Episódios

  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: the FDA has a warning about smart phones and medical alerts, a few companies turn their attention to patch pumps, a new study looks at costs/benefits of CGM vs Fingerstick during pregnancy, T1D in the Super Bowl.. and more!

    Find out more about Moms' Night Out

    Please visit our Sponsors & Partners - they help make the show possible!

    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:

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    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

    Big warning from the FDA about medical alerts from smart phones. They’re warning that they’ve received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low blood sugar and even death.

    But the FDA warns that certain phone settings, such as pausing notifications, may cause patients to miss critical updates. In other cases, connecting the phone to a new audio source, such as a car stereo, could change the volume of the alerts users are accustomed to hearing.

    They have some recommendations to help, mostly just confirming alarms are working before you need them.. and I’ll link up the full story in the show notes.

    Reading between the lines here, it seems like the problem here may be the thousands of unregulated apps that make health claims – not just for people with diabetes. So it’s a good idea to check the apps you’re using and the companies that make them.

    https://www.seattletimes.com/seattle-news/health/patients-using-diabetes-apps-can-miss-critical-alerts-heres-how-to-make-sure-youre-getting-them/

    XX

    What costs less during pregnancy? CGM or finger sticks? In the real word, a new study says CGM costs less…

    Okay, first keep in mind that the cost savings here wasn’t about the glucose monitoring supplies, it was about a lower rate of neonatal ICU admissions.

    In a base-case analysis in which researchers assumed all women would use seven finger sticks per day as dictated by the American Diabetes Association’s guidelines for diabetes management in pregnancy, CGM had a higher per-person cost than SMBG. However, in a real-world analysis in which women with a CGM used three finger sticks per day and those performing SMBG used five finger sticks daily, CGM was more cost-effective.

    In the real-world analysis, CGM users had a per-person cost of $2,747 for the CGM, $988 for finger sticks and $9,973 for neonatal ICU admissions. For SMBG, finger sticks cost $1,647 and neonatal ICU admission costs were $12,876. The reduction in neonatal ICU admission rates with CGM use led to a mean cost savings of $2,903 in the real-world analysis.

    “These findings justify paying for CGM devices in type 1 diabetes pregnancies, even in the U.S., which has an expensive health care system,”

    Polsky said future research should focus on the cost-effectiveness of automated insulin delivery systems in pregnancy.

    “Automated insulin delivery use has been shown to improve glycemic outcomes in type 1 diabetes pregnancies, but it is still unclear if it improves maternal or neonatal health outcomes and if it would be cost-beneficial,” Polsky said.

    https://www.healio.com/news/endocrinology/20250205/cgm-may-lead-to-lower-health-care-costs-for-pregnant-women-with-type-1-diabetes

    XX

    Couple of interesting comments from Medtronic at the recent JP Morgan Chase conference. The CEO says he company is “mainly a type 1 business, moving into type 2,” He says stated that their patch pumps program remains dynamic..

    Medtronic expects its 800-series pump to come in at around half the size of the latest-generation 780G. The post says the company plans for a pivotal study in 2025. Potential features could include extended reservoirs and extended-wear sets, plus a brand-new Android/iOS app.

    https://www.drugdeliverybusiness.com/medtronic-next-gen-insulin-pumps-coming/

    XX

    Beta Bionics also says they’re working on a tubeless patch that they plan to launch in 2027.

    The company reported the device has two parts. One reusable component holds the electronics that operate the device and motor. A second disposable part includes an adhesive patch, insulin reservoir, insertion device, and the cannula used to deliver insulin.

    Beta Bionics said the pump is planned for use in people with type 1 diabetes and later will expand its use for people with type 2. The company also reported it is continuing work on an AID system that would, in addition to using insulin to lower blood sugar, also contain glucagon to raise blood sugar. Research is being conducted into dual-hormone systems, but none are available yet for people with diabetes.

    https://diatribe.org/diabetes-technology/tech-watch-diabetes-tech-news

    XX

    New approval for the treatment of diabetic macular edema. Susvimo is the “first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections,” the release said. This is the second indication for Susvimo, which is also approved for the treatment of wet age-related macular degeneration.

    https://www.healio.com/news/ophthalmology/20250204/fda-approves-susvimo-for-diabetic-macular-edema

    XX

    How about this one… drinking ketones improves heart health, a new small-scale study from the University of Portsmouth has found. This is the first time people with type 2 diabetes (T2D) have been given a drink with ketone esters - a supplement that is meant to plunge your system into ketosis - to monitor the effect on the heart. Ketosis is the metabolic state where your body is forced to burn fats instead of carbohydrates.

    but more research is needed because we only assessed participants on the day, which means we have no idea what the chronic impact of drinking ketones would be."

    The study was carried out after research showed The drug SGLT2i was used to lower glucose in patients with diabetes and longitudinal studies were showing that it was inadvertently protecting the heart. The hypothesis was that the drug induces ketosis and the heart was using ketones, which improved heart health, but the evidence for this was limited so our research set out to prove the connection."

    https://www.news-medical.net/news/20250205/Drinking-ketones-improves-heart-health-for-people-with-type-2-diabetes.aspx

    XX

    Another pump wants into the EU. Modular Medical looks to obtain a CE mark in the first quarter of 2026. The patch pump, MODD1, got FDA clearance last fall. The company says it will be available early this year.. but I haven’t heard much about it since the approval.

    https://www.drugdeliverybusiness.com/modular-medical-step-forward-ce-mark/

    XX

    New CGM system with a reusable applicator and rechargeable wearable transmitter moves forward. Trinity Biotech announced new pre-pivotal clinical data. This company is based in Ireland and is looking for iCGM approval down the road.. hoping to file with the FDA in 2026.

    https://www.drugdeliverybusiness.com/trinity-biotech-expects-submit-cgm-fda-2026/

    XX

    Body-weight cycling (also known as yo-yo dieting) has been shown to significantly increase the risk of kidney disease in people with type 1 diabetes, regardless of body mass index (BMI) and other traditional risk factors. This is a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism.

