Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice (DIANA)
This study is currently recruiting participants.
Verified April 2012 by German Cancer Research Center
Sponsor:
German Cancer Research Center
Collaborators:
University of Heidelberg
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: April 5, 2012
Last verified: April 2012
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Purpose
Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.500 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 (Baden-Württemberg, Germany). In a subgroup of about 248 patients with a dissatisfactory metabolic status ( > 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, as well as hospitalization and mortality.
The aim of the study is to develop an patient-orientated instrument implementable in the "normal" medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Other: Telephone counseling Other: No 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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 248 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Telephone counseling
|
Other: Telephone counseling
telephone counseling is executed once a months by the medical secretary of the general practitioners practices
|
|
No Intervention: 2
No telephone counseling
|
Other: No telephone counseling
The control group does not get a telephone counseling.
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742547
Contacts
| Contact: Hermann Brenner, MD, MPH | 0049-6221-548140 | h.brenner@dkfz-heidelberg.de |
| Contact: Elke Raum, MD, MPH | 0049-6221-548143 | e.raum@dkfz-heidelberg.de |
Locations
| Germany | |
| Christoph Lücke, MD | Recruiting |
| Beilstein, Baden-Württemberg, Germany, 71717 | |
| Contact: Christoph Lücke, MD 0049-7062-4444 | |
| Andrea Walliser-Klöpfer, MD | Recruiting |
| Benningen am Neckar, Baden-Württemberg, Germany, 71724 | |
| Contact: Andrea Walliser-Klöpfer, MD 0049-7144-14233 | |
| Nader Heydari, MD | Recruiting |
| Fellbach, Baden-Württemberg, Germany, 70737 | |
| Contact: Nader Heydari, MD 0049-711-589003 | |
| Adelheid Halttunen, MD | Recruiting |
| Gemmingen, Baden-Württemberg, Germany, 75050 | |
| Contact: Adelheid Halttungen, MD 0049-7267-911100 | |
| Jürgen Wollweber, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74072 | |
| Contact: Jürgen Wollweber, MD 0049-7131-84477 | |
| Axel Möller, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74081 | |
| Contact: Axel Möller, MD 0049-7131-5823411 | |
| Miroslaw Wyszynski, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74081 | |
| Contact: Miroslaw Wyszynski, MD 0049-7131-85187 | |
| Ullrich Barthelmes, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74080 | |
| Contact: Ullrich Barthelmes, MD 0049-7131-41414 | |
| Volker Naser, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74076 | |
| Contact: Volker Naser, MD 0049-7131-161295 | |
| Hans-Joachim Essich, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74072 | |
| Contact: Hans-Joachim Essich, MD 0049-7131-81802 | |
| Andreas Wößner, MD | Recruiting |
| Heilbronn, Baden-Württemberg, Germany, 74078 | |
| Contact: Andreas Wößner, MD 0049-7131-44079 | |
| Ulrich Hofmann, MD | Recruiting |
| Ilsfeld-Auenstein, Baden-Württemberg, Germany, 74360 | |
| Contact: Ulrich Hofmann, MD 0049-7062-95030 | |
| Hans Martin Schweizer, MD | Recruiting |
| Korntal, Baden-Württemberg, Germany, 70825 | |
| Contact: Hans M Schweizer, MD 0049-711-831768 | |
| Eberhard Rieker, MD | Recruiting |
