Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung - Full Text View

Sponsors and Collaborators:	German Cancer Research Center University of Heidelberg German Federal Ministry of Education and Research
Information provided by:	German Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00742547

Purpose

Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.500 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 (Baden-Württemberg, Germany). In a subgroup of about 250 patients with a dissatisfactory metabolic status ( > 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, as well as hospitalization and mortality.

The aim of the study is to develop an patient-orientated instrument implementable in the "normal" medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.

Condition	Intervention
Prevention Health Services Research	Other: Telephone counseling Other: No telephone counseling

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:

HbA1c [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Telephone counseling	Other: Telephone counseling telephone counseling is executed once a months by the medical secretary of the general practitioners practices
2 No telephone counseling	Other: No telephone counseling The control group does not get a telephone counseling.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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
Only broken German
Palliative health care with limited life expectancy
Emergency outpatient
All outpatients who attend the general practitioner by way of exception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742547

Sponsors and Collaborators

German Cancer Research Center

University of Heidelberg

German Federal Ministry of Education and Research

Investigators

Study Director:

Hermann Brenner, Prof. Dr. med.

German Cancer Research Center

More Information

Responsible Party:	German Cancer Research Center ( Prof. Dr. med. Hermann Brenner )
Study ID Numbers:	S-r86/zoo8
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00742547
Health Authority:	Germany: Ethics Commission; Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009