    Participants with greater weight fluctuations experienced a 40% decline in kidney health from baseline values

    https://www.news-medical.net/news/20250204/Yo-yo-dieting-found-to-harm-kidney-health-in-type-1-diabetes-patients.aspx

    XX

    Eli Lilly’s profit doubled in the fourth quarter, propelled by its hot-selling diabetes and obesity treatments, and the drugmaker came out with a mostly better-than-expected 2025 forecast. Overall, Lilly’s quarterly profit swelled to $4.41 billion.

    https://apnews.com/article/eli-lilly-fourth-quarter-mounjaro-zepbound-ca026922525a9e3abb1b75d329628bef

    XX

    Abbott starts a new campaign all about bias and misconceptions when it comes to diabetes. I’m excited that they seem to have worked here with the Behavioral Diabetes Institute.

    Nearly 70% believe there is stigma associated with their condition.1 Diabetes as a Punchline: 85% of people living with diabetes say they have seen inaccuracies about diabetes in the media, including on TV shows, movies, and social media, and 40% of people felt that diabetes is often used as the punchline of a joke.1

    Abbott's new Above the Bias initiative aims to help others see the world from the perspective of someone living with diabetes. The initiative builds upon efforts by several diabetes organizations, patient advocacy groups, and experts that continue to work to reduce stigma about diabetes.3 People can learn more about Above the Bias and watch the film at AboveBias.com.

    https://www.prnewswire.com/news-releases/abbotts-above-the-bias-film-reveals-misconceptions-can-impact-diabetes-care-302367723.html

    --

    When you watch the Super Bowl this weekend, watch for Noah Grey. .he’s the Kansas City Chiefs tight end who backs up Travis Kelce and he’s lived with type 1 since age 18.

    Grey spoke to media this week about how he loves to interact with kids who have T1D and their shared love of fruit gummies to treat lows.

    (sound here)

    Grey has been an ambassador for Tandem Diabetes and has talked about how he unhooks the pump but keeps his Dexcom on for games.

    https://www.yahoo.com/news/noah-gray-talks-helping-kids-010013649.html

    https://www.newsobserver.com/sports/college/acc/duke/article299730324.html

    --

    I want to take a moment to personally send my love and sympathy to the Gaskins family. These are the folks behind the amazing Macey’s Believer’s charity. Janice Gaskins passed away this week after a long fight with breast cancer. I’ve been reading all of the posts on her Facebook page – this is a woman who touched and changed a lot of lives.. so much for the better. May her memory be a blessing. Her life certainly was.

  • This week on Diabetes Connections, we’re exploring a groundbreaking approach to diabetes care that’s not just about providing treatment—but also about understanding the impact of giving. Unbound is leading a unique study to see if generosity and connection can improve health outcomes for both the donor and the recipient. I’m talking to Dan Pearson, Chief International Program Officer, about the study, who they’re looking for, and what they hope to learn

    Learn more about the study here

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    Check out VIVI Cap to protect your insulin from extreme temperatures

    The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:

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    Check out Stacey's books!

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    Reach out with questions or comments: info@diabetes-connections.

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  • This week on Diabetes Connections… people with Down Syndrome are more likely to develop diabetes than the general population. It’s not really known why.. but having that double diagnosis brings unique challenges. I’m talking to Rhonda Gray – her son Trevor was diagnosed at age 8 (2010) and is now in his early 20s. What does T1D management look like with Down syndeom s? What does it mean for independence, holding a job, all the usual concerns. And How did Nick Jonas spark a big change for Trevor?

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    Check out VIVI Cap to protect your insulin from extreme temperatures

    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

    Check out Stacey's books!

    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Dexcom updates investors on its 15-day sensor, TrialNet marks a big anniversary, Beta Bionics goes public, NFL fans support Mark Andrews and much 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

    Couple of quick updates from the JP Morgan Healthcare Conference. Dexcom’s CEO Kevin Sayer expects to launch a 15-day sensor in the second half of the year. That’s in front of the FDA right now. Competitor Abbott currently has 15-day sensors with its Freestyle Libre 2 Plus and Freestyle Libre 3 Plus devices, which the FDA cleared in 2023. Sayer also talked about expanded insurance coverage for the G7, to include more people with type 2. They haven’t pursued that with Stelo, the OTC version of their sensors.

    The company has begun work on a next-generation CGM. Sayer said the sensor will be smaller, less expensive and include better electronics. Dexcom is also studying new sensor probes, one of which can support multiple analytes, such as measuring lactate or ketones in addition to insulin.

    https://www.medtechdive.com/news/dexcom-ceo-stelo-otc-strategy-jp-morgan/737424/

    XX

    TrialNet reaches a big milestone – more than a quarter million people have learned their risk of developing T1D through screening.

    TrialNet screening is available to family members of those diagnosed with T1D. Having a family history of the disease places individuals at a 15 times greater risk than those with no family members with T1D.

    Over the course of VUMC’s 18 years participating in the program, the community of T1D patients has become increasingly more engaged with research efforts. More than ever, there is an eagerness to give back to others by participating in clinical trials that could help revolutionize care for those diagnosed with or at risk of developing T1D. In such trials, TrialNet typically takes drugs already shown to be effective in treating other autoimmune diseases and seeks to determine their efficacy in treating, delaying or preventing T1D.

    Spencer Mannahan, a 10-year-old patient at Monroe Carell Jr. Children’s Hospital at Vanderbilt, is participating in a TrialNet study that is looking to determine whether a treatment regimen using both rituximab and abatacept can preserve insulin production in patients newly diagnosed with T1D. Russell, one of the PIs for the study (Protocol TN-25), also treated Spencer’s father, Zach, when he was diagnosed with T1D as a child.

    She enrolled in a different TrialNet study (Protocol TN-31) examining the effect of abrocitinib and ritlecitinib on insulin production in newly diagnosed individuals. While the possibility exists that her insulin production could be preserved, O’Neal joined the study because it presented an opportunity to make a positive impact on future patients.

