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

Type 2 Diabetes Mellitus Clinical Trial

— DIANA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742547
• Other study ID #: S-r86/zoo8
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: December 10, 2013
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Telephone counseling
Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices

Locations

Country	Name	City	State
Germany	Christoph Lücke, MD	Beilstein	Baden-Württemberg
Germany	Andrea Walliser-Klöpfer, MD	Benningen am Neckar	Baden-Württemberg
Germany	Nader Heydari, MD	Fellbach	Baden-Württemberg
Germany	Adelheid Halttunen, MD	Gemmingen	Baden-Württemberg
Germany	Andreas Wößner, MD	Heilbronn	Baden-Württemberg
Germany	Axel Möller, MD	Heilbronn	Baden-Württemberg
Germany	Hans-Joachim Essich, MD	Heilbronn	Baden-Württemberg
Germany	Jürgen Wollweber, MD	Heilbronn	Baden-Württemberg
Germany	Miroslaw Wyszynski, MD	Heilbronn	Baden-Württemberg
Germany	Ullrich Barthelmes, MD	Heilbronn	Baden-Württemberg
Germany	Volker Naser, MD	Heilbronn	Baden-Württemberg
Germany	Ulrich Hofmann, MD	Ilsfeld-Auenstein	Baden-Württemberg
Germany	Hans Martin Schweizer, MD	Korntal	Baden-Württemberg
Germany	Eberhard Rieker, MD	Lauffen am Neckar	Baden-Württemberg
Germany	Bernd Leuchs, MD	Leonberg	Baden-Württemberg
Germany	Gerhard Günther, MD	Leonberg	Baden-Württemberg
Germany	Thomas Baartz, MD	Leonberg	Baden-Württemberg
Germany	Monika Muhler, MD	Loewenstein	Baden-Württemberg
Germany	Martin Heinrich, MD	Ludwigsburg	Baden-Württemberg
Germany	Ulrich Wagner, MD	Ludwigsburg	Baden-Württemberg
Germany	Franz Lang, MD	Marbach am Neckar	Baden-Württemberg
Germany	Jürgen Wirth, MD	Marbach am Neckar	Baden-Württemberg
Germany	Alfred Preisner, MD	Massenbachhausen	Baden-Württemberg
Germany	Michael Spiel, MD	Murr	Baden-Württemberg
Germany	Dietmar Kunz, MD	Neckarsulm	Baden-Württemberg
Germany	Hans-Jürgen Sommerer, MD	Neckarsulm	Baden-Württemberg
Germany	Hartmut Jungjohann, MD	Neckarsulm	Baden-Württemberg
Germany	Jürgen Herbers, MD	Pleidelsheim	Baden-Württemberg
Germany	Ulf-Michael Werner, MD	Remshalden	Baden-Württemberg
Germany	Frank Röder, MD	Schwaikheim	Baden-Württemberg
Germany	Gisela Gramlich, MD	Untergruppenbach	Baden-Württemberg
Germany	Ildiko Tasic	Vaihingen-Enz	Baden-Württemberg
Germany	Karl Schütz, MD	Weinsberg	Baden-Württemberg
Germany	Sigmund Jakob	Weinsberg	Baden-Württemberg
Germany	Kurt Weber, MD	Weissach	Baden-Württemberg
Germany	Dietmar Zinßer, MD	Winnenden	Baden-Württemberg
Germany	Odilo Schnabel, MD	Zaberfeld	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
German Cancer Research Center	German Federal Ministry of Education and Research, Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		18 months	No
Secondary	hospitalization		18 month	No
Secondary	CHD, mortality		18 months	No
Secondary	lipid metabolism control		18 months	No
Secondary	risk factor control (eg. body weight, physical activity, smoking)		18 months	No
Secondary	health-related quality of life		18 months	No
Secondary	incidence of diabetes-related complications		18 months	No