What to do when you can't fill your Ozempic or Mounjaro prescription - Advice from an endocrinologist

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FDA approved Omnipod 5 for people with type 2 who use insulin, Dexcom's Stelo, the first over the counter CGM, is now on sale. more evidence that bright light at night may increase the risk of diabetes, a price cut for Zepbound, 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: [email protected] 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 a first for any automated insulin delivery system, The FDA clears Omnipod 5 for people with type 2 diabetes. The new indication is based on data from the real-world multicenter SECURE-T2D trial of a racially diverse group of 305 adults with type 2 diabetes who were taking insulin. About half were also taking a glucagon-like peptide-1 (GLP-1) receptor agonist. Use of the Omnipod 5 resulted in a significant A1c reduction from 8.2% at baseline to 7.4% at 13 weeks (P Some doctors are already prescribing the Omnipod 5 off-label to some of their patients with type 2 and other types of diabetes. Private insurance will typically cover it, although prior authorization is often required. Medicare Part B requires certification of C-peptide deficiency for coverage of insulin pumps. This new indication is likely to increase uptake of the Omnipod 5 into primary care, where the vast majority of people with type 2 diabetes are managed. https://www.medscape.com/viewarticle/fda-clears-omnipod-5-system-type-2-diabetes-2024a1000fld XX For the first time, you can get a CGM over the counter, with no prescription. Dexcom began selling Stelo this week.. intended for people with Type 2 diabetes who don’t take insulin, although it can be used by people without diabetes. It costs 99 dollars for a one-time order of two sensors or $89 dollars for a monthly prescription. Stelo is a 15-day sensor based on Dexcom’s other glucose monitors. The main difference from prescription products is in what information users get through the app. Stelo flags glucose spikes, provides information on time-in-range goals, and includes meal and activity logging. The intent is to reveal how food, exercise and sleep can affect a person’s glucose levels. Competitor Abbott plans to launch two over-the-counter CGMs: one called Lingo, for people without diabetes, and one called Libre Rio, for people with diabetes who don’t use insulin. It has not yet priced either sensor. Abbott said it plans to debut its competing Lingo device this summer. The company has not said when it will launch its Rio CGM. https://www.medtechdive.com/news/dexcom-sells-stelo-over-the-counter-cgm/725310/ XX You’ll soon be able to get vials of Lilly’s popular weight loss drug, Zepbound, from a direct to consumer website, at a lower cost. This is still nearly 400 dollars a month for the lowest dose $550 for the next lowest and it will come in vials, not pens. Lilly and Novo have been struggling to make enough of their obesity medications to meet soaring demand, especially keeping up the pen supply. Lilly's medicines are now listed as available by the U.S. Food and Drug Administration, though they are not yet off the FDA's official shortage list where they have been most of the year. I haven’t seen this mentioned in any of the reporting but.. if it’s coming in a vial, you have to use a syringe to inject. Not much of a barrier to this group listening.. but pens have made using drugs like this much easier for a lot of people and I worry that going back to syringes is better for these companies than the patients. Zepbound is terzepatide, the same mediation as in Mounjaro. The latter is approved for people with type 2 diabetes, so this could be a way for some people to better access Mounjaro which is very hard to come by. https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-launches-single-dose-vials-zepbound-weight-loss-expand-us-supply-2024-08-27/ XX In a few months the US govermet will announce the list of 15 moe drugs they’ll negotiate Medicare prices for.. and Ozempic is a top candidate. This is speculation from Wall Street analysts but I think worth watching. All the drugs on their prediction list have been on the market since at least 2017 and are among those that the Medicare health program spends the most on. Under President Joe Biden's signature Inflation Reduction Act (IRA), prices for 10 highly popular prescription drugs used by Medicare will be cut by 38% to 79% in 2026. The industry has fought the negotiation program, saying it will stifle innovation. Government researchers predict that the use of diabetes drug Ozempic for weight loss would raise the U.S. deficit over the next 10 years at its current price. Medicare spent over $4.6 billion on the drug in 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/ozempic-wall-streets-list-2027-medicare-drug-negotiations-2024-08-23/ XX Type 2 diabetes and prediabetes are associated with accelerated brain aging, according to a new study from Karolinska Institutet in Sweden published in the journal Diabetes Care. The good news is that this may be counteracted by a healthy lifestyle. Type 2 diabetes is a known risk factor for dementia, but it is unclear how diabetes and its early stages, known as prediabetes, affect brain aging in people without dementia. Now, a comprehensive brain imaging study shows that both diabetes and prediabetes can be linked to accelerated brain aging. The study included more than 31,000 people between 40 and 70 years of age from the UK Biobank who had undergone a brain MRI scan (magnetic resonance imaging). The researchers used a machine learning approach to estimate brain age in relation to the person's chronological age.   Prediabetes and diabetes were associated with brains that were 0.5 and 2.3 years older than chronological age, respectively. In people with poorly controlled diabetes, the brain appeared more than four years older than chronological age. The researchers also noted that the gap between brain age and chronological age increased slightly over time in people with diabetes. These associations were attenuated among people with high physical activity who abstained from smoking and heavy alcohol consumption. https://medicalxpress.com/news/2024-08-healthy-lifestyle-counteract-diabetes-brain.html XX   Edgepark Commercial XX Another study showing the link between bright light at night and a higher risk of developing type 2. This study in the journet Lancet In the large modeling study, the research team investigated whether personal light exposure patterns predicted the risk of diabetes using data from approximately 85,000 people and around 13 million hours of light sensor data. The participants – who did not have type 2 diabetes – wore devices on their wrists for one week to track their light levels throughout the day and night. They were then tracked over the following nine years to observe whether they went on to develop type 2 diabetes. “Light exposure at night can disrupt our circadian rhythms, leading to changes in insulin secretion and glucose metabolism,” he says. Having more exposure to light at night (between 12:30 am and 6:00 am) was linked to a higher risk of developing type 2 diabetes, and this was true regardless of how much light people were exposed to during the day. The research accounted for other factors associated with type 2 diabetes, such as lifestyle habits, sleep patterns, shift work, diet, and mental health.   Even after taking these factors into account, the findings showed that getting more light at night was still a strong predictor of developing diabetes. https://scitechdaily.com/scientists-discover-simple-and-cheap-way-to-reduce-your-risk-of-diabetes/ XX Is there a link between voice pitch and glucose levels? And is it strong enough to one day perhaps lead to non-invasive glucose monitronig? Klick Labs published a new study in Scientific Reports today—confirming the link In "Linear Effects of Glucose Levels on Voice Fundamental Frequency in type 2 diabetes and Individuals with Normoglycemia," researchers investigated how blood glucose levels influence the frequency of the voice in 505 participants across three glycemic statuses—non-diabetic, prediabetic, and type-2 diabetic. Participants were fitted with continuous glucose monitors (CGMs) and recorded their voices multiple times daily for two weeks. The analysis revealed a linear relationship where an increase in CGM glucose levels corresponded to an increase in the fundamental frequency in the voice. The lead author says, "Whereas current glucose monitoring methods are often invasive and inconvenient, voice-based glucose monitoring could be as easy as talking into a smartphone, which could change the game for the estimated 463 million people around the world living with type 2 diabetes."   Klick Labs' latest research marks another step forward in its ongoing commitment to advancing the detection and management of diabetes using voice tech and machine learning. Their October 2023 study in Mayo Clinic Proceedings: Digital Health demonstrated that voice and AI can screen for type 2 diabetes with high accuracy.   https://medicalxpress.com/news/2024-08-diabetes-links-blood-glucose-voice.html#google_vignette XX Earlier this year we talked to the teenager behind a free bolus calculator. The FDA took T1D1 down, when they and Apple started cracking down on health tools without regulatory approval. Drew Mendalow has been working to bring it back and we have an update: He says, “Over the last two years, we have been tirelessly working to complete our FDA premarket submission. Thanks to contributions by the T1D community, we were able to complete the preparations needed for the Human Factors Study. The trial itself is the last, vital piece needed before we can submit the app to the FDA. Now, we're thrilled to announce that the team at Dexcom has graciously offered to run the study for us!” It’s a big deal – kudos to Dexcom and to Drew. We’ll let you know when T1D1 is back in the app store. XX Join us again soon!

