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Life-Long Monitoring of Diabetes Mellitus in Veneto Region

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Self-monitoring for patients with Dibetes mellitus
Sponsored by
Regione Veneto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Telemonitoring, Telemedicine, Diabetes mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "De Lellis" Hospital - Diabetology-Endocrinology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Self-monitoring for patients with Dibetes mellitus type 2

Arm Description

Usual care: treatment as usual

Self-monitoring for patients with Dibetes mellitus type 2

Outcomes

Primary Outcome Measures

Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Glycated hemoglobin (HbA1c) levels

Secondary Outcome Measures

Number of hospitalisations.
Number of hospitalisations due to diabetes.
Bed days of care
Bed days of care due to diabetes.
Number of visits with specialists
Number of access to ER
Mental status measured through Hospital Anxiety and Depression Scale (HADS).
Number of visits with specialists in diabetic center

Full Information

First Posted
March 30, 2012
Last Updated
October 27, 2015
Sponsor
Regione Veneto
Collaborators
European Commission, Azienda ULSS 4 Alto Vicentino
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1. Study Identification

Unique Protocol Identification Number
NCT01569893
Brief Title
Life-Long Monitoring of Diabetes Mellitus in Veneto Region
Official Title
RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regione Veneto
Collaborators
European Commission, Azienda ULSS 4 Alto Vicentino

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Telemonitoring, Telemedicine, Diabetes mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care: treatment as usual
Arm Title
Self-monitoring for patients with Dibetes mellitus type 2
Arm Type
Experimental
Arm Description
Self-monitoring for patients with Dibetes mellitus type 2
Intervention Type
Other
Intervention Name(s)
Self-monitoring for patients with Dibetes mellitus
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
Glycated hemoglobin (HbA1c) levels
Time Frame
At the entry point of intervention and at the end (12 months)
Secondary Outcome Measure Information:
Title
Number of hospitalisations.
Time Frame
12 months
Title
Number of hospitalisations due to diabetes.
Time Frame
12 months
Title
Bed days of care
Time Frame
12 months
Title
Bed days of care due to diabetes.
Time Frame
12 months
Title
Number of visits with specialists
Time Frame
12 months
Title
Number of access to ER
Time Frame
12 months
Title
Mental status measured through Hospital Anxiety and Depression Scale (HADS).
Time Frame
At the entry point of intervention and at the end (12 months)
Title
Number of visits with specialists in diabetic center
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Calcaterra, MD
Organizational Affiliation
Local Health Authority "Alto Vicentino" of Thiene (VI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
"De Lellis" Hospital - Diabetology-Endocrinology Department
City
Schio
State/Province
Vicenza
ZIP/Postal Code
36015
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.renewinghealth.eu
Description
Related Info

Learn more about this trial

Life-Long Monitoring of Diabetes Mellitus in Veneto Region

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