Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, education, self-management, insulin therapy
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.
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.
Interventions
BEHAVIORALMEDIAS 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)
BEHAVIORALCurrent ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)
Sponsors
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A1c values | six month follow up after termination of the programs |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Quality of life using the SF 12 mental and physical composite scales | six month follow up |
| lipids (total cholesterol, triglycerides, HDL and LDL) | 6 month follow up |
| weight (Body mass index) | 6 month follow up |
| Self care behavior (Summary of Self-Care Activities Scale) | 6 month follow up |
Countries
Germany
Outcome results
None listed