Febrile Neutropenia
Conditions
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.
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.
Interventions
DEVICEIDION iTempShield
Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
Sponsors
IDION Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy 2. Subject is ≥ 18 years or older. 3. Subject is being treated or coming to the infusion center for clinical follow up every 2 weeks. 4. Subject has an iOS or Android phone. 5. Subject is willing to install the Idion app on his/her phone. 6. Subject self identifies as proficient in smart phone use. 7. Subject is willing to allow Idion to send text reminders to take temperature or complete surveys. 8. Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a no notification mode. 9. Subject or subject caretaker is able and willing to complete subject surveys. 10. Subject is willing and able to provide written informed consent in English or Spanish. 11. Subject is willing and able to comply with all study procedures, requirements, assessments, visits, and complete questionnaires.
Exclusion criteria
1. Non-English or Spanish speakers 2. Unable to provide informed consent 3. Subjects with known adhesive allergy for silicon adhesives 4. Subjects with history of Medical Adhesive-Related Skin Injury (MARSI) 5. Subjects with no available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the IDION Shield remote subject temperature monitoring service. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the clinical course of subjects with elevated temperatures | 6 Months | 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. |
| To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service. | 6 Months | Subject and clinician satisfaction (based on surveys). |
Other
| Measure | Time frame | Description |
|---|---|---|
| To analyze reimbursement for remote subject management. | 6 Months | Amount of Medicare reimbursement potential. The clinician app will automatically enroll the patient into a CMS approved reimbursement, and we also track their insurance (private and Medicare) in the application. This information is to determine what potential reimbursements could be. |
Countries
United States
Contacts
Primary ContactSam Barend
Outcome results
None listed