Clinical trial NCT00742547: Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice
Official title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: prevention
health services research
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: German Federal Ministry of Education and Research
First posted: 2008-08-27
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: HbA1c
timeFrame: 18 months
Secondary outcomes:
measure: hospitalization
timeFrame: 18 month
measure: CHD, mortality
timeFrame: 18 months
measure: lipid metabolism control
timeFrame: 18 months
measure: risk factor control (eg. body weight, physical activity, smoking)
timeFrame: 18 months
measure: health-related quality of life
timeFrame: 18 months
measure: incidence of diabetes-related complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Beilstein
country: Germany
facility: Christoph Lücke, MD
state: Baden-Württemberg
city: Benningen am Neckar
country: Germany
facility: Andrea Walliser-Klöpfer, MD
state: Baden-Württemberg
city: Fellbach
country: Germany
facility: Nader Heydari, MD
state: Baden-Württemberg
city: Gemmingen
country: Germany
facility: Adelheid Halttunen, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Hans-Joachim Essich, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Jürgen Wollweber, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Volker Naser, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Andreas Wößner, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Ullrich Barthelmes, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Axel Möller, MD
state: Baden-Württemberg
city: Heilbronn
country: Germany
facility: Miroslaw Wyszynski, MD
state: Baden-Württemberg
city: Ilsfeld-Auenstein
country: Germany
facility: Ulrich Hofmann, MD
state: Baden-Württemberg
city: Korntal
country: Germany
facility: Hans Martin Schweizer, MD
state: Baden-Württemberg
city: Lauffen am Neckar
country: Germany
facility: Eberhard Rieker, MD
state: Baden-Württemberg
city: Leonberg
country: Germany
facility: Bernd Leuchs, MD
state: Baden-Württemberg
city: Leonberg
country: Germany
facility: Gerhard Günther, MD
state: Baden-Württemberg
city: Leonberg
country: Germany
facility: Thomas Baartz, MD
state: Baden-Württemberg
city: Loewenstein
country: Germany
facility: Monika Muhler, MD
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
facility: Ulrich Wagner, MD
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
facility: Martin Heinrich, MD
state: Baden-Württemberg
city: Marbach am Neckar
country: Germany
facility: Franz Lang, MD
state: Baden-Württemberg
city: Marbach am Neckar
country: Germany
facility: Jürgen Wirth, MD
state: Baden-Württemberg
city: Massenbachhausen
country: Germany
facility: Alfred Preisner, MD
state: Baden-Württemberg
city: Murr
country: Germany
facility: Michael Spiel, MD
state: Baden-Württemberg
city: Neckarsulm
country: Germany
facility: Hans-Jürgen Sommerer, MD
state: Baden-Württemberg
city: Neckarsulm
country: Germany
facility: Dietmar Kunz, MD
state: Baden-Württemberg
city: Neckarsulm
country: Germany
facility: Hartmut Jungjohann, MD
state: Baden-Württemberg
city: Pleidelsheim
country: Germany
facility: Jürgen Herbers, MD
state: Baden-Württemberg
city: Remshalden
country: Germany
facility: Ulf-Michael Werner, MD
state: Baden-Württemberg
city: Schwaikheim
country: Germany
facility: Frank Röder, MD
state: Baden-Württemberg
city: Untergruppenbach
country: Germany
facility: Gisela Gramlich, MD
state: Baden-Württemberg
city: Vaihingen-Enz
country: Germany
facility: Ildiko Tasic
state: Baden-Württemberg
city: Weinsberg
country: Germany
facility: Karl Schütz, MD
state: Baden-Württemberg
city: Weinsberg
country: Germany
facility: Sigmund Jakob
state: Baden-Württemberg
city: Weissach
country: Germany
facility: Kurt Weber, MD
state: Baden-Württemberg
city: Winnenden
country: Germany
facility: Dietmar Zinßer, MD
state: Baden-Württemberg
city: Zaberfeld
country: Germany
facility: Odilo Schnabel, MD
state: Baden-Württemberg
Study officials:
affiliation: German Cancer Research Center
name: Hermann Brenner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mons U, Raum E, Kramer HU, Ruter G, Rothenbacher D, Rosemann T, Szecsenyi J, Brenner H. Effectiveness of a supportive telephone counseling intervention in type 2 diabetes patients: randomized controlled study. PLoS One. 2013 Oct 30;8(10):e77954. doi: 10.1371/journal.pone.0077954. eCollection 2013.
citation: Kramer HU, Raum E, Ruter G, Schottker B, Rothenbacher D, Rosemann T, Szecsenyi J, Brenner H. Gender disparities in diabetes and coronary heart disease medication among patients with type 2 diabetes: results from the DIANA study. Cardiovasc Diabetol. 2012 Jul 27;11:88. doi: 10.1186/1475-2840-11-88.