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

August 8, 2014 updated by: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEDIAS 2 ICT
MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients
Behavioral: MEDIAS 2 ICT
MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants)
Active Comparator: Current ICT program (ACC)
This education program consists of 10 lessons combining an insulin education program with an hypertension program
Behavioral: Current ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life using the SF 12 mental and physical composite scales
Time Frame: six month follow up
six month follow up
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
Time Frame: 6 month follow up
6 month follow up
diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)
Time Frame: 6 month follow up
6 month follow up
Self care behavior (Summary of Self-Care Activities Scale)
Time Frame: 6 month follow up
6 month follow up
lipids (total cholesterol, triglycerides, HDL and LDL)
Time Frame: 6 month follow up
6 month follow up
weight (Body mass index)
Time Frame: 6 month follow up
6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIDAM-02-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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