Evaluation of Two Self-management Oriented Diabetes Education Programs for Insulin Therapy in Type 2 Diabetes (MEDIAS-2-I)

This study is currently recruiting participants.
Verified September 2012 by Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor:
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT00901992
First received: May 12, 2009
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

Two diabetes education programs for the initiation of insulin therapy were developed. One program is for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT), the other is for the initiation of a conventional insulin therapy (MEDIAS 2 CT). In the evaluation, these two new developed programs are compared with two education programs which are currently used for the diabetes education. It is expected that the two new developed programs (MEDIAS 2 ICT and MEDIAS 2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of these programs will be tested.

The results regarding the intervention arms "MEDIAS ICT" vs. " ACC-ICT" (control condition) and the intervention arms "MEDIAS 2 CT" vs. "ACC-CT" (control condition) will be separately analyzed and published.


Condition Intervention
Type 2 Diabetes
Behavioral: MEDIAS 2 ICT
Behavioral: Current ICT program (ACC-ICT)
Behavioral: MEDIAS 2 CT
Behavioral: Current CT program (ACC-CT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Two Self-management Oriented Diabetes Education Programs for the Initiation of Intensive or Conventional Insulin Therapy in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:
  • A1c values [ Time Frame: six month follow up after termination of the programs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life using the SF 12 mental and physical composite scales [ Time Frame: six month follow up ] [ Designated as safety issue: No ]
  • diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Self care behavior (Summary of Self-Care Activities Scale) [ Time Frame: 6 month follow up ] [ Designated as safety issue: Yes ]
  • lipids (total cholesterol, triglycerides, HDL and LDL) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  • weight (Body mass index) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDIAS 2 ICT
MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients
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)
Active Comparator: Current ICT program (ACC-ICT)
This education program consists of 10 lessons combining an insulin education program with an hypertension program
Behavioral: Current ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)
Experimental: MEDIAS 2 CT
MEDIAS 2 CT - education program for the initiation of conventional insulin treatment (CT) in type 2 diabetic patients
Behavioral: MEDIAS 2 CT
MEDIAS 2 CT is a newly developed education program for the initiation of conventional insulin therapy in type 2 diabetic patients (6 lessons of group sessions for 4-8 participants)
Active Comparator: Current CT program (ACC-CT)
This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients
Behavioral: Current CT program (ACC-CT)
The program consists of 6 lessons and is conducted in group settings (4-8 participants)

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. EDIAS 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-ICT) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin [16,17] and a hypertension education program for the treatment of hypertension [18,19]. 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-ICT) consisted of 10 lessons, which were conducted as group sessions.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901992

Contacts
Contact: Bernhard Kulzer, PhD +49 7931 594 ext 151 kulzer@diabetes-zentrum.de

Locations
Germany
Diabetes Centre Mergentheim Recruiting
Bad Mergentheim, Germany, 97980
Contact: Thomas Haak, MD    +49 7931 594 ext 101    haak@diabetes-zentrum.de   
Principal Investigator: Thomas Haak, MD         
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim
  More Information

No publications provided

Responsible Party: Norbert Hermanns, Prof. Dr., Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT00901992     History of Changes
Other Study ID Numbers: FIDAM-02-09
Study First Received: May 12, 2009
Last Updated: September 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
type 2 diabetes
education
self-management
insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014