Mary Tyler Moore Dead at 80
Mary Tyler Moore was diagnosed with type 1 diabetes at the age of 33...
NEW YORK (AP) — Mary Tyler Moore, the star of TV's beloved "The Mary Tyler Moore Show" whose comic realism helped revolutionize the depiction of women on the small screen, has died.
Moore died Wednesday with her husband and friends nearby, her publicist, Mara Buxbaum, said. She was 80.
Moore gained fame in the 1960s as the frazzled wife Laura Petrie on "The Dick Van Dyke Show." In the 1970s, she created one of TV's first career-woman sitcom heroines in "The Mary Tyler Moore Show."
She won seven Emmy awards over the years and was nominated for an Oscar for her 1980 portrayal of an affluent mother whose son is accidentally killed in "Ordinary People."
She had battled diabetes for many years. In 2011, she underwent surgery to remove a benign tumor on the lining of her brain.
The entire AP article is here.
Decision Moves Continuous Glucose Monitors One Step Closer to Medicare Coverage
great news from JDRF.org !!
January 12, 2017
Continuous glucose monitoring (CGM) devices approved by the FDA for use in making diabetes treatment decisions are durable medical equipment, according to a decision today by the Centers for Medicare & Medicaid Services (CMS). That determination removed a major roadblock to the devices’ coverage under Medicare. Today’s decisions mean that CGMs approved by the FDA for use in making diabetes treatment decisions are eligible for reimbursement under Medicare.
Today’s decision creates a pathway for Medicare coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Although the significant benefits of CGM use have been known since 2008, CMS had previously refused to consider covering the devices under Medicare, saying they did not meet the statutory definitions of durable medical equipment or any other category the agency could cover. Today’s decision removes that impediment.
“JDRF is encouraged by this decision, which will bring us closer to Medicare coverage for continuous glucose monitors,” said Aaron J. Kowalski, PhD, JDRF’s Chief Mission Officer. “I want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible.”
the entire press release can be found here on the JDRF website
Dexcom G5 Mobile Gains Apple Watch Complications!
Do you know what watch complications are?
Complications are the newest feature for the Apple Watch app. Dexcom G5 users with an Apple Watch can choose from 4 different watch faces and by just lifting their wrist they can quickly and easily see their glucose level and trend arrow.
“Complications are small visual elements on the watch face that communicate important information to the user. The term complication comes from watch making, where the addition of features added complexity to the watch construction. Complications are visible whenever the user looks at the watch face, and users can customize which complications are displayed. The number of slots available for complications on a given watch face varies, but most support at least two or three complications.”
Dexcom representatives told me....
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"We have seen many social media posts indicating that our users have purchased the Apple Watch primarily because Dexcom CGM glucose data is available on the watch. We are excited that this release will allow our users with an Apple Watch even greater convenience for those who want this important information in an easy-to-use and discreet form."
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"Close collaboration took place with Apple to get the watch platform to support our use case of 288 updates/day to make this feature possible for CGM. The Dexcom Watch Face was shown at last year’s World Wide Developers Conference in September, and its currently being promoted on Apple’s website in two locations, (1) on great new features of watchOS3, and (2) third-party ecosystems that make the Apple Watch great. Below are screenshots from both of Apple’s website locations."
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"As part of Dexcom’s commitment of continuous improvement in the quality and user experience of our apps, the 1.6 release also includes several sustaining improvements and enhancements."
Dexcom apps are available for iOS here.
Click here to learn more about Dexcom
Dexcom G5 App v1.6 and Apple Watch running watchOS 3 or later required. US only.
FDA: No Fingerstick Needed with Dexcom G5 CGM
by John Gever
Managing Editor, MedPage TodayDecember 20, 2016
WASHINGTON -- The FDA has approved an expanded indication for Dexcom's G5 Mobile continuous glucose monitor, allowing it to be used alone without supplementary fingerstick glucose testing.
"This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test," the agency said in announcing the decision. Previously, the system had been approved as an adjunct to fingerstick testing.
But the new approval does not mean patients can forget about fingerstick testing entirely. "Users are warned that the system must be calibrated using a fingerstick blood sample at least once every 12 hours," the FDA stressed.
In deciding to expand the indication, the FDA relied on findings from two 7-day clinical trials involving a total of 130 adults and children as young as 2. Results from the continuous monitor were compared with those from standard fingerstick meters and from lab tests of blood glucose. Those studies indicated that the continuous monitor was accurate enough to be used alone to guide treatment.
The FDA noted that the device still comes with risks including hyper- and hypoglycemia stemming from inaccurate readings. Also, redness and irritation may occur at the site where the device's skin patch is applied.
The agency also indicated that acetaminophen-containing products can "falsely raise glucose readings" from the device.
Novo Nordisk Receives FDA Approval of Tresiba® for Use in Children
Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes
Tresiba® is the only long-acting insulin approved for use in people with type 1 and type 2 diabetes as young as age one
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1
"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily."
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1
Once-daily Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) is available in Novo Nordisk's latest insulin delivery device – FlexTouch® – as a 100 units/mL or 200 units/mL pen. Tresiba® U-100 FlexTouch® can deliver up to 80 units of insulin in a single injection. Tresiba® U-200 FlexTouch® can dose up to 160 units in a single injection. FlexTouch® is also the only prefilled insulin pen with no push-button extension.1
Eligible patients with commercial insurance can use the Tresiba® Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Eligibility and other restrictions apply. For complete terms and conditions and any questions regarding eligibility, visit https://www.tresiba.com/instant-savings-card/eligibility.html or call 1-855-834-3466.