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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Type 2 Diabetes	Behavioral: MEDIAS 2 ICT; Behavioral: Current ICT program (ACC-ICT)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	186 participants
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
Study Start Date :	May 2009
Actual Primary Completion Date :	April 2010
Actual Study Completion Date :	August 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Quality of life using the SF 12 mental and physical composite scales [ Time Frame: six month follow up ]
2. diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes) [ Time Frame: 6 month follow up ]
3. 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 ]
4. Self care behavior (Summary of Self-Care Activities Scale) [ Time Frame: 6 month follow up ]
5. lipids (total cholesterol, triglycerides, HDL and LDL) [ Time Frame: 6 month follow up ]
6. weight (Body mass index) [ Time Frame: 6 month follow up ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Publications of Results:

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 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