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Clinical Trials/NCT00742547
NCT00742547
Completed
Not Applicable

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

German Cancer Research Center37 sites in 1 country204 target enrollmentOctober 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
German Cancer Research Center
Enrollment
204
Locations
37
Primary Endpoint
HbA1c
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
December 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

HbA1c

Time Frame: 18 months

Secondary Outcomes

  • health-related quality of life(18 months)
  • lipid metabolism control(18 months)
  • risk factor control (eg. body weight, physical activity, smoking)(18 months)
  • hospitalization(18 month)
  • CHD, mortality(18 months)
  • incidence of diabetes-related complications(18 months)

Study Sites (37)

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