Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice (DIANA)

December 10, 2013 updated by: German Cancer Research Center

DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung

Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c > 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.

The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Beilstein, Baden-Württemberg, Germany, 71717
        • Christoph Lücke, MD
      • Benningen am Neckar, Baden-Württemberg, Germany, 71724
        • Andrea Walliser-Klöpfer, MD
      • Fellbach, Baden-Württemberg, Germany, 70737
        • Nader Heydari, MD
      • Gemmingen, Baden-Württemberg, Germany, 75050
        • Adelheid Halttunen, MD
      • Heilbronn, Baden-Württemberg, Germany, 74072
        • Hans-Joachim Essich, MD
      • Heilbronn, Baden-Württemberg, Germany, 74072
        • Jürgen Wollweber, MD
      • Heilbronn, Baden-Württemberg, Germany, 74076
        • Volker Naser, MD
      • Heilbronn, Baden-Württemberg, Germany, 74078
        • Andreas Wößner, MD
      • Heilbronn, Baden-Württemberg, Germany, 74080
        • Ullrich Barthelmes, MD
      • Heilbronn, Baden-Württemberg, Germany, 74081
        • Axel Möller, MD
      • Heilbronn, Baden-Württemberg, Germany, 74081
        • Miroslaw Wyszynski, MD
      • Ilsfeld-Auenstein, Baden-Württemberg, Germany, 74360
        • Ulrich Hofmann, MD
      • Korntal, Baden-Württemberg, Germany, 70825
        • Hans Martin Schweizer, MD
      • Lauffen am Neckar, Baden-Württemberg, Germany, 74348
        • Eberhard Rieker, MD
      • Leonberg, Baden-Württemberg, Germany, 71229
        • Bernd Leuchs, MD
      • Leonberg, Baden-Württemberg, Germany, 71229
        • Gerhard Günther, MD
      • Leonberg, Baden-Württemberg, Germany, 71229
        • Thomas Baartz, MD
      • Loewenstein, Baden-Württemberg, Germany, 74245
        • Monika Muhler, MD
      • Ludwigsburg, Baden-Württemberg, Germany, 71634
        • Ulrich Wagner, MD
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Martin Heinrich, MD
      • Marbach am Neckar, Baden-Württemberg, Germany, 71672
        • Franz Lang, MD
      • Marbach am Neckar, Baden-Württemberg, Germany, 71672
        • Jürgen Wirth, MD
      • Massenbachhausen, Baden-Württemberg, Germany, 74252
        • Alfred Preisner, MD
      • Murr, Baden-Württemberg, Germany, 71711
        • Michael Spiel, MD
      • Neckarsulm, Baden-Württemberg, Germany, 74081
        • Hans-Jürgen Sommerer, MD
      • Neckarsulm, Baden-Württemberg, Germany, 74172
        • Dietmar Kunz, MD
      • Neckarsulm, Baden-Württemberg, Germany, 74172
        • Hartmut Jungjohann, MD
      • Pleidelsheim, Baden-Württemberg, Germany, 74385
        • Jürgen Herbers, MD
      • Remshalden, Baden-Württemberg, Germany, 73630
        • Ulf-Michael Werner, MD
      • Schwaikheim, Baden-Württemberg, Germany, 71409
        • Frank Röder, MD
      • Untergruppenbach, Baden-Württemberg, Germany, 74199
        • Gisela Gramlich, MD
      • Vaihingen-Enz, Baden-Württemberg, Germany, 71665
        • Ildiko Tasic
      • Weinsberg, Baden-Württemberg, Germany, 74189
        • Karl Schütz, MD
      • Weinsberg, Baden-Württemberg, Germany, 74189
        • Sigmund Jakob
      • Weissach, Baden-Württemberg, Germany, 71287
        • Kurt Weber, MD
      • Winnenden, Baden-Württemberg, Germany, 71364
        • Dietmar Zinßer, MD
      • Zaberfeld, Baden-Württemberg, Germany, 74374
        • Odilo Schnabel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
  • Ability to take part in the study

Exclusion Criteria:

  • Nursing home resident
  • Insufficient knowledge of the German language
  • Palliative health care with limited life expectancy
  • Emergency outpatient
  • All outpatients who attend the general practitioner by way of exception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No telephone counseling + usual care
Experimental: Telephone Counseling
Telephone counseling + usual care
Other: Telephone counseling
Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
hospitalization
Time Frame: 18 month
18 month
CHD, mortality
Time Frame: 18 months
18 months
lipid metabolism control
Time Frame: 18 months
18 months
risk factor control (eg. body weight, physical activity, smoking)
Time Frame: 18 months
18 months
health-related quality of life
Time Frame: 18 months
18 months
incidence of diabetes-related complications
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

German Federal Ministry of Education and Research
Heidelberg University

Investigators

  • Principal Investigator: Hermann Brenner, MD, MPH, German Cancer Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-r86/zoo8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Telephone counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe