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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742547
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : December 11, 2013
Heidelberg University
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
German Cancer Research Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Telephone counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Study Start Date : October 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. hospitalization [ Time Frame: 18 month ]
  2. CHD, mortality [ Time Frame: 18 months ]
  3. lipid metabolism control [ Time Frame: 18 months ]
  4. risk factor control (eg. body weight, physical activity, smoking) [ Time Frame: 18 months ]
  5. health-related quality of life [ Time Frame: 18 months ]
  6. incidence of diabetes-related complications [ Time Frame: 18 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742547

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: German Cancer Research Center Identifier: NCT00742547     History of Changes
Other Study ID Numbers: S-r86/zoo8
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by German Cancer Research Center:
health services research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases