Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes (MEDIAS-2-ICT)
|ClinicalTrials.gov Identifier: NCT00901992|
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : August 11, 2014
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|
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 (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- A1c values [ Time Frame: six month follow up after termination of the programs ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901992
|Diabetes Centre Mergentheim|
|Bad Mergentheim, Germany, 97980|
|Principal Investigator:||Norbert Hermanns, PhD||Forschungsinstitut der Diabetes Akademie Mergentheim|