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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Device: BioSticker

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Colorado Research Center
    • Denver, Colorado, United States, 80217-3364
      • UCHealth-Metro Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

20 patients with leukemia, lymphoma, myeloma and other blood cancers undergoing treatment with cytotoxic chemotherapy, stem cell transplant or CAR T-cells following IRB consent. Patients will be included who are >18 years old, 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, are capable of informed consent and agree to collect a self-check temperature log.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BioSticker; This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
BioSticker Impact on Length of Hospitalization	Hospitalization during the 28 days will be extracted from the medical record	28 days
BioSticker Impact on ICU transfers	ICU transfers during the 28 days will be extracted from the medical record	28 days
BioSticker Impact on Delays in Chemotherapy	Delays in chemotherapy during the 28 days will be extracted from the medical record	28 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: BioIntelliSense, Inc
• Investigators: Principal Investigator: Glen Peterson, Colorado Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Stem cell transplant; Cytotoxic Chemotherapy; CAR T-cell treatments
• Additional Relevant MeSH Terms: Cytopenia; Neoplasms by Site; Leukocyte Disorders; Hematologic Diseases; Leukopenia; Agranulocytosis; Neoplasms; Hematologic Neoplasms; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: 20-2517.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No