Functional wearable hydrogel microneedle platform for continuous ketone monitoring: Translating from rodents to humans.

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Not reported in abstract — no quantitative accuracy metrics (e.g., mean absolute relative difference, correlation coefficient) provided

• Primary Outcome: Reliable tracking of dynamic ketone fluctuations across in vitro, rodent (healthy and diabetic), swine, and human models using the integrated HMN-CKM patch

• Nnt Or Sensitivity: Sensitivity and specificity not reported; no 2×2 table data available. In vitro characterisation parameters (linear range, limit of detection) reported in full paper but not abstracted here

• Confidence Interval: Not reported

Clinical Application

The HMN patch is described as painless and wearable, suggesting reasonable patient acceptability. However, patch adhesion duration, sensor drift over time, calibration requirements, wireless data transmission, and skin tolerability across diverse populations have not been reported. Manufacturing scalability and cost for routine clinical use are unknown. There is currently no TGA-approved wearable continuous ketone monitor available in Australia. DKA management is guided by RACGP and Diabetes Australia frameworks, with blood ketone testing (beta-hydroxybutyrate >3 mmol/L) used for DKA diagnosis. The PBS does not subsidise ketone monitoring strips for most patients. A validated wearable CKM device could complement existing CGM technology (e.g., Dexcom G7, FreeStyle Libre 3, both TGA-approved) and reduce DKA-related hospitalisations, which carry significant burden on Australian public hospitals. TGA regulatory pathway (Class IIb or III medical device) would require substantially more clinical validation data than currently presented. RACGP endorsement would require prospective trials in Australian type 1 diabetes populations. Potentially applicable to individuals with type 1 diabetes at risk of DKA, and possibly type 2 diabetes patients on SGLT2 inhibitors at risk of euglycaemic DKA. Current evidence supports application only in research/pilot settings.

Abstract

Diabetic ketoacidosis (DKA) is a life-threatening complication of diabetes, driven by excessive ketone production; it is most common in type 1 diabetes. Continuous ketone monitoring (CKM) could enable earlier detection and prevention of DKA, yet no wearable CKM solution is clinically available. We present a wearable CKM patch that couples hydrogel microneedles (HMNs) for painless interstitial fluid (ISF) access with an enzymatic, electrochemical biosensor for on-patch detection of ketone bodies. The HMN patch and ketone biosensor were individually characterized and optimized in vitro, then integrated into a single platform. We validated the performance of the integrated CKM sensing patch across species: in vivo testing in healthy and diabetic rats, translation to a swine model, and a pilot evaluation in human participants. The CKM sensing patch reliably tracked dynamic ketone fluctuations in all models. To our knowledge, this is the first HMN-based biosensor tested in humans. These results establish a minimally invasive, wearable approach for continuous ketone tracking with the potential to transform outpatient DKA monitoring and early intervention.

References

1. 1.Sadeghzadeh, S., Li, P., Zheng, H., Ausri, I. R., GhavamiNejad, P., Caron-Godon, C., Devries, M. C., Graham, M., Quadrilatero, J., & Poudineh, M. (2026). Functional wearable hydrogel microneedle platform for continuous ketone monitoring: Translating from rodents to humans. Biosensors & Bioelectronics. Advance online publication. https://doi.org/10.1016/j.bios.2026.118640