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Type 2 Diabetes MellitusDIANANCT00742547

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

A study testing Telephone counseling in people with Type 2 Diabetes Mellitus, run by German Cancer Research Center at 37 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Telephone counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
37 sitesGermany
Study dates
Oct 2008to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Germany37 sites

  • Christoph Lücke, MD

    Beilstein, Baden-Wurttemberg, 71717

  • Andrea Walliser-Klöpfer, MD

    Benningen am Neckar, Baden-Wurttemberg, 71724

  • Nader Heydari, MD

    Fellbach, Baden-Wurttemberg, 70737

  • Adelheid Halttunen, MD

    Gemmingen, Baden-Wurttemberg, 75050

  • Hans-Joachim Essich, MD

    Heilbronn, Baden-Wurttemberg, 74072

  • Jürgen Wollweber, MD

    Heilbronn, Baden-Wurttemberg, 74072

  • Volker Naser, MD

    Heilbronn, Baden-Wurttemberg, 74076

  • Andreas Wößner, MD

    Heilbronn, Baden-Wurttemberg, 74078

  • Ullrich Barthelmes, MD

    Heilbronn, Baden-Wurttemberg, 74080

  • Axel Möller, MD

    Heilbronn, Baden-Wurttemberg, 74081

  • Miroslaw Wyszynski, MD

    Heilbronn, Baden-Wurttemberg, 74081

  • Ulrich Hofmann, MD

    Ilsfeld-Auenstein, Baden-Wurttemberg, 74360

  • Hans Martin Schweizer, MD

    Korntal, Baden-Wurttemberg, 70825

  • Eberhard Rieker, MD

    Lauffen am Neckar, Baden-Wurttemberg, 74348

  • Bernd Leuchs, MD

    Leonberg, Baden-Wurttemberg, 71229

  • Gerhard Günther, MD

    Leonberg, Baden-Wurttemberg, 71229

  • Thomas Baartz, MD

    Leonberg, Baden-Wurttemberg, 71229

  • Monika Muhler, MD

    Löwenstein, Baden-Wurttemberg, 74245

  • Ulrich Wagner, MD

    Ludwigsburg, Baden-Wurttemberg, 71634

  • Martin Heinrich, MD

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Franz Lang, MD

    Marbach am Neckar, Baden-Wurttemberg, 71672

  • Jürgen Wirth, MD

    Marbach am Neckar, Baden-Wurttemberg, 71672

  • Alfred Preisner, MD

    Massenbachhausen, Baden-Wurttemberg, 74252

  • Michael Spiel, MD

    Murr, Baden-Wurttemberg, 71711

  • Hans-Jürgen Sommerer, MD

    Neckarsulm, Baden-Wurttemberg, 74081

  • Dietmar Kunz, MD

    Neckarsulm, Baden-Wurttemberg, 74172

  • Hartmut Jungjohann, MD

    Neckarsulm, Baden-Wurttemberg, 74172

  • Jürgen Herbers, MD

    Pleidelsheim, Baden-Wurttemberg, 74385

  • Ulf-Michael Werner, MD

    Remshalden, Baden-Wurttemberg, 73630

  • Frank Röder, MD

    Schwaikheim, Baden-Wurttemberg, 71409

  • Gisela Gramlich, MD

    Untergruppenbach, Baden-Wurttemberg, 74199

  • Ildiko Tasic

    Vaihingen-Enz, Baden-Wurttemberg, 71665

  • Karl Schütz, MD

    Weinsberg, Baden-Wurttemberg, 74189

  • Sigmund Jakob

    Weinsberg, Baden-Wurttemberg, 74189

  • Kurt Weber, MD

    Weissach, Baden-Wurttemberg, 71287

  • Dietmar Zinßer, MD

    Winnenden, Baden-Wurttemberg, 71364

  • Odilo Schnabel, MD

    Zaberfeld, Baden-Wurttemberg, 74374

Other trials in Germany

About this study

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

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.

Being tested
Telephone counseling
Keywords
prevention, health services research
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone counselingOther

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

Study groups in NCT00742547
Study groupRoleWhat they receive
Control groupNo interventionNo telephone counseling + usual care
Telephone CounselingExperimentalTelephone counseling + usual care
Receives: Other: Telephone counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: 18 months

Secondary outcomes (6)

  1. hospitalization

    Measured: 18 month

  2. CHD, mortality

    Measured: 18 months

  3. lipid metabolism control

    Measured: 18 months

  4. risk factor control (eg. body weight, physical activity, smoking)

    Measured: 18 months

  5. health-related quality of life

    Measured: 18 months

  6. incidence of diabetes-related complications

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00742547
Sponsor's protocol ID
S-r86/zoo8
Acronym
DIANA
Status last verified
Dec 2013
First submitted
26 Aug 2008
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Telephone counseling in people with Type 2 Diabetes Mellitus, run by German Cancer Research Center at 37 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00742547, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.

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