    These clinical trials support TrialNet’s goal of a future without T1D. Research is underway on new methods of blocking the advance of T1D in patients with diabetes-related antibodies. One study will investigate whether T cells that have been activated against insulin can be specifically targeted, rather than issuing a treatment that targets all the body’s T cells (thus rendering the patient immunocompromised).

    TrialNet, the largest clinical trial network assembled to change the course of Type 1 diabetes, is funded by the National Institutes of Health through grant number NCT00097292.

    For more information about screening for Type 1 diabetes risk if it runs in your family, contact [email protected], visit www.trialnet.org, or contact the Vanderbilt Type 1 Diabetes TrialNet Program at 615-936-8638.

    https://news.vumc.org/2025/01/22/milestone-in-vumc-affiliated-diabetes-screening-and-research-program-underscores-impact-of-clinical-trials/

    XX

    Another study links air pollution to type 2 diabetes. This is from Wayne State University, and established a robust association between exposure to benzene, a prevalent airborne volatile organic compound, and insulin resistance in humans across all ages.

    “In this study, we exposed mice to benzene to see how it affects their blood glucose levels and energy expenditure,” she explained. “Our research revealed that within seven days of exposure, they developed high blood glucose insulin levels.”

    https://today.wayne.edu/medicine/news/2025/01/23/study-links-air-pollution-exposure-to-type-2-diabetes-susceptibility-65321

    XX

    Adults with overweight or obesity and type 2 diabetes who are given the sodium glucose cotransporter 2 (SGLT-2) inhibitor drug dapagliflozin alongside moderate calorie restriction achieve much higher rates of remission compared with calorie restriction alone. The researchers say this study provides a practical strategy to achieve remission for patients with early type 2 diabetes.

    As well as helping to lower blood sugar levels, SGLT-2 inhibitors can also lead to weight loss, but their effect alongside calorie restriction on diabetes remission has not yet been investigated in a randomised controlled trial.

    To address this, researchers carried out a trial involving 328 patients with type 2 diabetes of less than six years' duration at 16 centres in mainland China from 12 June 2020 to 31 January 2023.

    Participants were aged 20-70 years with a body mass index (BMI) greater than 25 and were not taking any anti-diabetic medication other than metformin.

    https://www.news-medical.net/news/20250123/Dapagliflozin-and-calorie-restriction-show-higher-remission-rates-in-type-2-diabetes.aspx

    XX

    Beta Bionics has set the terms for its plan to go public, with a goal of raising at least $114 million to support its artificial pancreas system for people with Type 1 diabetes. That’s as we’re recroding, it’s likely they will have begun trading on the NASDAQ by now.. the ticker is BBNX.

    Beta Bionics’ iLet system was first cleared by the FDA for people ages six and up with Type 1 diabetes in May 2023. The Fierce Medtech Fierce 15 winner has since expanded its blood sugar sensor compatibility to include Abbott’s FreeStyle Libre and Dexcom’s G6 and G7 platforms.

    The company also said it plans to pursue new clinical studies and an FDA clearance that would enable the iLet’s use among people with Type 2 diabetes. The ultmite goal is to have a dual-chambered pump with both insulin and glucagon.. but I didn’t find anything about that in the articles about this IPO.. I followed up with Beta Bionics and they told me that the dual chambered pump is still very much the goal. Not sure why most of the publications left that out.. but good to hear.

    https://www.fiercebiotech.com/medtech/artificial-pancreas-maker-beta-bionics-aims-raise-120m-nasdaq-ipo

    XX

    Large new study estimates the size of the current US population with type 1 diabetes and project growth over the next ten years. They say about 2 million live with type 1.. about 1.79 million adults and 290-thousand children. Growth in the ten years is predicted to be about 10%

    https://jheor.org/article/124604

    XX

    The American Diabetes Association® (ADA) teams up with Xeris Pharmaceuticals® makers of Gvoke – ready to use emergency glucagon.

    It is estimated that up to 46% of people with type 1 diabetes and 21% of those with type 2 diabetes using insulin experience at least one severe hypoglycemia event each year.2

    The ADA, with support from Xeris, seeks to rectify the low rates of appropriate glucagon prescriptions by developing education materials and training resources for health care professionals and people living with diabetes, as well as through a national awareness campaign to educate people on who is at risk for severe hypoglycemia and should have glucagon, preferably ready-to-use, as a safety net.

    https://www.prnewswire.com/news-releases/the-american-diabetes-association-and-xeris-pharmaceuticals-announce-national-collaboration-to-provide-life-saving-hypoglycemia-education-and-awareness-302355703.html

    XX

    XX

    Wearing a CGM makes pharmacy students better at counseling patients. New study randomly assigned students to wear a CGM during lab sessions.. those who did had a higher average counseling score during the encounter with a patient and a higher overall confidence score. There was also a statistically significant positive correlation between average confidence and average empathy, and empathy and counseling performance.

    https://www.drugtopics.com/view/hands-on-cgm-training-helps-student-pharmacists-prepare-for-career

    XX

    Mark Andrews Bills Mafia

    Baltimore Ravens tight end Mark Andrews received a host of negative attention after flubbing a potential game-tying two-point conversion in Sunday night's loss to the Buffalo Bills.

    In the face of the online rage, Bills Mafia is again showing some support.

    Bills fan Nicholas Howard kicked off a GoFundMe to back Breakthrough T1D, a global Type 1 diabetes research organization that Andrews has supported.

    "As many of you know, Ravens TE wasn't able to catch the game-tying 2-point conversion and upset Ravens fans," Howard wrote. "On top of that, the TE has been receiving death threats and nasty comments after his performance last night. We want Bills Mafia to donate to Marks charity for [Type 1] diabetes."

    As of Wednesday morning, the fund raised more than $50,000 for the charity.

