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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

March 30, 2012
January 20, 2014
March 2012
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01569893 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Life-Long Monitoring of Diabetes Mellitus in Veneto Region
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes 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.

  • 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
    Intervention: Other: Self-monitoring for patients with Dibetes mellitus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
598
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01569893
G. A. 250487 - Veneto WP8Cl2
Yes
Regione Veneto
Regione Veneto
  • European Commission
  • Azienda ULSS 4 Alto Vicentino
Principal Investigator: Francesco Calcaterra, MD Local Health Authority "Alto Vicentino" of Thiene (VI)
Regione Veneto
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP