The US FDA has approved Tidepool Loop, an app designed to automate insulin dosing. Born out the do-it-yourself, "we are not waiting" movement, it has designs and features not in the first wave of commercial automated systems like Omnipod 5 and Tandem’s Control IQ. CEO Howard Look talks to Stacey about what was approved here and what Tidepool Loop is all about. If you’ve followed this story closely, you’re going to be surprised to learn about a few changes that have happened along the road to approval.. and to learn the questions that Tidepool will have to answer next. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Learn more about Tidepool: https://www.tidepool.org/ Our previous episodes with Howard Look:  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  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: info@diabetes-connections.com    

Tidepool Loop gets FDA approval - CEO Howard Look on what comes next

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.

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This week, creating a bihormonal pump – using insulin and glucagon in one device - has been the goal of Beta Bionics since before the company even had that name. Now that they’ve launched the insulin-only version of their iLet, we’re getting an update on the dual chambered version. The big news is a new agreement with Xeris to supply that shelf-stable glucagon. But there are still a lot of questions. We’re talking to the CEOs of both companies. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Find out more about Moms' Night Out - registration is open for Denver! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies  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: info@diabetes-connections.com

Insulin and Glucagon in the same pump? Explaining the Beta Bionics - Xeris partnership

This week, talking with one of the lawyers bringing a class-action lawsuit against the insulin companies.. a lawsuit that has been inching forward since 2017. It was set to be settled for 500-million dollars and a four year price cap, but then judge said no.  Attorney Steve Berman will talk about that last minute surprise, why he’s still going forward, and  what he needs now from the diabetes community. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. My guest is Attorney Steven Berman from the firm Hagens (Haagens like Haagen Daas) Berman. Steve co-founded Hagens Berman in 1993 after his prior firm refused a fast food e coli case. That turned out to be the famous case against Jack in the Box, which resulted in a class action settlement and changed many food safety laws. He’s also been involved in cases against Big Tobacco and, as you’ll hear, other medical pricing lawsuits.   Learn more about the case and fill out the form to see if you're entitled to compensation here: https://www.hbsslaw.com/cases/insulin-overpricing#block-form-block-destination Find out more about Moms' Night Out - registration is open for Denver! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies  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: info@diabetes-connections.com

Inside the class-action lawsuit against  insulin pricing, with Attorney Steve Berman

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: more older adults are being diagnosed with type 1 and people with T1D are living longer, Eversense gets iCGM designation, new drug to prevent low BG is being tested, Tandem diabetes app recall, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies  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: info@diabetes-connections.com Episode transcription with links:  Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.  XX  In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark  XX  Type 1 diabetes is increasingly affecting older adults in the US, with prevalence rates peaking in those aged 45 to 64, according to recent research published in JAMA.1  The life expectancy for people with T1D has increased over the last 15 years, which has led to increased prevalence among older adults.2 The CDC currently estimates that approximately 1.8 million people in the US have T1D.3  The study utilized data from the 2019 to 2022 cycles of the National Health Interview Survey (NHIS), representative of the noninstitutionalized US population. The study included over 141,000 participants (110,283 adults and 30,708 youths).  The increasing prevalence of T1D in older adults suggests that further research is needed to develop treatment guidelines that include strategies to optimize treatment in older adults living with T1D. Current clinical practices often extrapolate from data on younger populations or those with type 2 diabetes, which may not be entirely appropriate for older adults with specific needs in terms of cardiovascular and glycemic management.     https://www.ajmc.com/view/t1d-prevalence-rising-among-us-adults-study-finds  XX  Pancreatic cancer research may have implications for diabetes. These reserachres were looking at an enzyme called focal adhesion kinase (FAK). During the trials, quote - "The pancreas looked weird, almost like it was trying to regenerate after an injury," Even weirder, a cluster of cells in the pancreas were expressing both insulin and amylase. In normal mice and humans, the blood sugar-regulating hormone insulin is produced by beta cells, while amylase, a digestive enzyme, is manufactured by different cells. The functions of acinar and beta-cells are very distinct, so it didn't make sense that the cluster of cells looked like a combination of the two.  Esni and his team had in fact stumbled upon this holy grail. In a new Nature Communications paper, the researchers show that a FAK-inhibiting drug, which has been studied in cancer treatment, converted acinar cells into acinar-derived insulin-producing (ADIP) cells and helped regulate blood glucose in diabetic mice and a single non-human primate.  The findings suggest that FAK inhibitors could be a new avenue as a replacement for insulin therapy in diabetic patients.  With the eventual hope of launching a clinical trial to test FAK inhibitor in diabetes patients, Esni and his team are now planning long-term experiments in mice to look at the duration of hyperglycemia control after a single course of the drug in mouse models for type 1 or type 2 diabetes. They're also investigating the effects of FAK inhibition in pancreatic tissues from human donors.  https://medicalxpress.com/news/2024-05-repurposed-cancer-drug-diabetes-nudging.html  XX  A report published today by Doctors Without Borders/Médecins Sans Frontières (MSF) and T1International shows astonishing markups by pharmaceutical corporations on insulin injection pens and newer diabetes medicines.  Currently, only half of all the people in the world who need insulin have access to it.  Doctors without borders  is among the few humanitarian groups currently procuring insulin pens.  Based on MSF’s research of the cost of production, long-acting insulin pens, which are the standard of care in high-income countries, could be sold at profit for as low as $111 per patient per year, which includes insulin and the device needed to inject it. This is 30 percent less than human insulin in a vial with syringes, which have always been thought to be the most affordable option     The US must do more to ensure equitable access to diabetes drugs worldwide  “While the announcement of a recent US Senate investigation into Novo Nordisk’s GLP-1 drug prices is an important step, the US government must do more to ensure equitable access to diabetes drugs worldwide,”  https://www.doctorswithoutborders.org/latest/diabetes-only-half-people-who-need-insulin-world-have-access-it  XX  The U.S. FDA on Wednesday warned about a software glitch found in the Tandem Diabetes' t:slim X2 insulin pump, classifying the issue as a Class I recall, the agency's most serious type of recall. HOWEVER.. this happened in March and Tandem says it’s been resolved. Here’s what happened..     The error was found in the Apple iOS-based software version of the t:connect mobile app used for the t:slim X2 insulin pump with Control-IQ technology.  The defect causes the app to crash down and relaunch repeatedly, leading to excessive Bluetooth communication, which in turn drains the pump battery and leads to an unexpected pump shutdown.  More than 85K t:slim X2 insulin pumps distributed in the U.S. between February 12 and March 13 have been affected by the issue, which the FDA has categorized as a correction.  Tandem Diabetes (TNDM) sent a letter to affected customers in March requesting them to update the app.  After a discussion with the management, Citi said that 98% of users have updated their apps to version 2.7.1, released on March 13. The company has not seen any issues with the latest app version and expects the update to permanently fix the defect. Citi retains its Neutral rating on the stock.  XX  HIGH POINT, N.C., March 04, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate, cadisegliatin, in adults diagnosed with T1D.  The Phase 3 study will assess two doses of orally administered cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use a continuous glucose monitor (CGM). The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.  It received a breakthrough therapy designation (BTD) based on its Phase II trial (NCT03335371), which showed a 40% decrease in the frequency of severe and symptomatic hypoglycaemic events along with a decrease in serum and urine ketone events in the treatment group.  Cadisegliatin is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Cadisegliatin (TTP399) is an investigational liver-selective glucokinase activator that has been studied in healthy volunteers and in patients with type 1 and type 2 diabetes.  XX  Timing is everything.. the same day we released our episode about the Eversense CGM last week, Senseonics, in collaboration with Ascensia Diabetes Care, has announced that its Eversense product received an integrated continuous glucose monitoring (iCGM) designation from the US Food and Drug Administration (FDA).  This marks Eversense as the first fully implantable device to achieve such status, paving the way for future devices of its kind through the FDA’s De Novo pathway.  The iCGM designation signifies that the system can be integrated with compatible medical devices, such as insulin pumps, to create an automated insulin delivery (AID) system.  https://www.medicaldevice-network.com/news/senseonics-eversense-icgm-designation-fda/  XX  Commercial  XX        XX  A big win for Georgians with Medicaid who have #diabetes. Governor Brian Kemp signed into law a bill that expands #CGM access to persons with Medicaid and diabetes who are insulin therapy and removes the age limitation and endocrinology requirement. Please see ADA press release below. Please share.  https://lnkd.in/g_WVTNpi American Diabetes Association     XX  61-year-old ultrarunner Linda Carrier is the first woman to complete the World Marathon Challenge (seven marathons on seven continents in seven days) three times.     Plus, she has run 78 marathons and 55 half-marathons and is currently in the process of running a marathon in all 50 states with just 12 to go.     To add to the wow factor, Carrier has accomplished it all while managing type 1 diabetes for nearly 50 years.     “I naturally like to challenge myself, and when someone says [you have] a life-shortening disease, I’m like, heck it’s not. I’m going to show them that I’ll be the longest-living type 1 diabetic,” Carrier told Healthline.     She was 14 years old when she learned she had the condition. Because her older sister had been diagnosed a few years before, Carrier was familiar with the symptoms. She also knew the outlook was daunting.  She will finish her latest goal of running a marathon in all 50 states next October in Twin Cities, Minnesota. The race will be sponsored by Medtronic.     “Seems like the perfect way to finish,” Carrier said. “And to show that type 1 diabetes should not stop you from reaching any of your goals, whatever it might be.”  https://www.healthline.com/health-news/linda-carrier-diabetes-marathon  XX  Join us again soon!

In the News.. T1D increasing in older adults, new iCGM designation, low BG prevention tested, and more!

This week, what growing up with diabetes meant for career choices, financial decisions, and family relationships. Madison Carter is a local news anchor who makes T1D very visible – and she does not hold back. She’s generous with incredible insight into how she was raised, sacrifices her family made and what her mom and dad have to say now. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Find out more about Moms' Night Out - registration is open for Denver! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies  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: info@diabetes-connections.com

Tidepool Loop gets FDA approval - CEO Howard Look on what comes next

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