Omnipod® 5 has been cleared by the FDA!
Insulet, makers of the Omnipod tubeless insulin pump, just announced that they have received clearance from the FDA for their Omnipod® 5 Automated Insulin Delivery System. The first tubeless system with compatible smartphone control. Press release below.
Later today the Juicebox Podcast will have an exclusive interview with two surprise guests about the announcement that will be full of juicy product details! There will be a special link in the episode to a website all about the Omnipod® 5.
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PRESS RELEASE:
Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control
ACTON, Mass.--(BUSINESS WIRE)— Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes. Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates
with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
Omnipod 5 is designed to make it easier than ever to manage glucose with no multiple daily injections,
no tubes, and zero fingersticks1 to help simplify life with diabetes.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
The Omnipod 5 System2 consists of the tubeless Pod enhanced with SmartAdjustTM technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.
Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.
“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, President and CEO of Dexcom. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”
Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no
commitment, and no obligation. In the coming days, Insulet will offer Omnipod 5 in a limited market
release so that the Company can incorporate learnings to deliver a best-in-class product experience.
Omnipod 5 is expected to be broadly available shortly after the limited market release.
Omnipod 5 was recently selected as a CES® 2022 Innovation Award honoree in two categories: Health
and Wellness and Wearable Technologies. The CES Innovation Awards is an annual competition
honoring outstanding design and engineering in consumer technology products.
People with diabetes can enjoy the benefits of Pod Therapy today through OmnipodPromiseTM, which
allows new and existing users to start on Omnipod DASH® and upgrade to Omnipod 5 at no additional
cost when coverage is available.
To learn more, visit the Omnipod website.
Insulet will provide additional details about today’s announcement on the Company’s fourth quarter 2021 earnings conference call on February 23, 2022 at 4:30 p.m. (Eastern Time). The link to the live call will be available here and will be archived for future replay. To participate in the live call via phone, please pre-register online here to receive a telephone number, passcode, and a unique registrant ID required to enter the call.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device
company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod
product platform. The Omnipod Insulin Management System provides a unique alternative to traditional
insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days
of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique
design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin
subcutaneous drugs across other therapeutic areas. For more information, please visit
insulet.com and omnipod.com. Forward-Looking Statement:
This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 24, 2021 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
1 If a user’s glucose alerts and readings from the G6 do not match symptoms or expectations or a user is taking over the recommended maximum dosage amount of 1000mg of acetaminophen every six hours, one should use a blood glucose meter to make diabetes treatment decisions.
2 The Omnipod 5 Automated Insulin Delivery System is comprised of SmartAdjustTM technology (cleared in K203774), the Omnipod 5 Pod and Omnipod 5 App (cleared in K203768) and the Omnipod 5 SmartBolus Calculator (cleared in K203772). Integration with the Dexcom G6 CGM is required for automated insulin delivery.
©2021 Insulet Corporation. Omnipod, Omnipod DASH, Omnipod 5, SmartAdjust, and OmnipodPromise are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. Dexcom G6 is a registered trademark of Dexcom and used with permission. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.
Contacts:
Investor Relations:
Deborah R. Gordon
Vice President, Investor Relations (978) 600-7717 dgordon@insulet.com
Media:
Angela Geryak Wiczek
Senior Director, Corporate Communications (978) 932-0611
awiczek@insulet.com
Source: Insulet Corporation
Five Million Downloads and Streams
I started making the Juicebox Podcast 2,580 days ago
That means that it took seven years to amass five million downloads/streams. In that time I have spoken to countless people who live with, or love someone who has diabetes. I have learned from all of you. I know about your fears, how you love, accept, defy, triumph and persevere. I’ve heard stories about mental illness, second chances, regret and euphoria. Your stories add to my understanding of diabetes and the human experience.
I’ve come to think of the collective podcast as art in some ways. All I can do is create in the form that it makes sense to me. After I share with you, the course that my words find in the world is largely out of my hands. Growth like this requires that someone else, besides me, cares enough about the show to keep it alive in the consciousness of others.
Thank you for listening, for sharing and for caring for my art after it leaves my control. Your support made this happen and it is the reason why I am predicting three million new downloads/streams in 2022. We are going to get to eight million a whole hell of a lot faster than we got to five.
This celebration is as much yours as it is mine. Please help me celebrate today by sharing your remembrances and feelings.
Thank you,
Scott
On This day, January 11 1922: Insulin Was First Used to Treat Diabetes
On Jan. 11, 1922 fourteen-year-old Leonard Thompson was injected with a pancreatic extract prepared by Dr. Frederick Banting, and medical student, Charles Best.
Although his blood sugars went down a little, there was not a lot of change following Thompson’s initial injection, according to the University of Toronto’s heritage website.
But biochemist Bert Collip, who had been working with Banting and Best in a lab provided by the university’s head physiologist, Prof. J.J.R.. Macleod, developed a method to refine the extract and daily injections of this extract started Jan. 23. Improvement was immediate and remarkable. The boy’s blood sugar levels dropped to normal levels (Thompson would live another 13 years with daily injections of insulin, before dying of tuberculosis.)
It was not a cure but it was a monumental breakthrough in treatment for what had been an untreatable disease.
In March, 1922 a paper describing the case of Leonard Thompson, and six other patients the Banting and Best team treated with the refined extract, was published in the Canadian Medical Association Journal. It was the first official announcement of an extract developed to alleviate the symptoms of diabetes.
