Diabetes Connections Type 2

No nagging and no lecturing! Just good information about what's new for people with type 2 diabetes. A lot has changed; there are new tools and even new ways of thinking about diabetes. We're sharing quick facts and bringing you interviews with tech companies, advocates, and fascinating people living with type 2. Host Stacey Simms has been called “A diabetes podcast pioneer” by Healthline. You’ll get actionable info that will help you thrive!

In the News...Does insulin use differ by gender? Diabetes & Covid update, fully implantable CGM studied, and more! 07/19/2024

In the News...Does insulin use differ by gender? Diabetes & Covid update, fully implantable CGM studied, and more! 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 Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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 < 7% at 1 year and the secondary endpoint of insulin independence. 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. 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 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.” XX Join us again soon! /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/32203982

What is EPI? The link to diabetes (and whether you're at risk) 07/10/2024

In the News... Generic GLP-1, All-in-one sensor and infusion set, 365-day CGM and more! 07/05/2024

In the News... Generic GLP-1, All-in-one sensor and infusion set, 365-day CGM and more! 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 Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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! /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/32017467

What to do when you can't fill your Ozempic or Mounjaro prescription - Advice from an endocrinologist 06/26/2024

In the news.. Insulin pen shortage, Omnipod 5 update, once-weekly insulin approved in Canada, and more! 06/21/2024

In the news.. Insulin pen shortage, Omnipod 5 update, once-weekly insulin approved in Canada, and more! 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 Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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! /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/31812812

What is a diabetologist (and should you see one?) 06/12/2024

In the News... Dexcom to Apple Watch, Metformin during pregnancy, Mounjaro shortage update... and more! 06/07/2024

In the News... Dexcom to Apple Watch, Metformin during pregnancy, Mounjaro shortage update... and more! 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! Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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. 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. 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 /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/31638637

Transforming Diabetes Care: GlucosePATH Makes Personalized Medication Recommendations 05/29/2024

Inside the class-action lawsuit against insulin pricing, with Attorney Steve Berman 05/15/2024

In the News.. T1D increasing in older adults, new iCGM designation, low BG prevention tested, and more! 05/10/2024

In the News.. T1D increasing in older adults, new iCGM designation, low BG prevention tested, and more! 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 Please visit our Sponsors & Partners - they help make the show possible! Learn more about from extreme temperatures Learn more about Drive The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: 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 .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! /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/31216827

Diabetes in the hospital - what patients need to know 05/01/2024

In the News... Ingredients linked to T2D, genetic T1D research, new SGLT-2 guidelines and more! 04/26/2024

Dr. Nina Cash on becoming a Sports Illustrated Swimsuit Model at 57, with type 2 diabetes 04/17/2024

In the News... Dexcom-to-watch update, Wegovy studies, night time hypo research and more! 04/12/2024

Diabetes Education is boring! This group wants YOUR input to make it better. 04/03/2024

In the News... diabetes drug pricing, vial shortage, pump using Tidepool Loop cleared, insulin cows and more! 03/29/2024

Does every person with type 2 diabetes need a Continuous Glucose Monitor (CGM)? 03/20/2024

In the News... ATTD updates, new CGMs, drops for diabetes eye disease, scholarships and more! 03/15/2024

Navigating the Art of Medicine in the Age of AI with Dr. Allen Sussman 03/13/2024

Navigating Diabetes and Your Eye Health 03/06/2024

In the News... MicroGlucagon to speed up insulin, SGLT2 & false positive tests, FDA warns about non-invasive glucose monitors and more! 03/01/2024

From Restrictive Diets to Realistic Solutions with Dr. Mike Roussell 02/21/2024

In the News.. Tandem Mobi released, surprising outcomes for type 2 surgery, exercise and diabetes studies, T1D at the Super Bowl, and more! 02/16/2024

A new CGM made for people with type 2 - Learn about Dexcom's Stelo 02/14/2024

Need a CGM? Ask your pharmacist. A new pilot program aims to improve access 02/07/2024

