Life-Long Monitoring of Diabetes Mellitus in Veneto Region

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569893
• Other study ID #: G. A. 250487 - Veneto WP8Cl2
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: October 27, 2015
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: Regione Veneto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Italy	"De Lellis" Hospital - Diabetology-Endocrinology Department	Schio	Vicenza

Sponsors (3)

Lead Sponsor	Collaborator
Regione Veneto	Azienda ULSS 4 Alto Vicentino, European Commission

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Glycated hemoglobin (HbA1c) levels		At the entry point of intervention and at the end (12 months)	No
Secondary	Number of hospitalisations.		12 months	No
Secondary	Number of hospitalisations due to diabetes.		12 months	No
Secondary	Bed days of care		12 months	No
Secondary	Bed days of care due to diabetes.		12 months	No
Secondary	Number of visits with specialists		12 months	No
Secondary	Number of access to ER		12 months	No
Secondary	Mental status measured through Hospital Anxiety and Depression Scale (HADS).		At the entry point of intervention and at the end (12 months)	No
Secondary	Number of visits with specialists in diabetic center		12 months	No

External Links

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