Blog Tag: diabetes

Senseonics Gets Green Light from FDA on Implantable Glucose Monitoring System

Senseonics recently received Premarket Approval from the Food and Drug Administration (FDA) for its Eversense® Continuous Glucose Monitoring (CGM) System. According to Senseonics, the Eversense® CGM System is the first and only implantable device to allow for continuous blood-glucose monitoring for as long as three months.

The Eversense ® CGM system includes an implantable glucose sensor, a wearable transmitter, and the Eversense Mobile App. Senseonics advertises the sensor as utilizing fluorescent, glucose indicating polymer technology to measure glucose in the interstitial fluid. According to Senseonics, measurements from the sensor are conveyed to the wearable transmitter, which wirelessly communicates with the Eversense Mobile App to display real-time glucose measurements, trends, and alerts. 

Commenting on the FDA approval, Senseonics President and CEO Tim Goodnow stated:

 “With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way.”

J&J Accepts Platinum Equity’s $2.1B Offer for its LifeScan Subsidiary; Receives Offer for Advanced Sterilization Products Subsidiary

On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said

We are committed to putting our financial resources and global operating expertise to work in support of the company’s core mission to improve the quality of life for people living with diabetes.

LifeScan offers blood glucose monitoring products to patients for the care of diabetes under the OneTouch brand. According to the press release, LifeScan business earned approximately $1.5 billion in revenue in 2017. Platinum Equity previously reported that LifeScan President Valerie Asbury would continue leading the business.

In February 2018, Bloomberg reported that Johnson & Johnson was seeking to sell off its sterilization products division for as much as $2 billion. The selling price has increased as Johnson & Johnson announced on June 6, 2018, receipt of a binding offer from Fortive Corp. to acquire Advanced Sterilization Products (ASP), a division of Ethicon Inc., for approximately $2.8 billion. If accepted, Johnson & Johnson indicated it expects the proposed transaction to close no later than early 2019.

ASP sells sterilization products under the STERRAD and CYCLESURE brands. ASP’s high level disinfection products are sold under the EVOTECH brand. Johnson & Johnson reported that ASP earned approximately $775 million in revenue in 2017.

 

FDA Approves Prickless Glucose Monitoring System

FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients.  The glucose monitoring tool will allow patients to monitor their glucose levels the without painful and inconvenient finger pricks of traditional glucose monitoring.

According to an Abbott press release, the FreeStyle Libre system will allow patients to self-apply the sensor (which is about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with painless scans of a small hand-held reader over the scanner.  This is in contrast to traditional blood glucose monitoring, which may require some patients to finger stick up to 12 times per day.

According to the Centers for Disease Control and Prevention, over 29 million Americans have diabetes.  The FreeStyle Libre system, which became available by prescription from most retail pharmacies in the U.S. by the end of 2017, should enable patients to better manage their disease.  Healthline reports that the product has been available for several to patients in other areas of the world.  Dr. Maria Tulpan of Lenox Hill Hospital in New York, NY commented:

What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.

Abbott states that the FreeStyle Libre Flash Glucose Monitoring System is based on proprietary technology and lists over 50 U.S. Patents issued to Abbott Diabetes Care, Inc., that is believes are associated with the device.  Representative examples include U.S. Patent Nos. 8,889,305, 9,000,929, and 9,014,774.

Diabetes Monitoring Technology Moving Toward Consumer Convenience

Diabetes Monitoring Technology Moving Toward Consumer Convenience

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System.  According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via taking fingertip blood samples using a fingerstick.

Traditionally, fingersticks required one to prick their finger to obtain blood droplets for diabetes monitoring devices to work.  The Libre flash instead uses a more discreet method of operation–a small sensor wire is inserted below the skin’s surface which continuously measures and monitors glucose levels.  According to Abbott, a mobile reader is used to measure glucose levels when a user waves the mobile reader above the sensor wire.  It is intended for use in people 18 years of age and older with type I or II diabetes.  After an initial 12-hour acclimation period, it can be worn for up to 14 days.  Because a diabetic patient’s pancreas can not produce insulin, those patients frequently must monitor their blood sugar and regularly inject themselves with insulin when their blood sugars spike.

Bloomberg and Reuters report that other companies have been left behind.  Johnson & Johnson is closing its insulin-pump unit after failing to keep up with Medtronic Plc. DexCom Inc., the current leader in glucose-monitoring systems, which, in turn, lost a third of its market value on Sept. 28 after Abbott’s Libre got approval.

The Centers for Disease Control and Prevention notes that more than 30 million people in the U.S. have diabetes.  People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes).  When the body doesn’t have enough insulin or cannot use it effectively, sugar builds up in the blood.  High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or legs.