    Related Links

    Lamar Jackson, Ravens bemoan missed opportunities in loss to Bills, defend Mark Andrews

    Ravens WR Zay Flowers: Missing 2024 playoff run due to injury 'took a little toll on me'

    Biggest winners and losers from Sunday's Divisional Round NFL playoff games

    The Ravens thanked Bills fans for supporting Andrews.

    "Shout out to Bills Mafia for showing support to our guy Mark Andrews and donating to the [BreakthroughT1D] organization, which works towards curing and improving the lives of those dealing with Type 1 diabetes," the club posted.

    Andrews was diagnosed with Type 1 diabetes as a child, an autoimmune disease for which there is currently no cure. He's one of several NFL players diagnosed with Type 1 -- Kansas City Chiefs tight end Noah Gray is another.

    "Breakthrough T1D [formerly JDRF] greatly appreciates the generosity of the Buffalo Bills community and the many fans who were compelled to donate after Sunday's game," the organization said in a statement to ESPN's Alaina Getzenberg. "These donations will support research and advocacy on behalf of the 1.6 million Americans who, like Mark Andrews, live with type 1 diabetes."

    It's not the first time that Bills fans have donated to the cause of a non-Buffalo player. Back in January 2018, Buffalo fans famously donated to the charity of former Cincinnati Bengals quarterback Andy Dalton after his win over Baltimore helped Buffalo make its first playoff appearance in nearly two decades. Over and over again, Bills Mafia has shown it will support a good cause when some spew hate.

    https://www.nfl.com/news/bills-fans-supporting-ravens-te-mark-andrews-after-drop-by-donating-to-type-1-diabetes-research

  • Lauren Bongiorno has spent years helping others thrive with diabetes through her company, Risely Health. Now, as she approaches motherhood, she’s sharing what it’s been like to navigate pregnancy with type 1 diabetes. From expectations vs. reality to a major stress event with her husband and even clashing with her doctors, Lauren opens up about this incredible and challenging chapter in her life.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    Check out VIVI Cap to protect your insulin from extreme temperatures

    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

    Check out Stacey's books!

    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • We're taking a deep dive into Medtronic’s InPen with missed meal dose detection. This was approved just a few weeks ago and paves the way for the launch of what they’re calling Smart MDI. I’m taking to Madison Smith, Therapy Chief Engineer for MDI Systems at Medtronic Diabetes. She’ll explain what’s new here, how it all works and what she – as someone who lives with type 1 – would love to see next .

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    Check out VIVI Cap to protect your insulin from extreme temperatures

    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

    Check out Stacey's books!

    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, 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

    Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success.

    This is very early and hasn’t yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin.

    Sana’s CEO says

    “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.”

    I’ve reached out to Sana to get more on this.. love to talk to them soon.

    https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html

    XX

    FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). Studies showed a meaningful reduction in A1C but a meaningful increase in DKA.

    The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD.

    Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors. According to Lexicon, Inpefa will continue to be manufactured and made available to patients.

    https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/

    XX

    Two companies we’ve been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They’ve announced a new partnership agreement. From the release:

    Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor."

    Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed.

    https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg

    XX

    Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device.

    https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/

    XX

    Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems.

    There’s a long history here – UVA is where the Control IQ algorithm was developed. This agreement seems to keep the team together for another decade.

    https://www.businesswire.com/news/home/20250107162995/en/Tandem-Diabetes-Care-Enters-Multi-Year-Research-Collaboration-with-UVA-Center-for-Diabetes-Technology-for-Development-of-Advanced-Insulin-Delivery-Systems

    XX

    New study says insulin is still the best treatment for gestational diabetes, compared to oral glucose-lowering medications. Metformin and gluburide are being closely looked at since they're easier to administer, less costly, and have better acceptance among patients. But this study says insulin was a bit better – slight more babies were born larger for the metformin group, and more moms had hypoglycemia.

    https://www.medpagetoday.com/obgyn/pregnancy/113651

    XX

    In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.

    Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding.

    https://www.biospace.com/fda/novo-launches-citizen-petition-to-block-compounded-victoza

    XX

    Bit of an update on compounded terzepatide and semaglutide. The FDA is allowing a grace period of 60 days before starting to enforce the end of allowing compounds of Mounjaro.

    Meanwhile, semaglutide remains on the FDA’s shortage list for several dose strengths, though all doses have been reported as “available” since late October 2024.

    Compounding pharmacies, especially larger 503B “outsourcing facilities,” maintain they provide an essential public service by offering lower-cost versions of medications that can cost over $1,000 per month. Many insurers still refuse to cover brand-name GLP-1 products for weight loss. Yet the FDA has reported hundreds of adverse event reports allegedly linked to compounded versions of these drugs, which do not undergo the same rigorous manufacturing inspections and clinical testing as approved brands.

    https://www.drugdiscoverytrends.com/compounders-and-drugmakers-clash-over-compounded-weight-loss-drugs-with-fda-in-the-middle/

    XX

    Interesting story here.. this study says a fecal transplant can help people with type 1 and severe gastroenteropathy. The researchers say diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited.

    Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention.

    After four weeks, Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome.

    https://www.medscape.com/viewarticle/fmt-shows-early-success-type-1-diabetes-bowel-issues-2025a10000bg

    XX

    A couple of weeks ago, listeners told me that the Dexcom geofencing issue we reported on seems to be resolved. Dexcom is now confirming this. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn’t reinstall or use the app without customer support. As of last month, the geofencing issue has now been resolved with the latest Dexcom G7 2.6 app update.

    Can I travel with my Dexcom G7? | Dexcom

    XX

    Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead the U.S. market for CGMs, agreed on Dec. 20 to resolve all outstanding patent disputes and not sue each other over patents for 10 years.

