Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
- Conditions
- Febrile Neutropenia
- Interventions
- Device: IDION iTempShield
- Registration Number
- NCT05576220
- Lead Sponsor
- IDION Inc.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group IDION iTempShield Subjects being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy
- Primary Outcome Measures
Name Time Method To evaluate the IDION Shield remote subject temperature monitoring service. 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.
- Secondary Outcome Measures
Name Time Method To evaluate the clinical course of subjects with elevated temperatures 6 Months 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.
To assess subject and clinician satisfaction and compliance with the remote subject temperature monitoring service. 30 days 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.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States