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Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory

NCT03764709 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-12-05

No results posted yet for this study

Summary

Study Information Indication\* This is a prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).

Phase\*: 4, observational prospective

Number of subjects\*:

GROUP A and GROUP B: N=300 patients (150 per arm)

Conditions

  • Patient Monitoring

Interventions

DEVICE

Vital signs wireless monitoring system

WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).

Sponsors & Collaborators

  • ASL Roma 6

    collaborator OTHER

  • Azienda Socio Sanitaria Territoriale del Garda

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-27
Primary Completion
2021-01-27
Completion
2021-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764709 on ClinicalTrials.gov