    Dexcom and Abbott previously reached a settlement in 2014 related to their diabetes devices, which included a cross-licensing deal and an agreement not to sue each other until 2021. After that agreement expired, the companies filed a volley of patent lawsuits.

    https://www.medtechdive.com/news/abbott-dexcom-settle-cgm-patent-lawsuits/736300/

  • Every January the Consumer Electronics Show gives us a glimpse at what technology might be coming. This show used to be full of phones and TV screens, but more and more CES is featuring health care. We’re taking a deep dive into one of the innovations on display - VIVI Smart - which aims to make multiple daily injections easier. Plus, other diabetes tech from the show that we think we’ll actually be using.. and some that may be more wishful thinking.

    My guest this week is Ron Nagar, the founder and CEO of TempraMed, the company that makes the VIVI Cap. I’ve talked about this product before, and we’ve used it with success.. Ron will talk about what’s new here. I think this is a great and really interesting trend to make MDI easier and more automated. Most people around the world do not use insulin pumps and while I’m grateful for the automation of the AID systems – it’s really important that companies continue to serve the entire diabetes population.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Disclosure: Tempramed has donated a VIVI Cap for our Moms' Night Out and is an affiliate sponsor of the podcast.

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  • This week, a look ahead to 2025! What will the new year bring for diabetes technology, research, and practical stuff that we’ll actually use? A fun conversation about the next twelve months with endocrinologist Dr. David Ahn. He's Chief of Diabetes at the Mary and Dick Allen Diabetes Center for Hoag Hospital and shares tech reviews and other options on social media here

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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    Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

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  • It's a special end of the year episode of Diabetes Connections!

    We produced more than 70 podcast episodes this year. In my mind, these are the top ten biggest T1D stories we covered. What do YOU think is the top story? What did I miss? Let me know in the FB group or email me!

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    Drive research that matters through the T1D Exchange

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  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more!

    Find out more about Moms' Night Out

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    Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

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    Learn about Dexcom

    Edgepark Medical Supplies

    Check out VIVI Cap to protect your insulin from extreme temperatures

    Learn more about AG1 from Athletic Greens

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    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

    Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.

    A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.

    HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.

    Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups,

    There were no differences between groups or concerns in other safety measures, including hypoglycemia.

    https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex

    XX

    Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health.

    Stelo users will start seeing the features this week. The AI is modeled after Google Cloud’s Vertex AI and Gemini models. We’ll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare.

    BTW this press release is the first time I’ve seen what seems to be a new slogan for Dexcom – Discover What You’re Made Of.

    https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing

    XX

    Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn’t reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention.

    XX

    Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company.

    The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.

    Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges.

    This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.

    https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html

    XX

    Can we add treating sleep apnea to the list of applications for terzepatide? That’s the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea.

    Eli Lilly said there was nearly a 20% reduction in weight among those in the trials.

    The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year.

    https://www.aol.com/popular-weight-loss-drug-could-131507702.html

    XX

    Health Canada okays Tandem’s tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors.

    Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7’s 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4.

    Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025.

    To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca.

    https://www.businesswire.com/news/home/20241210731189/en/Tandem-tslim-X2-Insulin-Pump-Now-Compatible-with-Dexcom-G7-CGM-in-Canada

    XX

    A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps.

    The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision.

    Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps.

    In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million.

    A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe’s Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea.

    The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet’s trade secrets.

    Insulet CEO Jim Hollingshead said the company is “extremely pleased with the jury’s verdict.” EOFlow did not immediately respond to a request for comment.

    https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/

    XX

    A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds.

    Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions.

    Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care.

    https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes

    XX

    New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable.
    In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them.

    We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support.
    For more information, please visit: https://lnkd.in/gTDhnDc4

    XX

    I’m also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2.

    https://www.medscape.com/viewarticle/icymi-top-10-diabetes-endocrinology-stories-2024-2024a1000n6u?&icd=login_success_email_match_fpf

    XX

    That’s it for the last In the News of 2024! Don’t miss out episode next week with a look ahead to what we’re watching in 2025.

    I’m SS I’ll see you back here soon…

  • A few weeks ago, Sernova they announced their cell pouch system of islet cell transplants has seen seven people achieve insulin independence and has kept one person off of insulin injections for four years. What does that really mean going forward?

    I’m talking to their new CEO Jonathan Rigby and to Frank Shannon, Senior Vice President, Clinical Development and Regulatory Affairs

    More about Sernova here

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    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

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  • The concept and practice of screening for type 1 diabetes has changed significantly in the last decade. It used to be something you might have heard about at diabetes camp or a conference and weren’t quite sure what to do with the information. But now, you can get actionable results with the approval of Tzield and potential development of other prevention treatments. But what do people with diabetes actually think about screening? Beyond Type 1 asked.. you answered.. and we’re talking about it.

    Full info on the screening survey here

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    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

    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:

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  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: A push to change the defined stages of T1D, InsuJet is approved in Canada, new study linked T2D and dementia, new drug looked at to prevent hypoglycemia, big honors for a T1D author and more!

    Our interview with Clare Edge here.

    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:

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    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

    The understanding of type 1 has changed a lot in the last 10-15 years, specifically with the definition of stages of the disease. Now some researchers suggest the current 2015 model is ready for another update.

    University of Florida Health diabetes researchers and collaborators last week issued a call to action in The Lancet Diabetes & Endocrinology, urging the development of a more precise method of calculating type 1 diabetes risk.

    Under the current staging system, this is Stage 1 of the disease, when a patient does not yet have elevated blood sugar but has two or more of these autoantibodies in the blood.

    Stage 2 is diagnosed when blood sugar begins to rise, indicating a dysfunctional pancreas in a patient who does not yet have clinical type 1 diabetes. That comes in Stage 3 with high blood sugar and, eventually, the classic symptoms of the disease, including frequent urination, weight loss and fatigue.

    Jacobsen, however, said the staging system requires more precision. This is especially important as the current staging model determines if a patient is eligible to receive a drug therapy called teplizumab, the only Food and Drug Administration-approved medication that can delay the onset of type 1 diabetes by an average of two years.

