It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: It's World Diabetes Day and we have a LOT of news to get to! Daily oral insulin tested to prevent T1D, mothers and sons and a T1D link, stem cell updates, Tandem Android news, Omnipod's workplace campaign and more!

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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.

It's world diabetes day! It is marked every year on 14 November, the birthday of Sir Frederick Banting, who co-discovered insulin along with Charles Best in 1922.

WDD was created in 1991 by International Diabetes Federation (IDF) and the World Health Organization and became an official United Nations Day in 2006 with the passage of United Nations Resolution 61/225.

There will be a ton of stuff in your feeds today and that's great! I'm going to keep this to a pretty normal in the news episode.. although I do have my own World Diabetes Day announcement – I want YOUR community commercials. You could have an ad for your event or your blog or your project right here! There's a post on the website explaining it all and I'll come back at the end of the episode and tell you more.

The Primary Oral Insulin Trial (POInT) is the first large-scale clinical trial to test whether giving at-risk children daily oral insulin could prevent or delay type 1 diabetes (T1D). Conducted by researchers from Helmholtz Munich and the Technical University of Munich across five European countries, the study enrolled more than 1,000 children with a genetic risk for T1D. Results published in The Lancet show that while oral insulin did not prevent the development of islet autoantibodies—an early sign of diabetes—it was safe and well tolerated. Importantly, researchers found that some children who received oral insulin developed diabetes more slowly than those given a placebo, suggesting potential protective effects in certain genetic subgroups.

Further analysis revealed that the response to treatment depended on the child's insulin gene variant. Children with genetic versions that raise diabetes risk appeared to benefit, showing delayed onset of the disease, while those without the risk variant did not. These findings point toward a future of personalized prevention, where genetic screening could help identify which children might benefit most from oral insulin. Researchers will continue following the participants until age 12 to assess long-term effects. The study marks a major milestone in decades of diabetes prevention research, highlighting both the promise and complexity of developing tailored, early interventions against type 1 diabetes.

Joint US-Chinese research looking at generating new beta cells from stomach cells.

Upon turning on the "genetic switch," the human stomach cells were converted to insulin-secreting cells within the mice and resembled pancreatic beta cells with respect to gene and protein expression.

Encouragingly, when those experiments were done with diabetic mice, insulin secreted from the transformed human cells helped control blood sugar levels and ameliorated diabetes. The scientists hope that a similar approach can be taken to convert cells from a patient's own stomach into insulin-secreting cells directly within the body. Importantly, additional studies are needed to address if this approach is safe and effective to be used in patients.

https://www.technologynetworks.com/cell-science/news/human-stomach-cells-tweaked-to-make-insulin-406694

A new study in Nature Metabolism may help explain why children born to mothers with type 1 diabetes are less likely to develop the disease early in life compared to those whose fathers or siblings have it. Researchers looked at nearly 2,000 mothers and their children and found that kids whose moms have type 1 diabetes show changes in their DNA that may actually help protect them. These aren't genetic mutations, but epigenetic changes — chemical tags that turn certain genes on or off. The study found these changes in genes tied to the immune system and type 1 diabetes risk, suggesting that a mother's condition during pregnancy can shape her child's immune response in a protective way.

Scientists identified more than 500 areas of DNA where these changes occurred, many in regions that control how the body's immune system works. Most of the changes appeared to calm down the kind of overactive immune response that leads to type 1 diabetes. Researchers even created a "methylation score" to help measure this protective effect. They say the next step is to confirm these results in more diverse groups and figure out exactly how these DNA changes help prevent early diabetes.

https://www.news-medical.net/news/20251110/Maternal-type-1-diabetes-may-protect-children-from-developing-the-disease.aspx

A new study from Karolinska Institutet and Stockholm University reveals that sons born to mothers with type 1 diabetes may develop early vascular dysfunction—independently of metabolic health. The finding may help shape future strategies to prevent cardiovascular disease early in life.

Children of women with type 1 diabetes are known to be at increased risk of developing cardiovascular diseases. This new study, published in Cell Reports Medicine, is the first to show that the risk is linked to early dysfunction in blood vessel cells in sons, even before any metabolic issues arise.

