Life-Long Monitoring of Diabetes Mellitus in Veneto Region

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Self-monitoring for patients with Dibetes mellitus

• Registration Number: NCT01569893
• Lead Sponsor: Regione Veneto

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Status Verified: 2014-01
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-monitoring for patients with Dibetes mellitus type 2	Self-monitoring for patients with Dibetes mellitus	Self-monitoring for patients with Dibetes mellitus type 2

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c) levels	At the entry point of intervention and at the end (12 months)
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)

Secondary Outcome Measures

Name	Time	Method
Number of visits with specialists in diabetic center	12 months
Bed days of care	12 months
Bed days of care due to diabetes.	12 months
Number of visits with specialists	12 months
Number of access to ER	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 hospitalisations.	12 months
Number of hospitalisations due to diabetes.	12 months

Trial Locations

Locations (1)

"De Lellis" Hospital - Diabetology-Endocrinology Department; 🇮🇹 Schio, Vicenza, Italy