Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.
The present study aims to examine the clinical and financial effects and the patients'
perception and satisfaction of home telemedicine support system for diabetes management
versus standard (usual) care. In the intervention group the patients will be provided with a
blood glucose meter and a mobile phone and their data will be transferred via the mobile to
the regional database and will be assessed by the allocated care team. Appropriate
counseling on treatment and symptoms or problems related to diabetes will also be provided.
Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the
exercise habits will be assessed by the use of questionnaires. In addition the patients'
satisfaction from the use of the telemedicine service will be studied. A Cost-Effective
Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service
compared with the usual care from the health and social perspective. The effect of the
tele-health service in the organization structure of the outpatient hospital department will
be evaluated with a qualitative study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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