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

Condition(s) studied

Investigational drug(s) / intervention(s)

AK+ Guard™ ECG Application: An investigational Software as a Medical Device (SaMD) that analyzes Lead I electrocardiogram (ECG) data using artificial intelligence to detect moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L). ECG inputs may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch, HeartBeam).

Study summary

The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD).

Study objectives are:

* Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw.
* Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.

Eligibility

Primary outcome measure(s)

• Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L — Baseline (Day 0)
  Defined as serum K+ ≥ 6.5 mmol/L
• Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs) — Daily monitoring up to 4 weeks (Day 28)
• Arm 2B: (b) Mean System Usability Scale (SUS) score — Study completion at Week 4 (Day 28)
  10-item scale with final score between 0 and 100. The SUS score is an index of perceived usability (not a percentage), with higher scores indicating better usability. A score above 68 is generally considered above average usability, while lower scores suggest more usability concerns. The reported outcome will be the mean SUS score across participants.
• Arm 2B: (c) Net Promoter Score (NPS) — Study completion at Week 4 (Day 28)
  Participant-reported likelihood of recommending the system to others, measured on a 0-10 scale, with higher scores indicating greater likelihood to recommend. Individual responses are converted into a Net Promoter Score (NPS), which ranges from -100 to +100. Positive values (\>0) indicate overall customer loyalty and advocacy.

Trial sites (1)

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