TIMMY3 Thermometer for Fever

No longer recruiting at 4 trial locations

Overseen By Ashley Wagoner, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baxter Healthcare Corporation

Must not be taking: Antipyretics, Barbiturates, Antipsychotics

Disqualifiers: Anatomical abnormalities, Neutropenic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the accuracy of a new thermometer called the TIMMY3. It measures temperatures in three ways: under the arm, in the mouth, or rectally. The goal is to ensure the device provides accurate readings for individuals with and without fevers. Participants should be comfortable with these methods and must not have eaten, smoked, or exercised in the last 20 minutes. Newborns to adults who meet these criteria can consider joining the trial. As an unphased trial, this study allows participants to contribute to developing a potentially more accurate thermometer for everyday use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not take antipyretics (like aspirin, acetaminophen, or ibuprofen) within 120 minutes before the study.

What prior data suggests that the TIMMY3 thermometer is safe for temperature measurement?

Research has shown that the Timmy3 Module, which measures body temperature under the arm, in the mouth, and rectally, is designed to be safe. No specific studies report problems or side effects from its use, suggesting it is likely well-tolerated.

The testing phase for this device is marked as "Not Applicable," a term often used for devices or non-drug tools. This designation usually indicates the device is considered low risk, especially since thermometers are generally known to be safe.

In summary, while specific data on side effects is lacking, the type of device and existing research suggest that the Timmy3 Module is unlikely to cause safety issues for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TIMMY3 Thermometer for Fever trial because it explores different methods of accurately measuring body temperature, which is crucial for diagnosing and managing fevers. Unlike traditional thermometers, which may focus on a single method like oral or rectal temperature measurement, the TIMMY3 Module is testing axillary, oral, and rectal methods across various age groups, including newborns to adults. This comprehensive approach aims to determine the most reliable and effective method for different age groups and conditions, potentially improving fever detection and management across diverse patient populations.

What evidence suggests that the TIMMY3 thermometer is effective for measuring fever?

This trial will compare different methods of temperature measurement using the TIMMY3 Thermometer. Research has shown that taking a temperature rectally, one of the methods tested in this trial, provides the most accurate core body temperature measurement. Studies have found that rectal thermometers yield more precise results than other methods. Another method under study is oral temperature readings, which factors like eating, drinking, or smoking can affect, potentially reducing accuracy. The trial will also assess axillary temperature measurement, which is usually less reliable and can differ by a few degrees from oral and rectal readings. Overall, rectal measurements are considered the best for accuracy, especially when exact temperature readings are crucial. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric Fernandez, M.D.

Principal Investigator

Baxter Healthcare Corporation

Are You a Good Fit for This Trial?

This trial is for individuals from newborns to adults, specifically those aged 7-17 must agree to participate. Participants or their guardians must understand English, consent to the study's procedures, and be calm and cooperative. They should also have been in a stable room temperature for at least 20 minutes before having their temperature taken.

Inclusion Criteria

I am a full-term newborn, child, or adult.

The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site

Subject must be willing and able to comply with the study procedures

Exclusion Criteria

The study subject has any known contraindication to oral, axillary, or rectal temperature measurements

The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature

The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Testing of the TIMMY3 thermometry module for clinical accuracy using SureTemp Plus algorithms

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Timmy3 Module

Trial Overview The trial is testing the accuracy of the TIMMY3 thermometry module when used with the Connex CSVM device. It aims to ensure that this method of measuring body temperature meets international standards (ISO 80601-2-56:2017 + A1 2018).

How Is the Trial Designed?

Group I: Rectal Temperature Measurement Experimental Treatment 1 Intervention

Rectal temperature measurements for all age groups (newborn to subjects older than 18 years of age) with no restrictions. Both febrile and non-febrile subjects included in this arm.

Group II: Oral Temperature Measurement Experimental Treatment 1 Intervention

Oral temperature measurements for subjects age Group C as 5 years or older. Both febrile and non-febrile subjects included in this arm.

Group III: Axillary Temperature Measurement Experimental Treatment 1 Intervention

Adult Axillary temperature measurement supports age Group C where C contains 18 years and older subjects. Pediatric Axillary temperature measurement supports newborn to 5 years and less than 18 years old. Both febrile and non-febrile subjects included in this arm.

Who Is Running the Clinical Trial?

Baxter Healthcare Corporation

Lead Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Published Research Related to This Trial

Continuous temperature monitoring using the TempTraq patch in a pilot study of 10 pediatric patients showed improved fever detection compared to standard episodic monitoring, identifying fevers that were missed or delayed by over 12 hours.

Caregivers found the TempTraq patch to be tolerable and easy to apply, suggesting it could be a practical tool for monitoring fever in immunocompromised patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study. Sampson, M., Hickey, V., Huber, J., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-febrile-illness-2024-8a1a2

TIMMY3 Thermometer for Fever · Info for Participants The TIMMY3 Thermometer for Fever is unique because it likely involves a novel method of temperature measurement, potentially improving accuracy or ease of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12725545/

How reliable is axillary temperature measurement? Ninety-five percent of axillary measurements fell within a 2.5-3 degrees C range around respective paired oral/rectal measurements. The mean difference ...

3. semanticscholar.org semanticscholar.org/paper/Accuracy-of-digital-tympanic%2C-oral%2C-axillary%2C-and-Jensen-Jensen/3b4e19980c4725c664ceeda65701023ab431fcbc

[PDF] Accuracy of digital tympanic, oral, axillary, and rectal ... Infrared tympanic thermometer can accurately measure the body temperature in children in an emergency room setting. · Measurement Accuracy of Fever by Tympanic ...

4. seattlechildrens.org seattlechildrens.org/research/centers-programs/nursing-research/featured-research/better-way-take-childrens-temperatures/

A Better Way to Take Children's Temperatures A study that showed temporal thermometers are more precise and less disruptive than taking a child's temperature orally or under the arm.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2564126/

An evaluation of tympanic thermometry in a paediatric ... Tympanic measurements had a sensitivity of 76% whereas axillary measurements had a sensitivity of only 24% with rectal temperatures of 38–38.9 °C. Conclusion.

6. semtrainers.com semtrainers.com/wp-content/uploads/2020/11/2020NHC_Catalog_31Jul2020_LowRes-1.pdf

CATALOG • Phantom measurement in case: 81/4 in. x 53/16 in. x 13/4 in ... • Realistic anatomy includes mouth, tongue, oral pharynx, larynx, epiglottis, vocal.

7. ahschools.us ahschools.us/cms/lib/MN01909485/Centricity/Domain/496/School%20Health%2010_2019.pdf

Sourcewell Contract # 061417 Bid Reference Number: ... ... MEASUREMENT OF JT MOTION GUIDE TO GONIOMETRY BOOK. EACH. 39. 11046 ... MODULE'S OF BASIC NURSING SKILLS VOL 2. EACH. 89. 11184. $107.88 ...

8. yumpu.com yumpu.com/en/document/view/26489487/healthcare-catalogue-spectrum-nasco-shopping-mall-divisions

Healthcare Catalogue - SPECTRUM Nasco Shopping Mall ... VII is CPU controlled and presents data specific to the module in use. Includes two<br />. built-in Sounders, plus two extra Sounders, two ...

9. inprom.com.hk inprom.com.hk/ipc/model/Catalog/ESP%20Catalogue.pdf

Contents A life size flexible model comprising upper humerus, scapula and clavicle fitted with ligaments and painted to show origins and insertions of the muscles.

10. alfacare.no alfacare.no/userfiles/file/Erler-Zimmer%202018-2019.pdf

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