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

German Cancer Research Center

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Telephone counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00742547

S-r86/zoo8

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Control group

No Intervention group

Description:

No telephone counseling + usual care

Telephone Counseling

Experimental group

Description:

Telephone counseling + usual care

Treatment:

Other: Telephone counseling