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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Telephone counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No telephone counseling + usual care | |
| Experimental: Telephone Counseling<br>Telephone counseling + usual care | Other: Telephone counseling<br>* Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, health services research