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Completed

NCT Number: NCT01569893

Life-Long Monitoring of Diabetes Mellitus in Veneto Region

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"De Lellis" Hospital - Diabetology-Endocrinology Department

Schio, Vicenza, 36015, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring for patients with Dibetes mellitus

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.

Primary outcomes

  1. 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)

  2. Glycated hemoglobin (HbA1c) levels

    Time frame: At the entry point of intervention and at the end (12 months)

Secondary outcomes

  1. Number of hospitalisations.

    Time frame: 12 months

  2. Number of hospitalisations due to diabetes.

    Time frame: 12 months

  3. Bed days of care

    Time frame: 12 months

  4. Bed days of care due to diabetes.

    Time frame: 12 months

  5. Number of visits with specialists

    Time frame: 12 months

  6. Number of access to ER

    Time frame: 12 months

  7. Mental status measured through Hospital Anxiety and Depression Scale (HADS).

    Time frame: At the entry point of intervention and at the end (12 months)

  8. Number of visits with specialists in diabetic center

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Regione Veneto

Other

Collaborators

  • Azienda ULSS 4 Alto Vicentino
  • European Commission

Registry information

Official study title

RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 3, 2012
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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