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NCT Number: NCT02748239

Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Centre Mergentheim

Bad Mergentheim, 97980, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDIAS 2 CT

Behavioral

The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).

Current CT program

Behavioral

The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).

Primary outcomes

  1. A1c values

    Time frame: six months follow up after termination of the programs

Secondary outcomes

  1. Quality of life

    Time frame: six months follow up

    QoL will be assessed using the Short Form Health Survey (SF-12) questionnaire.

  2. Diabetes knowledge

    Time frame: six months follow up

    A diabetes knowledge test for insulin treatment in type 2 diabetes will be used

  3. Diabetes related emotional burden

    Time frame: six months follow up

    Diabetes related emotional burden / diabetes related distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire

  4. Diabetes related distress

    Time frame: six months follow up

    Second questionnaire for assessing diabetes related distress is the Diabetes Distress Scale (DDS)

  5. Self-care behavior

    Time frame: six months follow up

    The Summary of Diabetes Self-Care Activities (SDSCA) scale will be used.

  6. Depression

    Time frame: six months follow up

    The German version of the Center of Epidemiological Studies Depression Scale (CES-D) will be used.

Sponsors and collaborators

Lead sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Other

Registry information

Official study title

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

Acronym: MEDIAS-2-CT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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