In the News.. weight loss & cancer study for T2D, new pump submitted, Summer Olympic hopeful with T1D and more! 02/02/2024

Adjusting to a Type 2 Diabetes Diagnosis - PR Pro Matt Friedman 01/31/2024

Insulin Use with Type 2 Diabetes: Navigating Solutions, Avoiding Stigma 01/24/2024

In the News... Spray insulin tested, Dexcom T2D sensor submitted, A1C period pads... and more! 01/19/2024

In the News... Spray insulin tested, Dexcom T2D sensor submitted, A1C period pads... 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: Vertex pauses their stem cell transplantation trials after a patient death, spray insulin is tested, learning more about Dexcom's sensor for type 2, measuring A1C through menstrual blood and more! Find out more about Please visit our Sponsors & Partners - they help make the show possible! from extreme temperatures Learn more about Here's where to find us: Learn more about everything at our home page Reach out with questions or comments: [email protected] Episode transcript: 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… XX Vertex Pharmaceuticals, Inc. has paused a study of stem cell–derived, fully pancreatic islet cell replacement therapy (VX-880) following two patient deaths. Neither death is related to the therapy itself - called VX-880 – according to the company. Vertex says they plan to share full data soon. In the study that was paused, 14 patients with type 1 received infusions of VX-880 and standard immunosuppression. After 90 days, 13 of the patients have an A1C under 7 without using exogenous insulin. This was the study that made a big splash in the New York Times in late 2021 with the headline “A Cure for Type 1 Diabetes?” and featuring Brian Shelton among others. Shelton is one of the two patients who have died. https://www.medscape.com/viewarticle/vertex-pauses-islet-cell-study-after-patient-deaths-2024a10000oe XX Early days but researchers in Norway are testing an insulin body spray. Patients squirt the insulin directly on to their inner forearm, where skin tends to be thinner, allowing easier absorption. Within minutes, it gets absorbed into the bloodstream. This joins other research on skin patches packed with micro-needles that punch tiny and reportedly painless holes in the skin to let insulin seep through. The spray contains insulin and propylene carbonate, a chemical often used in cosmetic skin creams to help them penetrate the outer layers of the skin. In this case, it’s hoped the chemical — attached to insulin in the spray droplets — will help the hormone seep as far as the tiny blood vessels that lie beneath the surface of the skin, where the hormone will then get absorbed into the bloodstream. InsuLife, the Norwegian company developing the body spray, is setting up a trial involving 12 patients with type 1 diabetes to see how different doses of the spray compare with injected insulin in controlling blood-sugar levels. It is used just before a meal, like injected insulin. The clinical trial was set up after a study involving five people found the spray reduced blood sugar levels by about 20 per cent after a meal. https://www.dailymail.co.uk/health/article-12965203/insulin-spray-arm-diabetes-jab-Hope-sight-millions.html XX The FDA clears the Qvin’s Q-Pad™ A1c Test System which uses menstrual blood to get an A1C result. The kit is intended for the collection of menstrual blood samples by individuals 18 years of age and older using the Q-Pad, a pad with an embedded blood collection strip (Q-Strip). Each kit includes 2 Q-Pads, a return sample container, and a stamped mailing pouch. The FDA clearance was based on data from a clinical validation study that included 198 participants. Samples were collected using the Q-Pad Kit and were returned to the laboratory by mail. To provide the reference sample, a venous blood draw was performed on participants by a phlebotomist. An analysis of both samples demonstrated that the clinical performance of the Q-Pad test system in measuring HBA1c was equivalent to the traditional method of blood testing. https://www.empr.com/home/news/fda-approved-q-pad-test-system-uses-menstrual-blood-to-measure-hba1c/ XX Learning more about Dexcom’s upcoming CGM designed for people with type 2 who don’t use insulin. It’s to be called Stelo and they’ve submitted to the FDA with an eye on a late summer launch. I was at the announced last June – this is a system that will have very few alerts and alarms.. Stelo looks a lot like the G7 but will have different software and will last