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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00742547
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2008-10
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	18 months

Secondary Outcome Measures

Name	Time	Method
CHD, mortality	18 months
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
incidence of diabetes-related complications	18 months

Trial Locations

Locations (37)

Christoph Lücke, MD; 🇩🇪 Beilstein, Baden-Württemberg, Germany

Andrea Walliser-Klöpfer, MD; 🇩🇪 Benningen am Neckar, Baden-Württemberg, Germany

Nader Heydari, MD; 🇩🇪 Fellbach, Baden-Württemberg, Germany

Adelheid Halttunen, MD; 🇩🇪 Gemmingen, Baden-Württemberg, Germany

Hans-Joachim Essich, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

Jürgen Wollweber, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

Volker Naser, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

Andreas Wößner, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

Ullrich Barthelmes, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

Axel Möller, MD; 🇩🇪 Heilbronn, Baden-Württemberg, Germany

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