Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis

NCT07595848 | Not Yet Recruiting

• 1 other identifier: 101160941
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sepsis

Keywords

Sepsis prediction; Remote patient monitoring; Temperature monitoring

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 48 hours of patient monitoring

Secondary Outcomes (1)

• Correlation between IDRO sweat lactate measurements and standard blood lactate measurements

  Up to 48 hours of patient monitoring

Study Arms (2)

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.

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.

Device: CPC12S Telemonitoring System with Temperature/Humidity Sensor; Device: IDRO Sweat Lactate Sensor

Interventions

CPC12S Telemonitoring System with Temperature/Humidity Sensor DEVICE

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.

CPC12S + Temp/Humidity + IDRO Sensor; CPC12S + Temperature/Humidity Sensor

IDRO Sweat Lactate Sensor DEVICE

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.

CPC12S + Temp/Humidity + IDRO Sensor

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability or unwillingness to provide informed consent or comply with study requirements.
• ICU stay shorter than 6 hours.
• 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.

Sponsors & Collaborators

• Check Point R & D Ltd: lead

MeSH Terms

Conditions

Sepsis

Interventions

Body Temperature

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05