NCT05180838

Remote Temperature Data for Early Detection of Febrile Neutropenia

Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

Detailed description

The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following: * Respiratory rate, heart rate at rest and skin temperature * Body position, activity levels, sleep status * High-resolution gait analysis and fall detection * Symptomatic events BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DEVICE	BioSticker	The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring

Timeline

• Start date: 2021-10-07
• Primary completion: 2022-09-01
• Completion: 2024-03-31
• First posted: 2022-01-06
• Last updated: 2024-11-21

Locations

2 sites across 1 country: United States