An interventional study of Connex CVSM with Timmy3 module in Febrile Illness, sponsored by Baxter Healthcare Corporation. Completed at 5 sites in United States. Open to participants aged 1 Day to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Baxter Healthcare Corporation · Not applicable, Interventional, and Diagnostic
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.
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.
Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
Exclusion Criteria:
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.
Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Febrile and non-febrile subjects aged 5 years or older.
Device: Connex CVSM with Timmy3 module
Febrile and non-febrile pediatric subjects \<1 year to \<18 years.
Device: Connex CVSM with Timmy3 module
Febrile and non-febrile adult subjects \>= 18 years old.
Device: Connex CVSM with Timmy3 module
Febrile and non-febrile adult and pediatric subjects newborn and older.
Device: Connex CVSM with Timmy3 module
Connex Vital Signs Monitor with the Timmy3 Investigational module
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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[2\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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 \[4\]).
Time frame: 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.
Time frame: 20-30 minutes
| Milestone | All Enrolled Subjects |
|---|---|
| Started | 373 |
| Included in oral iso analysis set | 105 |
| Included in the rectal iso analysis set | 105 |
| Included in the axillary pediatric iso analysis set | 105 |
| Included in the axillary adult iso analysis set | 105 |
| Completed | 369 |
| Not completed | 4 |
| Withdrew: Due to investigator's discretion | 1 |
| Withdrew: Due to other reasons | 3 |
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 \[2\]).
| degree Celsius | Oral Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias | -0.08 ± 0.454 | -0.21 ± 0.474 |
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 \[2\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias | -0.01 ± 0.291 | -0.24 ± 0.399 |
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 \[2\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias | 0.01 ± 0.231 | -0.22 ± 0.237 |
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 \[2\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias | -0.03 ± 0.364 | -0.25 ± 0.503 |
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 \[2\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias | 0.00 ± 0.657 | -0.29 ± 0.380 |
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 \[2\]).
| degree Celsius | Pediatric Axillary Temperature Measurement |
|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias | -0.04 ± 0.377 |
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 \[2\]).
| degree Celsius | Adult Axillary Temperature Measurement |
|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias | -0.02 ± 0.531 |
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 \[4\]).
| degree Celsius | Oral Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement | 0.91 | 0.95 |
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 \[4\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement | 0.58 | 0.80 |
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 \[4\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement | 0.46 | 0.47 |
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 \[4\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement | 0.73 | 1.01 |
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 \[4\]).
| degree Celsius | Pediatric Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement | 1.31 | 0.76 |
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 \[4\]).
| degree Celsius | Pediatric Axillary Temperature Measurement |
|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement | 0.75 |
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 \[4\]).
| degree Celsius | Adult Axillary Temperature Measurement |
|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement | 1.06 |
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.
| degree Celsius | Oral Temperature Measurement | Pediatric Axillary Temperature Measurement | Adult Axillary Temperature Measurement | Rectal Temperature Measurement |
|---|---|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability | 0.25 | 0.28 | 0.29 | 0.35 |
Collected over Baseline to approximately 20 to 30 minutes after consent; no follow-up was required.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ISO Analysis Sets | 0/371 (0%) | 0/371 (0%) | 0/371 (0%) |
Baseline characteristics are reported for subjects in at least one ISO-compliant analysis set (N=281). Although 373 enrolled and 369 completed, ISO 80601-2-56:2017+A1:2018 required limiting analysis to the first 105 subjects per mode (oral, rectal, pediatric axillary, adult axillary) meeting age and febrile criteria. Some subjects participated in multiple modes, so totals across sets do not equal unique subjects.
| Age, Customized(Participants) | ISO Analysis Sets |
|---|---|
| <3 months | 29 |
| 3 months to <1 year | 29 |
| 1 year to <5 years | 58 |
| >= 5 years | 165 |
| Sex: Female, Male(Participants) | ISO Analysis Sets |
|---|---|
| Female | 146 |
| Male | 135 |
| Race and Ethnicity Not Collected(Participants) | ISO Analysis Sets |
|---|
| Region of Enrollment(participants) | ISO Analysis Sets |
|---|---|
| United States | 281 |
| Mode(s) of Thermometry Consented to(Participants) | ISO Analysis Sets |
|---|---|
| Oral | 132 |
| Rectal | 122 |
| Axillary | 216 |
| Febrile Status - Oral(Participants) | ISO Analysis Sets |
|---|---|
| Febrile | 38 |
| Not Febrile | 67 |
| Febrile Status - Axillary Pediatric(Participants) | ISO Analysis Sets |
|---|---|
| Febrile | 43 |
| Not Febrile | 62 |
| Febrile Status - Axillary Adult(Participants) | ISO Analysis Sets |
|---|---|
| Febrile | 34 |
| Not Febrile | 71 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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