Evaluating the AK Guard12 ECG Software for Detecting Severe High Potassium in Adults with Chronic Kidney Disease Assessing Accuracy, Usability, and Remote Monitoring in Outpatient and Home Settings

What this Trial Is About

Researchers are evaluating the AK Guard21 software, an investigational medical device designed to detect moderate to severe hyperkalemia high potassium levels in adults with chronic kidney disease CKD stages III-IV. This observational pilot study aims to assess the diagnostic accuracy of the software in an outpatient setting and its usability and reliability during daily remote monitoring. The study focuses on adults at risk of hyperkalemia, including those on specific kidney-related therapies, by analyzing Lead I ECG data from standard or wearable devices. The study includes two arms Arm 2A involves participants scheduled for routine outpatient potassium blood tests who will have ECGs recorded using three devices 12-lead ECG, Apple Watch, HeartBeam. The softwares diagnostic performance for detecting high potassium is compared to lab results. Arm 2B includes a subset of these participants who agree to use the Apple Watch and study app for daily ECG recordings at home for up to four weeks. Participants also complete weekly surveys and may return for confirmatory lab tests if high potassium is indicated. Participants will have ECGs collected and compared to blood potassium levels to evaluate sensitivity, specificity, and other diagnostic measures. During the remote monitoring phase, researchers will track daily compliance, data completeness, and system reliability, including app performance and user experience through surveys. The study measures include diagnostic accuracy at baseline and usability scores after four weeks. The total participation duration varies with the arm, including up to four weeks of remote monitoring.

AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring