Blog Tag: Glucose Monitoring

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.”

Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval

Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen. According to Xeris’ President and CEO Paul Edick:

Xeris is on-track to submit an NDA for our ready-to-use glucagon rescue pen for the treatment of severe hypoglycemia in late Q2 of this year.  We will use the data from the Phase 3b study to gain additional information regarding the entire treatment episode, including preparation and administration time of the current glucagon emergency kits versus our rescue pen auto-injector, for people with diabetes who may require glucagon in emergency situations.

Xeris also recently released results from a Human Factors usability and reliability study which, according to Xeris, demonstrated a 99% success rate for patients in administering full doses of glucagon with the rescue pen using a simple 2-step process.

Xeris notes that glucagon treatment is critical for persons susceptible to severe hypoglycemic events. Severe hypoglycemia, if untreated, can result in seizures, coma, brain damage, and if left unaddressed, even death. Along with insulin, glucagon helps maintain the glycemic control system which in turn keeps blood glucose at optimum levels within the body. The American Diabetes Association recommends glucagon be prescribed for persons facing increased risks of hypoglycemia. According to Xeris, due to limitations in current glucagon products and the difficulty involved in administration methods (especially in emergency situations), such treatments have been underutilized by persons at risk of suffering from severe hypoglycemic events.

According to Xeris, their rescue pen aims to provide ready-to-use, room-temperature stable, and injectable and infusible drug formulations. Xeris’ proprietary XeriSolTM and XeriJectTM formulations are currently being examined for administration in both subcutaneous and intramuscular delivery sites. Xeris states that unlike some injectable drug formulations provided as a powder that is later reconstituted with water at the time of administration, Xeris’ formulations are non-aqueous, ultra-concentrated and ultra-low volume, biocompatible solutions or pastes. Xeris also reports that their formulations are packaged in a ready-to-use compatible syringe, such as its rescue pen auto-injector, or other compatible devices, such as vials, pens, or pumps. 

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.”