The team is now investigating the long-term effects of maternal diabetes, with a particular focus on why sons seem to be affected earlier than daughters.

https://medicalxpress.com/news/2025-11-sons-mothers-diabetes-early-vascular.html

A new study presented at Kidney Week 2025 has shown that the drug finn-uh-near-own a nonsteroidal mineralocorticoid-receptor antagonist, significantly reduced albuminuria—a key marker of kidney damage—in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This is the first major breakthrough for this population in more than 30 years. Researchers found that patients taking finerenone saw a 25% average reduction in albuminuria compared to placebo, an improvement that suggests a lower long-term risk for dialysis or kidney transplant. The phase 3 FINE-ONE trial involved 242 adults with T1D and CKD, and results showed benefits as early as three months. The drug was generally well tolerated, with side effects similar to those seen in patients with type 2 diabetes, though mild hyperkalemia (high potassium levels) was slightly more common.

Experts say the findings could change the way doctors treat kidney complications in type 1 diabetes, an area that hasn't seen new therapies since the early 1990s. Currently, treatment options rely on blood pressure and blood sugar management, along with renin-angiotensin system (RAS) inhibitors. Finerenone, which is already approved for type 2 diabetes-related CKD, targets overactivation of a receptor that drives kidney damage. Based on these results, Bayer plans to seek FDA approval in 2026 for use in people with T1D and CKD. Researchers and clinicians alike are calling the study "groundbreaking," noting that it opens the door to future research on how finerenone might not just slow kidney decline—but possibly prevent it altogether.

https://www.medscape.com/viewarticle/finerenone-offers-hope-kidney-disease-type-1-diabetes-2025a1000uzi?form=login

This week, Tandem Diabetes Care (Nasdaq:TNDM) announced a major milestone for its Mobi miniature durable insulin pump system.

San Diego-based Tandem revealed that it received FDA approval for the Android version of its Mobi mobile app. Clearance brings Mobi — which the company describes as the world's smallest, durable automated insulin delivery system — to more users. The pump, which pairs with Tandem's Control-IQ+ algorithm, previously worked with iOS software.

Tandem — one of the largest diabetes tech companies in the world — expects to begin a limited rollout next month, followed by full commercial availability in early 2026. This marks the latest milestone for the company, which continues to expand its offerings and widen its reach within the diabetes patient population.

We had a great interview with Tandem on our previous episode, but as I said at the time, it was coming before their earnings call. So here's an update:

The company plans to submit the tubeless mobi to the fda before the end of this year.. possible approval and shipping date is hoped for by middle of 2026.

Trials for their fully closed loop next-generation algorithm which we tlkaed abou ton the show should be launched in 2026

The Sigi patch pump will be developed and launched as a next-generation version of the Mobi

Great job by Dr. David ? Ahn – he posted on IG after getting a message from tandem CEO John Sheridan?

1. First, the Tandem X3 *is* still absolutely in development, contrary to my speculation In yesterday's video. As many of you appropriately pointed out, there is definitely a market for a 300 unit pump, a pump with a screen, and a pump that does not require smartphone control. So from our brief chat, the sense I got that is that the X3 would be more of a refresh of the X2 with newer components, such as a USB-C connector and better memory, rather than a total redesign from the ground up. In terms of timing, all I could get was that it was "not too far distant in the future," which could mean anything I guess, but at least it's still on the way!

2. Next up, he also reassured me that they are working closely with Dexcom to support the G7 15 Day sensor within the next few months. I suspected as much, but it's always good to hear confirmation.

3. Lastly, he did confirm that Tandem is far along in developing a Caregiver/Follow app to allow the remote viewing of glucose and insulin data from a Tandem pump. He explained that it will be based on Sugarmate, the popular diabetes data dashboard app that Tandem acquired back in Jun 2020. While I don't know if every feature will make it into the Tandem caregiver app, Sugarmate is well-liked for its highly customizable dashboard and highly configurable alerts. Sugarmate even has the option to send a text message or phone call for urgent lows. Regardless, a true follow/Caregiver app will be welcomed with open arms by all caregivers and Tandem users who use Libre 3 Plus.

https://time.com/7318020/worlds-top-healthtech-companies-2025/

Senseonics submits Eversense 365 – their year long implantable CGM for a CE mark, European Approval and expect to launch there soon. Eversense will be integrated with the sequel twist pump – again I'm hearing soon but no timeline. Intersting to note that one year inseration was approved in the US just about a year ago, so the first patients will be having their CGMs changed out – for the first time – pretty soon.

https://www.drugdeliverybusiness.com/senseonics-q2-2025-sales-beat-ce-mark/

A confusing study out of Rutgers - these researcher say metformin reduces some of the key benefits normally gained from regular physical activity. These include improvements in blood vessel health, physical fitness, and the body's ability to regulate blood sugar.

