N/A N=72 Supportive Care

AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring

Fever · Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT07145541 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer — 0.0 degrees Celsius

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aion Tempshield Device (Device)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: AION Biosystems
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer	0.0	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07145541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.