NCT06056011

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

Completed NA Results posted Last updated 11 March 2026

What this trial tests

NA trial testing Connex CVSM with Timmy3 module in Febrile Illness in 373 participants. Completed in 18 March 2025.

Timeline

19 February 2024

Primary endpoint
18 March 2025

18 March 2025

Quick facts

Lead sponsor	Baxter Healthcare Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	373
Start date	19 February 2024
Primary completion	18 March 2025
Estimated completion	18 March 2025
Sites	5 locations across United States

Drugs / interventions tested

• Connex CVSM with Timmy3 module

Conditions studied

• Febrile Illness — all drugs for Febrile Illness →

Sponsor

Baxter Healthcare Corporation — full company profile →

Who can join

Adults 1 Day to 99, any sex, with Febrile Illness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Oral Temperature Measurement	-0.08	± 0.454
Rectal Temperature Measurement	-0.21	± 0.474

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	-0.01	± 0.291
Rectal Temperature Measurement	-0.24	± 0.399

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	0.01	± 0.231
Rectal Temperature Measurement	-0.22	± 0.237

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	-0.03	± 0.364
Rectal Temperature Measurement	-0.25	± 0.503

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	0.00	± 0.657
Rectal Temperature Measurement	-0.29	± 0.380

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	-0.04	± 0.377

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias Primary · 20-30 minutes

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 \[2\]).

Group	Value	95% CI
Adult Axillary Temperature Measurement	-0.02	± 0.531

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement Primary · 20-30 minutes

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 \[4\]).

Group	Value	95% CI
Oral Temperature Measurement	0.91
Rectal Temperature Measurement	0.95

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement Primary · 20-30 minutes

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 \[4\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	0.58
Rectal Temperature Measurement	0.80

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement Primary · 20-30 minutes

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 \[4\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	0.46
Rectal Temperature Measurement	0.47

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement Primary · 20-30 minutes

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 \[4\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	0.73
Rectal Temperature Measurement	1.01

Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement Primary · 20-30 minutes

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 \[4\]).

Group	Value	95% CI
Pediatric Axillary Temperature Measurement	1.31
Rectal Temperature Measurement	0.76

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.