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A weekly basal plus semaglutide is in the works, but not for the US right now, Tandem updates it's app recall, liver targeted insulin study, a weird walking story, and Lance Bass educates about LADA.  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: [email protected] 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 Novo Nordisk moves ahead with a new combination: once-weekly insulin icodec and semaglutide. Called IcoSema, Novo plans to submit for approval in Europe, Canada, Japan and Australia but NOT the US. As we told you earlier this summer, icodec – once weeky basal insulin – was not approved by the US FDA. Semaglutide is the molecule underpinning Novo’s immensely popular GLP-1 drugs Ozempic and Wegovy. Icodec has been approved as Awiqli in places like Europe, Canada, Japan and Australia but was snubbed by the FDA last month. The FDA has left the door open for another application, but Novo says they don’t expect to iron it out this year. In studies, the combination worked well to lower A1C for people with type 2 and they lost weight. They also had fewer lows. https://www.fiercepharma.com/pharma/corrected-after-icodec-rejection-novo-nordisk-wont-file-application-once-weekly-insulin-and   XX An update from Tandm on their app recall. Back in March they notified users of the recall because of an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience even after an updated version of the app was released. Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at [email protected] or (877) 801-6901. https://www.businesswire.com/news/home/20240812040222/en/Tandem-Diabetes-Care-Provides-Update-on-March-2024-Nationwide-Recall-of-tconnect-Mobile-App-for-iOS-Devices XX If you are an adult who has type 1 diabetes, you may be eligible to participate in a trial examining the impact of an investigational liver-targeted insulin on blood glucose control, A1C, and nighttime lows. This study is researching whether administering a liver-targeting insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro), will improve glycemic control. HDV-L insulin is designed to act on the liver to enhance glucose storage and decrease the frequency of severe hypoglycemia in individuals requiring insulin. It is not currently approved for use. For this trial, researchers are recruiting roughly 230 adults with type 1 diabetes aged 18-79 who are on multiple daily injections (MDI). This study is recruiting in California, Colorado, Florida, Georgia, Illinois, Indiana, New York, North Carolina, Ohio, and Texas. To enroll or learn more about this study, contact Todd Hobbs, MD at Diasome Pharmaceuticals at [email protected] or call 216-780-9324. Clinical Trials Identifier: NCT06238778 https://diatribe.org/diabetes-research/new-study-tests-liver-targeted-insulin-type-1-diabetes XX Sanofi is investing heavily to boost insulin production. They opened a new facility in Germany for the basal insulin Lantus and they announced they will invest over one billion dollars to expand production capacity in France. Sanofi’s considerable investment in insulin production is especially important given that other insulin companies appear to be focusing their efforts on production of GLP-1 medications like Mounjaro and Ozempic, rather than insulin. This has left some patients worried that Novo Nordisk and Lilly will leave them behind to pursue more lucrative products for weight loss, especially after Novo Nordisk decided to discontinue the basal insulin Levemir. https://diatribe.org/diabetes-medications/sanofi-build-new-state-art-insulin-plant   XX Hoping to talk to Abbott and Medtronic soon about their partnership announced earlier this month. The companies announced that Abbot will create an integrated continuous glucose monitor that works only with Medtronic’s diabetes technology and be sold exclusively by Medtronic. Along with announcing the partnership, Medtronic said Wednesday it received FDA approval for its Simplera CGM, which does not require fingersticks or overtape, unlike the company’s previous sensors. The Simplera Sync sensor, which is designed to work with Medtronic’s automated insulin delivery algorithm, is under FDA review separately. https://www.medtechdive.com/news/abbott-medtronic-partnership-automated-insulin-delivery/723600/ XX Researchers have developed a novel computer algorithm that can predict various diseases like diabetes or stroke, just by analysing the colour of the human tongue with 98 per cent accuracy. The imaging system developed by Middle Technical University (MTU) and the University of South Australia (UniSA) in Australia can diagnose conditions such as diabetes, stroke, anaemia, asthma, liver and gallbladder issues, Covid-19, and other vascular and gastrointestinal diseases. "The colour, shape, and thickness of the tongue can reveal a litany of health conditions," said Ali Al-Naji, adjunct Associate Professor at MTU and UniSA. The paper published in Technologies describes how the system analyses tongue colour to provide real-time diagnoses, demonstrating that AI can advance medical practices significantly. The breakthrough was achieved through a series of experiments using 5,260 images to train machine-learning algorithms to detect tongue colour. Researchers received 60 tongue images from two teaching hospitals in the Middle East, representing patients with diverse health conditions. The AI model matched tongue colour with the correct disease in nearly all cases. https://www.ndtv.com/world-news/new-algorithm-analyses-tongue-to-predict-diabetes-stroke-with-98-accuracy-6327124 XX Big roundup article from the UK Guardian all about 6 projects all around smart insulin. Not a lot new here, but it caused a lot of chatter. I’ll link it up – good summary of all of the research happening in the space right now. Glucose-responsive insulin is the idea that you could give one injection and the insulin would respond to the rise and fall of glucose levels without further action by the person.   https://www.theguardian.com/society/article/2024/aug/11/scientists-hail-smart-insulin-responds-changing-blood-sugar-levels-real-time-diabetes XX Edgepark Commercial XX Lance Bass (like glass) continues to keep the public posted on his recent LADA diagnosis. The boy band singer showing his IG audience more about what’s also called diabetes 1.5 and explaining how he was first diagnosed with type 2. XX Ok, brace yourself – I promise this is a real story. The Fart Walk is actually good for you. Ok.. stay with me. This is really just a great silly reframing of something we all know, and I couldn’t resist putting it in here. A wellness influencer put this out – you may have seen it – claiming the after dinner stroll can limit your risk of type 2 diabetes. A lot of studies confirm that – along with it having benefits if you already have diabetes. The flatulence part – or a release of gastric pressure – is also a known benefit of moving more after meals. So it’s funny, farts are always funny, but if it gets more people to walk after they eat I’m all for it.   https://people.com/fart-walk-benefits-what-is-it-type-2-diabetes-8694630#:~:text=Wellness%20influencer%20Mairlyn%20Smith%20has,of%20day%20you%20do%20it XX Join us again soon!

