Remote Temperature Data for Early Detection of Febrile Neutropenia

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05180838
• Other study ID #: 20-2517.cc
• Status: Active, not recruiting
• Start date: October 7, 2021
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Febrile Neutropenia
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
United States	Colorado Research Center	Aurora	Colorado
United States	UCHealth-Metro Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	BioIntelliSense, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of BioSticker compared to self-check	Patients will self-temperature check every 6 hours or at least two times per day, and will log these temperatures in a paper record with date, time and temperature noted.	28 days
Secondary	BioSticker Impact on Patient reported temperature	Patients will report a single oral temperature of =38.3°C (101°F) or a temperature of =38.0°C (100.4°F) sustained over a one-hour period to our clinic nurses or 24/7 on-call advanced practitioner and will be directed to the Emergency Department or clinic for initiation of antibiotics and FN work-up and management as per usual practice.	28 days
Secondary	BioSticker Impact on Length of Hospitalization	Hospitalization during the 28 days will be extracted from the medical record	28 days
Secondary	BioSticker Impact on ICU transfers	ICU transfers during the 28 days will be extracted from the medical record	28 days
Secondary	BioSticker Impact on Delays in Chemotherapy	Delays in chemotherapy during the 28 days will be extracted from the medical record	28 days