AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring

NCT07145541 | Completed Results FDA Device

• 1 other identifier: STUDY00000455
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the effectiveness of the AION BIOSYTEMS, INC. tempshield ("Shield") temperature monitoring device and platform in detecting body temperature for children 2-4 years old. The ED Research team will be deploying this device on all qualified patients who are awaiting inpatient admission from the emergency department and who have consented to participating in the study. Patients will be asked to keep the device on for a maximum of 7 hours during their stay in the emergency department. There is a potential clinical benefit that fevers will be detected earlier in subjects wearing the AION BIOSTYEMS, INC. tempshield. It is hoped that information gained from the study will help assist clinical care workflow and the treatment of future patients.

Conditions

Fever; Sepsis

Outcome Measures

Primary Outcomes (1)

• Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer

  Temperature from the study participants will be collected via the AION TempShield and the Welch Allyn 901053 electronic thermometer. The difference output measure was then calculated by subtracting the TempShield-reported temperature from the Welch Allyn temperature. I.e., outcome measure = Welch Allyn temperature - TempShield temperature

  24 Hours

Study Arms (1)

Aion Tempshield Device

EXPERIMENTAL

Device: Aion Tempshield Device

Interventions

Aion Tempshield Device DEVICE

The AION BIOSYSTEMS, INC. tempshield is a skin-applied, continuous temperature monitor. It is battery powered, communicates using Bluetooth LE to a smartphone, then to a clinician dashboard, and is designed to be worn continuously for up to 60 days. Its primary use is for patient monitoring in hospital or post-discharge from a healthcare facility. Through the tempshield system, clinicians can be notified if a patient's temperature exceeds a given threshold. The tempshield system is centered around a non-invasive temperature sensor placed against the patient's skin, in the pectoral region just below the collar bone. The temperature sensor is held in place with a silicone adhesive tape similar to a custom shaped piece of medical tape. The silicone adhesive tape is hypoallergenic.

Aion Tempshield Device

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female patients between ages 1 years - 4 years of age
• Confirmed oral temperature of \>=99.5 F for febrile participants
• Willing and likely (based on the investigator's judgement) to comply with all study requirements

You may not qualify if:

• Participants who are allergic to silicone
• Adolescents with sensory issues who may find it difficult to have a wearable device on their chest.
• Participants presenting an anatomical limitation that would prevent the use of the wearable device

Sponsors & Collaborators

• AION Biosystems: lead

Study Sites (1)

Children's Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Fever; Sepsis

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Results Point of Contact

• Title: Samara Barend
• Organization: AION Biosystems

sam@aionbiosystems.com

9079024986

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 28, 2025
• Study Start: January 31, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Locations

US (1)