Life-Long Monitoring of Diabetes Mellitus in Veneto Region
RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus
1 other identifier
interventional
598
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2012
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 28, 2015
January 1, 2014
2.2 years
March 30, 2012
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Glycated hemoglobin (HbA1c) levels
At the entry point of intervention and at the end (12 months)
Secondary Outcomes (8)
Number of hospitalisations.
12 months
Number of hospitalisations due to diabetes.
12 months
Bed days of care
12 months
Bed days of care due to diabetes.
12 months
Number of visits with specialists
12 months
- +3 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONUsual care: treatment as usual
Self-monitoring for patients with Dibetes mellitus type 2
EXPERIMENTALSelf-monitoring for patients with Dibetes mellitus type 2
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regione Venetolead
- European Commissioncollaborator
- Azienda ULSS 4 Alto Vicentinocollaborator
Study Sites (1)
"De Lellis" Hospital - Diabetology-Endocrinology Department
Schio, Vicenza, 36015, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Calcaterra, MD
Local Health Authority "Alto Vicentino" of Thiene (VI)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
October 28, 2015
Record last verified: 2014-01