5e). 2019 Apr 26;4(4):1072-1080. doi: 10.1021/acssensors.9b00288. Colorimetric biosensors measure the change in light absorption, whereas photometric sensors measure light intensity or photon output from a luminescent or fluorescent process with photomultiplier tubes, charge coupled detectors, or similar systems [18]. David Freeman: Methodology (equal); Writing original draft (equal); Writing review and editing (equal). For example, one-third to two-thirds of diabetic patients have cardiovascular and cerebrovascular diseases, renal diseases, eye diseases, or neuropathy3,4. Briefly, an MN-based sensing device consists of micron-sized arrays that are arranged on a miniature patch in a specific order. A thinner Prussian blue layer could provide a wider measurement range, which was essential for detecting a high glucose level in the ISF. The concentrations of analytes in ISF are linked to their concentration in blood plasma.1 Water and small polar molecules diffuse between the two compartments paracellularly, i.e., between the cells of the capillary wall while larger and/or more lipophilic molecules are transported transcellularly i.e., by uptake and secretion by the cells of the capillary wall. In this example, it was a hydrolysis reaction that was monitored rather than an oxidation reaction, and this was achieved by coating the microneedles with a pH sensitive layer of iridium oxide (IrOx).28,29. Evaluation of a minimally invasive glucose biosensor for continuous tissue monitoring. Before conducting the experiments, all mice were fasted for 8h and were anesthetized appropriately using the anesthetic agent pentobarbital. Glucose-responsive gold nanocluster-loaded microneedle patch for type 1 diabetes therapy. A microneedle device with an immobilized oxidase poised at a suitable potential will, therefore, generate a current that is dependent on the concentration of the enzyme's substrate molecule. Interpretation: 2015 Jul 15;26(7):1289-96. doi: 10.1021/acs.bioconjchem.5b00211. Effect of microneedle design on pain in human volunteers. This is to mimic the situation of eating food. 2023 Mar 29;5(2):dlad036. 4c. Naing, C. & Mak, J. W. Salivary glucose in monitoring glycaemia in patients with type 1 diabetes mellitus: a systematic review. The devices were able to measure the changing concentration of penicillin in ISF, showing similar time dependent changes to the current gold standard microdialysis and to free drug in serum (analyzed by mass spectrometry). Figure 4a shows the sequential addition of different glucose concentrations into a phosphate buffer solution, and the current signal increases as the glucose concentration increases. The current value on each day was recalibrated according to its relative response over 7 days (Fig. Am. We further emphasize immobilization strategies to attach biorecognition elements to electrode materials. The sensing performances were first studied under different simulated environments, including a pure buffer solution, simulated ISF, and a plasma environment. Biomed. The point to quantify the current was approximately 40s after each addition of glucose. The earliest and most extensively studied electrochemical biosensors are those based on oxidase or dehydrogenase enzymes.1517 Oxidases catalyze the oxidation of target molecules by molecular oxygen with the latter's concomitant reduction to hydrogen peroxide (or in a few cases water). k Compression test on the microneedle array by a universal material testing machine. A 99 microneedle array was designed and printed, and the center-to-center distance of two adjacent microneedles was 600m. This, in turn, may challenge the way that we currently think about pharmacokinetics and pharmacodynamics (PK/PD). A digital light processing machine (from MoonRay, SprintRay Technology Ltd. or S140, BMF Precision Technology Ltd., China) was employed to fabricate the device. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Tear glucose analysis for the noninvasive detection and monitoring of diabetes mellitus. Figure 3b shows the study of this device selectivity by comparing the signals from the interferences and glucose. Sens. Nat. Epub 2023 Mar 26. This site needs JavaScript to work properly. 29, 100348 (2020). Pagn M, Suazo D, Del Toro N, Griebenow K. Biosens Bioelectron. Under the plasma environment, 50l of goat plasma (Senber Biotechnology Co., China) was dropped onto the sensor, and 2l of different concentrations of glucose were added incrementally onto the working electrode. 