Febrile NeutropeniaNCT05576220
Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
A study testing IDION iTempShield in people with Febrile Neutropenia, run by IDION Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- IDION iTempShield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
Shannon Williams, 843-792-2201, wilshann@musc.edu
Michelle Hudspeth, MD
About this study
Official title: Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy at Risk for Developing Infections and/or Cytokine Release Syndrome
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.
Read the detailed description
The purpose of the study is to evaluate the remote patient temperature monitoring service of the Idion Shield system in patients undergoing outpatient stem cell transplantation or CAR-T therapy who are at risk for developing infections and/or cytokine release syndrome. Febrile neutropenia remains a significant complication of treatment and often it is the first and sometimes the only sign or symptom of infection in this vulnerable patient population.
CAR-T patients are at risk for not only febrile neutropenia but also cytokine release syndrome (CRS), a systemic inflammatory response that can lead to hypoxia and shock. Fever is typically the first sign and hallmark of this potentially life-threatening condition. Routine measurement of body temperature is an important aspect of monitoring for signs of infection in patients receiving chemotherapy and for CRS in CAR-T patients.The current of standard of care for patients is to take their oral temperature when they feel ill and directing them to call their physician when their oral temperature reading is above 100.4. Having continuous temperature monitoring using the IDION iTempShield may provide early detection and intervention while reducing hospitalization rates, improving outcomes, and preventing death. With an increase in technological advancements and telemedicine, remote monitoring has shown to reduce health costs while providing closer follow-up for patients. The study will also analyze the potential reimbursement through Medicare to show the cost-benefit for remote monitoring utilizing the IDION iTempShield.
- Conditions
- Febrile Neutropenia
- Being tested
- IDION iTempShield
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDION iTempShieldDevice
Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy Receives: Device: IDION iTempShield |
| Control Group | No intervention | Retrospective 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Secondary outcomes (4)
To evaluate the clinical course of subjects with elevated temperatures
Review the treatment course of all subjects participating in the study to determine if any subjects received treatment as a response to the temperature alert and what percentage of these subjects went to the hospital. Review the treatment course for those who were admitted from admission to discharge of subjects who were admitted due to a temperature excursion. This data will need to be pulled from two asynchronous source the EMR and the Clinician Application. The information that is being compared is outpatient or admission to hospital.
Measured: 6 Months
To evaluate the clinical course of subjects with elevated temperatures
Compare the level of care for chemotherapy patients admitted to the hospital wearing the iTempShield versus those not wearing the iTempShield. Level of care will focus specifically on whether or not patients were admitted to the ICU upon admission to the hospital and if they were being treated for sepsis. The "control group" will comprise of up to 105 patients who are undergoing stem cell transplant or CAR-T therapy. Subjects in the control group will be identified via retrospective chart review and data collected on these subjects will be done in a de-identified manor. The "control group" will comprise of 105 patients directly preceding the intervention group who are undergoing stem cell transplant or CAR- T therapy. The control group of subjects will be compared to those in the intervention group. The level of care will focus specifically on whether subjects were admitted to the ICU upon admission to the hospital and if they were being treated for sepsis.
Measured: 6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
Subject and clinician satisfaction (based on surveys).
Measured: 6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
Subject and clinician adherence to the protocol; reason for non-adherence, number of subjects who comply and wear the Shield for the entire 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start30 Apr 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDION Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576220
- Sponsor's protocol ID
- IDN001
- Status last verified
- Mar 2023
- First submitted
- 2 Oct 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy at Risk for Developing Infections and/or Cytokine Release Syndrome
- ClinicalTrials.gov ID
- NCT05576220
- Acronym / sponsor ID
- IDN001
- Conditions
- Febrile Neutropenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- IDION Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to evaluate the remote patient temperature monitoring service of the Idion Shield system in patients undergoing outpatient stem cell transplantation or CAR-T therapy who are at risk for developing infections and/or cytokine release syndrome. Febrile neutropenia remains a significant complication of treatment and often it is the first and sometimes the only sign or symptom of infection in this vulnerable patient population.
CAR-T patients are at risk for not only febrile neutropenia but also cytokine release syndrome (CRS), a systemic inflammatory response that can lead to hypoxia and shock. Fever is typically the first sign and hallmark of this potentially life-threatening condition. Routine measurement of body temperature is an important aspect of monitoring for signs of infection in patients receiving chemotherapy and for CRS in CAR-T patients.The current of standard of care for patients is to take their oral temperature when they feel ill and directing them to call their physician when their oral temperature reading is above 100.4. Having continuous temperature monitoring using the IDION iTempShield may provide early detection and intervention while reducing hospitalization rates, improving outcomes, and preventing death. With an increase in technological advancements and telemedicine, remote monitoring has shown to reduce health costs while providing closer follow-up for patients. The study will also analyze the potential reimbursement through Medicare to show the cost-benefit for remote monitoring utilizing the IDION iTempShield.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: IDION iTempShieldSubjects being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy |
| Control Group | No intervention | –Retrospective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDION iTempShieldSubject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy | Device | Intervention group |
Primary outcome
To evaluate the IDION Shield remote subject temperature monitoring service.
Time frame: 6 Months
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.
To evaluate the IDION Shield remote subject temperature monitoring service.
Time frame: 6 Months
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.
To evaluate the IDION Shield remote subject temperature monitoring service.
Time frame: 6 Months
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.
To evaluate the IDION Shield remote subject temperature monitoring service.
Time frame: 6 Months
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.
To evaluate the IDION Shield remote subject temperature monitoring service.
Time frame: 6 Months
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.
4 secondary outcomes
To evaluate the clinical course of subjects with elevated temperatures
Time frame: 6 Months
To evaluate the clinical course of subjects with elevated temperatures
Time frame: 6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
Time frame: 6 Months
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDION iTempShield in people with Febrile Neutropenia, run by IDION Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Barend (917-902-4986, Sam@idion.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the IDION Shield remote subject temperature monitoring service. (time frame: 6 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.