Innovative Wearable Devices Offer Patients a New Way to Manage Their Conditions

NEW YORK, May 11, 2020 /PRNewswire/ -- Around the world, there is an increasing number of people who have been diagnosed with lifestyle-associated diseases, such as hypertension and diabetes, which has created the need to monitor their health on a regular basis. By using self-monitoring wearable devices, patients are now capable of gathering crucial data related to various conditions, as well as other health parameters and then forward the data to their doctor for review. The medical wearable device market has been rapidly growing in recent years, not only because of the practical implications of such devices but in large part thanks to emerging economies such as India, China, and Brazil. The healthcare infrastructure in these economies is rapidly developing, and technology plays a more important role than ever before. Additionally, the growing adoption of mobile platforms, increasing adoption of AI and 5G, and the growing awareness and preference for home healthcare are all expected to help further boost the market. Overall, the global wearable healthcare devices market is projected to reach USD 46.6 Billion by 2025 from USD 18.4 Billion in 2020 and at a CAGR of 20.5% from 2020 to 2025, according to MarketsandMarkets. Nemaura Medical, Inc. NMRD, Abbott Laboratories ABT, Masimo Corporation MASI, Fitbit, Inc. FIT, DexCom, Inc. DXCM.

Major companies like Apple and Samsung are heavily involved in the innovation of wearable devices, which are now capable of performing a wide range of features including cellular connectivity, health monitoring, contactless payment and more. Fitness trackers are expected to continue to hold the largest share in the wearable medical devices market in the near future. This is due to the device's affordability and ability to track various parameters, such as the number of steps taken and calories burned, which are essential for fitness. Another segment that is quickly becoming more accessible is that of blood glucose monitoring devices (BGMD), which are used to measure glucose levels in diabetic patients, and help analyze glucose level patterns by providing continuous and real-time readings. In recent times, the appearance of medical devices that help consumers monitor their glucose levels has attracted the FDA's attention. According to MedCity News, Courtney Lias, Director of the Division of Chemistry and Toxicology Devices Office, part of FDA's Center for Devices and Radiological Health, who spoke strongly in support of developing interoperable devices that could wirelessly communicate, not only with each other but with other digital apps. "We want to incentivize interoperability and open systems through optimized regulatory pathways," Lias said, noting that the agency has taken two regulatory actions to create a "pathway for devices to become integrated with each other including apps."

Nemaura Medical, Inc. NMRD just announced breaking news this morning regarding, "positive initial user-volunteer data from its head-to-head comparison with a major incumbent CGM device. sugarBEATÒ was developed as a viable, flexible, and cost-effective alternative to invasive continuous glucose monitors ("CGM"), and the company plans to seek reimbursement in key territories.   

Earlier this year Nemaura announced that following discussions with various healthcare insurers, it was planning head-to-head comparisons with one or more major incumbent CGM devices. The aim of these studies was to position sugarBEATÒ as a cost-effective, flexible alternative to marketed invasive CGM, allowing continuous glucose monitoring on days the user chooses, and therefore, we believe, reducing the overall cost burden to users and healthcare insurers alike. Today, the Company reported early results comparing data between sugarBEATÒ and a major incumbent CGM device, demonstrating sugarBEATÒ accuracy on par with the incumbent CGM device, using a single finger prick calibration. Further details can be viewed on a report published on the company's website at: https://nemauramedical.com/publications/

Dr Faz Chowdhury, CEO of Nemaura, stated: 'The primary objective of these user studies comparing sugarBEATÒ with marketed CGMs was to demonstrate that similar long term clinical outcomes can be achieved irrespective of whether CGM is used every day of the month or only on a few days of the week or month.  We believe that the implications of this would be that the annual cost per user would dramatically fall, making it affordable for the 90% of the diabetic population that are Type 2, the majority of whom do not require continuous daily monitoring, and those persons with Type 1 diabetes who are not currently using any CGM for whom having an occasional daily glucose profile would provide a powerful insight into the control over their blood sugar levels and Time-in-Range profiles. Our overall goal is to empower users with data that helps them develop control over their glucose fluctuations and guide them towards improved Time-in-Range profiles to reduce the long term complications of diabetes and help potentially reverse Type 2 diabetes, and also help those with pre-diabetes from developing diabetes. We believe that sugarBEAT is uniquely positioned to be able to achieve these goals, given that existing invasive CGMs are costly and do not have the flexibility of wear and resulting cost-advantage that we believe sugarBEAT provides.'