Talking about any possible complications from diabetes can be scary – and most of us only think of kidney issues in the worst possible way: transplant and dialysis. But there’s a lot you can do to stay healthy and there’s news from just this summer about how new medications are making a big difference to reduce your risk. My guests this week are Dr. Bob Gabbay, Chief Scientific and Medical Officer, American Diabetes Association and Dr. Jeff Giullian, Chief Medical Officer of DaVita. DaVita Kidney Care is a leading provider of kidney care in the United States. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More information about Kidney health here Find out more about Moms' Night Out - registration is open for Denver and Philadelphia! Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads 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]

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A new study looks at insulin needs in men vs women, updates on stem cell transplants and a new look at COVID 19 and T1D plus a fully implantable CGM is announced. We'll also tell you about a T1D athlete drafted to the MLB. Lots more in this week's episode, full transcipt below.  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: [email protected] 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 Do men and women have different insulin requirements? A new study conducted across Europe says yes – women overall need less. Published in the Journal of Diabetes Science and Technology this looked at over 9,000 adults with type 1 diabetes using data from patients using the Diabeloop Generation 1 (DBLG1) hybrid closed-loop pump system. In this study, women needed 14-percent less insulin overall than men. These researchers say these findings have important implications for the practical management of insulin therapy and highlight the necessity of considering gender as a crucial factor in diabetes treatment. The treatment guidelines provided by American and European Diabetes Societies do not currently have gender-specific recommendations for insulin-weight ratios. The co-founder and Chief Scientific and Technical Officer for Diabeloop. “This study also highlights the capacity to discover new insights from big-data analysis of real-world data.” *Insulin Requirements According to Gender and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery, https://doi.org/10.1177/19322968241252366). https://www.theglobeandmail.com/investing/markets/markets-news/GetNews/27419187/diabeloop-study-reveals-significative-gender-differences-in-insulin-requirements-for-type-1-diabetes-patients/   XX New drug therapy in those lucky diabetic mice boosted insulin-producing cells by 700% over three months, effectively reversing the disease. Scientists at Mount Sinai and City of Hope have been able to grow new beta cells in the body, in a matter of months. The therapy involved a combination of two drugs: one is harmine, a natural molecule found in certain plants, which works to inhibit an enzyme called DYRK1A found in beta cells. The second is a GLP1 receptor agonist. The latter is a class of diabetes drug that includes Ozempic, The researchers tested the therapy in mouse models of type 1 and 2 diabetes.. The signs of the disease quickly reversed, and stayed that way even a month after stopping the treatment.   The results are intriguing, but of course being an animal study means there’s still much more work to be done before it could find clinical use. So far, harmine alone has recently undergone a phase 1 clinical trial in humans to test its safety and tolerability, while other DYRK1A inhibitors are planned for trials in humans next year. https://newatlas.com/medical/diabetes-reversing-drug-boosts-insulin-producing-cells/ XX Stem cell–derived beta-cell replacement therapy continues to show benefit in people with type 1 diabetes at a high risk for severe hypoglycemia. New info from Vertex shows that of a total 17 patients who received a full dose of their  investigational allogeneic stem cell–derived, fully differentiated pancreatic islet cell replacement therapy (VX-880), three, thus far, have achieved the primary study efficacy endpoint of elimination of severe hypoglycemic episodes with A1c Others are on the same trajectory, Piotr Witkowski, MD, PhD, professor of surgery at The University of Chicago, Chicago, said at the recent American Diabetes Association (ADA) 84th Scientific Sessions. In his presentation, Witkowski also provided details about the deaths of two study participants that the company had announced in January 2024, neither of which were related to the VX-880 product. In fact, there have been no severe adverse events related to the product itself, with most due to either the infusion procedure or the immunosuppression. "These data highlight the curative potential of VX-880 in people living with type 1 diabetes and support further evaluation of VX-880 toward pivotal development," Witkowski said. For now, patients selected for the study are those who experience frequent severe hypoglycemia deemed to be a greater risk to the patient than that of immunosuppression. However, Ahn pointed out, "With VX-880, the obvious fly in the ointment is the need for immunosuppression which carries significant risk…There are multiple solutions being proposed, but we are still waiting for data as promising as the initial Vertex data is on that front." https://www.medscape.com/viewarticle/stem-cell-derived-islets-continue-show-benefit-t1d-2024a1000cx1 XX Still lots of COVID studies coming in about type 1. A German study suggests COVID 19 may speed up progression of existing but presymptomatic T1D in kids. These researchers had been screening and following children in an early presymptomatic stage of type 1 diabetes for several years. They noticed an increase in the numbers of Incidence of clinical type 1 diabetes nearly doubled after the pandemic started. "We know that the virus can infect the pancreatic islets so it could be causing damage or change in the beta cells that make insulin," said Ziegler when discussing possible mechanisms behind this association. "Second, there is generalized inflammation during the infection and there may be a stimulation of the immune response. Third, there could be metabolic stress from the infection that affects the beta cells that make insulin. To dive into this topic, youth were identified in the German Fr1da-screening program from 2015 to 2023. All patients had presymptomatic diabetes defined as persistent, confirmed positive results for two or more islet autoantibodies. Their progression was monitored at 3- to 6-month intervals. Clinical type 1 diabetes was defined according to American Diabetes Association   COVID infection was either self-reported via the family or identified with SARS-CoV-2 antibodies were confirmed in blood samples collected at study visits.   