Patent analysis of digital sensors for continuous glucose monitoring.

The high need for optimal diabetes management among an ever-increasing number of patients dictates the development and implementation of new digital sensors for continuous glucose monitoring. The purpose of this work is to systematize the global patenting trends of digital sensors for continuous glucose monitoring and analyze their effectiveness in controlling the treatment of diabetes patients of different ages and risk groups. The Lens database was used to build the patent landscape of sensors for continuous glucose monitoring. Retrospective analysis showed that the patenting of sensors for continuous glucose monitoring had positive trend over the analyzed period (2000-2022). Leading development companies are Dexcom Inc., Abbott Diabetes Care Inc., Medtronic Minimed Inc., Roche Diabetes Care Inc., Roche Diagnostics Operations Inc., Roche Diabetes Care Gmbh, and Ascensia Diabetes Care Holdings Ag, among others. Since 2006, a new approach has emerged where digital sensors are used for continuous glucose monitoring, and smartphones act as receivers for the data. Additionally, telemedicine communication is employed to facilitate this process. This opens up new opportunities for assessing the glycemic profile (glycemic curve information, quantitative assessment of the duration and amplitude of glucose fluctuations, and so on), which may contribute to improved diabetes management. A number of digital sensors for minimally invasive glucose monitoring are patented, have received FDA approval, and have been on the market for over 10 years. Their effectiveness in the clinic has been proven, and advantages and disadvantages have been clarified. Digital sensors offer a non-invasive option for monitoring blood glucose levels, providing an alternative to traditional invasive methods. This is particularly useful for patients with diabetes who require frequent monitoring, including before and after meals, during and after exercise, and in other scenarios where glucose levels can fluctuate. However, non-invasive glucose measurements can also benefit patients without diabetes, such as those following a dietary treatment plan, pregnant women, and individuals during fasting periods like Ramadan. The availability of non-invasive monitoring is especially valuable for patients in high-risk groups and across different age ranges. New world trends have been identified in the patenting of digital sensors for non-invasive glucose monitoring in interstitial skin fluid, saliva, sweat, tear fluid, and exhaled air. A number of non-invasive devices have received the CE mark approval, which confirms that the items meet European health, safety, and environmental protection standards (TensorTip Combo-Glucometer, Cnoga Medical Ltd.; SugarBEAT, Nemaura Medical; GlucoTrack, GlucoTrack Inc.), but are not FDA-approved yet. The above-mentioned sensors have characteristics that make them popular in the treatment of diabetes: they do not require implantation, do not cause an organism reaction to a foreign body, and are convenient to use. In the EU, in order to increase clinical safety and the level of transparency about medical devices, manufacturers must obtain certificates in accordance with Regulation (EU) 2017/745, taking into account the transition period. The development of systems, which include digital sensors for continuous glucose monitoring, mobile applications, and web platforms for professional analysis of glycemic control and implementation of unified glycemic assessment principles in mobile healthcare, represent promising approaches for controlling glycaemia in patients.

Patent landscape review of non-invasive medical sensors for continuous monitoring of blood pressure and their validation in critical care practice.

Objectives: Continuous non-invasive monitoring of blood pressure is one of the main factors in ensuring the safety of the patient's condition in anesthesiology, intensive care, surgery, and other areas of medicine. The purpose of this work was to analyze the current patent situation and identify directions and trends in the application of non-invasive medical sensors for continuous blood pressure monitoring, with a focus on clinical experience in critical care and validation thereof. Materials and methods: The research results reflect data collected up to September 30, 2022. Patent databases, Google Scholar, the Lens database, Pubmed, Scopus databases were used to search for patent and clinical information. Results: An analysis of the patent landscape indicates a significant increase in interest in the development of non-invasive devices for continuous blood pressure monitoring and their implementation in medical practice, especially in the last 10 years. The key players in the intellectual property market are the following companies: Cnsystems Medizintechnik; Sotera Wireless INC; Tensys Medical INC; Healthstats Int Pte LTD; Edwards Lifesciences Corp, among others. Systematization of data from validation and clinical studies in critical care practice on patients with various pathological conditions and ages, including children and newborns, revealed that a number of non-invasive medical sensor technologies are quite accurate and comparable to the "gold standard" continuous invasive blood pressure monitoring. They are approved by the FDA for medical applications and certified according to ISO 81060-2, ISO 81060-3, and ISO/TS 81060-5. Unregistered and uncertified medical sensors require further clinical trials. Conclusion: Non-invasive medical sensors for continuous blood pressure monitoring do not replace, but complement, existing methods of regular blood pressure measurement, and it is expected to see more of these technologies broadly implemented in the practice in the near future.

Capillary carbon dioxide tension increases in hospital staff wearing filtering facepiece masks: a prospective crossover study.

Background: The COVID-19 pandemic has changed worldwide hygiene practices. In particular, the use of filtering face piece (FFP) masks markedly increased. Concerns have been raised regarding possible negative respiratory effects of wearing FFP masks. The aim of this study was to investigate gas exchange and subjective breathing effort in hospital personnel wearing FFP2 or FFP3 masks. Methods: In this prospective, single-centre, crossover study, 200 hospital workers were assigned to alternately wear FFP2 or FFP3 masks for 1 h during routine activities. Capillary blood gas analysis was performed to evaluate gas exchange while wearing the FFP masks. The primary end-point was the change in capillary partial pressure of carbon dioxide (PcCO2). In addition, capillary partial pressure of oxygen (PcO2), respiratory rate and subjective breathing effort were assessed at the end of each hour. Changes between time points and study groups were estimated using univariate and multivariate models. Results: PcCO2 increased from 36.8±3.5 to 37.2±3.3 mmHg (p=0.047) and 37.4±3.2 mmHg (p=0.003) in individuals wearing FFP2 or FFP3 masks, respectively. Age (p=0.021) and male sex (p<0.001) were significantly associated with increased PcCO2. Similarly, the PcO2 increased from 70.7±8.4 to 73.4±8.8 mmHg (p<0.001) and 72.8±8.5 mmHg (p=0.004) in individuals wearing FFP2 or FFP3 masks, respectively. Respiratory rate and subjective breathing effort increased significantly while wearing FFP2 and FFP3 masks (p<0.001 for all analyses). The order of wearing FFP2 or FFP3 masks did not significantly affect the results. Conclusions: An hour of wearing FFP2 or FFP3 masks increased PcCO2 values, respiratory rate and subjective breathing effort in healthcare personnel performing routine activities.