2016 Mar 15;77:1168-74. doi: 10.1016/j.bios.2015.11.005. and Y.C. Continuous glucose monitoring: review of an innovation in diabetes management. Hernndez-Ibez N, Garca-Cruz L, Montiel V, Foster CW, Banks CE, Iniesta J. Biosens Bioelectron. Several approaches to collecting and sampling ISF ex vivo have been proposed including reverse iontophoresis, hollow needle extraction, and microdialysis.7 These techniques are not suitable for continuous sensing; removal of the ISF for external analysis can cause the concentration of relevant molecules to change. After several iterations in the design and fabrication methods, microneedle sensor arrays were shown to be able to function continuously in vivo for both glucose and lactate measurements.2427, While metabolite measurements are important in managing conditions such as diabetes or sepsis, microneedle sensor arrays have applications beyond these endogenous analytes and have recently been applied to therapeutic drug monitoring (TDM). These sensors were finally dried and stored in a refrigerator at 4C. They, therefore, avoid nerve endings, so cause little discomfort and sit bathed by the ISF. Furthermore, the signals from this device are compared with those from a commercial blood glucose meter to obtain its accuracy for diabetes monitoring. During the fluctuation of the glucose levels in a normal or a diabetic mouse during a day, the subcutaneous glucose levels are monitored continuously and in real time. 5, eaaw9906 (2019). Diabetes Technol. We anticipate that the study could open exciting avenues for monitoring and managing diabetes, alongside fundamental studies of subcutaneous electronic devices. The difference between the height of the microneedle and the insertion depth may be attributed to the elastic deflection on the skin during microneedle insertion, resulting in part of the microneedle remaining outside the skin44,45. During diabetes management, any diabetic patient consumes meals every day, and after the intake of food, the blood sugar of the diabetic patient increases. 4, 1072 (2019). Mikrochim Acta. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Finally, the hypodermis (or subcutaneous tissue) is primarily a fatty layer that helps with thermoregulation, energy storage, and protection of deeper tissues.4,5 The fluid that bathes these tissues is called interstitial fluid (ISF) and forms a microcirculatory system, whereby it diffuses through the capillary walls and is taken up by the lymphatic system. Microneedle biosensors for real-time, minimally invasive drug monitoring of phenoxymethylpenicillin: a first-in-human evaluation in healthy volunteers Lancet Digit Health. By decreasing the device size, a stable sensorskin interface is formed, and monitoring results are not affected significantly by the motions of users. A linear detection range was clearly obtained from 0.8 to 24mM with a sensitivity of 0.07410.0004A/mM. e Current versus time curve from simulated interstitial fluids with different glucose concentrations. Although these results are promising, further studies are needed to help elucidate the roles of the microneedle structure and skin thickness for the continuous in vivo monitoring of diabetes. Would you like email updates of new search results? Comparison of fingertip vs palm site sampling on pain perception, and variation in capillary blood glucose level among patients with diabetes mellitus. Epub 2017 Jan 10. Sensors Abstract Levodopa is the most effective medication for treating Parkinson's disease (PD). Continuous glucose monitoring (CGM) can enhance diabetes management; by timely learning the glucose level fluctuation to adjust the treatment plan, this technology can be used to reduce hospitalization, save medical costs, minimize ineffective drug utilization, and save lives9,10. These teeth act as electrodes to detect changes in pH and can be coated with enzymes that react with a drug of choice, altering the local pH of the surrounding tissue if the drug is present. It is also important to consider the effect of ISF lag. Most molecules of interest will pass from the blood plasma into the ISF (all molecules of interest that are not directly produced within skin tissue). c Cyclic voltammograms of the sensor after the deposition of 8 cycles of Prussian blue. Sci. Slider with three articles shown per slide. Figure 5j, k show the results of the device for 7-day glucose monitoring in normal and diabetic mice. Cutaneous complications with continuous or flash glucose monitoring use: systematic review of trials and observational studies. Real-time