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Life-Long Monitoring of Diabetes Mellitus in Veneto Region

R

Regione Veneto

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Self-monitoring for patients with Dibetes mellitus

Study type

Interventional

Funder types

Other

Identifiers

NCT01569893
G. A. 250487 - Veneto WP8Cl2

Details and patient eligibility

About

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.

Full 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.

Enrollment

598 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

598 participants in 2 patient groups

Control group
No Intervention group
Description:
Usual care: treatment as usual
Self-monitoring for patients with Dibetes mellitus type 2
Experimental group
Description:
Self-monitoring for patients with Dibetes mellitus type 2
Treatment:
Other: Self-monitoring for patients with Dibetes mellitus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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