Life-Long Monitoring of Diabetes Mellitus in Veneto Region

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Usual care: treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Self-monitoring for patients with Dibetes mellitus type 2

Group Type EXPERIMENTAL

Self-monitoring for patients with Dibetes mellitus

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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