    The staging system, however, does not include a patient’s age and these researchers say additional markers that would be important to consider include a greater array of abnormal metabolic measures beyond blood sugar and the presence of more autoantibodies.

    https://www.gainesville.com/story/news/healthcare/2024/12/04/uf-health-scientists-propose-update-to-type-1-diabetes-staging-system/76734459007/

    XX

    A product called InsuJet gets approval in Canada. Made by NuGen Medical Devices, InsuJet™ is a needle-free injection system. It’s already approved for sale in 42 countries – not yet the US.

    Their website says InsuJet’s jet-injected fluid penetrates the skin through a small orifice of a special nozzle, creating a thin, high pressure stream. This way, insulin doesn’t remain around the place of injection, like it does with a needle. Instead, with InsuJet, the insulin is deposited into the subcutaneous tissue where it’s easily absorbed and acts faster– saving you money, time, and discomfort.

    https://finance.yahoo.com/news/nugen-announces-canada-wide-launch-221500674.html

    XX

    Individuals diagnosed with type 2 diabetes before the age of 50 may be at a higher risk of developing dementia later in life.

    A study led by researchers at NYU Rory Meyers College of Nursing, says the risk is notably greater among adults with obesity.

    Type 2 diabetes is a known risk factor for dementia. Although the underlying mechanisms are not fully understood, scientists think that some of the hallmarks of diabetes—such as high blood sugar, insulin resistance, and inflammation—may encourage the development of dementia in the brain.

    The researchers note that this greater understanding of the connection between diabetes onset, obesity, and dementia may help inform targeted interventions to prevent dementia.

    https://scitechdaily.com/diagnosed-young-with-diabetes-your-dementia-risk-may-be-higher/

    XX

    Embecta is out of the insulin patch pump business – just months after getting the ok from the FDA.

    Embecta received FDA clearance for its insulin patch pump in September. The device is indicated for people with Type 1 or Type 2 diabetes and includes a 300-unit insulin reservoir to support people with higher daily insulin needs.

    However, the version Embecta received clearance for was an open-loop patch pump, where users manually control insulin delivery, while the firm’s goal was to develop a closed-loop version, which automatically delivers insulin when needed.

    The CEO also expects competition in closed-loop devices for people with Type 2 diabetes to intensify, with Insulet receiving FDA clearance for its Omnipod 5 patch pump for Type 2 diabetes in August.

    https://www.medtechdive.com/news/embecta-discontinue-patch-pump/734059/

    XX

    Sanofi invests in a company developing a new drug to prevent hypoglycemia. We reported on Zucara Therapeutics back in 2022 and they’ve been moving ahead with ZT-01.

    ZT-01 is a medication being developed to help prevent dangerous low blood sugar (hypoglycemia) by fixing how the body normally fights it. In people without diabetes, a hormone called glucagon is released to raise blood sugar when it gets too low. But in people with insulin-dependent diabetes, like type 1 diabetes or some forms of type 2 diabetes, this process doesn’t work well because another hormone, somatostatin (SST), blocks glucagon from being released.

    ZT-01 works by blocking the effects of somatostatin, allowing the body to release more glucagon when it’s needed. This could help people with diabetes avoid severe low blood sugar episodes.

    https://www.prnewswire.com/news-releases/zucara-therapeutics-announces-strategic-investment-from-sanofi-as-part-of-us20-million-series-b-financing-302301820.html

    XX

    Omnipod 5 is now compatible with the FreeStyle Libre 2 plus. The company says the recent development “ makes Omnipod 5 the most connected tubeless AID system in the U.S.”

    It’s already compatible with Dexcom’s G6 and G7 CGMs.

    https://www.businesswire.com/news/home/20241120268759/en/Insulet-Announces-Omnipod%C2%AE-5-System-is-Now-Compatible-with-Abbott%E2%80%99s-FreeStyle-Libre-2-Plus-Sensor-in-the-U.S.

    XX

    A new study involving 11 clinical centers across the United States aims to uncover how type 1 diabetes (T1D) impacts brain health and cognitive function in children.

    Led by the Keck School of Medicine of the University of Southern California, this is a five-year study to explore critical questions about how environmental, lifestyle, social and clinical factors affect brain development during childhood — a period crucial for cognitive growth.

    https://www.managedhealthcareexecutive.com/view/new-study-to-explore-impact-of-type-1-diabetes-on-children-s-brain-development

    XX

    Dexcom looking to partner with smart ring company Oura. Originally launched to track sleep patterns, the latest Oura technology collects more than 20 biometrics ranging from heart rate and activity metrics to sleep and body temperature monitoring.

    The companies say the new partnership is intended to provide users with seamless integration between the two ecosystems so shared users can track their glucose levels and understand the impact of behaviors and biology on their metabolic health.

    https://www.forbes.com/sites/saibala/2024/11/29/smart-ring-maker-oura-hits-5-billion-in-valuation--strikes-major-partnership-with-dexcom/

    XX

    WEDNESDAY, Dec. 4, 2024 (HealthDay News) -- Taking even high doses of supplementary vitamin D won't lower an older person's odds for type 2 diabetes, new research confirms.

    They published their findings Dec. 2 in the journal Diabetologia.

    The new research followed on data from other studies that had suggested that people with especially low levels of vitamin D might face a higher risk for diabetes. That was true for people who were already prediabetic, especially.

    To find out, researchers led by Jirki Vyrtanen, from the University of Eastern Finland, randomly assigned nearly 2,300 people aged 60 or older to receive either placebo pills or 40 or 80 micrograms of vitamin D3 supplements per day, for five years.

    At the end of the five years, "105 participants developed type 2 diabetes: 38 in the placebo group, 31 in the group receiving 40 micrograms of vitamin D3 per day, and 36 in the group receiving 80 micrograms of vitamin D3 per day," according to a university news release.

    In other words, there were no significant differences in the rate at which people developed type 2 diabetes, regardless of how much supplemental vitamin D they took.

    Vytanen's team also saw no benefit from high-dose supplements on a person's blood sugar or insulin levels, or measures of overweight/obesity.

