Slideshows
The Past, Present and Future of Continuous Glucose Monitoring
A true artificial pancreas is not yet a reality, but researchers are making strides toward realizing the technology.
The GlucoWatch from Cygnus
The first continuous glucose monitor (CGM) device made available in the United States was Cygnus Inc.’s GlucoWatch biographer (pictured), which is no longer in use, approved in 1999 by the U.S. Food and Drug Administration (FDA). According to FDA approval information, the device was described as a wristwatch-like glucose monitoring system that took readings through the skin every 20 minutes for up to 12 hours at a time and was used to track trends in glucose levels over time. The device also had an integrated alarm feature, which would sound when the patient's blood sugar readings were too high or too low. Using the GlucoWatch was a somewhat arduous project for some patients. The device required a three-hour warm-up period and had to be calibrated with a finger stick measurement. According to diabetesmonitor.com, many users were dismayed because using the device still required frequent pin pricks. After calibration, the GlucoWatch then sent a low-level electrical current through a users’ body that pulled fluid through the skin. Electrodes in the device then monitored blood sugar levels. Some patients found this process very uncomfortable and even painful. Some patients reported skin irritation. A randomized study from researchers at the University College of London pointed out further shortcomings with the GlucoWatch device. Their results were published in the May 2009 edition of the journal Diabetic Medicine. Though only 6 percent were unable to tolerate wearing the device, participants noted inaccuracies in their readings on the next-generation GlucoWatch G2 Biographer. Another clinical study from the Stanford School of Medicine found that the GlucoWatch frequently triggered false alarms, erroneously telling users their blood sugar was too high. Out of 20 alarms sounded, only 10 cases actually correctly assessed a too-high reading, the other 10 were false positives. Now GlucoWatch has vanished from the diabetes care scene and Cygnus has stopped any further development.
The Dexcom G4 Platinum Receiver with Share from Dexcom
Dexcom Inc. released its first continuous glucose monitor (CGM) in 2006 seven years after its foundation in 1999. Today, the Dexcom G4 Platinum Receiver with Share (pictured) has Bluetooth wireless communication built in. Through secure wireless connections, the device allows remote viewing of glucose levels, trends and data between the person with diabetes and anyone else of their choosing such as family members or guardians. The U.S. Food and Drug Administration approved the set of mobile apps that partner with Dexcom’s continuous glucose monitor in January this year.
The FreeStyle Navigator II device from Abbott Laboratories
Abbott Laboratories Ltd. entered the blood glucose monitoring marketplace with the acquisition of MediSense in 1996. In April 2004, Abbott completed the acquisition of TheraSense, which makes developing blood glucose self-monitoring devices that require very small blood samples to deliver rapid test results, virtually pain free. The TheraSense acquisition strengthened Abbott’s position in the large and growing blood glucose monitoring market. Today, Abbott provides the FreeStyle Navigator II device (pictured). In addition to patients using the FreeStyle Navigator II alongside (or independently of) any insulin pump device, healthcare professionals may use the FreeStyle Navigator II with patients over short periods of time to identify what blood glucose variability takes place between finger-stick measurements and to identify possible changes to therapy.
The MiniMed 640G system from Medtronic
In 2006, U.S. Food and Drug Administration (FDA) approved Medtronic Inc.’s MiniMed Paradigm Real-Time insulin pump and continuous glucose monitor (CGM) system, a diabetes management integrated system and a major step toward the development of a “closed-loop” insulin delivery system or artificial pancreas that may one day mimic some functions of the human pancreas. The system was indicated for adult patients. In 2009, Medtronic received CE mark approval of the MiniMed Veo system in more than 50 countries outside of the United States. The new system was the first with “low glucose suspend,” a feature that automatically stops insulin delivery when sensor glucose levels hit a preset low threshold. In 2012, Medtronic partnered with the JDRF (formerly known as the Juvenile Diabetes Research Foundation), in collaboration with the Helmsley Charitable Trust, to advance CGM accuracy and reliability towards the next generation of artificial pancreas systems. The partnership focuses on accelerating the development of Medtronic’s redundant sensor system to deliver more accurate CGM technology for people with diabetes. In 2013, the FDA approved MiniMed 530G with Enlite, a first-generation artificial pancreas device system with “threshold suspend” automation for people with diabetes 16 years of age or older. The system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn't respond to the threshold suspend alarm. This year, Medtronic launched the MiniMed 640G system (pictured), a breakthrough toward an artificial pancreas for people with diabetes, outside the United States. The new system incorporates a new insulin pump design to provide convenient diabetes management with a simple user interface, full-color screen, remote bolus, and is waterproof in up to 3.6 meters of water for up to 24 hours at a time.
Artificial Pancreas in development at Imperial College London
The artificial pancreas has not been realized in its ideal sense yet—i.e., a device that perfectly mimics the function of a pancreas. The human pancreas is an endocrine gland producing several important hormones, including insulin, glucagon, somatostatin, and pancreatic polypeptide that circulate in the blood. The pancreas is also a digestive organ, secreting pancreatic juice containing digestive enzymes that assist digestion and absorption of nutrients in the small intestine. The pancreas’ main function, insulin production and management, is the motivator for efforts to create an artificial version of the organ. Manually managing the blood sugar level with insulin alone is arduous and inadequate. Last year, Harvard researchers they had found a potential way to produce large amounts of insulin-producing pancreatic beta cells from human embryonic stem cells. “There have been previous reports of other labs deriving beta cell types from stem cells. No other group has produced mature beta cells as suitable for use in patients,” said Douglas A. Melton, Ph.D., who led the research. “The biggest hurdle has been to get to glucose sensing, insulin-secreting beta cells, and that’s what our group has done.” Imperial College London is developing a bio-inspired artificial pancreas (prototype pictured) for treatment of diabetes. It differs from conventional closed-loop systems in that the algorithm is based on the glucose responses of biological alpha and beta cells of the pancreas providing physiological control, in addition to being fully implemented on a miniature microchip.
By Ranica Arrowsmith, Associate Editor 08.25.15
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