behavioral: Current CT program

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 Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetes Centre Mergentheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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).
Placebo Comparator: Current CT program; This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A1c values	six months follow up after termination of the programs

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: diabetes self-management education; insulin therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: FIDAM-02-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No