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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00901992

First Posted: May 14, 2009

Last Update Posted: August 11, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Purpose

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.

Condition	Intervention
Type 2 Diabetes	Behavioral: MEDIAS 2 ICT Behavioral: Current ICT program (ACC-ICT)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:

A1c values [ Time Frame: six month follow up after termination of the programs ]

Secondary Outcome Measures:

Quality of life using the SF 12 mental and physical composite scales [ Time Frame: six month follow up ]
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes) [ Time Frame: 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 ]
Self care behavior (Summary of Self-Care Activities Scale) [ Time Frame: 6 month follow up ]
lipids (total cholesterol, triglycerides, HDL and LDL) [ Time Frame: 6 month follow up ]
weight (Body mass index) [ Time Frame: 6 month follow up ]


Enrollment:	186
Study Start Date:	May 2009
Study Completion Date:	August 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901992

Locations


Germany
Diabetes Centre Mergentheim
Bad Mergentheim, Germany, 97980

Sponsors and Collaborators

Forschungsinstitut der Diabetes Akademie Mergentheim

Investigators


Principal Investigator:	Norbert Hermanns, PhD	Forschungsinstitut der Diabetes Akademie Mergentheim

More Information

Publications:

Hermanns N, Kulzer B, Maier B, Mahr M, Haak T. The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes. Patient Educ Couns. 2012 Feb;86(2):226-32. doi: 10.1016/j.pec.2011.05.017. Epub 2011 Jun 28.


Responsible Party:	Norbert Hermanns, Prof. Dr., Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:	NCT00901992 History of Changes
Other Study ID Numbers:	FIDAM-02-09
First Submitted:	May 12, 2009
First Posted:	May 14, 2009
Last Update Posted:	August 11, 2014
Last Verified:	August 2014

Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:


type 2 diabetes education self-management insulin therapy

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

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