SepsisIRHISNCT07595848
Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis
A study testing CPC12S Telemonitoring System with Temperature/Humidity Sensor and IDRO Sweat Lactate Sensor in people with Sepsis, run by Check Point R & D Ltd.
Trial summary
The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- CPC12S Telemonitoring System with Temperature/Humidity Sensor and IDRO Sweat Lactate Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Patients admitted to the intensive care unit who are at risk of developing sepsis.
- Patients with one or more relevant risk factors for sepsis, including pre-existing medical conditions, invasive medical devices, recent procedures or conditions, active infections, clinical risk factors, or prolonged ICU/hospital stay.
- Signed informed consent.Exclusion Criteria:
- Inability or unwillingness to provide informed consent or comply with study requirements.
- ICU stay shorter than 6 hours.
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- Damaged tattoos, bare skin, recent scar tissue, inflammation, infection, skin barrier alteration, serous or bloody discharge, or metal plates/nails at the area where the Macroduct Advanced system and IDRO device will be placed.
- Patients admitted to the ICU with already diagnosed sepsis.
- Patients participating in other clinical studies.
- Moribund patients or patients with very short life expectancy.
- Patients with do-not-resuscitate status at admission.
- Patients with implanted devices such as an implanted defibrillator, implanted neurostimulator, implanted pacemaker, or implanted ECG monitor.
- Patients in whom short-term interference between the Macroduct device and clinical monitoring cannot be accepted.
- Patients with a history of epilepsy or seizures.
- Pregnant patients or patients who may be pregnant.
- Patients with previous adverse reactions to electrotherapy.
- Patients who present adverse reactions during the first sampling with the Macroduct device.
- Patients for whom the procedure is contraindicated for medical reasons according to the physician's decision.
- Patients with known sensitivity or allergy to pilocarpine nitrate, or any medical contraindication to pilocarpine administration.
- Patients in environments with flammable anesthetics or oxygen-enriched environments.
Who cannot join
None listed.
About this study
The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Patients will be monitored for up to 48 hours, and the collected physiological and biomarker data will be used to support the development of artificial intelligence and machine learning models for sepsis prediction.
Read the detailed description
This is a prospective clinical performance study involving ICU patients at risk of developing sepsis. The study will assess the integration of portable sensor devices into the CPC telemonitoring platform for the collection and visualization of physiological and biomarker data.
The CPC12S device will collect vital physiological parameters, including electrocardiography, oxygen saturation, non-invasive blood pressure, respiratory rate, heart rate, body position, and physical activity. A CPC temperature and humidity sensor will be used for continuous monitoring of body temperature and humidity. In addition, the IDRO investigational sweat lactate sensor will be integrated into the system to collect sweat lactate data.
The study will be conducted in phases. In the first phase, patients will be monitored using the CPC12S device together with the temperature and humidity sensor. In the second phase, patients will be monitored using the CPC system, the temperature and humidity sensor, and the IDRO sweat lactate sensor.
All patients will be monitored for up to 48 hours. The collected data will be analyzed together with clinical information recorded by healthcare professionals. The primary objective is to support prediction of sepsis onset by integrating data from the CPC12S device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor. Secondary objectives include completing the integration of the IDRO sensor into the CPC system, validating the IDRO sweat lactate measurements against standard clinical blood lactate measurements, and developing an algorithm based on device-recorded and clinical data for sepsis prediction.
The data collected in this study will not be used to guide clinical decisions during the study. Medical care and clinical decisions will remain under the responsibility of the hospital medical team according to standard clinical practice.
- Conditions
- Sepsis
- Being tested
- CPC12S Telemonitoring System with Temperature/Humidity Sensor, IDRO Sweat Lactate Sensor
- Keywords
- Sepsis prediction, Remote patient monitoring, Temperature monitoring
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC12S Telemonitoring System with Temperature/Humidity SensorDevice
The CPC12S telemonitoring system will be used together with the CPC temperature and humidity sensor to collect physiological parameters, body temperature, and humidity data from ICU patients during the monitoring period.
IDRO Sweat Lactate SensorDevice
The investigational IDRO sweat lactate sensor will be used to collect sweat lactate measurements. The sensor will be integrated with the CPC system for data transmission, visualization, and analysis.
| Study group | Role | What they receive |
|---|---|---|
| CPC12S + Temperature/Humidity Sensor | Experimental | Participants will be monitored using the CPC12S telemonitoring device together with the CPC temperature and humidity sensor. Data will include physiological parameters, body temperature, and humidity during ICU monitoring. Receives: Device: CPC12S Telemonitoring System with Temperature/Humidity Sensor |
| CPC12S + Temp/Humidity + IDRO Sensor | Experimental | Participants will be monitored using the CPC12S telemonitoring system together with the CPC temperature and humidity sensor and the investigational IDRO sweat lactate sensor. Data will include physiological parameters, temperature, humidity, and sweat lactate measurements. Receives: Device: CPC12S Telemonitoring System with Temperature/Humidity Sensor; Device: IDRO Sweat Lactate Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUC-ROC) of the integrated sensor-based model for prediction of sepsis onset
The primary outcome is the predictive performance of the integrated sensor-based model for identifying sepsis onset in ICU patients. The model will use data collected from the CPC12S telemonitoring system, the CPC temperature/humidity sensor and, where applicable, the IDRO sweat lactate sensor. Sepsis onset will be determined by the clinical diagnosis recorded by the treating medical team and assessed according to Sepsis-3 criteria. Predictive performance will be reported as the area under the receiver operating characteristic curve (AUC-ROC).
