Clinical trial NCT01569893: Life-Long Monitoring of Diabetes Mellitus in Veneto Region
Official title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Telemonitoring
Telemedicine
Diabetes mellitus
Lead sponsor: Regione Veneto
Sponsor class: OTHER
Collaborators: name: European Commission
name: Azienda ULSS 4 Alto Vicentino
First posted: 2012-04-03
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
timeFrame: At the entry point of intervention and at the end (12 months)
measure: Glycated hemoglobin (HbA1c) levels
timeFrame: At the entry point of intervention and at the end (12 months)
Secondary outcomes:
measure: Number of hospitalisations.
timeFrame: 12 months
measure: Number of hospitalisations due to diabetes.
timeFrame: 12 months
measure: Bed days of care
timeFrame: 12 months
measure: Bed days of care due to diabetes.
timeFrame: 12 months
measure: Number of visits with specialists
timeFrame: 12 months
measure: Number of access to ER
timeFrame: 12 months
measure: Mental status measured through Hospital Anxiety and Depression Scale (HADS).
timeFrame: At the entry point of intervention and at the end (12 months)
measure: Number of visits with specialists in diabetic center
timeFrame: 12 months
Other outcomes:
Locations:
city: Schio
country: Italy
facility: "De Lellis" Hospital - Diabetology-Endocrinology Department
state: Vicenza
Study officials:
affiliation: Local Health Authority "Alto Vicentino" of Thiene (VI)
name: Francesco Calcaterra, MD
role: PRINCIPAL_INVESTIGATOR
References: