'Microneedle arrays for non-invasive continuous multianalyte sensing in diabetes'Electrozyme LLC7. PROJECT SUMMARYThe current generation of continuous glucose monitors (CGMs) are designed to be implanted transdermally forup to seven days after which the transducer is replaced by the wearer. Despite current advances in theanalytical merits of these devices, CGMs are still limited to the quantification of a single analyte (glucose) overrelatively short periods of time. However, it is increasingly recognized that proper glycemic managementrequires a more comprehensive examination of metabolic function. Blood catecholamines and ketones aresome examples of neurotransmitters and metabolites that can augment standard blood glucosemeasurements, hence providing added dimensions of information pertaining to the patient's glycemic controland overall metabolic health. Moreover, a reduction in the frequency that the transducer element is replacedwould further simplify the operation of CGMs and provide increased autonomy in the patient's routine. In lightof the current limitations of CGMs, our team has recently pioneered the development of a minimally-invasivebody-worn patch containing an addressable microneedle array with multiplexed sensing elements. Owing tothe novel method in which the electrochemical transducer is embedded within the apertures of an array ofhollow microneedles, the on-body biosensor is able to perform various bioanalytical functions directly at themicroneedle-transdermal fluid interface and does not require sophisticated microelectromechanical ormicrofluidic systems for fluid extraction and analysis. The novel implementation of conducting polymersprovides for both an effective means for the entrapment of the biorecognition element as well as the ability toimpart a high degree of perm-selectivity, thereby dramatically extending the biosensor's useful lifetime andspecificity. Furthermore, the utilization of a fluorocarbon paste mitigates the oxygen dependency thatobfuscates accurate blood glucose readings among current CGM solutions. In accordance with the projectplan, the research effort seeks to attain the following objectives: (1) design and fabrication of the multi-analytemicroneedle array sensor platform, (2) surface immobilization and surface chemistry, and (3) critical evaluationof the system performance. The proposed Phase I research aims at extending the microneedle array conceptup to the stage of preliminary clinical studies in order transform this laboratory-proven technology into acommercial product that can serve as a major contender in the USD $17B global market for glucose monitoringdevices and artificial pancreas systems. The technology and business objectives outlined in this proposal willhave a direct impact on basic research and clinical applications to enhance the current state of glycemicmanagement and thereby will improve the well-being of the population with diabetes.

Public Health Relevance

''Microneedle arrays for non-invasive continuous multianalyte sensing in diabetes''Electrozyme LLC8. PROJECT NARRATIVEThe proposed project aims to develop a non-invasive body-worn patch for multivariate; simultaneousmonitoring of key diabetes health biomarkers in a pain-free; continuous manner. This new microneedle arraypatch will simultaneously measure blood glucose and other hormones and metabolites; to generate acomprehensive ''diabetes health signature''. The proposed research will substantially advance the state-of-the-art in continuous glucose monitoring; and will provide added insight into the overall metabolic health of theindividual with diabetes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-EMNR-S (10))
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Arreaza-Rubin, Guillermo
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Electrozyme, LLC
United States
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