Cutting edge medical devices offer innovative options for diabetics

In the modern technologically-driven healthcare landscape, the business model of medical device companies has evolved from device makers to problem solvers. In effect, medical device manufacturers are now leveraging the Internet of Things (IoT) and the cloud to improve clinical workflow, help physicians remotely monitor patients with real-time data and analytics solutions and utilize innovative processes to cut costs and improve outcomes. For instance, novel wearable monitoring devices, equipped with the IoT technology, can communicate with smartphones, transferring crucial data to right to user friendly applications. Moreover, there has been an increasing focus on the development of smaller, more reliable, and more energy-efficient devices in recent years. Overall, the global wearable medical device market size is expected to reach USD 29.6 Billion by 2026 and register a Compound Annual Growth Rate (CAGR) of 17.7%, according to Transparency Market Research. Nemaura Medical Inc., DexCom, Inc., Tandem Diabetes Care, Inc., Insulet Corporation, Abbott Laboratories.

Blood glucose monitoring devices (BGM) take up a major portion of the market. These devices are available in a multitude of sizes as well as testing times, enabling patients and clinicians to detect high or low blood glucose levels, allowing for therapy modifications and protecting patients by confirming acute hypoglycemia or hyperglycemia promptly as well as offering patients broader self-care. The technology facilitates patient education about diabetes and its management and encourages people to adopt healthier habits. Furthermore, the increasing geriatric population is propelling market growth. According to the WHO, by 2050, the world’s aging population will swell to about 2 billion from 1 billion in 2020.

Nemaura Medical Inc. just announced breaking news that, “it has entered into a preliminary agreement with EVERSANA®, a pioneer of next-generation commercial services to the global life sciences industry.

The agreement covers the U.S. and all global sales and marketing of Nemaura’s Diabetes Management Solution, BEATdiabetes. The BEATdiabetes program is based on Nemaura’s noninvasive glucose monitoring solution, proBEAT. Nemaura and EVERSANA will work together to develop the optimal launch strategy for large-scale adoption of the diabetes management program, including franchising and direct sales to self-insured corporate clients and healthcare insurers.

In early pilot trials conducted over the last 12 months, the BEATdiabetes program yielded overall positive outcomes, demonstrating that sustainable, long-term weight loss and, therefore, improvement in the management of Type 2 diabetes is achievable. Incumbents in the space have also demonstrated clinically significant outcomes when such diabetes management programs are used in conjunction with continuous glucose monitors. Nemaura, however, has the advantage of its own proprietary noninvasive sensor technology which significantly reduces sensor costs, as the sensors are only worn a few days each month.

EVERSANA is widely regarded as the leader in digital therapeutic commercialization. Across the life sciences industry, the fully integrated commercialization provider works with more than 670 organizations, including innovative start-ups and established pharmaceutical companies.

Dr Faz Chowdhury, Nemaura Medical’s Chief Executive Officer, stated, “We are excited to be working with EVERSANA to bring our diabetes management solution to market. This is a culmination of several months of negotiations with EVERSANA following the encouraging outcome of the pilot studies. Diabetes management is an area of huge unmet need, and we anticipate that our solution will be very easy, simple to administer, and highly cost-effective, all elements supporting large-scale adoption.”

Jim Lang, Chief Executive Officer of EVERSANA, added, “Nemaura’s innovative programs and sensor technology potentially represent a major change in the way in which diabetes is addressed and how patients may be supported. We look forward to leveraging our full suite of commercialization services to support a successful U.S. launch.”

DexCom, Inc. announced on August 1st, the availability of the easy to use Dexcom ONE rt-CGM System on prescription via the NHS England, Wales, Scotland and Northern Ireland drug tariff to everyone with type 1 or type 2 diabetes using insulin. This marks the first time a rt-CGM, with no scanning and no finger pricks†, will be available to people with diabetes at the pharmacy level. Karen Baxter, Vice President, UK & Ireland, Benelux, France and Spain at Dexcom: “The addition of Dexcom ONE to the NHS England, Wales, Scotland and Northern Ireland drug tariff is enormous progress towards improving choice of diabetes tech, providing an alternative to burdensome finger pricks and scanning. We are incredibly proud of the diabetes community and are working hard to make it easier for them to access the best technology possible to manage their diabetes. As a next step, we will be working closely with healthcare professionals to ensure the diabetes community can benefit as quickly as possible from reimbursement and wider availability of Dexcom CGM.”

Tandem Diabetes Care, Inc., announced on July 21st, its acquisition of infusion set developer, Capillary Biomedical. “Infusion sets provide people flexible options in insulin pump wearability, and we are dedicated to expanding our portfolio of sets to offer our customers even greater choice in personalizing their therapy management system,” said John Sheridan, Tandem Diabetes Care president and chief executive officer. “Through this acquisition, and through our efforts with existing infusion set partners, we look forward to developing new and innovative infusion set solutions that are designed to extend wear time and enhance user experience, while reducing occlusions, body burden and waste.”

Insulet Corporation announced on September 20th, it has received CE marking under the European Medical Device Regulation for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes. “There is tremendous enthusiasm for Omnipod 5 from the global diabetes community, and we are thrilled to have achieved this latest milestone,” said Jim Hollingshead, President and CEO of Insulet. “With Omnipod 5, customers can enjoy the lifestyle benefits of a tubeless, wearable innovation and achieve positive clinical outcomes while managing their diabetes.”

Abbott Laboratories announced on September 20th, new data from the Real World Evidence of FreeStyle Libre (RELIEF) study showing the use of FreeStyle Libre, a continuous glucose monitoring system (CGM) significantly reduced the rate of hospitalizations due to acute diabetes events (ADEs) for people living with Type 2 diabetes on once-daily (basal) insulin therapy.1 These findings were published in the Journal of Diabetes Technology & Therapeutics and presented at the 58th Annual European Association for the Study of Diabetes (EASD) meeting. “The results of the RELIEF study highlight the value of FreeStyle Libre system in reducing serious diabetes-related events and hospitalizations among patients with Type 2 diabetes on basal-only therapy,” says Professor Jean-Pierre Riveline, Centre Universitaire du Diabète et de ses Complications, Hôpital Lariboisière. “The reductions are similar to the results seen among the larger cohort of people with Type 2 diabetes who were receiving multiple daily injections, suggesting that FreeStyle Libre technology therapy should be proposed as part of individualized care for patients with Type 2 diabetes on basal-only insulin, not just people on intensive insulin therapy.”
MB Bureau