The only weekly diabetes newscast! We’re covering the top stories of the past week including:
Big insulin recall from from Novo
FDA approval for Bigfoot’s Unity system
Lilly inks a new agreement
T1D athletes speak up about the COVID vaccine
These are planned for the month of May – Stacey shares live on Facebook every Wednesday. If you like it, we’ll keep it going! Full transcript and news/source links below.
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Episode transcript and links below:
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Hi, I’m Stacey Simms, the host of Diabetes Connections, a weekly podcast providing info & inspiration with a focus on people who use insulin. This is “In the news..” a new, short newscast full of the top diabetes news of the past week.
The goal here is to get you up to speed – quickly – with good info.
And let’s not forget.. Diabetes Connections In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff”
Let’s jump in!
In The News…
Novo Nordisk is voluntarily recalling nearly 15-hundred product samples because they were stored at the wrong temperature. This recall is only for product samples – NOT for the insulin you get at pharmacies or mail-order services. But it does cover Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy (ZUL-ti-fye like multiply). We’ll have a link in the show notes with all the info, batch and lot numbers to look for.
Side note we just got Tresiba samples for the first time from my son’s endo. So good timing there!.
You should receive a notice from your doctor if you have any of this insulin, but there’s a phone number to call and a way to report to the FDA as well. Again, link in the comments here on FB and in the show notes if you’re listening to the podcast.
Insulin sample recall: https://www.prnewswire.com/news-releases/novo-nordisk-issues-voluntary-nationwide-recall-of-levemir-tresiba-fiasp-novolog-and-xultophy-product-samples-due-to-improper-storage-temperature-conditions-301286839.html
Bigfoot Biomedical gets FDA approval for it’s Unity Diabetes Management System. This is a connected pen system – where the insulin pens, both long and short acting, take data from a Libre 2 continuous glucose monitor and give insulin dosing instructions.
You’ll get current glucose numbers as well as any recommended correction doses. The system also provides reminders for the long acting pen and provides low notifications.
The unity system was cleared for people 12 and older with Type 1 or Type 2 diabetes.
Bigfoot was founded in 2014 to create a commercial version of an existing DIY hybrid closed loop pump system. That is still in the works, under the Autonomy label. We’re working on talking to Bigfoot in the next week or so to catch up.
Bigfoot Unity FDA approved https://www.mobihealthnews.com/news/fda-greenlights-bigfoot-biomedicals-insulin-recommending-diabetes-management-system
After nearly a century, BD is spinning off its diabetes care business.
The split is expected to be completed in the first half of 2022, after which the segment will become a completely separate, publicly traded company, tentatively dubbed “NewCo.”
BD spins off: https://www.fiercebiotech.com/medtech/bd-to-spin-off-diabetes-care-business-into-newco-a-standalone-public-company
New deal for Eli Lilly and four diabetes management companies – integrating the not yet released Tempo Pen and Tempo Smart Button products.
The companies that signed with Lilly here are Dexcom, Glooko, myDiabby Healthcare and Roche’s MySugr. myDiabby is French and I’m sure I’ve pronounced it wrong.
These agreements are all about integrating with software platforms and allow for the collection and sharing of personal health data.
Lilly agreement with 4 diabetes companies: https://www.mobihealthnews.com/news/focused-diabetes-eli-lilly-inks-integration-deals-roche-dexcom-glooko-and-more
Tandem’s latest earning call in just a moment but first.. quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible.
- Inside the Breakthrough explores the idea of a “Eureka” moment. It’s historical wisdom mixed with modern insight – a little bit history show, little bit science show. The latest episode tells the story of Dr. Banting and the discovery of insulin. Every week is a different story – they’ve talked about snake oil and leaded gasoline & crime – but this week has info about the discovery of insulin that I’d never heard.. Banting had to sell his car to get money to buy dogfood. And of course, there’s scientific info as well. Listen to Inside the Breakthrough wherever you listen to podcasts..
Back to the news.. Tandem diabetes had it’s first quarter earnings call last week. Several highlights:
They have submitted a couple of new features to the FDA and are waiting on approval. First, still waiting for an update to the Control IQ algorithm to allow for more personalization
Second is the mobile bolus or what I call bolus by phone. They got some response from the FDA in March but this, like many projects, is delayed because of COVID. Tandem CEO John Sheridan says, “we’re no longer planning for our Q2 clearance, but we will be working to bring this highly sought after feature to market as quickly as possible.”
It’s still expected before the end of this year.
T-sport also pushed back, Sheridan wouldn’t give a specific date on that but when pressed, said probably a commercial release in summer 2022.
For parents of young children, Tandem has started a study of CIQ with toddlers as young as two.
Tandem earnings call transcript: https://www.fool.com/earnings/call-transcripts/2021/05/06/tandem-diabetes-care-inc-tndm-q1-2021-earnings-cal/
Max domi (DOE-mee like show me) shot https://twitter.com/BaileyAJohnson_/status/1391812883361714179
Finally, Some prominent athletes with type 1 are speaking up about urging people to get the COVID 19 vaccines. Indy driver Charlie Kimball did a PSA for the Indiana Dept of Health – I’ll link up that video.. and NHL player Max Domi (Doe-mee like show me) spoke out at a media avail. This quote was tweeted out by reporter Bailey Johnson. Domi says: in part, “I will never forget the feeling I got after having the vaccine. Just the sense of relief and freedom… as soon as I got it, it was like the world was lifted off my shoulders.
Once I did that, my game took off, I felt better about myself and was just enjoying life a lot more. Diabetes or not, it freed me up a lot and I’m thankful I had the opportunity to get it when I did.”
That’s Diabetes Connections – In the News. I’m going to do this for about a month and see what the response is. So far I’ve been thrilled to hear from a lot of you who like it. If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com.
Please join me wherever you get podcasts for our next episode -Tuesday – we’re talking about the importance of keeping insulin at the right temp during the hot weather.. not related to that Novo recall I told you about today, but definitely timely,
Thanks and I’ll see you then!