Measured: Up to 48 hours of patient monitoring
Secondary outcomes (1)
Correlation between IDRO sweat lactate measurements and standard blood lactate measurements
The correlation between sweat lactate values measured by the IDRO sensor and blood lactate values measured as part of routine ICU clinical practice will be assessed using Pearson or Spearman correlation coefficients.
Measured: Up to 48 hours of patient monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startJul 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Check Point R & D Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595848
- Sponsor's protocol ID
- 101160941
- Acronym
- IRHIS
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis
- ClinicalTrials.gov ID
- NCT07595848
- Acronym / sponsor ID
- IRHIS / 101160941
- Conditions
- Sepsis
- Keywords
- Sepsis prediction, Remote patient monitoring, Temperature monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Check Point R & D LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Patients will be monitored for up to 48 hours, and the collected physiological and biomarker data will be used to support the development of artificial intelligence and machine learning models for sepsis prediction.
Detailed description
This is a prospective clinical performance study involving ICU patients at risk of developing sepsis. The study will assess the integration of portable sensor devices into the CPC telemonitoring platform for the collection and visualization of physiological and biomarker data.
The CPC12S device will collect vital physiological parameters, including electrocardiography, oxygen saturation, non-invasive blood pressure, respiratory rate, heart rate, body position, and physical activity. A CPC temperature and humidity sensor will be used for continuous monitoring of body temperature and humidity. In addition, the IDRO investigational sweat lactate sensor will be integrated into the system to collect sweat lactate data.
The study will be conducted in phases. In the first phase, patients will be monitored using the CPC12S device together with the temperature and humidity sensor. In the second phase, patients will be monitored using the CPC system, the temperature and humidity sensor, and the IDRO sweat lactate sensor.
All patients will be monitored for up to 48 hours. The collected data will be analyzed together with clinical information recorded by healthcare professionals. The primary objective is to support prediction of sepsis onset by integrating data from the CPC12S device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor. Secondary objectives include completing the integration of the IDRO sensor into the CPC system, validating the IDRO sweat lactate measurements against standard clinical blood lactate measurements, and developing an algorithm based on device-recorded and clinical data for sepsis prediction.
The data collected in this study will not be used to guide clinical decisions during the study. Medical care and clinical decisions will remain under the responsibility of the hospital medical team according to standard clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPC12S + Temperature/Humidity Sensor | Experimental | Device: CPC12S Telemonitoring System with Temperature/Humidity SensorParticipants will be monitored using the CPC12S telemonitoring device together with the CPC temperature and humidity sensor. Data will include physiological parameters, body temperature, and humidity during ICU monitoring. |
| CPC12S + Temp/Humidity + IDRO Sensor | Experimental | Device: CPC12S Telemonitoring System with Temperature/Humidity Sensor, Device: IDRO Sweat Lactate SensorParticipants will be monitored using the CPC12S telemonitoring system together with the CPC temperature and humidity sensor and the investigational IDRO sweat lactate sensor. Data will include physiological parameters, temperature, humidity, and sweat lactate measurements. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult patients aged 18 years or older.
- Patients admitted to the intensive care unit who are at risk of developing sepsis.
- Patients with one or more relevant risk factors for sepsis, including pre-existing medical conditions, invasive medical devices, recent procedures or conditions, active infections, clinical risk factors, or prolonged ICU/hospital stay.
- Signed informed consent.Exclusion Criteria:
- Inability or unwillingness to provide informed consent or comply with study requirements.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPC12S Telemonitoring System with Temperature/Humidity SensorThe CPC12S telemonitoring system will be used together with the CPC temperature and humidity sensor to collect physiological parameters, body temperature, and humidity data from ICU patients during the monitoring period. | Device | CPC12S + Temp/Humidity + IDRO Sensor, CPC12S + Temperature/Humidity Sensor |
| IDRO Sweat Lactate SensorThe investigational IDRO sweat lactate sensor will be used to collect sweat lactate measurements. The sensor will be integrated with the CPC system for data transmission, visualization, and analysis. | Device | CPC12S + Temp/Humidity + IDRO Sensor |
Primary outcome
Area under the receiver operating characteristic curve (AUC-ROC) of the integrated sensor-based model for prediction of sepsis onset
Time frame: Up to 48 hours of patient monitoring
The primary outcome is the predictive performance of the integrated sensor-based model for identifying sepsis onset in ICU patients. The model will use data collected from the CPC12S telemonitoring system, the CPC temperature/humidity sensor and, where applicable, the IDRO sweat lactate sensor. Sepsis onset will be determined by the clinical diagnosis recorded by the treating medical team and assessed according to Sepsis-3 criteria. Predictive performance will be reported as the area under the receiver operating characteristic curve (AUC-ROC).
1 secondary outcome
Correlation between IDRO sweat lactate measurements and standard blood lactate measurements
Time frame: Up to 48 hours of patient monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CPC12S Telemonitoring System with Temperature/Humidity Sensor and IDRO Sweat Lactate Sensor in people with Sepsis, run by Check Point R & D Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUC-ROC) of the integrated sensor-based model for prediction of sepsis onset (time frame: Up to 48 hours of patient monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.