Diabetes Mellitus, Type 2
Conditions
Keywords
Telemonitoring, Telemedicine, Diabetes mellitus
Brief summary
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.
Detailed description
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.
Interventions
OTHERSelf-monitoring for patients with Dibetes mellitus
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.
Sponsors
European Commission
Azienda ULSS 4 Alto Vicentino
Regione Veneto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 Diabetes * HbA1c \> 53 mmol/mol (7.0 % according to NGSP) * Capability to use the devices provided * Being cognitively able to participate * Capability of filling in questionnaires in german or greek or italian language * Absence of severe comorbidity prevalent on diabetes with life expectancy \< 12 months
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health related quality of life of the patients measured by the SF-36 version 2 questionnaire | At the entry point of intervention and at the end (12 months) |
| Glycated hemoglobin (HbA1c) levels | At the entry point of intervention and at the end (12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Bed days of care | 12 months |
| Bed days of care due to diabetes. | 12 months |
| Number of visits with specialists | 12 months |
| Number of hospitalisations. | 12 months |
| Mental status measured through Hospital Anxiety and Depression Scale (HADS). | At the entry point of intervention and at the end (12 months) |
| Number of visits with specialists in diabetic center | 12 months |
| Number of access to ER | 12 months |
| Number of hospitalisations due to diabetes. | 12 months |
Countries
Italy
Outcome results
None listed