In the News... Ozempic compound warning, T1D Go Fund Me study, Tandem timeline update.. and more!

It's In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: FDA warning about compounded versions of semaglutides like Wegovy and Ozempic, new research on what people with diabetes who start Go Fund Me campaigns are asking for, Tandem's CEO gives an update on Dexcom G7 and Libre integration, follow-up on the French Open player denied insulin on the court, and more! Here's more info about Mom's Night Out: https://bit.ly/DMomsNightOut Please visit our Sponsors & Partners - they help make the show possible! Take Control with Afrezza  Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected]   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines happening now XX In the news is brought to you by Moms Night Out! Treat yourself to some time away with other moms who get it! XX The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain the same ingredients as the prescription products and may not be safe or effective. Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn't say what the problems were. The trouble is that those versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in people. As of May, Ozempic and Wegovy remain on the FDA's list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications. Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said. https://time.com/6284497/fda-warning-ozempic-wegovy/ XX ZVHER-ehv pronounce https://www.youtube.com/watch?v=u8spdvgpIzs French Open organizers reversed their initial decision denying Alexander Zverev access to insulin injections on the court. Initially they said he'd have to do his injections during off-court bathroom breaks, something players are limited to only two of. Zverev has lived with type 1 since he was three years old? And apparently there were complaints after he injected himself during his fourth-round match. Zverev said he was told it didn't look right when he injected himself on the court. "This is not a clever take because if I don't do it, my life will be in danger. But they said it looks weird," he said. And it prompted a response from type 1 diabetes research charity JDRF. In an open letter, the charity said: "We would like to emphasise that insulin administration is an essential aspect of type 1 diabetes management, and it should be treated with the same respect and understanding as any other medical intervention. "It is critical that athletes with diabetes, like Mr. Zverev, are given the necessary accommodations and support to effectively manage their condition while competing. This includes the ability to administer insulin when required, as recommended by their healthcare professionals." XX Many people with diabetes in the United States have turned to crowdfunding to pay their medical bills, even though a quarter of patients sampled had insurance, according a new study by Duke University researchers. In the United States, more than 40% of patients with diabetes struggle to pay their medical bills. Among those patients, more than half — 56% — have either delayed or foregone care entirely, Caroline E. Sloan, MD, MPH, a primary care physician at Duke University School of Medicine, and colleagues wrote. One estimate suggested that the average patient who is dependent on insulin and has insurance spends about $4,800 every year on physician visits, supplies, medications, hospitalizations and lost wages — the equivalent to 15% of the median U.S. per capita income. They evaluated 313 GoFundMe campaigns describing patients' medical situations, expenses and fundraising goals. The researchers included an oversampling of type 1 diabetes campaigns so they could have roughly even proportions of type 1 and non-type 1 diabetes campaigns "and ensure a wide breadth of experiences." Sloan and colleagues found that the median fundraising goal was $10,000, the median amount raised was $2,600, and just 14% of campaigns reached their goal. Additionally, 25% of fundraisers had insurance, but 49% of those who did have insurance said their out-of-pocket costs were still too high. Fewer than 10% requested money specifically for insulin; 48% of direct medical expenses were not directly related to glucose control. When it came to characteristics of campaigns for types of diabetes, they found that 21% of total campaigns — almost all of which were campaigns for type 1 diabetes — requested money for diabetic alert dogs. Campaigns not for type 1 diabetes mentioned indirect medical expenses more often than campaigns for type 1 diabetes: 63% vs. 34%. "Thirty-five percent of patients with type 1 diabetes started fundraising campaigns for diabetic alert dogs, which cost about $15,000 and are not covered by insurance because of high variability in effectiveness," the researchers wrote. "Clinicians who learn of a patient's intent to purchase a dog could redirect them toward proven management strategies, such as continuous glucose monitors." https://www.healio.com/news/primary-care/20230613/patients-with-diabetes-are-increasingly-turning-to-gofundme-to-pay-medical-bills XX XX United Healthcare