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Completed

NCT Number: NCT00742547

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christoph Lücke, MD, Beilstein, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Counseling

Other

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

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

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • German Federal Ministry of Education and Research
  • Heidelberg University

Registry information

Official study title

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

Acronym: DIANA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2008
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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