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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
154
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
Larissa, Thessaly, Greece
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time frame: 12 months minimum- at the entry point of the intervention and the end.
HbA1c levels
Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)
Time frame: 12 months minimum - at the entry point and every 3 months.
Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Nutrition habits assessed by validated questionnaire.
Time frame: 12 months minimum- at the entry point of the intervention and the end.
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time frame: at 2nd and at 12th month
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
Time frame: 12 months minimum
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