Vaccination against COVID-19 may be one way to protect presymptomatic type 1 diabetes youth from progression, Ziegler added. She said her group is currently testing whether COVID-19 vaccination can reduce new-onset, presymptomatic type 1 diabetes in a clinical trial  of children with genetic risk factors for the condition. https://www.medpagetoday.com/endocrinology/type1diabetes/111084 XX The FDA says no – for now - to Novo Nordisk's weekly insulin.  This has been approved in Canada and should be available there shortly. But the FDA says it wants more information related to the manufacturing process and the type 1 diabetes indication to complete the review. Novo said it does not expect to be able to fulfil the requests this year, and that it will work closely with the FDA regarding the next steps. The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1 diabetes due to risks of low blood sugar. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-novo-nordisks-weekly-insulin-2024-07-10/ XX A couple of weeks ago we spoke to the attorneys taking on CGM monitronig in schools. They’ve helped a family in Connecticut and set a precdent.  A child with autism and diabetes was not getting reasonable accommodations under the federal Americans with Disabilities Act in a public preschool program. I’ll link up the press release from the DOJ but this family wasn’t getting any support and it just wasn’t safe. The lawyers here tell me the ruling and settlement is just going to help them going forward as they try to make schools complient with CGM as a reasonable  accomodatin. https://www.justice.gov/usao-ct/pr/aba-therapy-provider-make-changes-comply-americans-disabilities-act   XX Ozempic could lower the risk of dementia and a range of other mental problems compared with other existing treatments for patients with diabetes. What’s more, researchers found that Ozempic cut nicotine dependence in those patients.   This study relied on medical records from more than 100,000 U.S. diabetes patients, including more than 20,000 who were prescribed semaglutide between December 2017 and May 2021. After a year, patients who took Ozempic had a 48% lower risk of developing dementia than those on Januvia. The risk in Ozempic patients was also 37% lower than those who took Glucotrol and 9% lower than those on Jardiance. Notably, previous research has determined that diabetes patients are at a greater risk of developing dementia. But the authors emphasized that the analysis is observational. The results need to be replicated in a controlled trial that assigns patients to randomly take Ozempic and the other drugs, according to Dr. Max Taquet, another Oxford clinical lecturer and senior study author. https://www.cnbc.com/2024/07/16/healthy-returns-ozempic-may-lower-dementia-risk-nicotine-use.html XX   Edgepark Commercial XX The Omnipod 5 with Dexcom G7 integration is now available through select pharmacies with full availability expected in the fall.   The System uses new Pods that are compatible with both Dexcom G6 and G7, but the prescription code will stay the same as the current Omnipod 5 Pods. This means the community will have similar insurance coverage and access to what they have with Omnipod 5 today.   If you're looking to start on Omnipod 5 and you're currently using Dexcom G7, your doctor will need to send a prescription for both the Omnipod 5 Intro Kit and Omnipod 5 Pods, compatible with Dexcom G6-G7, to ASPN Pharmacies.   You can learn more at https://www.omnipod.com/innovation/dexcom-g7.   If you are already using Omnipod 5, you will get the new Pods compatible with Dexcom G6 and G7 through your Pod refills. You do not need a new prescription. The week of July 29th, you will receive a free software update for the Omnipod 5 App to your Controller or compatible Android smartphone which is needed to use the System with Dexcom G7. Accept the update. We recommend you continue to use your current Omnipod 5 Pods and Dexcom G6 supplies until the new Pods compatible with Omnipod 5 with Dexcom G6-G7 are available at your preferred pharmacy.   We'll email our users when the new Pods are available in most pharmacies.   You can learn more at https://www.omnipod.com/innovation/new-compatible-devices   XX Big promises about long-term implantable blood glucose monitor from a company called Focus. They say they’re partnering with Glucotrack to quote - transform how people with diabetes interact with their condition. They’re not calling this a CGM – rather it’s a CBGM, continuous blood glucose monitor because it will measure glucose levels in blood, not in interstital fluid like CGMs do. They company says this is a fully subdermal location, with no external wearable. In preclinical studies, the CBGM has a MARD of 4.7% at day 90. That is MUCH lower than CGMs on the market – Dexcom and Libre are in the low 8s right now. BUT.. it hasn’t been fully tested in people yet. Human clinical trials are set to start later this year. https://www.drugdeliverybusiness.com/focus-collaborates-glucotrack-implantable-cbgm/ XX Big congrats to Jamie Ferrer (Chy-may Fer-rare) On Monday, Ferrer’s dream was realized when the Twins selected the Florida State outfielder in the fourth round (No. 126 overall) during Day 2 of the MLB Draft. Minnesota vice president of amateur scouting Sean Johnson said the club had its eyes on Ferrer since high school. “Recently, I was in Orlando at a conference called, “Friends for Life with CWD [Children with Diabetes],” and we had an event that was a sports day. … Kids would come up to me and either them or their families would ask me how I dealt with this [or that],” Ferrer said. “And seeing their faces light up whenever I said I was diagnosed at three and I played college baseball. … You hear people tell you no and that you can’t do this because you have Type 1 diabetes … So why not inspire as many people as I can?”   “I’m super proud of being a Type 1 athlete, and it’s something that I’ll never shy away from talking about or showing off my insulin pump because it’s who I am and it’s something that I’ve had to deal with my entire life.” https://www.mlb.com/news/jaime-ferrer-selected-no-126-overall-by-twins-in-2024-mlb-draft XX Join us again soon!

