DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
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.
Investigators
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)