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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: MEDIAS 2 ICT
* Behavioral: Current ICT program (ACC-ICT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c values |  | six month follow up after termination of the programs | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, education, self-management, insulin therapy