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

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ClinicalTrials.gov Identifier: NCT00742547
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : December 11, 2013
Sponsor:
Collaborators:
Heidelberg University
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
German Cancer Research Center

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Telephone counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Study Start Date : October 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
No telephone counseling + usual care
Experimental: Telephone Counseling
Telephone counseling + usual care
Other: Telephone counseling
Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 18 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742547


Locations
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Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Hermann Brenner, MD, MPH German Cancer Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT00742547    
Other Study ID Numbers: S-r86/zoo8
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Keywords provided by German Cancer Research Center:
prevention
health services research
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases