Clinical trial NCT05576220: Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Febrile Neutropenia
Lead sponsor: IDION Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the IDION Shield remote subject temperature monitoring service.
timeFrame: 6 Months
measure: To evaluate the IDION Shield remote subject temperature monitoring service.
timeFrame: 6 Months
measure: To evaluate the IDION Shield remote subject temperature monitoring service.
timeFrame: 6 Months
measure: To evaluate the IDION Shield remote subject temperature monitoring service.
timeFrame: 6 Months
measure: To evaluate the IDION Shield remote subject temperature monitoring service.
timeFrame: 6 Months
Secondary outcomes:
measure: To evaluate the clinical course of subjects with elevated temperatures
timeFrame: 6 Months
measure: To evaluate the clinical course of subjects with elevated temperatures
timeFrame: 6 Months
measure: To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
timeFrame: 6 Months
measure: To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service.
timeFrame: 30 days
Other outcomes:
measure: To analyze reimbursement for remote subject management.
timeFrame: 6 Months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: