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

NCT00901992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2014-08-11

No results posted yet for this study

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.

Conditions

Interventions

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)

BEHAVIORAL

Current ICT program (ACC-ICT)

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

Sponsors & Collaborators

  • Forschungsinstitut der Diabetes Akademie Mergentheim

    lead OTHER

Principal Investigators

  • Norbert Hermanns, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-04-30
Completion
2010-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901992 on ClinicalTrials.gov