Health Canada approves Dexcom G5 for dosing
Look at Canada leading the way... We don't usually see this. Very exciting... congrats to all of my Canadian readers!
press release from PR Newswire
With Health Canada approval, Dexcom G5® Mobile CGM System is the First and Only Medical Device in North America for Making Daily Diabetes Decisions Without Painful Fingersticks
Landmark approval marks a new standard of care for managing diabetes and dosing insulin in Canada
BURNABY, British Columbia, Nov. 14, 2016 /PRNewswire/ -- Dexcom, Inc. (NASDAQ: DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that Health Canada has approved its Dexcom G5 Mobile CGM system for "non-adjunctive" use by people with diabetes aged 2 years and older.
The "non-adjunctive" indication enables the use of the Dexcom G5 Mobile CGM system as a replacement to fingerstick glucose testing for diabetes treatment decisions, making it a significant new standard of care in diabetes management. This approval means that diabetes patients and their physicians can now make treatment decisions based on data reported by the Dexcom G5 Mobile CGM system alone, without the use of painful fingersticks associated with blood glucose meters (fingersticks are only needed every 12 hours to calibrate). With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system that sends glucose data directly to a smart device, freeing users from the need to carry a separate receiver. The device transmitter securely sends vital glucose information every five minutes directly to an app on iOS-enabled devices for real-time diabetes management. Users of the system can also select up to five designated recipients, or "followers" so they can remotely monitor the user's glucose information and receive alert notifications for added protection and peace of mind.
"News of the Canadian launch of the Dexcom G5 Mobile CGM System is truly exciting. CGM technology allows people with diabetes to view real time glucose data and trends, and the built-in alarms allow for intervention by the user to minimize the risk of hypoglycemia and hyperglycemia. It has become an invaluable component of diabetes management, especially for pediatric patients," said Dr. Angelo Simone, Pediatric Endocrinologist, Trillium Health Partners, Assistant Professor, Department of Pediatrics, University of Toronto. "As a Pediatric Endocrinologist I look forward to being able to review my patient's glucose data even before the family arrives in clinic."
"As a country singer, a pilot and a person living with diabetes, I benefit tremendously from the glucose readings that I get every 5 minutes from my Dexcom CGM," says George Canyon, Canadian Country singer and type 1 diabetic. "Now, seeing my glucose levels on my phone will enable me to manage my diabetes even better and do all the things that I love most without the inconvenience and pain of fingerstick testing multiple times a day, it's like a whole new world."
Before the landmark approval by Health Canada, the Dexcom system could only be used to augment glucose meter fingerstick testing. Canada is the first country in North America to approve the device with the non-adjunctive indication as a U.S. Food and Drug Administration (FDA) Advisory Panel voted in favor of granting a non-adjunctive claim in the U.S. this summer but a final FDA decision is still pending.
"The new indication in Canada for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and is a critical step forward for advancing diabetes technology to drastically change diabetes management," said Kevin Sayer, Dexcom President and Chief Executive Officer. "Now, people with diabetes in Canada who use the Dexcom G5 Mobile CGM system can make treatment decisions without having to perform multiple fingersticks daily, which has posed a significant barrier to properly managing diabetes in the past."
The Dexcom G5 Mobile CGM System will be available within the first three months of 2017.
App Update: Dexcom G5 Mobile
Available today: Dexcom G5 Mobile Update: v1.5.1
I'm excited for the big update that is in the works for the future, but for now... this is a nice little improvement to the app.
Click on the images below to understand the update.
Diabetes Dance Dare
Dancing is way better than dumping ice on your head...
This is Arden and her friend Nadia doing the Diabetes Dance Dare for the American Diabetes Association. The ADA does so many great things fort he diabetes community including providing legal counsel for children who are being treated poorly at school. #DiabetesDanceDare
I can't dance so I enlisted Arden...
Make your own video today, share on social media and tag #DiabetesDanceDare, @amdiabetesassn and dare three people to make a video of their own.
I'm daring you!
News: U.K. Airline Pilots Fit to Fly With Type 1 Diabetes
from MedPage - Ed Susman, Contributing Writer, MedPage Today
MUNICH – Commercial airline pilots flying withinsulin-controlled diabetes had no incidents of medical incapacitation in more than 18 months of study, researchers reported here.
Of the 26 insulin-treated pilots flying planes under the U.K. flag, a total of 8,897 blood glucose monitoring values had been recorded during 4,900 flight hours with more than 96% of the cockpit glucose monitoring readings indicating pilots with diabetes were in the "Green Zone" for safety, reported Julia Hine, MD, of the Royal Surrey County Hospital in Guildford, England.
In a presentation at the European Association for the Study of Diabetes, Hine said that for short and medium haul flights -- those of less than 6 hours duration -- 96% of 7,829 blood glucose monitoring readings were within the safe range. For long haul flights, 97% of 1,068 readings were within that "green" range.
The entire article is avail able here.
First Patients Enrolled in Clinical Trial for Omnipod Artificial Pancreas System
Look out future... Here come the Podders!
BILLERICA, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced the first patient has completed the feasibility study of the Omnipod Horizon™ Automated Glucose Control System (Omnipod Horizon System). The full study will evaluate the use of a personal Model Predictive Control algorithm with the Omnipod platform in 20 adults with type 1 diabetes and is taking place in a clinical research center setting to gather data to be used to evolve the algorithm in subsequent studies leading to FDA submission.
“We are very excited to be participating in Insulet’s artificial pancreas clinical trials,” said Jordan Pinsker, M.D., senior research physician at William Sansum Diabetes Center. “Working with Professor Francis J. Doyle III and Dr. Eyal Dassau, Sansum played a major role in the development of the original UC Santa Barbara Artificial Pancreas algorithm that Insulet acquired. We look forward to contributing to the clinical and development pathway as Insulet takes this promising technology to a commercial product.”
The Omnipod Horizon System will combine best-in-class technologies into one integrated system consisting of an on-body Omnipod tubeless pump, the latest Dexcom continuous glucose monitoring (CGM) technology, a modified version of Insulet’s handheld controller and state-of-the-art security system architecture. Insulet’s Omnipod Horizon System is unique in that the algorithm looks toward the future horizon of blood glucose levels, reacting quickly and efficiently to adjust insulin delivery to optimize outcomes for each user. The system will provide the same proven lifestyle benefits as the current Omnipod System, such as the discreet, reliable, tubeless form factor and up to three days of non-stop insulin delivery to make it easy to stay connected and avoid disruption of insulin delivery during routine activities like exercising and bathing.
“Our new Omnipod Horizon System is designed to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes,” said Patrick Sullivan, President and Chief Executive Officer. “With the first clinical study of our innovative artificial pancreas underway, we have taken another important step in fulfilling our mission to improve the lives of people with diabetes.”