Dr Chowdhury discussed the commercial rollout and unique positioning of sugarBEATÒ in an exclusive interview with Redchip, which can be viewed here: https://youtu.be/7Mujq9_wDOw.       

Nemaura also plans to launch proBEAT™ in the USA later this year, which is expected to help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by deploying sugarBEATÒ to act like a black box flight recorder. It is planned that big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently "fine-tuning" predictive algorithms and artificial intelligence based feedback and prompts. We believe that these will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle, targeting over 85 million people that are pre-diabetic and over 24 million people who have Type 2 diabetes in the US. Nemaura is intending to pursue reimbursement from healthcare insurers in the US for proBEAT™."

Abbott Laboratories ABT announced earlier this year that four real-world data abstracts are being presented during the 13th Advanced Technologies & Treatments for Diabetes (ATTD) in Madrid. The new data show that users of the FreeStyle Libre system have improved glucose control, increased time in target glucose range, and decreased time in hyperglycemia (high glucose levels) and hypoglycemia (low glucose levels), as well as reduced HbA1Ci, (average glucose levels over a three month period). "As the world leader in sensor-based glucose monitoring with more than two million users, Abbott's FreeStyle Libre system has an unmatched body of real-world evidence supporting its clinical benefits," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs, and chief medical officer, Diabetes Care, Abbott. "Time and time again, we've seen meaningful data that reaffirm our technology's direct impact in achieving better health outcomes for people with diabetes – and the findings at ATTD underscore how we're continuing to transform people's lives."

Masimo Corporation MASI announced on April 7th, that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet™ to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness."

Fitbit, Inc. FIT and WellCare Health Plans, Inc. announced last year their partnership, according to which Fitbit devices will be delivered to WellCare Medicaid members in Georgia who take positive steps to manage their diabetes by completing their annual diabetic eye exams. Beginning Jan. 1st, 2020, in an effort to help its members manage their condition and prevent complications from diabetes, WellCare is offering Georgia Medicaid members ages 18 and older with a diabetes diagnosis who are enrolled in the Fitbit Diabetes Program a Fitbit Inspire™ upon completing their annual diabetic eye exam. "We are excited to partner with Fitbit as we work to educate, motivate and support our members around the benefits of physical activity. Fitbit's fitness tracker complements WellCare's existing care management resources and will provide yet another resource to help our members living with diabetes manage their condition and improve their overall health and wellbeing," said Dr. Clarence Davis, WellCare's Senior Medical Director for Georgia.

DexCom, Inc. DXCM and Insulet Corporation have announced earlier this year a global commercialization agreement to combine current and future Dexcom continuous glucose monitoring systems (CGM) with Insulet's trusted tubeless insulin delivery Pod into the Omnipod Horizon™ System for automated insulin delivery, currently in pivotal trial. Under the terms of the non-exclusive agreement, the Omnipod Horizon Automated Insulin Delivery (AID) System will use sensor values from the Dexcom G6 and next generation G7 CGM systems to predict glucose levels into the future and automatically adjust the insulin dose required to help reduce the occurrence of blood glucose highs and lows. "Everyone at Dexcom is excited to be in the final stages of integrating Dexcom CGM technology into the Omnipod Horizon System," said Kevin Sayer, Executive Chairman, President and CEO of Dexcom. "This system will bring together the demonstrated accuracy of Dexcom CGM with Omnipod's tubeless insulin delivery Pod which provides a simple user experience and freedom from injections and tubes. It will be a truly transformative, automated insulin delivery system giving more options to people with diabetes." "This agreement with Dexcom represents an incredible milestone for our two organizations in realizing the benefits of interoperability," said Shacey Petrovic, President and CEO of Insulet. "The ability to integrate with new innovation efficiently will offer consumers the latest and greatest in Pod and sensor technology, while providing the freedom of choice so they can live life to the fullest."

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