NCT03764709: GreenLightHT

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

Status unknown NA Last updated 5 December 2018

What this trial tests

NA trial testing Vital signs wireless monitoring system in Patient Monitoring in 300 participants. Status unknown.

Timeline

27 January 2019

Primary endpoint
27 January 2021

31 March 2021

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale del Garda
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	300
Start date	27 January 2019
Primary completion	27 January 2021
Estimated completion	31 March 2021
Sites	1 location across Italy

Drugs / interventions tested

• Vital signs wireless monitoring system

Conditions studied

• Patient Monitoring — all drugs for Patient Monitoring →

Sponsor

Azienda Socio Sanitaria Territoriale del Garda

Who can join

Eligibility, any sex, with Patient Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline.
   Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, et al · · 2020 · cited 118× · PMID 32985262 · DOI 10.1177/1932296820954163
2. Implementation of Continuous Glucose Monitoring in the Hospital: Emergent Considerations for Remote Glucose Monitoring During the COVID-19 Pandemic.
   Galindo RJ, Aleppo G, Klonoff DC, Spanakis EK, et al · · 2020 · cited 107× · PMID 32536205 · DOI 10.1177/1932296820932903
3. Green Line Hospital-Territory Study: A Single-Blind Randomized Clinical Trial for Evaluation of Technological Challenges of Continuous Wireless Monitoring in Internal Medicine, Preliminary Results.
   Pietrantonio F, Vinci A, Rosiello F, Alessi E, et al · · 2021 · cited 12× · PMID 34639631 · DOI 10.3390/ijerph181910328