improvement of continuous glucose monitoring accuracy. Forlenza, G. P. et al. A linear relationship was observed between the currents from the microneedle biosensing device (Fig. Structural changes on the skin after inserting and removing the microneedle arrays were observed. Please enable it to take advantage of the complete set of features! Development of a Minimally Invasive Microneedle-Based Sensor for Continuous Monitoring of -Lactam Antibiotic Concentrations in Vivo. Biosensing in dermal interstitial fluid using microneedle based electrochemical devices. The selectivity of the biosensing device was then studied. Furthermore, we verified the sensing performance in a simulated ISF. Provided by the Springer Nature SharedIt content-sharing initiative, Microsystems & Nanoengineering (Microsyst Nanoeng) For the study of pH, temperature, and storage stabilities, the range of the noise is from 0.61 to 7.05%. Figure 2a shows that the microneedle arrays were manufactured by 3D printing. Welsh, J. A 45-degree line was obtained for all 118 points, and they were located in clinically acceptable error zones A (meaning no effect on clinical action) and B (representing small altered clinical action or no significant effect on clinical outcome). Next, the two-electrode system was first immersed in 0.5M H2SO4 for a CV measurement (A CHI660e, from CH Instruments, China), and it was performed at a rate of 1V/s with a voltage ranging from 0.2 to 1.2V for 10 cycles. This requires integration of batteries and communication systems that allow the patch to transmit to a display. a Schematic illustration of the preparation process for the biosensor. Gao, J. et al. 11, S17S24 (2009). National Library of Medicine Ascorbic acid and uric acid are electroactive substances. Outputs were captured as sensor current and compared with lactate concentrations from venous blood and microdialysis. Biol. The S140 machine (BMF Precision Technology Ltd., China) had a higher resolution (the x-axis and y-axis resolution could be 10m, and the layer height was 10m), and the materials used for printing were a biocompatible light-sensitive resin (BMF Precision Technology Ltd., China). Painless and continuous monitoring of interstitial glucose is highly desirable for diabetes management. Davis, S. P. et al. HHS Vulnerability Disclosure, Help Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Disord. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. Unauthorized use of these marks is strictly prohibited. Lane, J. D. et al. The detection results were highly correlated with those obtained from a commercial blood glucose meter. Bioanal. There have been several commercial subcutaneous glucose sensors for continuous monitoring of diabetes, such as G6 (Dexcom, San Diego, USA)22, Freestyle Libre (Abbott, Chicago, USA)23, and Guardian (Medtronic, Northridge, USA)24. 2023 Mar 22:e2207539. Liu, Y., Yu, Q., Luo, X. et al. Disclaimer. government site. ISSN 2055-7434 (online), Continuous monitoring of diabetes with an integrated microneedle biosensing device through 3D printing, https://doi.org/10.1038/s41378-021-00302-w, 3D-assembled microneedle ion sensor-based wearable system for the transdermal monitoring of physiological ion fluctuations, A Novel Needle-Injectable Millimeter scale Wireless Electrochemical Glucose Sensing Platform for Artificial Pancreas Applications, Subcutaneously implantable electromagnetic biosensor system for continuous glucose monitoring, Reduction of measurement noise in a continuous glucose monitor by coating the sensor with a zwitterionic polymer, Glucose-responsive insulin patch for the regulation of blood glucose in mice and minipigs, Smartphone-powered iontophoresis-microneedle array patch for controlled transdermal delivery, A fully inkjet-printed disposable glucose sensor on paper, An integrated wearable microneedle array for the continuous monitoring of multiple biomarkers in interstitial fluid, Sampling of fluid through skin with magnetohydrodynamics for noninvasive glucose monitoring, https://doi.org/10.1038/s41551-020-00650-4, http://creativecommons.org/licenses/by/4.0/, Tackling the challenges of developing microneedle-based electrochemical sensors. This work illustrates the feasibility of a microneedle based electrochemical biosensor for continuous glucose monitoring. These interferences would not cause a significant influence on the glucose sensing results. Apart from the Au element, there are also obvious peaks of C, N, and Fe, which demonstrates that the Prussian blue (Fe4[Fe(CN)6]3) layer was successfully deposited on the Au electrode. Fried, D. A. 91, 37783783 (2019). All article content, except where otherwise noted, is licensed under a Creative Commons Attribution (CC BY) license (. Health care 2020: reengineering health care delivery to combat chronic disease. Microdevices 20, 101 (2018). 