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

This study has been completed.
Sponsor:
Collaborators:
Heidelberg University
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00742547
First received: August 26, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Other: Telephone counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospitalization [ Time Frame: 18 month ] [ Designated as safety issue: No ]
  • CHD, mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • lipid metabolism control [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • risk factor control (eg. body weight, physical activity, smoking) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • incidence of diabetes-related complications [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742547

Locations
Germany
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
Volker Naser, MD
Heilbronn, Baden-Württemberg, Germany, 74076
Axel Möller, MD
Heilbronn, Baden-Württemberg, Germany, 74081
Hans-Joachim Essich, MD
Heilbronn, Baden-Württemberg, Germany, 74072
Jürgen Wollweber, MD
Heilbronn, Baden-Württemberg, Germany, 74072
Miroslaw Wyszynski, MD
Heilbronn, Baden-Württemberg, Germany, 74081
Ullrich Barthelmes, MD
Heilbronn, Baden-Württemberg, Germany, 74080
Andreas Wößner, MD
Heilbronn, Baden-Württemberg, Germany, 74078
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
Thomas Baartz, MD
Leonberg, Baden-Württemberg, Germany, 71229
Gerhard Günther, MD
Leonberg, Baden-Württemberg, Germany, 71229
Bernd Leuchs, MD
Leonberg, Baden-Württemberg, Germany, 71229
Monika Muhler, MD
Loewenstein, Baden-Württemberg, Germany, 74245
Martin Heinrich, MD
Ludwigsburg, Baden-Württemberg, Germany, 71640
Ulrich Wagner, MD
Ludwigsburg, Baden-Württemberg, Germany, 71634
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
Dietmar Kunz, MD
Neckarsulm, Baden-Württemberg, Germany, 74172
Hans-Jürgen Sommerer, MD
Neckarsulm, Baden-Württemberg, Germany, 74081
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
Investigators
Principal Investigator: Hermann Brenner, MD, MPH German Cancer Research Center
  More Information

No publications provided by German Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT00742547     History of Changes
Other Study ID Numbers: S-r86/zoo8
Study First Received: August 26, 2008
Last Updated: December 10, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Ministry of Education and Research

Keywords provided by German Cancer Research Center:
prevention
health services research

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

ClinicalTrials.gov processed this record on November 20, 2014