NCT01569893

Life-Long Monitoring of Diabetes Mellitus in Veneto Region

RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: Regione Veneto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	Self-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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-04-03
• Last updated: 2015-10-28

Locations

1 site across 1 country: Italy