FAYETTEVILLE, Ark. – Medical technology company SFC Fluidics has announced a new Industry Discovery and Development Partnership supported by JDRF to develop an insulin patch pump with open-protocol communication capabilities. JDRF launched its Open-Protocol Automated Insulin Delivery (AID) Systems Initiative in 2017 with the goal of working with key stakeholders to understand the regulatory and liability implications of an “open-protocol” AID ecosystem and to accelerate the delivery of such components to market. “We are excited to support SFC in its open-protocol pump development as a key step toward the realization of our goal of an open-protocol AID ecosystem,” said Daniel Finan, JDRF research director, in a statement. “We are hopeful that solutions such as this will greatly expand choice in the marketplace, increase adoption of advanced, life-improving technologies among people with T1D, and accelerate the cadence of innovation in these treatment options.” The development and delivery to market of a fully interoperable, open-protocol insulin pump is the goal of this JDRF-SFC partnership. The two-year funding commitment from JDRF enables SFC to accelerate the development and regulatory submission of an open-protocol patch pump system that enables seamless, secure connectivity with other devices like interoperable continuous glucose monitors and third-party AID algorithms. SFC will develop a fully functional patch pump that will operate on its own platform, as well as publish its communication protocol, so that approved devices can communicate with the patch pump.
CHICAGO – The U.S. Food and Drug Administration has approved Abbott’s FreeStyle Libre 14-day continuous glucose monitoring system. In the U.S., people with diabetes can wear the sensor up to 14 days with high accuracy. “People with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition,” said Jared Watkin, senior vice president, Abbott Diabetes Care, in a statement. The CGM system provides users with real-time glucose results, an eight-hour historical trend and an arrow showing the direction their glucose is going. Data from FreeStyle Libre can be shared with doctors and health care providers.
TAMPA, Fla. – Smart Meter, provider of the Cellular Diabetes Care Solution, is integrating its technology with Validic’s data connectivity platform for a diabetes management solution for patients, health care teams and population management programs. “Our collaboration with Validic enables us to seamlessly provide data to a wider group of health care professionals, integrate data into various health records and assist in delivering better care to those that need the most attention,” said Cliff McIntosh, CEO of Smart Meter, in a statement. The iGlucose solution uses cell-enabled technology to automatically transmit real-time blood glucose results to providers, eliminating the need for cables, synching devices and apps for people with diabetes. Health care teams can engage patients by viewing real-time results and seeing when their patient’s blood glucose results are out of range. “Through this partnership, we continue to broaden access to key clinical insights—generated outside the clinical setting—that are necessary to provide effective and targeted treatments and interventions,” said Drew Schiller, CEO of Validic, in a statement.
SAN DIEGO – Companion Medical has received CE Mark for the InPen system, a smart insulin pen paired with an integrated diabetes management app. While the system is currently available in the U.S., this clearance paves the way for launch in multiple international markets, said Sean Saint, CEO of Companion Medical, in a statement. “We look forward to introducing more sophisticated smart pen technology with integrated diabetes management tools to people with diabetes in Europe,” he said. “Our mission is to empower people living with diabetes and their health care providers with easy-to-use solutions that improve outcomes at a lower cost. The InPen system gives people with diabetes the tools they need to answer those questions precisely and accurately.” The system includes the ability for users to generate an Insights by InPen report, which displays aggregated glucose, insulin and meal data with detailed daily views, enabling providers to monitor glucose control and adherence patterns, identify the causes and effects of key decisions and make targeted improvements to therapy. Companion Medical plans to launch the InPen system in Europe next year.
BASEL, Switzerland – Roche has received CE Mark for its Accu-Chek Solo micropump system, a tube-free insulin delivery system that offers users the choice to bolus directly from the pump or from the fully-functional handheld, as well as to detach and re-attach the pump without wasting insulin. “This important milestone will enable us to further expand access to insulin pump therapy to those people with diabetes who can benefit most from this therapy option—so they can spend more time in their ideal target range and experience an improved quality of life,” said Roland Diggelmann, CEO of Roche Diagnostics, in a statement. The Accu-Chek Solo micropump integrates with Roche’s digital health solutions like the Accu-Check Smart Pix system. The company will initiate the pilot commercialization phase for the system in Austria, Poland, Switzerland and the UK in the coming weeks and is conducting a clinical study in several European countries.
EDINBURGH, Scotland, & SAN DIEGO – Dexcom has received CE Mark for its Dexcom G6 continuous glucose monitoring system for people with diabetes ages two years and up. “The Dexcom G6 represents the future of diabetes management,” said John Lister, Dexcom’s general manager for Europe, Middle East and Africa, in a statement. “Not only does the product eliminate the need for fingersticks, but it also maintains the performance, connectivity and accuracy that the diabetes community has come to expect from Dexcom CGM.” The Dexcom G6 was launched in the U.K. and Ireland in June and is expected to be introduced in other European countries later this year.
DUBLIN – First-year results from a partnership between Medtronic and UnitedHealthcare show that use of Medtronic’s MiniMed 630G insulin pump reduced preventable hospital admissions for people with diabetes by 27%.
The partner study included more than 6,000 UnitedHealthcare members with diabetes who used standalone pumps and pumps integrated with continuous glucose monitors, as well as members who are on multiple daily injections of insulin. “These positive results provide further evidence of the benefits of both automated insulin delivery and of value-based healthcare models” said Hooman Hakami, executive vice president and president of the Diabetes Group at Medtronic, in a statement. “Through this unique partnership, Medtronic and UnitedHealthcare have demonstrated a commitment by both organizations to prioritize innovation that improves health outcomes and lowers healthcare costs.”
In 2016, UnitedHealthcare and Medtronic announced an expanded relationship that gave UnitedHealthcare members with diabetes access to advanced insulin pump technologies and comprehensive support services offered by Medtronic. These offerings currently include the company’s most advanced MiniMed 670G hybrid closed-loop system featuring SmartGuard technology and Guardian Sensor 3, which automates the delivery of a personalized amount of basal insulin every five minutes based on real-time sensor glucose values.
“Our hope is that this agreement is just the beginning and that the entire health care community follows UnitedHealthcare’s lead to not only champion innovation in diabetes that has a clear and measurable tie to better outcomes and lower cost, but to also drive business models that reward those results as they are achieved,” said Hakami.
The results reflect the first year of a multiyear initiative between UnitedHealthcare and Medtronic. Both quality of care and cost will continue to be evaluated over the duration of the relationship, providing additional opportunities for more people enrolled in UnitedHealthcare plans to better manage their diabetes and for quality care to be delivered in a more cost-effective manner.
“These results show that patients with diabetes can benefit from using insulin pumps and comprehensive support services, thereby increasing the quality of the care they receive and reducing hospital admissions, as well as costs,” said Dr. Peter Pronovost, chief medical officer at UnitedHealthcare, in a statement. “The first-year results are encouraging, and we will monitor patients using Medtronic pump therapies to ensure we continue to see improved quality of care, fewer hospitalizations, and lower costs.”
‘It’s an important step for patients, caregivers and providers’
ABBOTT PARK, Ill. – After hearing from a number of patients and other stakeholders, the Centers for Medicare & Medicaid Services recently reversed its position on reimbursement for smartphone-connected continuous glucose monitors.
The agency will modify Medicare’s published coverage policy for CGMs to support their use in conjunction with a smartphone, including for data sharing.
Industry leaders were quick to applaud the decision, including Glenn Johnson, general manager of market access, and Joel Goldsmith, senior director of digital platforms, at Abbott Diabetes Care, which makes the Freestyle Libre CGM system.
HHTN:How will the decision by CMS impact the continuous glucose monitoring industry?
JOHNSON:This is an important step forward in simplifying diabetes management and yielding the way for future advances in smartphone-enabled continuous glucose monitoring technology. It reinforces the importance of our efforts to make this technology available for U.S. users in the near future.
HHTN:How will it benefit providers and patients?
JOHNSON:The CMS decision is an important step not just for patients, but also for caregivers and providers. For some people with diabetes, caregivers are there to provide support when needed, while others depend on their caregivers for daily tasks, such as medication intake and meals. Smartphone-enabled CGM technology provides those caregivers with peace of mind by allowing them to remotely follow their loved ones’ glucose levels and monitor in real time. Physicians can closely follow their patient’s glucose trends and patterns to make treatment decisions and help improve outcomes.
HHTN:What are some challenges standing in the way of a wider adoption of home health technology like continuous glucose monitors?
JOHNSON:Cost and reimbursement decisions play a big role in whether new health technologies can be widely adopted. At Abbott, our main priority is to provide patients with access to an innovative and affordable product that eliminates painful routine fingersticks for people living with diabetes. We believe that to be truly innovative, you have to find a way to become available to the masses, not just to an elite few who can afford it.
HHTN:How is technology impacting the delivery of home health care today?
GOLDSMITH:Technology has transformed healthcare delivery in the past few years by enabling us to bring new solutions to market that address key health challenges and improve patient outcomes. The diabetes market specifically has been steadily evolving as patients and health care providers are embracing wearable technologies for glucose monitoring; they are now connected at a much higher level and work in tandem to optimize diabetes management.
HHTN:What will it look like in the future?
GOLDSMITH:We believe that health care technology will continue to evolve to provide patients with actionable insights to improve disease management and that we are at the helm of pioneering how data can translate into improved outcomes by enabling people with diabetes to make more informed decisions about their care. This is just the beginning.
BILLERICA, Mass. – Insulet, a provider of tubeless insulin pumps featuring the Omnipod insulin management system, has received clearance from the U.S. Food and Drug Administration for its Omnipod DASH insulin management system. “Omnipod DASH embodies what users on multiple daily injections have been asking for in a diabetes management system,” said Patrick Sullivan, chairman and CEO, in a statement. “Our No. 1 priority is to continue to minimize the daily strain on those impacted by diabetes and we are confident that this system, and eliminating the system’s upfront cost, do just that.” The Omnipod DASH system features Bluetooth wireless technology for connectivity between the color touch-screen personal diabetes manager and tubeless waterproof pump, and is optimized for use with the CONTOUR NEXT ONE blood glucose meter, as well as the Omnipod DISPLAY and Omnipod VIEW apps.
SEATTLE – Brook, a chronic disease digital health platform provider, and New York health plan Independent Health are partnering to provide enhanced resources to help its members self-manage their care. In addition to collaboration on technology and delivery of new services, Independent Health is participating in a recent round of financing to help Brook complete a seed round of $4 million. “Today, technology can help personalize treatment using a process that can be customized and flexible,” said Oren Nissim, co-founder and CEO of Brook, in a statement. “Our partnership with Independent Health is groundbreaking for individuals seeking to manage their chronic diabetes condition, and it is equally exciting for medical and health care professionals.” Dr. Michael Cropp, president of Independent Health, will also join Brook’s board of directors. Brook is developing a personal health assistant technology that provides simple, impactful, data-driven support with medical and health services professional coaching to help individuals manage diabetes and other chronic conditions. Using mobile sensors, Brook tracks and interprets data like activity and sleep, and runs a routine analysis engine that captures diabetes and behavior data. Brook than combines and connects the use of a chatbot with a human expert team, providing patients with continuous support for their successful diabetes management.