3, 283288 (2009). Microneedles fabricated from alginate and maltose for transdermal delivery of insulin on diabetic rats. Phosphate buffer solution is a simple solution environment, and it was first studied for sensing glucose. Recent Advances in Microneedle-Based Sensors for Sampling, Diagnosis and Monitoring of Chronic Diseases by zgecan Erdem 1,, Ismail E 1,, Garbis Atam Akceoglu 1, Yeeren Saylan 2 and Fatih Inci 1,3,* 1 UNAMNational Nanotechnology Research Center, Bilkent University, Ankara 06800, Turkey 2 1. The microneedle in Fig. Geelhoed-Duijvestijn, P. et al. School of Materials Science and Engineering, Peking University, 100871, Beijing, P. R. China, Renal Division, Peking University Institute of Nephrology, Peking University First Hospital, 100034, Beijing, P. R. China, You can also search for this author in Recent advances in the field of microneedle devices are having an impact on both diagnostic and therapeutic approaches to sustaining healthy populations globally. Rev. 74, 725728 (1981). The skin is the largest organ in the human body and fulfills multiple roles from preventing water and nutrient loss to providing a barrier against environmental assaults from microorganisms, toxins, and particulates. This will be a function of both the design of the microneedles and the biocompatibility of the material in contact with tissue. These CV curves demonstrate that a potential range from 0.3 to 1V could all generate a clear sensing signal, and a typical potential of 0.6V could be used for further amperometric measurements. Therefore, the calibration procedure is necessary for further practical applications. Bookshelf Tackling the challenges of developing microneedle-based electrochemical sensors. I suggest to accept the manuscript after a minor revision. Continuous Measurement of Lactate Concentration in Human Subjects through Direct Electron Transfer from Enzymes to Microneedle Electrodes. Other recognition elements, such as aptamers or molecularly imprinted polymers (MIPs), are beginning to be investigated and have significant advantages over enzymes, most notably, they can each be targeted toward any molecule of interest, whereas enzymes require specific substrates. A new microneedle biosensor that noninvasively monitors penicillin levels in the body could help to ensure that each patient gets the right antibiotic dose, potentially improving outcomes while reducing adverse effects and antimicrobial resistance. Can precision antibiotic prescribing help prevent the spread of carbapenem-resistant organisms in the hospital setting? Int J Clin Pharmacol Ther. Lee, W. C. et al. Results The biosensor was well-tolerated. National Library of Medicine This is to mimic the situation of insulin treatment for diabetic patients. e Calibration curve of the sensor for the detection of H2O2. Interstitial fluid (ISF) is a small-volume compartment surrounded by cells that absorbs molecules from blood capillaries. Microneedle patch for the ultrasensitive quantification of protein biomarkers in interstitial fluid. II-LA-0313-200), Imperial College Biomedical Research Centre (BRC), the DHSC Centre for Antimicrobial Optimisation, at Imperial College, London, Mrieux Research Grants, and the European Union's Horizon 2020 research and innovation programme under Grant Agreement No. Bio-Sens. Timely calibration may eliminate the small errors caused by changes in the environment and the activity loss of GOD. As shown in Fig. Sci. Development of a Minimally Invasive Microneedle-Based Sensor for Continuous Monitoring of -Lactam Antibiotic Concentrations in Vivo Sally A. N. Gowers* , David M. E. Freeman , Timothy M. Rawson , Michelle L. Rogers , Richard C. Wilson , Alison H. Holmes , Anthony E. Cass , and Danny O'Hare Cite this: ACS Sens. Madden, J. et al. The devices yield continuous data and are substantially more comfortable to wear, easy to apply, and cheaper to produce than the alternatives. Appl. 2016, 4596316 (2016). Epub 2015 Jun 10. In contrast to blood, which is commonly drawn either by venepuncture or by a fingerstick drop of capillary blood, ISF may be accessed by penetrating only the very top layer of the epidermis, the stratum corneum. Nephrol. Copyright 2019 Authors, licensed under a Creative Commons Attribution 4.0 License. 