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

Type 2 Diabetes Clinical Trial

— MEDIAS-2-ICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901992
• Other study ID #: FIDAM-02-09
• Status: Completed
• Phase: N/A
• First received: May 12, 2009
• Last updated: August 8, 2014
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2014
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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)
• Current ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)

Locations

Country	Name	City	State
Germany	Diabetes Centre Mergentheim	Bad Mergentheim

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c values		six month follow up after termination of the programs	No
Secondary	Quality of life using the SF 12 mental and physical composite scales		six month follow up	No
Secondary	diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)		6 month follow up	No
Secondary	diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)		6 month follow up	No
Secondary	Self care behavior (Summary of Self-Care Activities Scale)		6 month follow up	Yes
Secondary	lipids (total cholesterol, triglycerides, HDL and LDL)		6 month follow up	No
Secondary	weight (Body mass index)		6 month follow up	No