“A message of hope to sufferers from diabetes goes out authentically today from the medical research laboratories of the University of Toronto. The modesty of medical men and scientific investigators of the genuine brand attempts to minimize the results obtained. The harm of exaggeration and the injustice to both parents and research men in awakening false and premature hopes before the extracts can possibly be manufactured cannot be over-emphasized. But the fact remains that one of the most important discoveries in modern medical research has been made at the university here. It is not a cure for diabetes, its authors state. Within six months, however, their discovery will be used on a large scale, they hope, to prolong life quite considerably at least. There will be no secrecy, as from the beginning. The medical profession will know all the facts.”
The Toronto Daily Star broke the news a day before other outlets. The March 22, 1922 bold all-capital headline ran eight columns on the front page: “Toronto doctors on track of diabetes cure.” A subhead stated: “Discovery made at University of Toronto will be means of prolonging life considerably — F.G. Banting and C.H. Best pushed experiments all last summer.”
The Star referred to the Alliston-born Banting — who had won the Military Cross in 1916 for bravery in World War I — as being “strangely slow in speech” and “unassuming” but he also had “the reputation of coming across with the punch at the critical moment.”
Two months later, on May 22, 1922, Prof. Macleod delivered a paper on the U of T team’s findings to the American Association of Medical Physicists in Washington, D.C. and got a standing ovation. Macleod used the term “insulin” to describe the extract. According to the Canadian Encyclopedia, “in the eyes of most of the world,” this was considered the announcement of insulin.
The next year, on Oct. 26, 1923, the first Nobel prize awarded to Canadians was given to Banting and Macleod.
But the reaction of Banting and Macleod to the prize revealed a little of the testy relationship that had existed in the background between the two men.
According to an account on the website scienceheroes.com (similar to other published reports) Banting was furious that he was sharing the award with Macleod, not Best, and at first swore he “wouldn’t accept the award.” But friends persuaded him that it wouldn’t be smart to refuse the first Nobel for a Canadian (he remains the youngest Nobel Laureate in Physiology/Medicine). Instead, Banting announced he would split his share of the $40,000 monetary prize with Best.
read the story in it’s entirety at TheStar.com
Insulin Supply Disruption
After a number of people in the Juicebox Podcast private Facebook group reported having trouble getting some of their Novo Nordisk brand insulins, I reached out to Novo Nordisk to see if I could learn more. Their responses is below.
Novo Nordisk is currently experiencing some supply disruptions causing pockets of stock outages for several of our products across the US, including our insulins. At this time, shortages are being seen across our portfolio of insulin products. The disruption was caused by a temporary manufacturing issue that has now been resolved as well as general COVID-related shipping delays and materials sourcing. Importantly, supply is now consistently shipping out across the US from our warehouses, and we expect stock in pharmacies to be normalized in December. There are no supply issues impacting the Novo Nordisk GLP-1 diabetes products (Victoza, Ozempic, Rybelsus).
We encourage anyone who needs medicine now and can’t get it to speak to their health care provider about an appropriate treatment plan. We know this is a source of frustration and concern for those who rely on our medicines. We take our responsibility very seriously to supply the market with our medicine and we’re working hard to rectify the situation.
Dexcom G6 Meets Garmin
Press Release
LATHE, Kan./October 13, 2021/Business Wire – Garmin® International, Inc., a unit of Garmin Ltd. (NASDAQ: GRMN), today introduced the Dexcom Connect IQ apps, providing people with Type 1 and Type 2 diabetes who use the Dexcom® G6 Continuous Glucose Monitor (CGM) System1 with a way to quickly see their glucose levels and trends – even while working out – right on their compatible Garmin smartwatch or cycling computer.2 The apps can be downloaded now from the Connect IQ™ store.
“Dexcom’s CGM systems have revolutionized how people live with diabetes, and we are thrilled to offer our customers an even more convenient way to see their glucose levels,” said Dan Bartel,Garmin vice president of worldwide sales. “Users can not only see which way their glucose levels are trending without having to take their phone out, but can even do so while working out, when glucose levels have the potential to fluctuate quickly.”
The Dexcom Connect IQ apps, developed by Garmin, make it easy for people with diabetes to keep an eye on their glucose numbers at any time.
During the Day
Available for a wide range of Garmin smartwatches, the Dexcom Connect IQ app3 provides people with diabetes with a secondary way to view their glucose levels, right from their wrist. With their smartphone stowed away4, the app allows people with diabetes to see glucose levels and trends to get a clearer picture of where their numbers are heading, as well as a 3-hour history of glucose levels to look back on.
During an Activity
While out for a run, bike ride or other adventure, the Dexcom Connect IQ data field3 provides people with diabetes with a secondary way to view both their glucose levels and performance stats all in one place, so they can focus more on their workout. When training or racing with a compatible smartwatch or Edge® cycling computer, users can keep an eye on their glucose levels and trends, as well as their performance data, right on their Garmin device without pulling out their smartphone.4,5
“The addition of Garmin wearables and cycling computers to the Dexcom CGM ecosystem is an exciting advancement for Dexcom users who are now able to easily view and monitor their glucose levels from their favorite Garmin device,” said Jake Leach, chief technology officer at Dexcom. “Garmin is our first partner to connect to Dexcom G6 through our new real-time API – showcasing the value of integrated CGM and further solidifying Dexcom G6 as the most powerful and connected CGM in the world.”
The Dexcom Connect IQ apps are available for download from the Connect IQ Store now for customers in the United States.