15 August 2022; 121 (7): 070502. https://doi.org/10.1063/5.0097040. Saiki T, Ogata G, Sawamura S, Asai K, Razvina O, Watanabe K, Kato R, Zhang Q, Akiyama K, Madhurantakam S, Ahmad NB, Ino D, Nashimoto H, Matsumoto Y, Moriyama M, Horii A, Kondo C, Ochiai R, Kusuhara H, Saijo Y, Einaga Y, Hibino H. Heliyon. J. Diabetes Sci. A recent review has discussed the technology and benefits of near patient TDM and the use of microneedles in this regard has been illustrated with continuous penicillin monitoring.2, Antimicrobial resistance (AMR) is a concerning and growing problem that may be somewhat mitigated through TDM. Macromolecules such as small proteins or even antibodies have lower, but still significant ISF concentrations compared to plasma. This is especially important in certain patient populations such as neonates, who are challenging to draw blood from. Adv. Mice were maintained in individually ventilated cages and had access to standard laboratory food and water during free time. Hence, dermal tattoo biosensor fabricated by microneedle patches has the potential to be an ideal platform to achieve detection of multiple health-related biomarkers. Published by Elsevier Ltd. Although oxygen is a ubiquitous oxidant for these enzymes, the potential required to reoxidize the hydrogen peroxide is high enough to introduce potential interference from physiological reductants such as uric acid and ascorbic acid, as well as common pharmaceuticals such as acetaminophen. 2019, 4, 4, 1072-1080 128, 337343 (2015). The biosensing device was further characterized for the in vitro detection of glucose. Freeman DME, Ming DK, Wilson R, Herzog PL, Schulz C, Felice AKG, Chen YC, O'Hare D, Holmes AH, Cass AEG. Wearable Clinic: From Microneedle-Based Sensors to Next-Generation Healthcare Platforms. Specific pathogen-free conditions were provided to all mice, and all procedures of the animal experiments were approved by the Institutional Animal Care and Use Committee of Peking University First Hospital (Approval Number: J201957). However, these devices may not be suitable for diabetes monitoring from a medical viewpoint since the correlations between the glucose levels in blood and the glucose levels in these fluids vary for different population samples14,15,16,17,18, thus yielding inaccurate diabetes monitoring. These results indicate the possibility that the integrated microneedle biosensing device could be used for the accurate and continuous monitoring of subcutaneous glucose. Epub 2023 Mar 26. HHS Vulnerability Disclosure, Help f Calibration curve for the detection of glucose in simulated interstitial fluids. Curr. This has the obvious advantage of automating a process that previously took time from medical staff but has the added benefit of ensuring even a narrow therapeutic window is constantly achieved rather than drug levels rising and falling over time when drugs are taken orally or intravenously as a bolus. 2023 Apr 28;8(4):1639-1647. doi: 10.1021/acssensors.2c02780. Eye Res. Front Bioeng Biotechnol. A universal material testing machine (MTS SYSTEMS (China), Co., Ltd., China) was used to study the mechanical strength of microneedles under compression testing. Nyein, H. Y. Y. et al. The results demonstrate that, during the intake of sugar, the detection results of the subcutaneous glucose concentrations measured by the microneedle biosensing device correlate excellently with those from the blood glucose concentrations measured by a commercial glucose meter. Colloidal crystal microneedle patch for glucose monitoring. An excellent linear relationship was observed, with a slope of 0.108A/mM and an R2 of 0.9657 (Fig. These could include nucleic acid and peptide aptamers, ligand binding proteins, particularly antibodies as well as synthetic receptors such as molecularly imprinted polymers (MIPs) and host-guest molecules. The hydrogen peroxide can then be electrochemically re-oxidized to oxygen at around 0.7V (relative to a silver|silver chloride reference electrode), on a platinum or gold surface producing a current (two electrons for each hydrogen peroxide). Moreno RA, Boldrina L, Guermani A, Mazucheli J, Sverdloff C, Borges NC. Ther. The current response during the entire study tended to be stable and varied within 20%. The abdominal skin of the mouse was used as the model to investigate whether the microneedle array could be inserted into the skin. Increased data density allows for an increased chance of detection of time dependant changes, important for optimized