    The bottom line, according to the researchers: For any healthy, non-prediabetic person with healthy vitamin D levels, upping intake of the vitamin won't alter your odds for diabetes or its common risk factors.

    https://www.usnews.com/news/health-news/articles/2024-12-04/high-dose-vitamin-d-supplements-wont-prevent-diabetes-in-healthy-seniors

    XX

    Big congrats to author Clare Edge – recent guest on the podcast. Her book, Accidental Demons is featured on People Magazine’s top ten book gift suggestions for this year!


    Whether you’re looking for books about winter and the holidays, a primer on some of this year’s buzziest musicians and characters or that "one more chapter" kind of bedtime favorite, there’s sure to be a book out there to suit their taste.

    Bernadette Crowley, also known as Ber, comes from a long line of witches. When Ber is diagnosed with diabetes, however, she learns that every time she tests her blood sugar, demons accidentally slip into the human dimension — and it’s up to Ber and her sister, Maeve, to stop them. This fantastical book is a great escape for young readers over holiday break.

    Buy Now

    Top ten books

    https://people.com/kids-gift-book-suggestions-wicked-taylor-swift-books-8752097

  • This week, the question “What should the healthcare system for people with T1D look like? Led to something completely unique. It sounds too good to be true but Blue Circle Health is providing FREE care for people with type 1 diabetes. When I heard that, I knew I had to check it out.

    I’m talking to CEO Len D'Avolio about their recent expansion – Blue Circle Health is now in five states and plans to add more – what their goals are, and who’s actually paying for this.

    Learn more about Blue Circle Health

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    Previous holiday episodes here

    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

    Drive research that matters through the T1D Exchange

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    Reach out with questions or comments: info@diabetes-connections.

  • This week, we know you’re gearing up for holiday shopping and watching those Black Friday specials, so we’re making a list of diabetes tech that should be on your list! I’m chatting with Justin from Diabetech about devices and apps that don’t make diabetes easy but can lighten the load a bit. Some of these are even a little but fun.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Join us at an upcoming Moms' Night Out event!

    Previous holiday episodes here

    We work with some of the companies/products featured in this episode. Listed here for full disclosure and so you can find what you might be looking for!

    Sweet Dreams Justin has worked on sponsored content Sugar Pixel Justin's affiliate link: https://bit.ly/SugarPixel Frio Get 10% off with code JUSTIN10 - Use link: https://bit.ly/FRIO Frio has been a sponsor of Moms' Night Out Skin Grip Get 10% off with code JUSTIN10 - Use link: https://bit.ly/SkinGripJustin Skin Grip has been a sponsor of Moms' Night Out Tempramed Tempramed has been a sponsor of 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

    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

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    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • Luna Diabetes is moving ahead with something completely new – automated dosing overnight for insulin pen users. This is an add-on therapy – a tiny pump designed for use only during sleep, you keep using injections during the day. Sounds like extra work and extra gear, but the people behind Luna say the benefits speak for themselves and that the idea is extremely well received. They’ve just moved into clinical trials and asking CEO John Sjolund to explain it all.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Learn more about Luna

    Check out the clinical trials for Luna (more locations may be added)

    Join us at an upcoming Moms' Night Out event!

    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

    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:

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    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: World Diabetes Day roundup, existing drugs examined for T1D prevention, Blue Circle Health expands its novel T1D care model, Mounjaro studied further, Canada approves a new pumps system, and tragedy in the diabetes community.

    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:

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    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

    Of course, World Diabetes Day was yesterday. November 14 marks the birthday of Sir Frederick Banting. who discovered insulin along with Charles Best in 1922. Lots of the tech companies are taking action.. I’m going to link up a great article highlighting what many of them are doing…. from Medtronics Blue Balloon challenge to Dexcom’s Nick Jonas video and a lot more.

    https://www.drugdeliverybusiness.com/world-diabetes-day-2024/

    XX

    A new triple combo therapy could restore insulin production in people with type 1 using existing medications. Levicure’s triple-combo oral therapy is already considered very safe, because it involves two drugs approved by the U.S. Food and Drug Administration (FDA) and a well-known supplement.

    The therapy is a combination of:

    DPP4-inhibitors, a common type 2 diabetes medication

    Proton pump inhibitors (PPIs), a drug for severe acid reflux

    A proprietary version of gamma-aminobutyric acid (GABA), a supplement often used to treat anxiety

    Levicure says the combined effect can block beta cell destruction, suppress autoimmunity, and restore beta cell function.

    So far, Levicure’s triple therapy has gone through only one retrospective chart review; it has not been put to the test in a randomized controlled trial

    https://www.diabetesdaily.com/blog/can-this-triple-combo-oral-therapy-restore-insulin-production-733261/

    XX

    Blue Circle Health is expanding it’s unique approach to type 1 care. Already active in Florida, Maine & Vermont, it will now be in Delaware and Ohio.

    Blue Circle Health is free and develops a personalized care plan for each participant, tailored to their unique needs, and offers comprehensive multidisciplinary support over a six-month period. It’s paid for by the Helmsley Charitable Trust. The program is available to people 18 years of age and older that speak Spanish or English, regardless of insurance coverage or citizen status. We’ve got an upcoming podcast episode all about Blue Circle coming up soon.

    https://www.prnewswire.com/news-releases/blue-circle-health-expands-to-delaware-and-ohio-to-address-health-system-barriers-to-type-1-diabetes-care-and-education-302304170.html

    XX

    An international team of experts has created the world's first evidence-based guide for eating lower and low carb. The group says until now, people with type 1 diabetes and their healthcare providers have lacked comprehensive resources to help implement this approach safely and effectively.

