Clinical trial NCT00901992: Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
Official title: Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
education
self-management
insulin therapy
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: A1c values
timeFrame: six month follow up after termination of the programs
Secondary outcomes:
measure: Quality of life using the SF 12 mental and physical composite scales
timeFrame: six month follow up
measure: diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
timeFrame: 6 month follow up
measure: diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)
timeFrame: 6 month follow up
measure: Self care behavior (Summary of Self-Care Activities Scale)
timeFrame: 6 month follow up
measure: lipids (total cholesterol, triglycerides, HDL and LDL)
timeFrame: 6 month follow up
measure: weight (Body mass index)
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Diabetes Centre Mergentheim
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Jun 28.