In the News.. FDA suspends stem cell study, Omnipod 5 wider rollout, Dexcom G7 update and more!

Diabetes Connections | Type 1 Diabetes

It's "In the News..." Got a few minutes? Get caught up! Top stories this week: An FDA hiccup for Vertex, Omnipod 5 starts wider rollout, New peek at Dexcom G7 features, Beta Bionic study info, "Hey Alexa, predict my blood sugar" and Healthline shuts down their main source of diabetes news and information.

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story – bit of a surprise for Vertex – the FDA puts a clinical hold on their newest trial. This is the company that made big headlines last fall – that New York Times article likely sent to you by everyone you know about a stem cell cure for type 1. That’s when Vertex reported data on the cell therapy from a single patient who achieved a “robust” restoration of islet cell function after receiving a drug called VX-880. That response is going strong they say at day 270. This week, Vertex showcased results from another patient and said a third patient has received the full dose. A company spokesman says they’re surprised by the clinical hold given the evidence so far and there have been no serious adverse events. They say they’ll work with the FDA to get the trial moving again as soon as possible. https://www.fiercebiotech.com/biotech/unwelcome-surprise-vertex-fda-slaps-hold-phase-12-diabetes-cell-therapy-study XX Insulet announces that Omnipod 5 has completed the Limited Market Release and will be rolling out to a wider audience soon. Those who signed up for what they call the interest list will be notified first – we’re told watch for that email this week. If you haven’t signed up, sit tight. Omnipod 5 still isn’t yet available through all insurers and at every pharmacy, but the roll out will continue slowly through the year. https://www.omnipod.com/current-podders/resources/omnipod-5/faqs?fbclid=IwAR1fghbXl4uP4H3z8DGovriAocpZyDyPzLdPzME_taonv3_ZfPC3XqukHJY XX We’re learning more about Dexcom’s G7 – approved in Europe and in front of the US FDA right now. Sensors will have a bit of a grace period – they’ll keep working 12 hours after the 10 days are up. You’ll also be able to silence the urgent low and sensor fail alarms for six hours – that’s new. I’m talking to CTO Jake Leach for next week’s long-format show and he’s got a lot of info to share. I asked as many of your questions as I could, so please come back for that one. XX New study results about the iLet, the insulin only bionic pancreas from Beta Bionics. This is one of the many studies presented at A-T-T-D.. People in the study saw about half a point come off their A1Cs after 13 weeks and there was no increase in hypoglycemia. They also saw more than 2 and a half hours more time in range. The iLet is unique in that you only enter your weight and tell the pump system when you’re eating – there are no basal rates or a need to enter carbs. No timeline for release but the company says its regulatory submission is currently under FDA review. https://www.globenewswire.com/news-release/2022/04/30/2433019/0/en/The-iLet-Bionic-Pancreas-Significantly-Reduced-HbA1c-and-Improved-Time-in-Range-vs-Standard-of-Care-for-a-Diverse-Range-of-People-with-Type-1-Diabetes.html XX Amazon.com's online pharmacy PillPack has agreed to pay almost 6-million dollars to resolve claims that it overcharged government health insurance programs by dispensing more insulin injector pens than patients needed. That’s the headline, but -editorial here – this story just shows a lot about what’s wrong with our system. Many of us have had this happen – used to be if you had a prescription for insulin pens, they’d just give you the box of 5 – even if the prescription was written for 3 or 4. Now, they have to break open the box and count out the exact amount. It’s not as though a patient was over-charged.. and that’s not the focus of this lawsuit. This was about government health insurance programs. I get it, we’re all paying for that in our taxes, but there’s got to be a better way. Maybe pass that co-pay cap, or let Medicare negotiate prices or just cap the price overall. Then this issue – and many others – goes away. https://www.reuters.com/legal/litigation/amazon-unit-pay-58-mln-insulin-overbilling-2022-05-02/ XX Walmart Health's telehealth company MeMD launched a virtual care diabetes program this past week. The initiative, known as the Walmart Health Virtual Care Diabetes Program, was developed for employers and payers as a standalone offering or as part of a comprehensive telehealth program. It’s a partnership with the ADA and includes a consultation with a licensed medical provider to discuss patient history, eating habits and more. https://www.healthcareitnews.com/news/walmart-launches-telehealth-program-aimed-diabetes XX Right back to the news in a moment but first we’ve got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It’s a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy. Sign up at T1DExchange.org slash Stacey (that’s S-T-A-C-E-Y). XX An Australian company joins the diabetes conversation on your Alexa device. Jade Diabetes says their My Jade skill can centralize logging, dose calculation and dose management. It can also suggest dose changes within 3 hours. They say “Jade is the only system to use accurate predictions to alert patients of future risks at a given time.” It uses info from CGMs, connected glucose meters, digital pens and data from Apple Health. https://www.businesswire.com/news/home/20220504005004/en/Jade-Diabetes-makes-Diabetes-Simpler-with-Alexa-Insulin-Dosing XX Really sad to hear that Healthline has decided to close down what I think has been just one of the best sources of Diabetes news & info.. Diabetesmine. It was started by Amy Tenderich after her diagnosis in 2003 and acquired by Healthline in 2013. I’ve had her and Managing Editor Mike Hoskins on the show many times. Amy’s amazing other project – D-Data Exchange will live on. These are the bi-annual #DData forums connect experts, advocates and innovators developing data platforms, apps, algorithms and next-gen devices to take full advantage of data-driven diabetes care. You may recall the term We Are Not Waiting was coined at the first D-Data exchange – it’s a cool place to be! The next one is coming up June 2nd, more info in the show notes. https://summer2022-ddata.eventbrite.com XX On this week’s long format episode, you’ll hear about the Mental Health Plus diabetes conference.. the organizers said every conference has one session on mental health – we really need more. So they did it. Love that! Next week, as I mentioned, Dexcom’s Chief Technical Officer on the G7, some interesting new info.. and I asked him all of your questions. Listen wherever you get your podcasts That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.