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Gum-Sized AI device could prevent deadly potassium spikes in kidney patients

NCT ID NCT06901960

Disease control Sponsor: Peking University First Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a small, AI-powered ECG device that looks like a stick of gum to help people with moderate-to-advanced chronic kidney disease monitor their potassium levels at home. Participants will use the device at least twice a week and receive alerts if levels are abnormal. The goal is to see if frequent monitoring reduces dangerous high potassium episodes over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-enhanced electrocardiogram device
What this could lead to
If successful, this device could help people with chronic kidney disease avoid dangerous high potassium levels by catching them early and prompting action.
What could go wrong
This is a relatively early-stage trial with 1066 participants, and the device's accuracy may vary in real-world use. It is not a treatment for kidney disease itself.

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 1,066 people

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

Started

Apr 2025

Expected to finish

Dec 2026

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 to 99 years

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: * Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - \<45 ml/min/1.73m²) * Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment) * Willingness to participate in the study with signed informed consent Exclusion Criteria: * Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months * Unwillingness or without the ability to monitor hyperkalemia using the study device * Patients with heart pacemaker implanted

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Hyperkalemia

As listed by the trial registrant

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

Chronic kidney disease (stages 3B-5)

How to take part

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

  1. The places running it

    3 sites. 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

  • Hubei Provincial Hospital of TCM

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430063, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • The First Affiliated Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, 530021, China

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