Life-Long Monitoring of Diabetes Mellitus in Veneto Region

October 27, 2015 updated by: Regione Veneto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

598

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Vicenza
      • Schio, Vicenza, Italy, 36015
        • "De Lellis" Hospital - Diabetology-Endocrinology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual care: treatment as usual
Experimental: Self-monitoring for patients with Dibetes mellitus type 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time Frame: At the entry point of intervention and at the end (12 months)
At the entry point of intervention and at the end (12 months)
Glycated hemoglobin (HbA1c) levels
Time Frame: At the entry point of intervention and at the end (12 months)
At the entry point of intervention and at the end (12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalisations.
Time Frame: 12 months
12 months
Number of hospitalisations due to diabetes.
Time Frame: 12 months
12 months
Bed days of care
Time Frame: 12 months
12 months
Bed days of care due to diabetes.
Time Frame: 12 months
12 months
Number of visits with specialists
Time Frame: 12 months
12 months
Number of access to ER
Time Frame: 12 months
12 months
Mental status measured through Hospital Anxiety and Depression Scale (HADS).
Time Frame: At the entry point of intervention and at the end (12 months)
At the entry point of intervention and at the end (12 months)
Number of visits with specialists in diabetic center
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regione Veneto

Collaborators

European Commission
Azienda ULSS 4 Alto Vicentino

Investigators

  • Principal Investigator: Francesco Calcaterra, MD, Local Health Authority "Alto Vicentino" of Thiene (VI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G. A. 250487 - Veneto WP8Cl2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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