Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
NCT ID: NCT00901992
Last Updated: 2014-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
186 participants
INTERVENTIONAL
2009-05-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes
NCT02748239
Diabetes and Sports: Evaluation of a Diabetes Education Module
NCT02076542
Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes
NCT05893927
MedStar Health Type 2 Diabetes Pathway to Control
NCT02925312
Healthcare Intervention Program on Treatment Adherence in People With Newly Diagnosed Type 2 Diabetes Mellitus.
NCT05719675
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MEDIAS 2 ICT
MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients
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)
Current ICT program (ACC)
This education program consists of 10 lessons combining an insulin education program with an hypertension program
Current ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Current ICT program (ACC-ICT)
This program is conducted in 10 lessons in a group setting (4-8 participants)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age \< 75 and age \> 17 years
* two years diabetes duration with oral treatment
* BMI \> 20 nad BMI \< 40 kg/m²
* informed consent
Exclusion Criteria
* dementia or other severe cognitive impairment
* severe complications
* severe conditions (e.g., cancer)
* gestational diabetes
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forschungsinstitut der Diabetes Akademie Mergentheim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Norbert Hermanns
Prof. Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Norbert Hermanns, PhD
Role: PRINCIPAL_INVESTIGATOR
Forschungsinstitut der Diabetes Akademie Mergentheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes Centre Mergentheim
Bad Mergentheim, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FIDAM-02-09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.