It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: the FDA has a warning about smart phones and medical alerts, a few companies turn their attention to patch pumps, a new study looks at costs/benefits of CGM vs Fingerstick during pregnancy, T1D in the Super Bowl.. and more! Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! 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XX Big warning from the FDA about medical alerts from smart phones. They’re warning that they’ve received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low blood sugar and even death. But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical updates. In other cases, connecting the phone to a new audio source, such as a car stereo, could change the volume of the alerts users are accustomed to hearing. They have some recommendations to help, mostly just confirming alarms are working before you need them.. and I’ll link up the full story in the show notes. Reading between the lines here, it seems like the problem here may be the thousands of unregulated apps that make health claims – not just for people with diabetes. So it’s a good idea to check the apps you’re using and the companies that make them. https://www.seattletimes.com/seattle-news/health/patients-using-diabetes-apps-can-miss-critical-alerts-heres-how-to-make-sure-youre-getting-them/ XX What costs less during pregnancy? CGM or finger sticks? In the real word, a new study says CGM costs less… Okay, first keep in mind that the cost savings here wasn’t about the glucose monitoring supplies, it was about a lower rate of neonatal ICU admissions. In a base-case analysis in which researchers assumed all women would use seven finger sticks per day as dictated by the American Diabetes Association’s guidelines for diabetes management in pregnancy, CGM had a higher per-person cost than SMBG. However, in a real-world analysis in which women with a CGM used three finger sticks per day and those performing SMBG used five finger sticks daily, CGM was more cost-effective. In the real-world analysis, CGM users had a per-person cost of $2,747 for the CGM, $988 for finger sticks and $9,973 for neonatal ICU admissions. For SMBG, finger sticks cost $1,647 and neonatal ICU admission costs were $12,876. The reduction in neonatal ICU admission rates with CGM use led to a mean cost savings of $2,903 in the real-world analysis. “These findings justify paying for CGM devices in type 1 diabetes pregnancies, even in the U.S., which has an expensive health care system,” Polsky said future research should focus on the cost-effectiveness of automated insulin delivery systems in pregnancy. “Automated insulin delivery use has been shown to improve glycemic outcomes in type 1 diabetes pregnancies, but it is still unclear if it improves maternal or neonatal health outcomes and if it would be cost-beneficial,” Polsky said. https://www.healio.com/news/endocrinology/20250205/cgm-may-lead-to-lower-health-care-costs-for-pregnant-women-with-type-1-diabetes XX Couple of interesting comments from Medtronic at the recent JP Morgan Chase conference. The CEO says he company is “mainly a type 1 business, moving into type 2,” He says stated that their patch pumps program remains dynamic.. Medtronic expects its 800-series pump to come in at around half the size of the latest-generation 780G. The post says the company plans for a pivotal study in 2025. Potential features could include extended reservoirs and extended-wear sets, plus a brand-new Android/iOS app. https://www.drugdeliverybusiness.com/medtronic-next-gen-insulin-pumps-coming/ XX Beta Bionics also says they’re working on a tubeless patch that they plan to launch in 2027. The company reported the device has two parts. One reusable component holds the electronics that operate the device and motor. A second disposable part includes an adhesive patch, insulin reservoir, insertion device, and the cannula used to deliver insulin. Beta Bionics said the pump is planned for use in people with type 1 diabetes and later will expand its use for people with type 2. The company also reported it is continuing work on an AID system that would, in addition to using insulin to lower blood sugar, also contain glucagon to raise blood sugar. Research is being conducted into dual-hormone systems, but none are available yet for people with diabetes. https://diatribe.org/diabetes-technology/tech-watch-diabetes-tech-news XX New approval for the treatment of diabetic macular edema. Susvimo is the “first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections,” the release said. This is the second indication for Susvimo, which is also approved for the treatment of wet age-related macular degeneration. https://www.healio.com/news/ophthalmology/20250204/fda-approves-susvimo-for-diabetic-macular-edema XX How about this one… drinking ketones improves heart health, a new small-scale study from the University of Portsmouth has found. This is the first time people with type 2 diabetes (T2D) have been given a drink with ketone esters - a supplement that is meant to plunge your system into ketosis - to monitor the effect on the heart. Ketosis is the metabolic state where your body is forced to burn fats instead of carbohydrates. but more research is needed because we only assessed participants on the day, which means we have no idea what the chronic impact of drinking ketones would be." The study was carried out after research showed The drug SGLT2i was used to lower glucose in patients with diabetes and longitudinal studies were showing that it was inadvertently protecting the heart. The hypothesis was that the drug induces ketosis and the heart was using ketones, which improved heart health, but the evidence for this was limited so our research set out to prove the connection." https://www.news-medical.net/news/20250205/Drinking-ketones-improves-heart-health-for-people-with-type-2-diabetes.aspx XX Another pump wants into the EU. Modular Medical looks to obtain a CE mark in the first quarter of 2026. The patch pump, MODD1, got FDA clearance last fall. The company says it will be available early this year.. but I haven’t heard much about it since the approval. https://www.drugdeliverybusiness.com/modular-medical-step-forward-ce-mark/ XX New CGM system with a reusable applicator and rechargeable wearable transmitter moves forward. Trinity Biotech announced new pre-pivotal clinical data. This company is based in Ireland and is looking for iCGM approval down the road.. hoping to file with the FDA in 2026. https://www.drugdeliverybusiness.com/trinity-biotech-expects-submit-cgm-fda-2026/ XX Body-weight cycling (also known as yo-yo dieting) has been shown to significantly increase the risk of kidney disease in people with type 1 diabetes, regardless of body mass index (BMI) and other traditional risk factors. This is a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. Participants with greater weight fluctuations experienced a 40% decline in kidney health from baseline values https://www.news-medical.net/news/20250204/Yo-yo-dieting-found-to-harm-kidney-health-in-type-1-diabetes-patients.aspx XX Eli Lilly’s profit doubled in the fourth quarter, propelled by its hot-selling diabetes and obesity treatments, and the drugmaker came out with a mostly better-than-expected 2025 forecast. Overall, Lilly’s quarterly profit swelled to $4.41 billion. https://apnews.com/article/eli-lilly-fourth-quarter-mounjaro-zepbound-ca026922525a9e3abb1b75d329628bef XX Abbott starts a new campaign all about bias and misconceptions when it comes to diabetes. I’m excited that they seem to have worked here with the Behavioral Diabetes Institute. Nearly 70% believe there is stigma associated with their condition.1 Diabetes as a Punchline: 85% of people living with diabetes say they have seen inaccuracies about diabetes in the media, including on TV shows, movies, and social media, and 40% of people felt that diabetes is often used as the punchline of a joke.1 Abbott's new Above the Bias initiative aims to help others see the world from the perspective of someone living with diabetes. The initiative builds upon efforts by several diabetes organizations, patient advocacy groups, and experts that continue to work to reduce stigma about diabetes.3 People can learn more about Above the Bias and watch the film at AboveBias.com. https://www.prnewswire.com/news-releases/abbotts-above-the-bias-film-reveals-misconceptions-can-impact-diabetes-care-302367723.html --
