Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes (MEDIAS-2-ICT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: MEDIAS 2 ICT Behavioral: Current ICT program (ACC-ICT) |
| 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 a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients |
- A1c values [ Time Frame: six month follow up after termination of the programs ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 186 |
| Study Start Date: | May 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | April 2010 (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)
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00901992
| Germany | |
| Diabetes Centre Mergentheim | |
| Bad Mergentheim, Germany, 97980 | |
| Principal Investigator: | Norbert Hermanns, PhD | Forschungsinstitut der Diabetes Akademie Mergentheim |
More Information
Publications:
| 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: | August 8, 2014 |
| 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, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Insulin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015