Novo Nordisk Receives FDA Approval for Fiasp®, a New Fast-Acting Mealtime Insulin

Press release 

Plainsboro, N.J. (September 29, 2017) – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.

Fiasp® Can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp® is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.

Fiasp® will be available in a pre-filled delivery device FlexTouch pen and a 10 mL vial.

Many adults with type 1 and type 2 diabetes struggle with blood sugar control after meals. The result of this has led to many people with diabetes not achieving their target A1C.

 “With Fiasp®, we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target,” said Bruce Bode, MD FACE, President of Atlanta Diabetes Associates and Associate Professor at Emory University School of Medicine. “The intention of rapid acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management.”

Fiasp® will launch at the same list price as NovoLog® and will be offered with a Savings Card program for eligible patients with commercial insurance to reduce co-pays. Fiasp® will also be available to eligible patients through the Novo Nordisk Patient Assistance Program. Patients and caregivers can obtain more information and access to the Novo Nordisk Patient Assistance Program by calling toll free at 866-310-7549.

The entire release is here.

Dexcom Opens their API to Third-party Developers

Dexcom leads the way in diabetes yet again...

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (Nasdaq: DXCM), the leader in continuous glucose monitoring (CGM), announced today the availability of a public API, empowering third-party developers to connect patient-authorized CGM data into a broad range of software applications. This pioneering approach to CGM data sharing is intended to enable a rich ecosystem of novel solutions and put the user in control of where and how they interact with their glucose data.

"In launching this developer platform, Dexcom combines our CGM data expertise with the creativity of the developer ecosystem to enable new solutions and business models in the treatment and management of diabetes," said Annika Jimenez, Senior Vice President of Data, Dexcom. "Dexcom believes in data mobility and customer choice. It also believes that the API opens up opportunities to drive Dexcom CGM data into the heart of new digital solutions for payers, providers, and most importantly people with diabetes."

Get to it diabetes app developers, go make something great!

Dexcom Dev Page

---

New Apple Ad features Dexcom: Here is why that is important to you

"my daughter was recently diagnosed with type 1 diabetes"

People living with T1D are understandably excited to hear the words, "my daughter was recently diagnosed with type 1 diabetes" in an Apple ad... but that is just the beginning of why this Apple Watch advertisement should get your heart pumping.

People reach out to Apple all the time to say how Apple Watch is helping them live healthier lives. Here, real customers read the actual stories they shared. Learn more: https://www.apple.com/apple-watch-series-3

The percentage of people with type 1 using continuous glucose monitoring technology is still relatively low. The barriers to adoption are multivariable. Cost, lack of insurance coverage, misunderstanding of what the technology brings to your life and plain just not knowing that it exists are but a few. The truth however is that even if you never find your way to a CGM this quick video, in my opinion, should still make you happy. Here's why.

We finally have a device manufacturer in the diabetes world who moved beyond the diabetes world. When Dexcom searched for others whose collaboration might improve their product, they didn't just form a relationship with a little start-up. They formed a relationship with Apple. The mention of Apple Watch integration with Dexcom in this ad, in my opinion, is not random. The mention didn't happen just because someone wrote a letter. It is there on purpose. This is Apple telling us what is important to them and a signal of where they are focusing their efforts when it comes to the health space. 

The company that put a smartphone into most every hand on the plant and the company that is hugely responsible for the technology that keeps my daughter healthy, they are dating. I think we are all going to like what their future children grow up to be. I'm even more excited when I think about the relationship that Dexcom has with Omnipod and the ways that the Apple connection could improve all aspects of the tech that helps to keep Arden's BGs where we want them. 

For the moment its great to hear diabetes in the mainstream in such a positive way, but I think that this is only the beginning of how Dexcom and Apple are going to make us smile. It is important to note that Dexcom advertises on the Juicebox Podcast but that I wrote this piece on my own. 

---

RECALL: Medtronic Infusion Sets

From Medtronic

Explanation of the Issue
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.

Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.

To see if your infusion sets are part of the recall please go to this page supplied by Medtronic

https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter

*****
Further Press release

---

Fitbit and Dexcom!

Fitbit and Dexcom to Develop Continuous Glucose Monitoring (CGM) Experience for People Living with Diabetes

press release

SAN FRANCISCO & SAN DIEGO--(BUSINESS WIRE)-- Fitbit (NYSE:FIT), the leading global wearables brand, and DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, today announced a collaboration to develop and market products to help people better manage their diabetes and get a more complete picture of their overall health with easy-to-use mobile tools.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170907005577/en/

The first planned initiative is to bring Dexcom CGM data to Fitbit's new smartwatch, Fitbit Ionic. Through this experience, Dexcom CGM users on either Android or iOS devices would be able to see both activity and glucose levels, right on their wrist.

View fullsize

"The strength of our brand and our ability to track critical health metrics continuously for up to 4+ days1, coupled with Dexcom's market leadership in CGM, present a powerful combination that we hope will help millions of people better manage their diabetes," said James Park, CEO of Fitbit. "With Ionic, we are focused on driving positive health outcomes and more health focused tools, and this collaboration is a wonderful example of how we plan to bring that vision to our users."

Dexcom CGM Display on Fitbit Ionic will provide data for those living with diabetes

The World Health Organization estimates2 that more than 400 million people around the world are living with diabetes. For those individuals being able to see both physical activity and glucose can be a vital tool for effectively managing their diabetes.

"The collaboration between Dexcom and Fitbit is an important step in providing useful information to people with diabetes that is both convenient and discreet," said Kevin Sayer, President and CEO, Dexcom. "We believe that providing Dexcom CGM data on Fitbit Ionic, and making that experience available to users of both Android and iOS devices, will have a positive impact on the way people manage their diabetes."

A health and fitness first platform, Ionic offers a highly personalized experience not previously seen in other smartwatches. Ionic features a relative SpO2 sensor, industry-leading GPS tracking, on-device dynamic workouts, improved heart rate tracking, and water resistance up to 50 meters. Plus, smart features like contactless payments, on-board music, smart notifications, and a variety of popular apps and clock faces available in the Fitbit App Gallery. Ionic also has all the core features from Fitbit like 4+ day battery life, automatic activity and sleep tracking, and cross-platform compatibility.

In addition to the Dexcom CGM display for Fitbit Ionic, with Fitbit's in-app Community, Dexcom CGM users will now be able to connect with millions of people, where they can ask questions, seek support and share successes in managing their health.

The companies are targeting availability as soon as possible in 2018 and will continue to explore opportunities to work together to develop tools and resources aimed at helping people better manage their diabetes.

---

Dexcom is a sponsor of the Juicebox Podcast. You can use this link to find out more about our favorite continuous glucose monitoring system.