    The guide provides essential information for dietitians and nutritionists and empowers them to work collaboratively with individuals and families who are interested in reducing carbohydrates. It’s free and we’ve got the download link in the show notes.

    https://www.newswire.ca/news-releases/international-team-launches-first-guide-for-carbohydrate-reduction-in-type-1-diabetes-883729104.html

    XX

    A new pump system is available in Canada. mylife YpsoPump insulin pump and CamAPS FX hybrid closed-loop algorithm by Health Canada.

    mylife Loop consists of the mylife YpsoPump, a lightweight intuitive insulin pump, integrated with the CamAPS FX hybrid closed-loop, a mobile phone-based algorithm, and the Dexcom G6 Continuous Glucose Monitoring (CGM) System. Working together, these components provide an innovative, automated insulin delivery (AID) system designed to simplify insulin therapy and improve glycemic control for Canadians living with diabetes.

    "The approval of the mylife YpsoPump and CamAPS FX marks an important milestone as we bring these advanced technologies to the Canadian market," said Sébastien Delarive, Chief Business Officer of Ypsomed Diabetes Care. "Although Ypsomed is relatively new in Canada, our established leadership in diabetes care throughout Europe provides a solid foundation for delivering innovative solutions to Canadians living with type 1 diabetes."

    "We are excited to see both mylife YpsoPump and CamAPS FX approved," said Karina Schneider, General Manager at Ypsomed Canada. "This step brings us closer to offering an integrated solution that will help simplify diabetes management for Canadian patients, empowering them to take more control of their health."

    https://finance.yahoo.com/news/ypsomed-camdiab-receive-health-canada-205500840.html

    XX

    The FDA updates the labels for all GLP-1 receptor agonists with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound).

    the Medication Guide section of the label also has new additions. Patients are counseled to tell their healthcare provider if they are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

    They are alerted that the GLP-1 RAs they are taking may cause serious side effects, including food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sedation.

    Patients are advised to tell all their healthcare providers that they are taking a GLP-1 RA before they are scheduled to have surgery or other procedures.

    https://www.medscape.com/viewarticle/fda-updates-glp-1-label-pulmonary-aspiration-warning-2024a1000k84?form=fpf

    XX

    Following an impressive data drop this summer highlighting the potential for Eli Lilly’s tirzepatide to stave off progression to Type 2 diabetes in prediabetic patients, the Indianapolis-based drugmaker is laying out full results from its longest completed study of the dual GIP/GLP-1 receptor agonist to date.

    In the three-year SURMOUNT-1 trial, tirzepatide curbed the risk of disease progression to Type 2 diabetes by 94% versus placebo in adult prediabetes patients who were obese or overweight, Lilly said in a release Wednesday. The number represents a pooled result from three tirzepatide doses (5 mg, 10 mg and 15 mg) studied in the trial.

    Putting those results into perspective, one new case of diabetes could be prevented for every nine patients treated with tirzepatide, which is marketed in the U.S. as Mounjaro for Type 2 diabetes and as Zepbound for obesity, Lilly said.

    https://www.fiercepharma.com/pharma/lilly-unwraps-detailed-data-showing-tirzepatide-kept-nearly-99-pre-diabetic-patients

    XX

    Edgparke commeical?

    XX

    https://www.bloomberg.com/news/articles/2024-10-25/apple-secretly-tests-blood-sugar-app-in-sign-of-health-ambitions

    XX

    XX

    And finally, many of you have likely already heard but we had some incredibly tragic news in the diabetes community, especially for the Breakthrough T1D ride community. I’m going to read from the Breakthrough T1D website:

    The leadership, staff, and volunteers of Breakthrough T1D mourn the tragic, sudden loss of five T1D Champions on Friday, Nov. 1, 2024.

    Jeff and Michelle Bauer, Josh and Tammy Stahl and Barry Sievers were all killed in a singe car crash.

    The group included two married couples and one single individual—all very close friends and veteran Breakthrough T1D Ride participants.

    Of this incredibly impactful group, I knew Michelle Bauer personally, I met her as Michelle Alswager – you may know her as Jesse’s mom. Her son, Jesse died from complications of type 1 in 2010. And that year, mile 23 on the JDRF ride was created as a mile of silence in memory of Jesse. Now all riders are asked to ride in silence for that mile not only in memory of Jesse, but all those lost to type 1 diabetes.

    Michelle wrote her book, Jesse Was Here and created a program that’s part of Beyond Type 1 to this day, all to help other families going through grief. She called me a few years ago when she was thinking of writing her book and I’m so grateful for our conversations and that our conversations may have helped her get it out there into a world where it’s so needed. But we need Michelle here to talk about grief.

    More about talking to Michelle about the book).

    Please, write the book, ride the bike, do the ironman, follow your heart and your dreams. All of these incredible people gone too soon.

    https://www.breakthrought1d.org/news-and-updates/breakthrough-t1d-mourns-tragic-sudden-loss-of-five-ride-champions/

    Thanks for joining me..

  • Qvin is a small company intent on prioritizing women’s health. And they’re doing it in a way no one has thought to do before. They got FDA clearance to measure A1c with their patented period pads. Qvin is the first and only FDA-cleared menstrual pad scientifically proven to collect blood for lab testing. Featured in Time Magazine’s best inventions of 2024, CEO Dr. Sara Naseri tells me this is just the start of what they want to do for women’s health autonomy.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Learn more about Qvin

    Join us at an upcoming Moms' Night Out event!

    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

    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)

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    Check out Stacey's books!

    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.

  • Living with type 1 diabetes as a professional athlete is an exercise in intense management and mental stamina. Gary Forbes did it before today’s technology – no CGMs or AID pumps, not even fast acting insulin at the start of his career! – and without a diabetes community. He’s making up for lost time with that last bit.. connecting in a way that he says has changed how he looks at T1D. Of course, we’re talking about basketball – as one of only three NBA players with type 1, Gary has a very unique perspective and a great message he’s getting out in a new comic series.

    This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

    Learn more about Gary's comics: Sole Survivors

    Learn more about Diabetes Legends and Rob Howe's other projects

    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

    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)

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    Check out Stacey's books!

    Learn more about everything at our home page www.diabetes-connections.com

    Reach out with questions or comments: info@diabetes-connections.