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

from PRNewswire

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.

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Bold is my Favorite Word

A long time ago on a Diabetes Facebook page that now seems far away...

The sky was always falling... Real conniptions were omnipresent... Shit was bananas... You name the panic, it was at the disco. We were ALL GOING TO DIE, like right now.

I am very happy to report that the sky is not falling and that we are all going to be fine. However, there was a time when you wouldn't have known that if you were a person looking for support (in some corners of the diabetes community), but that time seems to be changing more with each passing day. I couldn't be any more pleased to see it go or any happier to learn of what has replaced it. Maybe I should explain.

Living with diabetes requires support and finding that support online can actually be a huge and extremely helpful part of moving forward. There can however, be a downside; for example... What happens when you "arrive" online two days after the person that you are suddenly taking advice from? To you this well-meaning person seems sage like and you are apt to take their words as law. What happens when your new found guru is scared (as most rightfully are in the beginning) and at a loss for what to do next? Well, when they are afraid your understanding quickly aligns with theirs as it enforces your fear and uncertainty. That fear often imprints on you and all of your expectations and experiences going forward become tinted in that light. Now maybe you'll get lucky and log on while someone who is a little farther along the path is online and offering answers. In that situation the positive attitude and learnid experience that follow will lead you in a more positive direction. But what happens when twenty people offer their opinions in a thread and they all seem to be different - usually our minds will find truth in the feelings that we are currently experiencing. Basically, if the new person is scared, they follow the fear based answers and vice-versa. These initial interactions are, in my opinion, of vital importance especially early after diagnosis.

Many years ago I made it my personal goal to try and affect that part of our community. I thought that if enough newly diagnosed people felt empowered, understood insulin and began seeing positive outcomes sooner than expected, when it was their turn to give back to the community they'd begin from that position. I believe that when you have a bit of information, support, perspective and a reasonable yet positive expectation; you are well on your way down the path that leads to a healthier and happier life with diabetes.

Basically Instead of...

Q. I'm seeing mealtime spikes, what can I do?

A. Too bad sister, that's diabetes. You're screwed.

I was hoping for...

Q. I'm seeing mealtime spikes, what can I do?

A. Have you tried to pre-bolus? Tell me more about the starting BG when you ate. Don't worry this is easily fixed by understanding how insulin works - you're going to be fine!

I wanted to change the perception that all is lost and there is no way out because I don't believe that and it is simply not true. In my experience the sooner you have a meaningful direction supported by actionable facts, that sooner things will be okay again.

So I began to write blogs about ignoring fear, I talked more openly about how we manage, how insulin works and taking more control in endo appointments and while your children are sleeping and in school. I wanted people to have a chance to begin at the end. I thought this was possible because (do you want to hear a secret?)... largely confidence is one part preparedness and one part pollyanna. All you really need to begin to live well with type 1 is the facts and someone to stand on the other side of the room cheering for you with blinding encouragement. Recently I've begun to notice that those private Facebook groups that I spoke about are trending toward "yes you can and here's how" and getting away from, "dig a hole and climb in - you're cooked". There has even been a severe reduction in the posts that are designed to draw in people who are struggling so everyone can commiserate in a way that allows for them to give up. When giving up feels (and has been assured by others) like the only path left, struggles will follow. There is nothing wrong with a good cry once and a while but after that, back up, keep going, find a better answer than the one you currently have and put it into practice.

Of all of the things that I've tried I am particularly proud of a few Juicebox Podcast episodes that I see people talking about online. Every time that I see someone saying that they are being 'bold with insulin', my heart warms in ways that you can't imagine. 

So thank you if you've been part of ignoring the fear and being bold and for sharing your strength instead of your anxiety, you are shaping a community that will help to form a new generation of what people living with diabetes expect from their lives. Happy Diabetes Awareness Month!

Listen to the Juicebox Podcast on: itunes/ios - google play/android - iheart radio -  or your favorite podcast app. subscribe today!

Omnipod of the Future Revealed

Omnipod had a shareholder meeting this week and the slideshow that accompanied it was full of interesting stuff...

Timeline for new products and innovation 

Exciting!

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Relationship with Lilly to bring concentrated insulin

Looks like concentrated insulin keeps form factor small while adding enough insulin for people with greater needs...

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New Bluetooth PDM and an Artificial Pancreas 

Looks like the plan is to first release the Dash (new PDM) followed by the Horizon Artificial Pancreas system...

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The entire slide deck can be found here, it has lots more info and business type stuff. I only brought you the exciting diabetes tech images. I need to get an Omnipod representative back on the Juicebox podcast. Good times ahead folks, good times! Lots of questions...

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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.

The entire press release can be found here.

World Diabetes Day in NYC with Dexcom

Arden is a Dexcom Warrior... 

Arden had the opportunity to join Dexcom CEO Kevin Sayer on World Diabetes Day as he opened the trading day by ringing the NASDAQ bell - it was a great time! I brought you back some pictures and video.

Dexcom covered our lodging, gas, parking and one meal (that meal came with a cookbook). We paid for everything else (and it's New York City). They did not ask me to post about the day, but I'm assuming that they knew I would - because, ya know - it was a fantastic day for diabetes awareness!!!

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Related: Health Canada approves Dexcom G5 for dosing