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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MEDIAS 2 ICT
Current ICT program (ACC-ICT)
Sponsored by
Forschungsinstitut der Diabetes Akademie Mergentheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, education, self-management, insulin therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetes Centre Mergentheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEDIAS 2 ICT

Current ICT program (ACC)

Arm Description

MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients

This education program consists of 10 lessons combining an insulin education program with an hypertension program

Outcomes

Primary Outcome Measures

A1c values

Secondary Outcome Measures

Quality of life using the SF 12 mental and physical composite scales
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)
Self care behavior (Summary of Self-Care Activities Scale)
lipids (total cholesterol, triglycerides, HDL and LDL)
weight (Body mass index)

Full Information

First Posted
May 12, 2009
Last Updated
August 8, 2014
Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim
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1. Study Identification

Unique Protocol Identification Number
NCT00901992
Brief Title
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
Acronym
MEDIAS-2-ICT
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, education, self-management, insulin therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDIAS 2 ICT
Arm Type
Experimental
Arm Description
MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients
Arm Title
Current ICT program (ACC)
Arm Type
Active Comparator
Arm Description
This education program consists of 10 lessons combining an insulin education program with an hypertension program
Intervention Type
Behavioral
Intervention Name(s)
MEDIAS 2 ICT
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Current ICT program (ACC-ICT)
Intervention Description
This program is conducted in 10 lessons in a group setting (4-8 participants)
Primary Outcome Measure Information:
Title
A1c values
Time Frame
six month follow up after termination of the programs
Secondary Outcome Measure Information:
Title
Quality of life using the SF 12 mental and physical composite scales
Time Frame
six month follow up
Title
diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)
Time Frame
6 month follow up
Title
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
Title
Self care behavior (Summary of Self-Care Activities Scale)
Time Frame
6 month follow up
Title
lipids (total cholesterol, triglycerides, HDL and LDL)
Time Frame
6 month follow up
Title
weight (Body mass index)
Time Frame
6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Hermanns, PhD
Organizational Affiliation
Forschungsinstitut der Diabetes Akademie Mergentheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Centre Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21715124
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.
Results Reference
result

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

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