According to Bloomberg, “the bulk of the sales are to the 1.25 million American diabetes patients with the most severe form of the disease, type 1.  There’s a larger, mostly untapped market: the about 20 million Americans with type 2, whose body’s ability to use insulin fades slowly over time and who don’t regularly use tools to manage their disease.”

 

 

Sanofi & Verily Launch a Diabetes Joint Venture

Sanofi, a French multinational pharmaceutical company, and Verily Life Sciences LLC (formerly Google Life Sciences), Alphabet’s U.S.-based company devoted to the study of life sciences, recently announced the launch of Onduo, a joint venture created through collaboration between the two companies in diabetes treatment. Bloomberg and Reuters reported that Sanofi is inventing $248 million in the joint venture, and Verily the equivalent amount.

According to the announcement by Sanofi and Verily, Onduo will “leverage Verily’s experience in miniaturized electrics, analytics, and consumer software development, and Sanofi’s clinical expertise and experience in brining innovative treatments to people living with diabetes.” The announcement also mentioned that Onduo will initially focus on the type 2 diabetes community, specifically on “developing solutions that could help people make better decisions about their day to day health, ranging from improved medication management to improved habits and goals.”

Stefan Oelrich, head of diabetes at Sanofi, said to the Wall Street Journal that the collaboration between Verily and Sanofi could yield a new product much faster than traditional drug development.  He expected Onduo to launch its first product within 2 to 3 years, compared to the roughly 10 years it takes to develop a new medicine.

The joint venture came out about a year after Sanofi and Verily agreed to collaborate to improve care and outcomes for people with type 1 and type 2 diabetes.  Onduo is one of many joint ventures that Verily have created in collaboration with other major pharmaceutical and medical device companies, including Galvani Bioelectronics, a joint venture with GlaxoSmithKline (GSK), and Verb Surgical, a joint venture with Johnson & Johnson’s Ethicon.

Sanofi and Verily appointed Joshua Riff, formerly a senior vice president of prevention and well-being at UnitedHealth Group’s Optum, as the chief executive officer of Onduo.  The joint venture is based in Kendall Square, Cambridge, MA.

First FDA Approval of Closed-Loop Insulin Pump

First FDA Approval of Closed-Loop Insulin Pump

Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system.  Medtronic explains that the system uses a computer algorithm in combination with a wearable glucose monitor that automatically measures glucose levels every five minutes after which it automatically administers any insulin needed by the patient.  While the system does not completely automate insulin management—users still have to enter mealtime carbohydrates and must periodically calibrate the sensor, among other tasks—nevertheless, Lori Laffel, an endocrinologist at Harvard University’s Joslin Diabetes Center, says that the approval was a “big step forward.”

According to Medtronic, the MiniMed 670G system features Medtronic’s SmartGuard HCL algorithm and new Guardian Sensor 3, which can be worn continuously for up to seven days.  The system is approved for the treatment of type 1 diabetes in individuals fourteen years of age or older and provides continuous delivery of basal insulin (at rates selectable by the user) and administers insulin boluses (in amounts that can also be adjusted by the user).  According to the U.S. Centers for Disease Control and Prevention, approximately 5% of people with diabetes have type 1 diabetes, which is also commonly referred to as “juvenile diabetes.”

Richard M. Bergenstal, M.D., the principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, states:

With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes—particularly for minimizing glucose variability and maximizing time in the target range.

Following Medtronic’s recent approval, experts and analysts have also opined on what future insulin delivery systems could provide.  For example, Aaron Kowalski, PChief Mission Officer and Vice President of Research at JDRF, an organization dedicated to type 1 diabetes research, states:

This is a fantastic step forward, but we are not done, JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology.  Next generation systems are in the pipeline that could provide even better outcomes with less burden.

 

Mayo Clinic and Gentag, Inc. To Develop Wireless Sensors for Treatment of Obesity and Diabetes

Mayo Clinic and Gentag, Inc. have reached a joint intellectual property (IP) agreement to develop wearable biosensors designed to fight obesity and diabetes.  According to the press release, the agreement will allow certain patent rights and technologies of both Mayo Clinic and Gentag to be combined and commercialized.

The press release indicates that the two firms will also license third parties to combine Mayo Clinic’s clinical expertise with Gentag’s wearable skin patch technologies, and that more than 50 issued patents and technologies are being offered for licensing under the agreement.

The press release states that wearable patch sensors may be a “game-changer;”  the wearable patch sensors are the size of a small bandage, and include a sensor that communicates via a diabetes management system compatible with cell phones; and the system will allow researchers to monitor movement and develop treatments.

Additionally, the press release notes that Mayo’s Micro-Miniature Transceiver chip will be integrated with Gentag’s radar-responsive tag technology and integrated under the new license to develop a new type of communication chip that will combine Near Field Communication (NFC), Body Area Networks (BAN), as well as long-range wireless communication and geolocation.

The press release is available here.