Life-Long Monitoring of Diabetes Mellitus in Veneto Region
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Other: Treatment as usual Other: Self-monitoring for patients with Dibetes mellitus |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus |
- 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) ] [ Designated as safety issue: No ]
- Glycated hemoglobin (HbA1c) levels [ Time Frame: At the entry point of intervention and at the end (12 months) ] [ Designated as safety issue: No ]
- Number of hospitalisations. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of hospitalisations due to diabetes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Bed days of care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Bed days of care due to diabetes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of visits with specialists [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of access to ER [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mental status measured through Hospital Anxiety and Depression Scale (HADS). [ Time Frame: At the entry point of intervention and at the end (12 months) ] [ Designated as safety issue: No ]
- Number of visits with specialists in diabetic center [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 598 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
Usual care: treatment as usual
|
Other: Treatment as usual
Participants in the control group receive usual care. They continue to visit the GP's office and / or hospital. During the visit, a glucometer test shows the trend of blood glucose using a paper diary, and also the prescribed clinical examinations.
|
|
Experimental: Self-monitoring for patients with Dibetes mellitus type 2
Self-monitoring for patients with Dibetes mellitus type 2
|
Other: 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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Francesco Calcaterra, MD | 0445 598226 | francesco.calcaterra@ulss4.veneto.it |
| Contact: Gianluigi Scannapieco, MD | 0422323232 | gscannapieco@ulss.tv.it |
| Italy | |
| "De Lellis" Hospital - Diabetology-Endocrinology Department | Recruiting |
| Schio, Vicenza, Italy, 36015 | |
| Principal Investigator: Francesco Calcaterra, MD | |
| Principal Investigator: | Francesco Calcaterra, MD | Local Health Authority "Alto Vicentino" of Thiene (VI) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Regione Veneto |
| ClinicalTrials.gov Identifier: | NCT01569893 History of Changes |
| Other Study ID Numbers: | G. A. 250487 - Veneto WP8Cl2 |
| Study First Received: | March 30, 2012 |
| Last Updated: | March 30, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Regione Veneto:
|
Telemonitoring Telemedicine Diabetes mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013