for about 15 days per sensor. https://www.theverge.com/2024/1/11/24034098/dexcom-stelo-cgm-diabetes-health-tech-ces-2024 XX Tandem Diabetes Care's t:slim X2 Insulin Pump Automated Insulin Delivery System is now the first to incorporate the Abbott FreeStyle Libre 2 Plus Sensor for users in the United States. The FreeStyle Libre 2 Plus sensor is a modified version of the FreeStyle Libre 2 sensor cleared in 2023 by the US Food & Drug Administration for use with automated insulin delivery (AID) systems. The move follows Tandem's December announcement of integration with the recently available 10-day Dexcom G7 sensor. https://www.medscape.com/viewarticle/tandem-insulin-pump-system-integrates-libre-sensor-2024a10000iq?form=fpf XX If you use Omnipod 5 with an Android, there’s a software update you need to do. The FDA has issued a Class one correction recall. due to a software error that occurs when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point. This recall is not a product removal and users should have already received an alert that won’t let them use the app until they do the software update. . XX Embecta continues to move ahead with its insulin patch pump.. submitting a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. This is a disposable pump for people with type 2 diabetes. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study. Henry Anhalt, chief medical officer, says nine out of 10 people with diabetes live with type 2 diabetes. However, Anhalt says the majority of automated insulin delivery systems cater to those with type 1 diabetes. Embecta aims to offer more options and tools to the broader diabetes care community, he says. https://www.drugdeliverybusiness.com/embecta-submits-insulin-patch-pump-fda/ XX Update on insulin prices.. as a few prices changes went into affect at the beginning of the year. So, what took effect this month was that Sanofi followed suit with Eli Lilly and Novo Nordisk to implement this cap on insulin co-pays at $35 that took effect January 1. And that comes after the provisions of the Inflation Reduction Act capped insulin for people on Medicare at $35. The Medicare cap is automatic and part of policy. For everyone with commercial insurance, the cap is voluntary from the companies. For those without government or private insurance, the picture is more complicated. If your insulin is still more than $35 per month, ask your pharmacist for coupons or check out getinsulin dot org. https://www.pbs.org/newshour/show/new-law-caps-insulin-prices-for-some-with-diabetes-but-cost-remains-high-for-millions XX Commercial XX XX Young adults who reported higher stress during their teenage years to adulthood were more likely to have high blood pressure, obesity and other cardiometabolic risk factors than their peers who reported less stress, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association. Cardiometabolic risk factors often occur together and are a significant cause of cardiovascular disease. These include obesity, Type 2 diabetes or prediabetes, high cholesterol and high blood pressure, researchers noted. In 2020, cardiometabolic diseases, including cardiovascular diseases and Type 2 diabetes, were the most prevalent chronic health conditions and collectively accounted for nearly a quarter of all deaths in the U.S., according to the American Heart Association statistics. In 2023, the American Heart Association noted the strong connections among cardiovascular disease, kidney disease, Type 2 diabetes and obesity, and suggested redefining cardiovascular risk, prevention and management. https://finance.yahoo.com/news/childhood-stress-linked-higher-risk-100000670.html XX Shout out to NBC News for a great story they did recently on LADA – featuring two women who have both been on this podcast. Dr. Phyllisa DeRoze and Mila Clark were both first misdiagnosed with type 2 before they got a correct diagnosis of LADA. I’ll link up the NBC story along with our chats with both women.. thanks to Mila for giving me a mention as one of the voices in the diabetes community who made her think was she had might not be type 2.. but could be LADA. https://www.nbcnews.com/health/diabetes/diagnosed-type-2-diabetes-may-different-form-disease-rcna132571 XX Join us again soon! /episode/index/show/841bdfd4-b5e2-442f-b753-198b0dc98f8c/id/29552193

Get Kitchen Confident! The Happy Diabetic's Recipe for Living Well with Type 2 Diabetes 01/16/2024

Diabetes Connections Type 2

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