Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
1 other identifier
interventional
210
1 country
1
Brief Summary
IDION is currently seeking FDA approval for this device- the IDION iTempShield. It is a skin-safe, FDA complaint and non-invasive device that can read and monitor skin temperature. Having continuous temperature monitoring using the IDION iTempShield may provide early detection of a fever for patients with febrile neutropenia. Febrile neutropenic fever is common in patients receiving chemotherapy and can often indicate infection. The main potential benefit potenially experienced from participating in this study would be the early detection of fever. There is a potential benefit that infection will be detected earlier in subjects wearing the IDION iTempShield.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedMarch 14, 2023
March 1, 2023
Same day
October 2, 2022
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
To evaluate the IDION Shield remote subject temperature monitoring service.
The ability of the Idion System to transmit alerts if there is a temperature excursion sustained for at least 15 minutes above the alert protocol. There is a full data set time correlated with temp data in, battery voltage status and alerts that have been sent by Idion. The data will be mined and compared with the number of alerts and the timing of those alerts in the database.There will be times when the mobile device is offline due to mobile device battery exhaustion or distance traveled away from the device (left mobile at home) and these alerts will be missed.
6 Months
To evaluate the IDION Shield remote subject temperature monitoring service.
The accuracy of the Idion iTempShield as validated by subject taking their temperature manually with the thermometer, to be captured in the subject app. This data is transmitted to the clinician application, and this will demonstrate subject use and shield interoperability.
6 Months
To evaluate the IDION Shield remote subject temperature monitoring service.
The ability of the Idion iTempShield to be paired with the subject's phone. This data will be subjective data.This endpoint will be calculated as the number of successful pairings (i.e., where pairing was confirmed by Idion System) divided by the total number of pairing attempts. The point estimate of the successful pairings along with a 90% confidence interval will be presented.
6 Months
To evaluate the IDION Shield remote subject temperature monitoring service.
Test alert protocol with clinicians pre-pilot to simulate an alert event. Testing will entail inputting a manual temperature of over 100.4 into the patient app. If the clinician receives a phone call, text, or email alerting them that there has been a temperature event, this test will be deemed successful. If this is not functioning properly the software will be adjusted and a new test will be performed. If this cannot be done, then the Pilot will be paused until corrected.
6 Months
To evaluate the IDION Shield remote subject temperature monitoring service.
The incidence of Idion iTempShield-alerted temperature events in the overnight hours (9pm-6am and 12am-6am). Analyze temperature trends and clinical course at 3 hours pre and post alert and 6 hours pre and post alert. This is not the normal course of treatment for these subjects. This data set is an attempt to uncover temperature trends that may change the course of treatment for cancer patients.
6 Months
Secondary Outcomes (4)
To evaluate the clinical course of subjects with elevated temperatures
6 Months
To evaluate the clinical course of subjects with elevated temperatures
6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
30 days
Other Outcomes (1)
To analyze reimbursement for remote subject management.
6 Months
Study Arms (2)
Intervention group
EXPERIMENTALSubjects being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
Control Group
NO INTERVENTIONRetrospective data from the control group comprised of 105 patients directly preceding the intervention group who are underwent stem cell transplant or CAR-T therapy. Such control group information will be obtained via a research data request. Only de-identified data will be obtained for these subjects.
Interventions
Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
Eligibility Criteria
You may qualify if:
- Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
- Subject is ≥ 18 years or older.
- Subject is being treated or coming to the infusion center for clinical follow up every 2 weeks.
- Subject has an iOS or Android phone.
- Subject is willing to install the Idion app on his/her phone.
- Subject self identifies as proficient in smart phone use.
- Subject is willing to allow Idion to send text reminders to take temperature or complete surveys.
- Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
- Subject or subject caretaker is able and willing to complete subject surveys.
- Subject is willing and able to provide written informed consent in English or Spanish.
- Subject is willing and able to comply with all study procedures, requirements, assessments, visits, and complete questionnaires.
You may not qualify if:
- Non-English or Spanish speakers
- Unable to provide informed consent
- Subjects with known adhesive allergy for silicon adhesives
- Subjects with history of Medical Adhesive-Related Skin Injury (MARSI)
- Subjects with no available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDION Inc.lead
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2022
First Posted
October 12, 2022
Study Start
April 30, 2023
Primary Completion
April 30, 2023
Study Completion
July 30, 2023
Last Updated
March 14, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share