DIY Pioneer Dana Lewis was diagnosed with something called EPI – exocrine pancreatic insufficiency a couple of years ago. She’d never heard of it and was shocked to find out diabetes is considered a common co-condition. In fact, 20-30 percent of people with diabetes can end up with EPI. EPI can cause a lot of discomfort and stomach issues – and health issues if left untreated. Of course, Dana jumped in, publishing a review of studies and now- creating studies of her own. She’ll explain what she’s doing, why she needs your help, and more about this condition that doesn’t get much attention. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Find your Exocrine Pancreatic Insufficiency Symptom Score using Dana Lewis's new tool: https://danamlewis.github.io/EPI-PEI-SS/ Learn more from Dana here Find out more about Moms' Night Out - registration is open for Denver and Philadelphia! Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads 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]

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The Eversense CGM could soon be approved for one year of continuous use, the first generic GLP-1 medication is launched, a new company tauts and all-in-one sensor and pump infusion set, a new diabetes accessory in the Roblox game, 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: [email protected] 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 The first ever generic GLP-1 medication will soon be available in the US. It’s a generic of Victoza, originally approved by the FDA in 2010 for diabetes, is part of the same class of drugs that includes Ozempic and Mounjaro. Liraglutide is Glucagon-like peptide-1 receptor agonists (otherwise known as GLP-1s or GLP-1 RAs) are a class of incretin drugs that mimic the body’s natural hormones to help treat diabetes and obesity. However, the popularity of the drugs has spiraled out of control at times, leading to shortages and supply chain issues in the US and abroad.  The arrival of a GLP-1 generic drug provides reasons to be hopeful for doctors and patients alike, but there are also caveats. Couple of caveats - liraglutide is injected once daily (vs. weekly) and many doctors say it doesn’t work as well for as many people as semaglutide and terzepatide. No confirmation on the price Two other generic options are being developed and could launch in December 2024. Patents for newer GLP-1 medications like Ozempic and Wegovy won’t expire until several years down the road https://www.healthline.com/health-news/victoza-generic-glp1-drug-available XX Senseonics plans to launch a 365-day sensor in the U.S. in the fourth quarter of this year. A one-year Eversense CGM could be a game changer for the company.   In 2024, Senseonics expects to more than double U.S. new patient starts and increase the global installed base by around 50%. The growth is built on the current 180-day version of Senseonics’ implantable Eversense CGM. Eversense’s 180-day sensor can need calibrating twice a day, something Senseonics CEO Tim Goodnow said “has been a competitive disadvantage.” Users calibrate the 365-day sensor once a week. Senseonics is in talks with insulin pump manufacturers about integrating its Eversense CGM with their devices but has yet to commit to a timeline for finalizing an agreement. https://www.medtechdive.com/news/senseonics-365-day-cgm-2025-sales/719717/ XX People who take Ozempic or Wegovy may have a higher risk of developing a rare form of blindness, a new study suggests. Still, doctors say it shouldn’t deter patients from using the medicines to treat diabetes or obesity.   Last summer, doctors at Mass Eye and Ear noticed an unusually high number of patients with non-arteritic anterior ischemic optic neuropathy, or NAION, a type of eye stroke that causes sudden, painless vision loss in one eye.   The condition is relatively rare — up to 10 out of 100,000 people in the general population may experience it — but the doctors noted three cases in one week, and each of those patients was taking semaglutide medications. The risk was found to be greatest within the first year of receiving a prescription for semaglutide.   The study, published Wednesday in the medical journal JAMA Ophthalmology, cannot prove that semaglutide medications cause NAION. And the small number of patients — an average of about 100 cases were identified each year — from one specialized medical center may not apply to a broader population. The ways that semaglutides interact with the eyes are not entirely understood. And the exact cause of NAION is not known either. The condition causes damage to the optic nerve, but there is often no warning before vision loss.   For now, patients who are taking semaglutide or considering treatment should discuss the risks and benefits with their doctors, especially those who have other known optic nerve problems such as glaucoma or preexisting visual loss, experts say https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-ozempic-linked-with-sight-threatening-eye-disorder-study-2024-07-03/ XX We got some updates at ADA about the over the counter CGMS Dexcom Stelo and Abbot’s Libre. Dexom plans a late august launch of stelo, which you’ll order from their website – it won’t be physically in stores. Abbott also plans to sell its wellness-oriented Lingo device this summer through an e-commerce website. That’s a sensor that’s been available in other coutnires for a while, but was recently okayed in the US. It’s not meant for people with diabetes. The Libre Rio is designed or adulst with type 2 who don’t use insulin. No timing yet on that product’s launch. Neither Abbott nor Dexcom have disclosed pricing for the upcoming products. https://www.medtechdive.com/news/abbott-dexcom-over-the-counter-cgm-launch/719928/ XX Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine. Omnipod 5 is currently cleared in the U.S. for people with Type 1 diabetes. Insulet hopes to expand the pump to people with Type 2 diabetes, with an expected launch in early 2025. The FDA has not yet cleared any automated insulin delivery systems for people with Type 2 diabetes, Insulet said. The company has a basal-only insulin pump, called Omnipod Go, that was cleared for people with Type 2 diabetes last year, but it does not connect to other devices. Even though Omnipod 5 is not currently indicated for Type 2 diabetes, doctors prescribe it for their patients with full reimbursement since the pharmacy channel doesn’t distinguish between Type 1 or Type 2 patients, J.P. Morgan analyst Robbie Marcus wrote in a research note on Sunday. https://www.medtechdive.com/news/insulet-omnipod-5-type-2-diabetes-study/719644/ XX In the keynote address at the American Diabetes Association annual conference, FDA Commissioner Dr. Robert Califf expressed concerns about the rising rates of diabetes in the U.S. Though revolutionary medications and technologies for diabetes and weight loss continue to emerge, these treatments are vastly underused. The silver lining lies with type 1 diabetes therapies, which are showing great promise in clinical trials. “For the larger epidemic of type 2 diabetes, we’re failing right now,” Califf said. “I don't say that lightly.” A huge problem, Califf said, is access. While most health insurance plans cover medical devices and medications for diabetes, without insurance, costs add up quickly. Ozempic, for example, costs nearly $1,000 per month without insurance. Studies have found that regardless of insurance status, roughly 26% of Americans skipped or delayed treatment due to cost. https://diatribe.org/diabetes-management/fda-commissioner-says-were-failing-people-type-2-diabetes XX Embecta presented two abstracts at the American Diabetes Association Scientific Sessions last weekend making the case for its insulin patch pump for Type 2 diabetes. The company submitted the device for Food and Drug Administration clearance in late 2023. The diabetes device company developed a patch pump with a larger insulin reservoir that can hold up to 300 units. Embecta, which is better known for making equipment such as pen needles and insulin syringes, has been developing its first patch pump. The company found that a device with a larger insulin reservoir could provide longer wear times and fewer disposable patches. https://www.medtechdive.com/news/embecta-insulin-patch-pump-volume-american-diabetes-association/719779/ XX   Pump/CGM sensor in one The niaa signature patch pump, shown with a watch displaying current blood sugar level The niaa signature patch pump has a manual bolus button and is part of an in-development AID system. Swiss technology maker Pharmasens demonstrated a new semi-reusable tubeless patch pump and glucose sensor in the same compact device, called the niia signature, which the company says can be worn for five days.   