NCT05576220

Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: IDION Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DEVICE	IDION iTempShield	Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy

Timeline

• Start date: 2023-04-30
• Primary completion: 2023-04-30
• Completion: 2023-07-30
• First posted: 2022-10-12
• Last updated: 2023-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study