CClinicalTrials.gg
CompletedNCT00742547DIANAUpdated Dec 11, 2013

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

An interventional study of Telephone counseling in Type 2 Diabetes Mellitus, sponsored by German Cancer Research Center. Completed at 37 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by German Cancer Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • prevention
  • health services research
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 204 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

German Cancer Research Center is the lead sponsor of 46 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (actual)

Study arms

  • No intervention
    Control group

    No telephone counseling + usual care

  • Experimental
    Telephone Counseling

    Telephone counseling + usual care

    Other: Telephone counseling

Interventions

  • OtherTelephone counseling

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

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: 18 months

Secondary outcomes

  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

07

Study locations

37 sites
  • Christoph Lücke, MD
    Beilstein, Baden-Württemberg 71717, Germany
  • Andrea Walliser-Klöpfer, MD
    Benningen am Neckar, Baden-Württemberg 71724, Germany
  • Nader Heydari, MD
    Fellbach, Baden-Württemberg 70737, Germany
  • Adelheid Halttunen, MD
    Gemmingen, Baden-Württemberg 75050, Germany
  • Hans-Joachim Essich, MD
    Heilbronn, Baden-Württemberg 74072, Germany
  • Jürgen Wollweber, MD
    Heilbronn, Baden-Württemberg 74072, Germany
  • Volker Naser, MD
    Heilbronn, Baden-Württemberg 74076, Germany
  • Andreas Wößner, MD
    Heilbronn, Baden-Württemberg 74078, Germany
  • Ullrich Barthelmes, MD
    Heilbronn, Baden-Württemberg 74080, Germany
  • Axel Möller, MD
    Heilbronn, Baden-Württemberg 74081, Germany
  • Miroslaw Wyszynski, MD
    Heilbronn, Baden-Württemberg 74081, Germany
  • Ulrich Hofmann, MD
    Ilsfeld-Auenstein, Baden-Württemberg 74360, Germany
  • Hans Martin Schweizer, MD
    Korntal, Baden-Württemberg 70825, Germany
  • Eberhard Rieker, MD
    Lauffen am Neckar, Baden-Württemberg 74348, Germany
  • Bernd Leuchs, MD
    Leonberg, Baden-Württemberg 71229, Germany
  • Gerhard Günther, MD
    Leonberg, Baden-Württemberg 71229, Germany
  • Thomas Baartz, MD
    Leonberg, Baden-Württemberg 71229, Germany
  • Monika Muhler, MD
    Loewenstein, Baden-Württemberg 74245, Germany
  • Ulrich Wagner, MD
    Ludwigsburg, Baden-Württemberg 71634, Germany
  • Martin Heinrich, MD
    Ludwigsburg, Baden-Württemberg 71640, Germany
  • Franz Lang, MD
    Marbach am Neckar, Baden-Württemberg 71672, Germany
  • Jürgen Wirth, MD
    Marbach am Neckar, Baden-Württemberg 71672, Germany
  • Alfred Preisner, MD
    Massenbachhausen, Baden-Württemberg 74252, Germany
  • Michael Spiel, MD
    Murr, Baden-Württemberg 71711, Germany
  • Hans-Jürgen Sommerer, MD
    Neckarsulm, Baden-Württemberg 74081, Germany
  • Dietmar Kunz, MD
    Neckarsulm, Baden-Württemberg 74172, Germany
  • Hartmut Jungjohann, MD
    Neckarsulm, Baden-Württemberg 74172, Germany
  • Jürgen Herbers, MD
    Pleidelsheim, Baden-Württemberg 74385, Germany
  • Ulf-Michael Werner, MD
    Remshalden, Baden-Württemberg 73630, Germany
  • Frank Röder, MD
    Schwaikheim, Baden-Württemberg 71409, Germany
  • Gisela Gramlich, MD
    Untergruppenbach, Baden-Württemberg 74199, Germany
  • Ildiko Tasic
    Vaihingen-Enz, Baden-Württemberg 71665, Germany
  • Karl Schütz, MD
    Weinsberg, Baden-Württemberg 74189, Germany
  • Sigmund Jakob
    Weinsberg, Baden-Württemberg 74189, Germany
  • Kurt Weber, MD
    Weissach, Baden-Württemberg 71287, Germany
  • Dietmar Zinßer, MD
    Winnenden, Baden-Württemberg 71364, Germany
  • Odilo Schnabel, MD
    Zaberfeld, Baden-Württemberg 74374, Germany
08

References and documents

Publications

  • 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. PubMed 24205043 ↗
  • 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. PubMed 22838970 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00742547
Lead sponsor
German Cancer Research Center
Collaborators
Heidelberg University, German Federal Ministry of Education and Research
Responsible party
Sponsor
First posted
Aug 27, 2008
Start date
Oct 2008
Primary completion
Jul 2012
Completion
Dec 2012
Last update
Dec 11, 2013

Study contacts

Hermann Brenner, MD, MPH
principal investigator · German Cancer Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion