Life-Long Monitoring of Diabetes Mellitus in Veneto Region

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
European Commission
Azienda ULSS 4 Alto Vicentino
Information provided by (Responsible Party):
Regione Veneto
ClinicalTrials.gov Identifier:
NCT01569893
First received: March 30, 2012
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Self-monitoring for patients with Dibetes mellitus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Regione Veneto:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Glycated hemoglobin (HbA1c) levels [ Time Frame: At the entry point of intervention and at the end (12 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hospitalisations. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of hospitalisations due to diabetes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bed days of care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bed days of care due to diabetes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits with specialists [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of access to ER [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mental status measured through Hospital Anxiety and Depression Scale (HADS). [ Time Frame: At the entry point of intervention and at the end (12 months) ] [ Designated as safety issue: No ]
  • Number of visits with specialists in diabetic center [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 598
Study Start Date: March 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Usual care: treatment as usual
Experimental: Self-monitoring for patients with Dibetes mellitus type 2
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569893

Locations
Italy
"De Lellis" Hospital - Diabetology-Endocrinology Department
Schio, Vicenza, Italy, 36015
Sponsors and Collaborators
Regione Veneto
European Commission
Azienda ULSS 4 Alto Vicentino
Investigators
Principal Investigator: Francesco Calcaterra, MD Local Health Authority "Alto Vicentino" of Thiene (VI)
  More Information

Additional Information:
No publications provided

Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01569893     History of Changes
Other Study ID Numbers: G. A. 250487 - Veneto WP8Cl2
Study First Received: March 30, 2012
Last Updated: January 20, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Regione Veneto:
Telemonitoring
Telemedicine
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014