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 whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large treatment care center.
The study is designed to evaluate the impact of telemonitoring on the management of Diabetes Mellitus compared with outpatient usual care. From a clinical point of view, the measurements of HbA1c will be taken to assess glycaemic control and the trial will allow to investigate how telemonitoring contributes to improve Diabetes mellitus patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
598
Patients are equipped with a telemonitoring kit composed by a portable glucose meter and a gateway device for data transmission. The patient can monitor his blood glucose level with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms.
"De Lellis" Hospital - Diabetology-Endocrinology Department
Schio, Vicenza, Italy
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time frame: At the entry point of intervention and at the end (12 months)
Glycated hemoglobin (HbA1c) levels
Time frame: At the entry point of intervention and at the end (12 months)
Number of hospitalisations.
Time frame: 12 months
Number of hospitalisations due to diabetes.
Time frame: 12 months
Bed days of care
Time frame: 12 months
Bed days of care due to diabetes.
Time frame: 12 months
Number of visits with specialists
Time frame: 12 months
Number of access to ER
Time frame: 12 months
Mental status measured through Hospital Anxiety and Depression Scale (HADS).
Time frame: At the entry point of intervention and at the end (12 months)
Number of visits with specialists in diabetic center
Time frame: 12 months
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