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NCT Number: NCT00901992

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MEDIAS 2 ICT

Behavioral

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)

Behavioral

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

Primary outcomes

  1. A1c values

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

Secondary outcomes

  1. Quality of life using the SF 12 mental and physical composite scales

    Time frame: six month follow up

  2. diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)

    Time frame: 6 month follow up

  3. diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)

    Time frame: 6 month follow up

  4. Self care behavior (Summary of Self-Care Activities Scale)

    Time frame: 6 month follow up

  5. lipids (total cholesterol, triglycerides, HDL and LDL)

    Time frame: 6 month follow up

  6. weight (Body mass index)

    Time frame: 6 month follow up

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 Intensive Insulin Therapy in Type 2 Diabetic Patients

Acronym: MEDIAS-2-ICT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 14, 2009
Registry last updated
Aug 11, 2014

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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