Pilot phase clinical trial of a wearable, electrochemical aptamer-based patch for continuous drug concentration measurement.

PAPER pubmed Nature biotechnology 2026 Other Effect: unclear Evidence: Very low

Read original paper → DOI: 10.1038/s41587-026-03010-w PMID: 41639270 Evidence Lab

Abstract

As some drugs have narrow therapeutic windows and high inter-patient exposure variability, they require concentration measurements to ensure their safe and effective dosing. To improve on the current practice of sparse blood sampling, we are developing wearable 'patches' bearing electrochemical aptamer-based sensors on small, solid needles. Here we describe a pilot phase trial testing their safety and performance in six healthy human participants. The patches were found to be safe and nearly pain free, and they captured concentrations of vancomycin in the dermal interstitial fluid with 5-minute resolution over 24 hours, although, due to sensor degradation, we primarily describe data from the first 12 hours after insertion. Fitting interstitial fluid and plasma concentrations to compartmental pharmacokinetic models revealed distribution and clearance dynamics that are not detected with current sparse sampling approaches. Patches placed at different bodily sites exhibited consistent trends both within and across participants. With further testing and optimization, including real-time wireless data transmission, such patches could aid precision dosing of vancomycin and other drugs with narrow therapeutic windows. Australian New Zealand Clinical Trials Registry registration: ACTRN12622000280707 .

AI evidence extraction

At a glance

Study type

Other

Effect direction

unclear

Population

Healthy human participants

Sample size

Exposure

· 24 hours (primarily first 12 hours analyzed due to sensor degradation)

Evidence strength

Very low

Confidence: 74% · Peer-reviewed: yes

Main findings

In a pilot trial in six healthy participants, wearable electrochemical aptamer-based patches were reported to be safe and nearly pain free and measured vancomycin concentrations in dermal interstitial fluid at 5-minute resolution over 24 hours (with primary data described from the first 12 hours due to sensor degradation). Pharmacokinetic modeling of interstitial fluid and plasma concentrations indicated distribution and clearance dynamics not detected with sparse sampling, and patches at different body sites showed consistent trends within and across participants.

Outcomes measured

Safety
Pain/tolerability
Vancomycin concentration measurement in dermal interstitial fluid (5-minute resolution)
Comparison of interstitial fluid and plasma concentrations via compartmental pharmacokinetic modeling
Consistency of measurements across bodily sites

Limitations

Pilot phase trial
Small sample size (n=6)
Sensor degradation limited analysis primarily to the first 12 hours after insertion

View raw extracted JSON

{
    "study_type": "other",
    "exposure": {
        "band": null,
        "source": null,
        "frequency_mhz": null,
        "sar_wkg": null,
        "duration": "24 hours (primarily first 12 hours analyzed due to sensor degradation)"
    },
    "population": "Healthy human participants",
    "sample_size": 6,
    "outcomes": [
        "Safety",
        "Pain/tolerability",
        "Vancomycin concentration measurement in dermal interstitial fluid (5-minute resolution)",
        "Comparison of interstitial fluid and plasma concentrations via compartmental pharmacokinetic modeling",
        "Consistency of measurements across bodily sites"
    ],
    "main_findings": "In a pilot trial in six healthy participants, wearable electrochemical aptamer-based patches were reported to be safe and nearly pain free and measured vancomycin concentrations in dermal interstitial fluid at 5-minute resolution over 24 hours (with primary data described from the first 12 hours due to sensor degradation). Pharmacokinetic modeling of interstitial fluid and plasma concentrations indicated distribution and clearance dynamics not detected with sparse sampling, and patches at different body sites showed consistent trends within and across participants.",
    "effect_direction": "unclear",
    "limitations": [
        "Pilot phase trial",
        "Small sample size (n=6)",
        "Sensor degradation limited analysis primarily to the first 12 hours after insertion"
    ],
    "evidence_strength": "very_low",
    "confidence": 0.7399999999999999911182158029987476766109466552734375,
    "peer_reviewed_likely": "yes",
    "keywords": [
        "wearable patch",
        "electrochemical aptamer-based sensor",
        "continuous monitoring",
        "vancomycin",
        "interstitial fluid",
        "pharmacokinetics",
        "pilot clinical trial",
        "microneedles"
    ],
    "suggested_hubs": []
}

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AI-extracted fields are generated from the abstract/metadata and may be incomplete or incorrect. This content is for informational purposes only and is not medical advice.

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