Trial Outcomes & Findings for Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018 (NCT NCT06056011)
NCT ID: NCT06056011
Last Updated: 2026-03-11
Results Overview
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 \[2\]).
COMPLETED
NA
373 participants
20-30 minutes
2026-03-11
Participant Flow
Participant milestones
| Measure |
All Enrolled Subjects
All subjects who signed informed consent. Subjects could be included in one or more ISO analysis sets. ISO 80601-2-56:2017+A1:2018 required limiting analysis to the first 105 subjects per mode (oral, rectal, pediatric axillary, adult axillary) who met age and febrile distribution criteria.
|
|---|---|
|
Overall Study
STARTED
|
373
|
|
Overall Study
Included in Oral ISO Analysis Set
|
105
|
|
Overall Study
Included in the Rectal ISO Analysis Set
|
105
|
|
Overall Study
Included in the Axillary Pediatric ISO Analysis Set
|
105
|
|
Overall Study
Included in the Axillary Adult ISO Analysis Set
|
105
|
|
Overall Study
COMPLETED
|
369
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Enrolled Subjects
All subjects who signed informed consent. Subjects could be included in one or more ISO analysis sets. ISO 80601-2-56:2017+A1:2018 required limiting analysis to the first 105 subjects per mode (oral, rectal, pediatric axillary, adult axillary) who met age and febrile distribution criteria.
|
|---|---|
|
Overall Study
Due to Investigator's Discretion
|
1
|
|
Overall Study
Due to other reasons
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ISO Analysis Sets
n=281 Participants
All enrolled subjects who had an ISO compliant data set collected.
|
|---|---|
|
Age, Customized
<3 months
|
29 Participants
n=281 Participants
|
|
Age, Customized
3 months to <1 year
|
29 Participants
n=281 Participants
|
|
Age, Customized
1 year to <5 years
|
58 Participants
n=281 Participants
|
|
Age, Customized
>= 5 years
|
165 Participants
n=281 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=281 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=281 Participants
|
|
Region of Enrollment
United States
|
281 participants
n=281 Participants
|
|
Mode(s) of Thermometry Consented to
Oral
|
132 Participants
n=281 Participants
|
|
Mode(s) of Thermometry Consented to
Rectal
|
122 Participants
n=281 Participants
|
|
Mode(s) of Thermometry Consented to
Axillary
|
216 Participants
n=281 Participants
|
|
Febrile Status - Oral
Febrile
|
38 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Oral
Not Febrile
|
67 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Axillary Pediatric
Febrile
|
43 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Axillary Pediatric
Not Febrile
|
62 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Axillary Adult
Febrile
|
34 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Axillary Adult
Not Febrile
|
71 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed.
|
|
Febrile Status - Rectal
Febrile
|
40 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed
|
|
Febrile Status - Rectal
Not Febrile
|
65 Participants
n=105 Participants • Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias
|
-0.21 degree Celsius
Standard Deviation 0.474
|
-0.08 degree Celsius
Standard Deviation 0.454
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias
|
-0.24 degree Celsius
Standard Deviation 0.399
|
-0.01 degree Celsius
Standard Deviation 0.291
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=16 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=20 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias
|
-0.22 degree Celsius
Standard Deviation 0.237
|
0.01 degree Celsius
Standard Deviation 0.231
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=19 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=15 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias
|
-0.25 degree Celsius
Standard Deviation 0.503
|
-0.03 degree Celsius
Standard Deviation 0.364
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias
|
-0.29 degree Celsius
Standard Deviation 0.380
|
0.00 degree Celsius
Standard Deviation 0.657
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias
|
—
|
-0.04 degree Celsius
Standard Deviation 0.377
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[2\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias
|
—
|
-0.02 degree Celsius
Standard Deviation 0.531
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement
|
0.95 degree Celsius
|
0.91 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement
|
0.80 degree Celsius
|
0.58 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=16 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=20 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement
|
0.47 degree Celsius
|
0.46 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=19 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=15 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement
|
1.01 degree Celsius
|
0.73 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
n=35 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement
|
0.76 degree Celsius
|
1.31 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=35 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement
|
—
|
0.75 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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 \[4\]).
Outcome measures
| Measure |
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement
|
—
|
1.06 degree Celsius
|
—
|
—
|
PRIMARY outcome
Timeframe: 20-30 minutesPopulation: All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows: * Oral: \>=5 years * Rectal: \<1 year, \<3 months, 3 months to \<1 year, 1 year to 5 years, and \>=5 years * Pediatric Axillary: \<1 year, \<3 months, 3 months to \<1 year, 1 year to \<5 years, and 5 years to \<18 years * Adult Axillary: \>=18 years
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.
Outcome measures
| Measure |
Rectal Temperature Measurement
n=105 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
Pediatric Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the pediatric axillary body site
|
Adult Axillary Temperature Measurement
n=105 Participants
All enrolled subjects who had an ISO compliant data set collected for the axillary body site
|
Rectal Temperature Measurement
n=105 Participants
All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site
|
|---|---|---|---|---|
|
Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability
|
0.28 degree Celsius
|
0.25 degree Celsius
|
0.29 degree Celsius
|
0.35 degree Celsius
|
Adverse Events
ISO Analysis Sets
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Baxter Clinical Trials Disclosure Call Center
Baxter Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
- Publication restrictions are in place
Restriction type: OTHER