Clinical trial NCT02748239: Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes
Official title: Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes self-management education
insulin therapy
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 182
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 non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) 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 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.

Detailed description: The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused 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-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons, which were conducted as group sessions.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* two years diabetes duration with oral treatment
* BMI \> 20 and \< 40 kg/m²
* written 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 months follow up after termination of the programs
Secondary outcomes:
measure: Quality of life
timeFrame: six months follow up
measure: Diabetes knowledge
timeFrame: six months follow up
measure: Diabetes related emotional burden
timeFrame: six months follow up
measure: Diabetes related distress
timeFrame: six months follow up
measure: Self-care behavior
timeFrame: six months follow up
measure: Depression
timeFrame: six months 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: