NCT00901992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

May 12, 2009

Last Update Submit

August 8, 2014

Conditions

Type 2 Diabetes

Keywords

type 2 diabeteseducationself-managementinsulin therapy

Outcome Measures

Primary Outcomes (1)

  • A1c values

    six month follow up after termination of the programs

Secondary Outcomes (6)

  • Quality of life using the SF 12 mental and physical composite scales

    six month follow up

  • diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)

    6 month follow up

  • diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)

    6 month follow up

  • Self care behavior (Summary of Self-Care Activities Scale)

    6 month follow up

  • lipids (total cholesterol, triglycerides, HDL and LDL)

    6 month follow up

  • +1 more secondary outcomes

Study Arms (2)

MEDIAS 2 ICT

EXPERIMENTAL

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

Behavioral: MEDIAS 2 ICT

Current ICT program (ACC)

ACTIVE COMPARATOR

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

Behavioral: Current ICT program (ACC-ICT)

Interventions

MEDIAS 2 ICTBEHAVIORAL

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)

MEDIAS 2 ICT
Current ICT program (ACC-ICT)BEHAVIORAL

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

Current ICT program (ACC)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • current psychiatric disease
  • dementia or other severe cognitive impairment
  • severe complications
  • severe conditions (e.g., cancer)
  • gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Centre Mergentheim

Bad Mergentheim, 97980, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21715124RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Norbert Hermanns, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

DE(1)