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

NCT ID: NCT05576220

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-07-30

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.

Conditions

Febrile Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention group

Subjects being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy

Group Type: EXPERIMENTAL

IDION iTempShield

Intervention Type: DEVICE

Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IDION iTempShield

Subject is being treated for a cancer diagnosis with a plan for outpatient transplant or CAR-T therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IDION Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Central Contacts

Sam Barend

Role: CONTACT

Sam@idion.us

917-902-4986

Facility Contacts

Shannon Williams

Role: primary

wilshann@musc.edu

843-792-2201

Other Identifiers

IDN001

Identifier Type: -

Identifier Source: org_study_id