The top of the device, which includes Bluetooth connectivity and the electronic and mechanical parts to control the pump, separates from the disposable 300-unit reservoir along with the adhesive used to attach the device to the body via a steel cannula. A small button on the device allows manual bolusing. The company says an AID system will manage the device, controlled by smartphone.   PharmaSens' simpler basal-bolus patch pump, the niia essential, was submitted for FDA approval in late December. Availability of the niia signature AID system has yet to be announced. https://diatribe.org/diabetes-technology/diabetes-technology-display-ada-2024 XX Edgepark Commercial XX New international consensus statement offers guidance on the care and monitoring of people who are at high risk for type 1 diabetes (T1D). This is all about screening and testing for islet autoantibodies. These individuals are classified as: At risk or Stage 0 (single autoantibody or transient single autoantibody), Stage 1 (two or more autoantibodies with normoglycemia), and Stage 2 (two or more autoantibodies with dysglycemia but without symptoms and not yet meeting diagnostic criteria for Stage 3 clinical T1D). The document was presented on June 24, 2024 in a 90-minute symposium at the American Diabetes Association's annual Scientific Sessions and published simultaneously in both Diabetes Care and Diabetologia. "This is not guidance around who to screen or when to screen. This is guidance for the hundreds of thousands of people around the world who have participated in screening, mostly through research programs, and have been identified with positive autoantibodies and need care in the clinical setting," panel co-chair Anastasia Albanese-O'Neill, PhD, APRN, CDCES, of Breakthrough T1D, told Medscape Medical News.   The recommendations also include when to start insulin, and how to provide education and psychosocial support to individuals and family members of those given the early-stage T1D diagnosis. https://www.medscape.com/viewarticle/experts-advise-early-risk-monitoring-type-1-diabetes-2024a1000bpo XX Roblox has added a diabetic option, complete with insuli pen and Dexcom You can find it in the marketplace JDRF – now breakthrough t1d – started a world in roblox a couple of years ago as well Roblox is a super popular online game that a lot of kids play. https://www.roblox.com/games/5823990610/Breakthrough-T1D-World XX FFL next week! Join us again soon!

Medications like Ozempic and Mounjaro have fundamentally changed the way diabetes is treated. But even if your doctor writes the prescription and your insurance company covers it, getting your hands on the medication is getting harder and harder. We’re talking about what to do if you’re having trouble here – tips if you have to start and stop – and ways some have found to get their hands on the injections.  My guest is Dr. Michael Weintraub and endo and diabetologist at NYU, he’s a researcher and he sees patients, so he’s dealing with this almost every day. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. GLP-1 Supply Tracker: https://ro.co/weight-loss/supply-tracker/ More info about these medications: https://www.health.com/mounjaro-vs-ozempic-8400183 Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads 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]

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: South Africa runs out of insulin pens - and why this could happen anywhere, once-weekly insulin is approved in Canada, update on Omnipod 5 with Dexcom G7 rollout, more older people are getting type 1 but more people are living longer with it, CGM at the Olympics 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: [email protected] 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 Quick note – the American Diabetes Association Scientific Sessions is this weekend. That means new research studies will be released, technology announced, and likely lots of news will be made. I’m recording this before the conference starts – if there’s enough going on we may have an additional In the News next week. XX Our top story right now… XX No more insulin pens for South Africa.. .as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs. Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen. Novo Nordisk’s  drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A month’s supply of Ozempic in the United States costs about $1,000, far more than insulin. Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound. Novo Nordisk is continuing to supply human insulin in vials to South Africa, where more than four million people live with diabetes, but pens are considered much easier to use and more precise. The vial system was phased out for most South Africans in 2014. But recently, South Africa’s National Department of Health instructed clinicians that they should teach patients how to use vials and syringes of insulin instead of pens. I posted about this already and said this is a canary in the coal mine and everyone going to ADA should be asking Novo and Lilly about this. GLP medications are fantastic but insulin cannot be left behind. https://www.nytimes.com/2024/06/19/health/insulin-pens-south-africa-ozempic-wegovy.html XX Once a week basal insulin – for type 1 and type 2 – comes to Canada. Novo Nordisk announced that it’s version of insulin icodec will be available starting June 30th. They are calling it.. Awiqli – I promise I didn’t make that up.  Canada is the first country to get the product. Awiqli works as a time release of insulin over the course of a week. It is more expensive. And  Canada's Drug Agency, which assesses drugs and recommends whether they should qualify for reimbursement under public drug plans, is still doing the math here. No word on private insurers coverage yet. An FDA advisory board recently passed on approving weekly basal for people with type 1, saying the risk of low blood sugar was too great. But the full FDA hasn’t yet weighed in.   https://www.ctvnews.ca/health/world-s-first-weekly-insulin-injection-coming-to-canada-in-2-weeks-manufacturer-says-1.6929321 XX The prevalence of people over 65 living with type 1 diabetes  went up 180% in the past 30 years, a new study finds. That’s an increase of 1.3 million people over 65 in 1990 with the disease to 3.7 million in 2019, the authors noted in a study published on June 12 in The BMJ. Data included people from 204 countries and territories from 1990 to 2019. Dying from type 1 diabetes slipped by about 1% every year since 1990, the data also showed. The mortality for people 65 and up went down by 25% during the three decades covered in the study. The most rapid prevalence was in North Africa and the Middle East, and Western Europe, and the slowest increase in prevalence was in North America. All 21 regions around the world had an increased prevalence of type 1 diabetes in people over 65. The disease no longer contributes to a reduced life expectancy for many people due to medical care improvements, say these researchers. https://www.mcknights.com/news/report-type-1-diabetes-prevalence-in-older-adults-nearly-triples-since-1990s/ XX Hearing more about the limited rollout of Omnipod 5 with the Dexcom G7. This was announced