will now cover the Eversense E3 CGM System for people with type 1 diabetes and people with type 2 who use insulin. That's as of July 1. The Eversense E3 CGM is inserted just under the skin and stays there for six months. UnitedHealthcare is the largest health insurance company in the United States https://finance.yahoo.com/news/senseonics-announces-unitedhealthcare-coverage-eversense-110000925.html XX operational and commercial goals we set for this year," CEO John Sheridan said in a call with investors on Wednesday afternoon. That confidence is helped along in particular by the company's plans for a spate of product expansions and launches later this year. "Overall, there's an enthusiasm at Tandem as we approach being able to offer another wave of innovative products to the diabetes community," Sheridan said. "With these launches, we'll be building upon our reputation for offering high-quality products and services that reduce the burden of diabetes management." Among those launches will be the integration of Dexcom's G7 continuous glucose monitor sensor and Abbott's FreeStyle Libre 2 and 3 into Tandem's t:slim X2 insulin pump system, which Sheridan said would make Tandem's device "the first FDA-cleared insulin pump integrated with multiple CGM sensors." Those additions will come in the form of free, remote software updates, per the CEO, with the first updates slated to begin rolling out in the coming quarters. For each of the three integrated CGMs, Tandem will perform "internal walkabout testing" before adding them to its t:slim system in scaled launches first in the U.S. and then internationally; the process has already begun for Dexcom's G7 and Abbott's Libre 2 sensors, with the Libre 3 on track to be a "fast follow-up" after the previous model's U.S. launch this fall. Sheridan suggested that a "meaningful number of customers" could be using a G7-connected t:slim pump by the third quarter, while the FreeStyle Libre version of the tech should reach that same nebulous milestone in the fourth quarter Alongside the upgrades to its t:slim X2 pump, Tandem is also eyeing an upcoming launch for its new Mobi pump, which is still under FDA review. The pump is about half the size of the t:slim models and can be completely operated via a smartphone app. "Our dialogue with the agency remains constructive as we work through the process of FDA review and responding to questions," Sheridan said. "In the meantime, we continue to prepare for its launch in the second half of the year." https://www.fiercebiotech.com/medtech/tandem-plots-h2-launch-slimmed-down-insulin-pump-dexcom-and-abbott-cgm-integration XX XX Researchers at Washington University School of Medicine in St. Louis have identified a process in immune cells that links vitamin D deficiency during pregnancy to an increased risk of Type 2 diabetes in those born from those pregnancies. The research is published June 13 in the journal Nature Communications. Some theories of disease suggest that conditions in utero may have irreversible, lifelong consequences in offspring. The new study's principal investigator, Carlos Bernal-Mizrachi, MD, said that could be happening to the children of mothers who don't have adequate levels of vitamin D during pregnancy. https://www.news-medical.net/news/20230613/Vitamin-D-deficiency-during-pregnancy-linked-to-an-increased-risk-of-Type-2-diabetes-in-offspring.aspx XX In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I've taken the best elements from those events and created a brand new experience. We're going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D. XX Update on non invasive glucose monitoring.. Know Labs says they're in the next stage of their Bio-RFID sensor. Lots of behind the scenes and lab advancements here from what I can tell. But they release says: For 2023, Know Labs remains focused on external validation of its technology and contributing to its growing body of peer-reviewed evidence, which can be found at www.knowlabs.co/research-and-validation. The company will make further refinements to the Gen 1 Device as it works toward realizing its vision for the KnowU and UBand and bringing an FDA-cleared product to the marketplace. https://www.businesswire.com/news/home/20230607005237/en/Know-Labs-Completes-Build-of-Portable-Generation-1-Prototype-for-Non-Invasive-Glucose-Monitoring XX Dexcom focuses on mental heath during the UK Diabetes Awareness Week. They've released a new study showing 84% of people surveyed agree having diabetes can negatively impact mental health. Their news release goes on.. To honor the strength and resilience of the diabetes community, and to promote mental health and connection, Dexcom is encouraging people with diabetes - and their friends and family - to strike a #DexcomWarriorPose by hosting a day of free puppy yoga classes at Puppy Yoga London in Hoxton, London this Saturday 17 June. https://www.businesswire.com/news/home/20230612005039/en/New-Study-Shows-That-84-of-People-With-Diabetes-Struggle-With-Mental-Health1 XX On the podcast next week.. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon. ----