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Can a smartwatch stop sepsis? new study tests home monitoring to keep patients out of the hospital

NCT ID NCT06920979

Knowledge-focused Sponsor: University Hospital, Antwerp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether patients with serious infections who are at risk for sepsis can be safely monitored at home using wearable devices and a smartphone app. About 120 adults will take part, and the goal is to see if this approach can reduce hospital visits while still catching early signs of deterioration. It is an early-stage pilot study focused on feasibility, not a treatment or cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * This study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a risk of developing sepsis at the emergency department or at their primary care physician. Exclusion Criteria: * Patients that are severely ill and require immediate hospitalization Qucik Sepsis Related Organ Failure score (QSOFA) ≥ 1 National Early Warning Score (NEWS) ≥ 5 * Patients that demonstrate confusion, changes in mental state and/or an Mini-Mental State Examination (MMSE) below 26 * Presence of neuropenic fever * Patients currently undergoing immunosuppressive therapy or chemotherapy * Patients with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) * Suspicion of appendicitis, suspicion of meningitis or meningeal irritation, suspicion of or high risk of developing endocarditis * Complicated operation wounds at the time of screening * Proven pneumonia (CURB 65 score ≥ 1) * Emphysema, Chronic Obstructive Pulmonary Disease (COPD) GOLD \>1 or interstitial lung disease * Patients with oxygen at home \> 2 l/min on a chronic basis (severe underlying lung disease?) * Severe cardiovascular disease including: * Severe heart failure New York Heart Association (NYHA) class \> 1 * Endoprosthesis * Cardiac arrhythmia including atrial fibrillation * Severe heart valve abnormalities * Mechanic valve replacement * Recent acute myocardial infarct or coronarography (less than 1y ago) * Severe peripheral vascular morbidity * Acute chest pain (suspicion of acute coronary pathology) * Suspicion of/chance of septic arthritis

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Conditions

The condition(s) this trial relates to.

Infections infectious disease Sepsis infectious disease with sepsis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Home monitoring follow-up Infection Innovativeness Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antwerp University Hospital (UZA)

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.