Remote Temperature Data for Early Detection of Febrile Neutropenia

NCT ID: NCT05180838

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2024-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BioSticker

This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.

BioSticker

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages 18-80 years (inclusive)
• Provision to sign and date the consent form.
• Diagnosed with a hematologic malignancy and undergoing cytotoxic chemotherapy, stem cell transplants or CAR T-cell treatments at the Blood Disorders and Cell Therapies Center at UCHealth (BDCTC)
• Will have longitudinal care provided by the BDCTC for >1 additional month
• Receive chemotherapy or other therapies known to cause reductions in WBC <1000 on a routine basis
• Scheduled to be discharged home and self-monitor for FN and other complications
• Patient is willing to tell TSA or any security representative that you are wearing a "medical device"
• Patient has agreed to not submerge the device underwater including while swimming or bathing
• Patient is willing to complete a self-check temperature log comply and be available for the duration of the study
• Patient has access to a thermometer

Exclusion Criteria

• Patient that wears a defibrillator, pacemaker, or other implantable device
• Patient has broken skin including wounds, sores, or abrasions in the area that the BioSticker would be applied
• Patient has had a severe reaction to silicone adhesives
• Patient has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioIntelliSense, Inc

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen Peterson

Role: PRINCIPAL_INVESTIGATOR

Colorado Research Center

Locations

Colorado Research Center

Aurora, Colorado, United States

UCHealth-Metro Denver

Denver, Colorado, United States

Countries

United States

Other Identifiers

20-2517.cc

Identifier Type: -

Identifier Source: org_study_id