Trial Outcomes & Findings for VitalTraq for the Detection of CRS (NCT NCT06415656)
NCT ID: NCT06415656
Last Updated: 2026-07-15
Results Overview
Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
COMPLETED
NA
32 participants
Day 14
2026-07-15
Participant Flow
Participant milestones
| Measure |
Patients With Hematologic Malignancies
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Patients With Hematologic Malignancies
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Overall Study
Patient misunderstood instructions and did not start digital monitoring intervention
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1
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Baseline Characteristics
VitalTraq for the Detection of CRS
Baseline characteristics by cohort
| Measure |
Patients With Hematologic Malignancies
n=32 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Age, Continuous
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67.5 years
n=20 Participants
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Sex: Female, Male
Female
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16 Participants
n=20 Participants
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Sex: Female, Male
Male
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16 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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8 Participants
n=20 Participants
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Race (NIH/OMB)
White
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23 Participants
n=20 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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Region of Enrollment
United States
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32 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: Day 14Population: One participant did not begin digital monitoring.
Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=31 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population
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-0.29 degrees Celsius
Standard Deviation 0.92
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SECONDARY outcome
Timeframe: Day 14Population: One participant did not begin digital monitoring.
The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature \> 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=31 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements
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28.2 hours
Interval 17.2 to
The upper quartile was not estimable because the KM curve did not decline to 25% CRS-free probability during follow-up.
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SECONDARY outcome
Timeframe: Day 14Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively. Reported as the difference between the two measurements (TempTraq - SOC).
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=31 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population.
Systolic blood pressure
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6.25 mmHg
Standard Deviation 18.62
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VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population.
Diastolic blood pressure
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13.26 mmHg
Standard Deviation 12.42
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SECONDARY outcome
Timeframe: Day 14Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute. Reported as the difference between the two measurements (TempTraq - SOC).
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=31 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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VitalTraq's Ability to Measure Heart Rate in the Intended Use Population.
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-10.18 bpm
Standard Deviation 19.31
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SECONDARY outcome
Timeframe: Day 28Individual questions in a post-intervention survey feature 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree. The mean score is reported, giving a score range of 1 to 7, where a lower score indicates lower burden.
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=31 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Patient's Perspective on the Burden of Using TempTraq and VitalTraq
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2.62 score on a scale
Standard Deviation 1.55
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SECONDARY outcome
Timeframe: Day 14Population: Participants with grade 2+ CRS detected on both detection devices.
The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring. Reported as the difference between the two measurements (TempTraq - SOC).
Outcome measures
| Measure |
Patients With Hematologic Malignancies
n=1 Participants
Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.
TempTraq: TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.
VitalTraq: VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.
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|---|---|
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Lead Time by Which TempTraq and VitalTraq Can Detect Grade 2 or Higher Cytokine Release Syndrome (CRS) as Compared to the Standard of Care.
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79.6 hours
Standard Deviation NA
Only one participant had grade 2+ CRS detected on both devices. A true lead time could not be calculated due the limited number of grade 2+ CRS events detected.
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Adverse Events
Patients With Hematologic Malignancies
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place