Remote Temperature Data for Early Detection of Febrile Neutropenia

Completed

Conditions studied: Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT05180838

Run by

University of Colorado, Denver

People needed

20

Starts

2021-10-07

Expected to finish

2024-03-31

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Colorado Research Center — Aurora, Colorado, United States
• UCHealth-Metro Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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