in February but just seems to really be getting underway. A few people have received emails that people new to the system will be getting this first.. but that at the end of July current users will get a controller update so they can use G7 with the current pods. We’ll have more on this soon – I don’t have a link for you - but thanks to all of you who sent me those emails very much appreciate it. XX New life possible for Korean insulin pump EOPatch– this is a competitor to the Omnipod. A court has killed an injunction that meant the company, EOFlow, could not bring the patch pump to the US. Last year, the court initially granted that injunction and Medtronic backed out of an acquisition plan. No word yet from Medtronic if that deal is back on.. or if another company may work to bring EOFlow to the US. https://news.bloomberglaw.com/business-and-practice/ban-against-insulin-pump-patch-sales-reversed-by-federal-circuit XX The CeQur Simplicity patch is now FDA-cleared for up to 4 days of wear. This is a mechanical patch pump that replaces fast-acting injections. This is an extension from 3 days to four.. now each patch replaces up to 12 injections making it the longest wearable insulin delivery patch. The company says that can be 1000 fewer shots a year. Marketed mostly to people with type 2 diabetes who use insulin, the company says nearly 90% of patients using CeQur Simplicity reported following their insulin regimen better as compared to multiple daily injections.(4) The patch is clinically proven to improve glycemic control, with patients achieving significantly improved A1C and time-in-range (TIR) goals.(5,6) https://www.prweb.com/releases/cequr-simplicity-a-wearable-mealtime-insulin-delivery-device-obtains-fda-clearance-for-4-days-of-wear-to-further-simplify-diabetes-management-302173938.html XX A warning from Roche which says “dangerous counterfeits” of its diabetes medical devices ended up for sale on Amazon. Roche accused manufacturers and sellers based in India of selling counterfeit versions of test strips for its Accu-Chek glucometers.  This is part of a federal lawsuit. Roche said the counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche’s registered U.S. trademarks and fake expiration dates. After the suit was filed, a judge granted Roche’s request for a temporary restraining order to stop the defendants from selling the counterfeit products. The Amazon stores that were offering the products for sale appear to have been taken down. Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme all of the counterfeit products sent to the U.S. were stored at Amazon warehouses across the country, including in Brooklyn. https://www.cnbc.com/2024/06/10/roche-counterfeit-diabetes-medical-devices.html XX Edgepark Commercial XX Summer Olympics this year may be a showcase for CGMs. Abbott is sponsoring a Dutch long distance running, he’ll be wearing the Libre. Other athletes are using the CGMs in training and may wear as allowed in their sports. There isn’t a lot of proof yet that these devices make a big difference for people without diabetes.. but high level athletes are looking for any edge possible. Expect to hear a lot more about this in the lead up to the Olympics July 26th. https://learningenglish.voanews.com/a/olympic-athletes-turn-to-diabetes-technology-in-medal-chase/7653234.html XX Join us again soon!

Have you heard of a diabetologist? This is a newer specialty in the U-S that may help offset the lack of endocrinologists. Most people with type 2 see a general practitioner and the diabetology certification helps those doctors learn about the latest in diabetes care. We’ll talk about how to find one of these rare experts, why there could be more of them soon, and get advice about how to make the most of your diabetes visit to ANY doctor. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Please visit our Sponsors & Partners - they help make the show possible! Learn about Dexcom  Check out US MED Find out more about CeQur Simplicity Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  -- We have a monthly newsletter! Sign up today (no spam we promise)  Here's where to find us: YouTube (new!)  Facebook (Group) Facebook (Page) Instagram Threads 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]

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: Dexcom goes Direct to Watch in the US, Abbott gets FDA okay for its OTC CGM, new study about metformin during pregnancy, an update on semaglutides, JDRF changes its name, and more! We have a monthly newsletter! Sign up today (no spam we promise)  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 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] 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 Our top story this week – some CGM news… Dexcom announces Direct to Watch is here in the US. From the release: Using its own dedicated Bluetooth connection, Dexcom G7 sends glucose information and personalized alerts right to a user’s Apple Watch. Dexcom G7 is the only CGM system that can display glucose on multiple devices simultaneously and independently, including on a smartphone, smart watch, receiver or connected automated insulin delivery system.‡ Apple products are built with strong privacy protections and users have control over their data in the Health app. (If you like to keep track of these things, we are just over 7 years since the official announcement this was going to happen) XX FDA approves Abbot’s over-the-counter continuous glucose monitoring system. It’s called Lingo and comes a couple of months after Dexcom won clearance for its Stelo over-the-counter CGM. Abbott has been selling Lingo in the UK as more of a lifestyle device – not aimed at people with diabetes. They call it a consumer biowearable designed to help people make decisions about their overall health and wellness; Lingo is not intended for use in diagnosis, treatment or management of a disease or medical condition. No word yet on exactly what kind of app they’ll launch here in the US or if it will be marketed toward people with diabetes like the Libre currently is.. just as an OTC option. While it seems like the same hardware, the company has not confirmed that. https://www.drugdeliverybusiness.com/abbott-wins-fda-clearance-for-its-lingo-otc-glucose-monitor/ XX New study looking at the use of continuous glucose monitors (CGMs by rural children and adolescents living with type 1 diabetes. Previous studies examining the use of CGMs by children relied on prescription records to identify use of these devices, but just because someone is prescribed a CGM does not mean that they use one; barriers such as cost can stand in the way. this study instead identified use of these devices according to billing codes for the interpretation of CGM readings by the provider. The results unearthed a sizeable disparity. Those living in rural areas were significantly less likely to use a CGM than those in urban areas, even after adjusting for sex, race or ethnicity and insurance type. Specifically, compared with youth living in urban areas, the use of CGMs was 31% lower for children and adolescents living in small rural towns, and 49% lower for those living in isolated rural towns. The gap between rural and urban patients persisted across the four years of the study, even as the use of CGMs increased for all patient types during this time. These results are also relevant to people with type 2 diabetes who require insulin, Tilden said. The results also revealed that non-White patients, those who had public insurance and patients who lived in areas with a higher NPI all were less likely to use CGMs. More research is needed to explore the reasons for these disparities, but Tilden said they likely are a function of such issues as cost, reduced internet access, which CGMs require to relay their data, and distance from clinics and Medicaid-contracted pharmacies.   