| Lauffen am Neckar, Baden-Württemberg, Germany, 74348 | |
| Contact: Eberhard Rieker, MD 0049-7133-7992 | |
| Bernd Leuchs, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Bernd Leuchs, MD 0049-7152-43245 | |
| Gerhard Günther, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Gerhard Günther, MD 0049-7152-23498 | |
| Thomas Baartz, MD | Recruiting |
| Leonberg, Baden-Württemberg, Germany, 71229 | |
| Contact: Thomas Baartz, MD 0049-7152-21486 | |
| Monika Muhler, MD | Recruiting |
| Loewenstein, Baden-Württemberg, Germany, 74245 | |
| Contact: Monika Muhler, MD 0049-7130-402659 | |
| Martin Heinrich, MD | Recruiting |
| Ludwigsburg, Baden-Württemberg, Germany, 71640 | |
| Contact: Martin Heinrich, MD 0049-7141-86777 | |
| Ulrich Wagner, MD | Recruiting |
| Ludwigsburg, Baden-Württemberg, Germany, 71634 | |
| Contact: Ulrich Wagner, MD 0049-7141-926584 | |
| Jürgen Wirth, MD | Recruiting |
| Marbach am Neckar, Baden-Württemberg, Germany, 71672 | |
| Contact: Jürgen Wirth, MD 0049-7144-858347 | |
| Franz Lang, MD | Recruiting |
| Marbach am Neckar, Baden-Württemberg, Germany, 71672 | |
| Contact: Franz Lang, MD 0049-7144-5137 | |
| Alfred Preisner, MD | Recruiting |
| Massenbachhausen, Baden-Württemberg, Germany, 74252 | |
| Contact: Alfred Preisner, MD 0049-7138-7065 | |
| Michael Spiel, MD | Recruiting |
| Murr, Baden-Württemberg, Germany, 71711 | |
| Contact: Michael Spiel, MD 0049-7144-22060 | |
| Hartmut Jungjohann, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74172 | |
| Contact: Hartmut Jungjohann, MD 0049-7131-88100 | |
| Hans-Jürgen Sommerer, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74081 | |
| Contact: Hans-Jürgen Sommerer, MD 0049-7132-18688 | |
| Dietmar Kunz, MD | Recruiting |
| Neckarsulm, Baden-Württemberg, Germany, 74172 | |
| Contact: Dietmar Kunz, MD 0049-7132-88416 | |
| Jürgen Herbers, MD | Recruiting |
| Pleidelsheim, Baden-Württemberg, Germany, 74385 | |
| Contact: Jürgen Herbers, MD 0049-7144-82730 | |
| Ulf-Michael Werner, MD | Recruiting |
| Remshalden, Baden-Württemberg, Germany, 73630 | |
| Contact: Ulf-Michael Werner, MD 0046-7181-484977 | |
| Frank Röder, MD | Recruiting |
| Schwaikheim, Baden-Württemberg, Germany, 71409 | |
| Contact: Frank Röder, MD 0049-7195-53866 | |
| Dieter Böhm, MD | Withdrawn |
| Steinheim an der Murr, Baden-Württemberg, Germany, 71711 | |
| Gisela Gramlich, MD | Recruiting |
| Untergruppenbach, Baden-Württemberg, Germany, 74199 | |
| Contact: Gisela Gramlich, MD 0049-7131-70775 | |
| Ildiko Tasic | Recruiting |
| Vaihingen-Enz, Baden-Württemberg, Germany, 71665 | |
| Contact: Ildiko Tasic, MD 0049-7042-5310 | |
| Sigmund Jakob | Recruiting |
| Weinsberg, Baden-Württemberg, Germany, 74189 | |
| Contact: Sigmund Jakob, MD 0049-7134-8583 | |
| Karl Schütz, MD | Recruiting |
| Weinsberg, Baden-Württemberg, Germany, 74189 | |
| Contact: Karl Schütz, MD 0049-7134-8843 | |
| Kurt Weber, MD | Recruiting |
| Weissach, Baden-Württemberg, Germany, 71287 | |
| Contact: Kurt Weber, MD 0049-7044-971720 | |
| Dietmar Zinßer, MD | Recruiting |
| Winnenden, Baden-Württemberg, Germany, 71364 | |
| Contact: Dietmar Zinßer, MD 0049-7195-174733 | |
| Odilo Schnabel, MD | Recruiting |
| Zaberfeld, Baden-Württemberg, Germany, 74374 | |
| Contact: Odilo Schnabel, MD 0049-7046-321 | |
Sponsors and Collaborators
German Cancer Research Center
University of Heidelberg
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: | April 5, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013