← Diabetes Connections | Type 1 Diabetes
Diabetes Connections | Type 1 Diabetes
In the News...Tandem's new infusion set approved, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!
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It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Tandem's new infusion set is approved, Dexcom G7 compatibility with the Omnipod 5 iPhone app announced, Sernova cell-pouch moves...
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Foreign hello and welcome to Diabetes Connections in the News. I'm Stacey Sims and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. Our top story this week Tandem Diabetes gets FDA clearance for a new infusion set. The company shared in an SEC filing that its Capillary Biomedical subsidiary has has gotten clearance for its Steady Set infusion set. This is what they call an integrated inserter. It has a hidden needle, it is a one handed insertion and it is cleared to deliver insulin for up to three days of use. However, Tandem plans to submit a separate request to extend that to seven days and it doesn't expect to launch Steady Set until after it receives clearance for that extended use time. Many of us have been following this since Tandem acquired CatBio back in 2022 and and it's been pretty hush hush. CatBio has never accepted my requests for interviews. So I'm really excited to see this approval and I'm hoping to learn more. Big news from Insulet about Dexcom G7 and their Omnipod 5 iPhone app Healthcare providers are reporting that they have received emails this week saying that there will be compatibility with the Omnipod 5 iPhone app and the Dexcom G7, something many of you have been waiting for for a while. No true timeline here, but they said it should be in the next couple of weeks. Cernova announces positive data from its ongoing clinical trials in patients with type 1. This is what they call a cell pouch biohybrid organ as a functional Cure for type 1. Small study, just 12 people so far, but they show that eight of the 12 have achieved insulin independence. All patients in the study reached an A1C below 7 and that was maintained for the duration of the study. Still very early, but a lot more to come. It is good news though when you consider that Vertex ended work on one of its two clinical stage islet cell treatments earlier this year. New study in the European Heart Journal shows that people who develop type one in adulthood have an increased risk of cardiovascular disease and death and they do not have a better prognosis than those diagnosed earlier. But this study points to smoking, poor glucose control and obesity as the main risk factors. This is a registry based study looking at more than 10,000 people and they found that these folks, again diagnosed as adults, were less likely to use what these researchers call assistive devices such as insulin pumps. But the prognosis, these researchers say can be significantly improved by stopping smoking, preventing obesity and improving glucose control by using aid systems and other tools. Breakthrough T1D announced the publication of two peer reviewed journal articles that expand insight into the burdens of living with type 1. Diabetes 1 says that insulin therapy and today's diabetes technologies are not meeting the needs of people with type 1. They acknowledge progress has been made, but they talk about the significant daily burden, let alone premature death and complications, and talks about accelerating cell therapies. The second paper shares demographic information on the broad spectrum of Americans living with type 1 and looks at the changes this population may undergo in the next decade. We have this all linked up both studies. You can read that in the show notes over at diabetes-connections. Com. Every article and story that I talk about does have further information in those show notes. We talked about this a couple of weeks ago, but I wanted to make sure you know that Researchers are looking for people with type 1 for studies regarding the effectiveness of Tirzepatide brand names Manjaro and Zepbound that's currently only approved for people with type 2 diabetes. Research already indicates that the same benefits drugs like Tirzepatide have for people with type 2, improved blood sugar levels, more time and range benefits for heart and kidneys would likely extend to people with Type one. So this is a Lilly study. Lilly makes Tirzepatide. There's a phone number you can call to enroll or learn more. You have to have Type one and have been on insulin for at least a year prior to this screening. You gotta be over 18 years old and you must have an A1C of 7 to 10.5. Can't be below 7, can't be above 10.5. There's some more here. Again go to diabetes-connections.com and learn more. Roche Diagnostics is going to build a $550 million expansion to produce CGMs at their Indianapolis facility. Roche will use the site to make Accu check SmartGuard devices, which are right now only available in Europe. It is the company's first cgm. The Indianapolis site already produces the company's Accucheck diabetes test strips. No news here about whether Roche is going to submit for approval for this CGM device in the U.S. gopen receives FDA clearance. This is a user filled insulin pen. The company says more than 3 million insulin users in the US alone are dependent on syringes for daily insulin administration. GoPen allows users to refill their pen from standard insulin vials, reducing the cost per dose compared to traditional disposable pens. Interestingly, the Gopen one the American Diabetes association is innovation challenge to help people with diabetes. The company says the product will not be available immediately. There's some manufacturing and scale up to go here, but no pun intended. Essencia announces that Eversense365 is named the best new technology solution for diabetes management in the 2025 annual MedTech Breakthrough Awards program. This follows a gold award at last month's Edison Best New Products Awards. We recently told you that Eversense 365 has its first pump partner in the SQL MedTech twist pump. Our latest episode is all about that. We have a long interview with Asensi as President of cgm. It's the episode right before this one Front Office change at Dexcom Jake Leach, who joined the company in 2004 to lead the development of sensor electronics for its first commercial CGM system, has a new title. He became the company's Chief operating officer in 2022 and he is now President and Chief Operating Officer. I think Jake Leach is best known around here as the person I questioned the most about Direct to watch. So we will be sure to talk to him again soon. And that is it for in the news. I am Stacey Sims. If you like what you've heard, please share this show with somebody else in the diabetes community. I'll see you back here soon. Until then, be kind to yourself. Diabetes Connections is a production of Stacey Sims Media. Alright, so served all wrongs, avenged.