The next step is figuring out how to eliminate those disparities. These researchers are seeking funding to design an intervention that uses telemedicine and partners with a network of 35 clinics across Kansas to deliver specialty care to diabetes patients in rural areas.   https://www.kumc.edu/about/news/news-archive/diabetes-monitoring-disparities.html XX Metformin is just as safe to use during pregnancy to treat type 2 diabetes as insulin. The study, which hasn’t been published yet in a peer-reviewed journal, tracked health data and potential long-term side effects of using metformin during pregnancy for up to 11 years postpartum. While today’s popular GLP-1 medications, such as Ozempic, are not approved yet for use during pregnancy, metformin and insulin have been used during pregnancy for decades. https://www.medicalnewstoday.com/articles/metformin-may-be-as-safe-as-insulin-to-treat-diabetes-during-pregnancy XX Once weekly basal insulin is a no go from an FDA advisory panel. They found the potential benefits of the investigational once-weekly basal insulin analog icodec (Novo Nordisk) don't outweigh the increased risk for hypoglycemia in people with type 1 diabetes. We’ve been following this for a long time. Most of the trials here have been in people with type 2 – and the FDA hasn’t publicly raised concerns about efficacy and safety seen in any of those trials. But the type 1 trial found a significant increase in serious or severe hypoglycemia with icodec compared with degludec (4.66 vs 1.0 events per 100 patient-years; 14 events in nine patients versus three in three patients), with the greatest incidence in the icodec group on days 2-4 after injection. None of the events resulted in treatment discontinuation or study withdrawal. This doesn’t mean the FDA can’t approve the drug – and the panel mentioned that they hope the FDA would work with Novo Nordisk to – quote - make sure that if this is approved there are as many guardrails as possible to make sure we don't harm people with type 1 diabetes." https://www.medscape.com/viewarticle/advisory-panel-votes-against-once-weekly-insulin-type-1-2024a10009we XX The shortage of Ozempic and Mounjaro continues… with some doctors offering advice of what to do if you can’t fill your prescription. Health care company Ro recently launched a public crowd-sourced shortage tracker to help patients. The company says they also share the patient-reported shortages to the FDA. Chae says some patients could discuss with their doctor off-label use of other medications, like liraglutide injections (such as Trulicity, for example), depending on their preexisting conditions. Patients may also consider trying compounded semaglutide. Compounded drugs are made to order in local pharmacies, but Chae says be wary of them: Because of their bespoke nature, the drugs' safety isn’t regulated by the FDA. “The state of Mississippi, North Carolina and West Virginia have banned these compounded drugs,” he said. https://www.scrippsnews.com/health/popular-diet-and-diabetes-drugs-in-short-supply-as-demand-surges XX Commercial XX Big news from JDRF – they’ve changed their name to "Breakthrough T1D." Here’s the statement: "Breakthrough T1D was selected following a rigorous, data-informed process because it more accurately conveys the nonprofit's ability to connect with and work on behalf of the entire type 1 diabetes community," The median age for a person living with T1D worldwide is 37 years. Only about one in five are aged 20 years or younger, two thirds are aged 20-64 years, and another one in five are aged 65 years or older.   The organization was founded in 1970 by parents of children with T1D and was originally called the "Juvenile Diabetes Foundation." The "research" part was added in 2012 to reflect that aspect of its mission. We will have much more on this next week – Tuesday’s episode is an interview with JDRF. Oops with Breakthrough T1D. https://www.medscape.com/viewarticle/type-1-diabetes-group-grows-jdrf-now-breakthrough-t1d-2024a1000afr XX Android users – heads up! The FDA has approved a hybrid, closed-loop, insulin-delivery Android app. In May, CamDiab, revealed that the CamAPS FX had received approval. CamAPS FX is approved for people with type 1 diabetes who are two years of age or older, including those who are pregnant.   CamAPS FX works in unison with the FreeStyle Libre 3 and the Dexcom G6 to produce a hybrid, closed-loop system that is compatible with the Ypsomed mylife YpsoPump. The app and those pumps are already approved in several other countries. You may recall that the YspoPump had a partnership with Lilly to bring that pump to the US – but that deal died in 2022. Yspomed is still moving forward to get FDA approval for their pump. https://beyondtype1.org/fda-approves-camaps-fx-hybrid-closed-loop-insulin-delivery-app/?fbclid=IwZXh0bgNhZW0CMTEAAR137RhLAt2GfIJ_BBYMrhU2R-maQ0EQmwOFhPfKN9iCnG2BKWY6dEB0sTk_aem_ATLPk1xWOnLNzPz7LvYINbTdCVMZk7pcRmma2pgG5MIo0OfinomTSgjsTsTpW_fE6GNVRnScZS6UGzaTvP1SewNW XX Driven by payments for diabetes treatments — especially insulin — prescription drugs for metabolic diseases now make up nearly one quarter of total national pharmaceutical spending, reported a study of spending trends by therapeutic class. The detailed examination of a decade's worth of US drug spending also found changes in who pays for the medicines, with an overall drop in out-of-pocket costs, except in the metabolic disease category. The findings add to concerns about the costs of US diabetes treatments. Annual US spending on diabetes medicines surged from $27.2 billion in 2011 to $89.2 billion in 2020,  according to this paper was published online in Research in Social and Administrative Pharmacy. In the same period, total annual pharmaceutical spending rose at a far slower rate. Yet much of the persistent gain in the cost of diabetes treatments in this same period was due to a decades-old drug, insulin, a cornerstone of diabetes care. https://www.medscape.com/viewarticle/study-raises-concerns-about-rising-cost-diabetes-meds-2024a1000a8e XX The number of people aged over 16 with insulin-dependent diabetes and eating disorder symptoms is as high as one in four, a study has revealed. Researchers from the University of Eastern Finland examined the findings from 45 past studies, looking at data from almost 11,600 people with insulin-dependent diabetes. They say that understanding the extent of the issue is the first step in developing treatment pathways, citing Finland as an example of a country which does not have care pathways for people with both diabetes and eating disorders. Of course, neither does the US. Typical eating disorder symptoms include restricting food intake and binge eating. Symptoms particular to insulin-dependent diabetes include insulin omission, which is when individuals restrict or skip insulin doses due to fears of putting on weight. The prevalence of eating disorder symptoms was higher in women than in men, a finding previously made in young people too. The age of an individual was not found to be a factor, with eating disorders occurring regardless of age group. https://www.diabetes.co.uk/news/2024/jun/1-in-4-people-with-insulin-dependent-diabetes-have-eating-disorder-symptoms-research-shows.html XX Congrats to Kate Farnsworth who recently won Diabetes Action Canada Catalyst for Change award. Many of you know Kate from the early DIY days.. Kate Farnsworth is the patient partner co-lead for the Innovations in Type-1 Diabetes Program. Kate has been heavily involved in the Do-It-Yourself #wearenotwaiting movement since her daughter Sydney was diagnosed with type 1 diabetes at the age of 8. With a background in information technology and graphic design, Kate has lent her skillset to developing diabetes watch faces for remote monitoring used by patients worldwide. Kate has created an online patient-driven support community for people who are exploring DIY closed-loop solutions and continues to advocate for all people with diabetes to have access to the best tools to manage their diabetes. Very nice to see this award go to someone very well deserved. XX Join us again soon