Trial Outcomes & Findings for AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring (NCT NCT07145541)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

24 Hours

Results posted on

2025-11-19

Participant Flow

Recruitment occurred at Children's National Hospital from 1/31/2024 until 9/17/2024.

Participant milestones

Participant milestones
Measure	AION TempShield 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.
Overall Study STARTED	72
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AION TempShield Device n=58 Participants 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.
Sex: Female, Male Female	25 Participants n=58 Participants
Sex: Female, Male Male	33 Participants n=58 Participants
Age, Customized Age = 2 years	6 Participants n=58 Participants
Age, Customized Age = 3 years	16 Participants n=58 Participants
Age, Customized Age = 4 years	37 Participants n=58 Participants

PRIMARY outcome

Timeframe: 24 Hours

Population: 33 participants did not complete the study

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

Outcome measures

Outcome measures
Measure	AION TempShield Device n=39 Participants 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.
Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer	0.0 degrees Celsius Interval -0.7 to 0.7

Adverse Events

AION TempShield Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samara Barend

AION Biosystems

Phone: 9079024986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place