- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901992
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes (MEDIAS-2-ICT)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bad Mergentheim, Germany, 97980
- Diabetes Centre Mergentheim
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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)
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Active Comparator: Current ICT program (ACC)
This education program consists of 10 lessons combining an insulin education program with an hypertension program
|
This program is conducted in 10 lessons in a group setting (4-8 participants)
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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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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