drug dosing in which a therapeutic window must be hit or biomarker monitoring in illness where changes in analyte concentration may precede more serious outcomes. Each error bar was from three sensors. This test provides one glucose level at a time, and during diabetes management, a person needs to check their glucose levels several times a day. Scanning rate: 100mV/s. l Clark error grid for the microneedle biosensing device. c Measurement repeatability of the biosensing device. The authors declare no competing interests. Sharma, S. et al. 8, 2100827 (2021). In this Perspective, we focus on solid microneedle biosensors and discuss the advantages of these devices over alternative clinical diagnostic platforms as well as the technical challenges presented. Then glucose was intraperitoneally injected into the nondiabetic mice (10% glucose at 0.1ml/10g), and the diabetic mice received insulin (0.5U/ml at 0.054ml/10g). These concentrations are low enough and would not affect glucose sensing. The conventional Clark error grid was used to analyze the comparison between the reference blood glucose value and the glucose value measured by this device (the data came from eight normal and eight diabetic mice). Diabetes Technol. As shown in the figure, there was an obvious deviation in the oxidation peak, which demonstrated that Prussian blue was successfully deposited. The blood glucose concentrations were measured using a commercial blood glucose meter. Technol. For comparison, a linear curve was plotted between the sensing results from the microneedle biosensing device and the detection results from the commercial blood glucose meter. In addition, the blood glucose levels of a diabetic mouse decreased concurrently (Fig. One limitation of the oxidase/hydrogen peroxide approach is that at the working potential for hydrogen peroxide oxidation other endogenous and exogenous molecules are oxidized. In this study, we unprecedentedly show continuous monitoring of diabetes with an integrated microneedle biosensing device. Regional and correlative sweat analysis using high-throughput microfluidic sensing patches toward decoding sweat. e An SEM image of 3D printed cone-shaped microneedles with a base diameter of 400m and a height of 1.5mm fabricated by using MoonRay (SprintRay Technology Ltd., China) and clear light-sensitive resin. Microneedle biosensors use a series of microscopic 'teeth' to penetrate the skin and detect changes in the fluid between cells. Comparative bioavailability study of two phenoxymethylpenicillin potassium tablet formulations in healthy volunteers. j The loaddisplacement curve on a microneedle by an in situ nanomechanical test system. 5f). Figure 2 shows the fabrication process of the integrated microneedle sensing device and its performance for detecting H2O2. A working electrode potential of 0.6V versus Ag/AgCl was used for detecting H2O2. Inadequate vitamin C status in prediabetes and type 2 diabetes mellitus: associations with glycaemic control, obesity, and smoking. 8600 Rockville Pike Each electrode occupies a certain array of microneedles, and Au or Ag/AgCl is coated onto the microneedle surface. Modeling and measurement of correlation between blood and interstitial glucose changes. Volunteers reported very little discomfort associated with the application and wearing of the device. Sensing with in situ probes is, therefore, our preferred method and should have a suitable time resolution (minutes) for typical rates of change in concentration. S1). b Cyclic voltammograms of the sensor after the deposition of 1 and 8 cycles of Prussian blue. The results reveal that the new microneedles lactate sensor holds interesting promise for the development of a real-time monitoring device to be used in sport medicine and clinical care. Common examples include ascorbic acid (vitamin C) and glutathione. Careers. Sci. 2023 May 4;11:1166857. doi: 10.3389/fbioe.2023.1166857. Thompson, N. D. & Perz, J. F. Eliminating the blood: ongoing outbreaks of hepatitis B virus infection and the need for innovative glucose monitoring technologies. The proposed flexible microneedle biosensor exhibits a good analytical performance with wide linear dynamic range, high sensitivity, long-term stability as well as fast response to L-Dopa dynamic concentration fluctuation in-vivo. Through designing the structure of the microneedles, the microneedle systems could reach the dermis without reaching the pain points and cause little pain or no pain30,31.
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