NCT02748239

Brief Summary

A new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) 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 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable type-2-diabetes

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

February 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

April 13, 2016

Last Update Submit

August 8, 2016

Conditions

Type 2 Diabetes

Keywords

diabetes self-management educationinsulin therapy

Outcome Measures

Primary Outcomes (1)

  • A1c values

    six months follow up after termination of the programs

Secondary Outcomes (6)

  • Quality of life

    six months follow up

  • Diabetes knowledge

    six months follow up

  • Diabetes related emotional burden

    six months follow up

  • Diabetes related distress

    six months follow up

  • Self-care behavior

    six months follow up

  • +1 more secondary outcomes

Study Arms (2)

MEDIAS 2 CT

ACTIVE COMPARATOR

The MEDIAS CT is a newly developed education program for the initiation of a conventional insulin therapy in type 2 diabetic patients.

Behavioral: MEDIAS 2 CT

Current CT program

PLACEBO COMPARATOR

This program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients.

Behavioral: Current CT program

Interventions

MEDIAS 2 CTBEHAVIORAL

The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).

MEDIAS 2 CT
Current CT programBEHAVIORAL

The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).

Current CT program

Eligibility Criteria

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

You may qualify if:

  • type 2 diabetes
  • two years diabetes duration with oral treatment
  • BMI \> 20 and \< 40 kg/m²
  • written 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

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

April 13, 2016

First Posted

April 22, 2016

Study Start

February 1, 2013

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)