Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

NCT06056011 | Completed Results FDA Device

• 1 other identifier: 60128116
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.

Conditions

Febrile Illness

Outcome Measures

Primary Outcomes (15)

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias

  Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula \[2\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement

  Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas \[3\] and \[4\]).

  20-30 minutes

• Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability

  Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas \[5\] and \[6\]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability.

  20-30 minutes

Study Arms (4)

Oral Temperature Measurement

EXPERIMENTAL

Febrile and non-febrile subjects aged 5 years or older.

Device: Connex CVSM with Timmy3 module

Pediatric Axillary Temperature Measurement

EXPERIMENTAL

Febrile and non-febrile pediatric subjects \<1 year to \<18 years.

Device: Connex CVSM with Timmy3 module

Adult Axillary Temperature Measurement

EXPERIMENTAL

Febrile and non-febrile adult subjects \>= 18 years old.

Device: Connex CVSM with Timmy3 module

Rectal Temperature Measurement

EXPERIMENTAL

Febrile and non-febrile adult and pediatric subjects newborn and older.

Device: Connex CVSM with Timmy3 module

Interventions

Connex CVSM with Timmy3 module DEVICE

Connex Vital Signs Monitor with the Timmy3 Investigational module

Adult Axillary Temperature Measurement; Oral Temperature Measurement; Pediatric Axillary Temperature Measurement; Rectal Temperature Measurement

Eligibility Criteria

• Age: 1 Day - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
• Subjects that are minors must provide assent to the clinical site's policy (if approved by Baxter) and/or the study sponsor's policy to participate in the study.
• Subject or the legally authorized representative (LAR) must sign the informed consent form in order for the subject to participate.
• Subject must be willing and able to comply with the study procedures.
• Age: normal weight (full-term) newborn to adult
• The study subject is in ambient temperature for at least 20 minutes prior to participating.
• The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site.
• The study subject is not physically or emotionally agitated/uncooperative.
• The study subject or legal guardian speaks/understands fluent English.

You may not qualify if:

• Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
• The study subject has anatomical abnormalities that would affect temperature.
• The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
• The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
• 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.).
• Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
• Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
• Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.
• Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (5)

First Georgia Physicians Group

Fayetteville, Georgia, 30214, United States

Location

Mankato Clinic

Mankato, Minnesota, 56001, United States

Location

John R. Oishei Children's Hospital

Buffalo, New York, 14203, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Forest Lane Pediatrics

Dallas, Texas, 75230, United States

Location

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Eric Fernandez, M.D.

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: February 19, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)