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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00742547
Acronym
DIANA
Enrollment
204
Registered
2008-08-27
Start date
2008-10-31
Completion date
2012-12-31
Last updated
2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

prevention, health services research

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.

Interventions

OTHERTelephone counseling

Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices

Sponsors

Heidelberg University
CollaboratorOTHER
German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
German Cancer Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HbA1c18 months

Secondary

MeasureTime frame
CHD, mortality18 months
lipid metabolism control18 months
hospitalization18 month
health-related quality of life18 months
incidence of diabetes-related complications18 months
risk factor control (eg. body weight, physical activity, smoking)18 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026