Since 2006, doctors have typically encouraged patients with elevated blood sugar levels to combine metformin with exercise, expecting that the two proven treatments would produce stronger results together. However, the new research suggests this may not be the case.

In this study, Exercise alone improved vascular insulin sensitivity, meaning blood vessels responded better to insulin and allowed more blood flow to muscles. This matters because insulin's ability to open blood vessels helps shuttle glucose out of the bloodstream and into tissues, lowering blood sugar after meals.

But when metformin was added, the improvements shrank. The drug also diminished gains in aerobic fitness and reduced the positive effects on inflammation and fasting glucose.

The findings don't mean people should stop taking metformin or exercising, Malin said. Instead, it raises urgent questions for doctors about how the two treatments can be combined and the need for close monitoring. Malin hopes future research will uncover strategies that preserve the benefits of both.

https://scitechdaily.com/popular-diabetes-drug-metformin-may-cancel-out-exercise-benefits-study-warns/

https://www.medtechdive.com/news/Revvity-Sanofi-diabetes-test-Kihealth-seed-round/802133/

Dexcom recalled an Android app for its G6 glucose sensor due to a software problem that could cause the app to terminate unexpectedly.

The issue could cause users to miss alarms, alerts or notifications related to estimated glucose values, according to a Food and Drug Administration database entry posted Oct. 30.

The glucose sensor and the app are still available, but Dexcom required users to update the app to a new version.

Dexcom began the recall on Aug. 28. The FDA designated the event as a Class 1 recall, the most serious kind.

Dexcom sent a notification to customers in September about the software bug, which applies to version 1.15 of the G6 Android app. To use the app, customers must update it to a new version, according to the entry.

https://www.medtechdive.com/news/dexcom-recall-g6-cgm-app/804630/

https://www.medscape.com/viewarticle/automated-insulin-delivery-boosts-glycemic-control-youth-2025a1000ub3

Tidepool partners with smart ring maker OURA.. press release says: to support a groundbreaking dataset intended to be broadly available for diabetes research, with participation limited to individuals who opt in through Tidepool.

Tidepool will pair biometric data from Oura Ring – sleep, activity, heart rate, temperature trends, and menstrual cycles – with diabetes device data, including continuous glucose monitors (CGMs) and insulin pumps. The result will provide researchers with an unprecedented dataset to accelerate the development of new clinical guidelines, next-generation diabetes technology, and personalized care models.

Recruitment is expected to launch in early 2026 through an IRB-approved study. By opting in to this study, participants consent to sharing their data with Tidepool's Big Data Donation Project, where data is de-identified and, with participant consent, shared with academics, researchers, and industry innovators to accelerate diabetes research.

https://aijourn.com/tidepool-collaborates-with-oura-to-advance-inclusive-diabetes-research-through-wearables/

Eli Lilly launches two new clinical trials for baricitinib. These phase 3 trials will investigate whether the drug can delay T1D onset or progression and will open for recruitment soon.

Baricitinib has the potential to extend the "honeymoon period" of T1D, meaning that it could preserve remaining insulin-producing beta cells earlier in disease progression. More beta cells mean better blood sugar management—and potentially reduced long-term complications.

JAK inhibitors, including baricitinib, are already FDA-approved for other autoimmune diseases, such as rheumatoid arthritis, alopecia, and more. JAK signaling pathways are associated with overactive immune responses, so blocking this pathway may turn down the immune response.

The phase 2 Breakthrough T1D-funded BANDIT study was key in showing that this drug is safe and effective in T1D.

Importantly, baricitinib is a once-daily oral pill—meaning its use is simple and easy.

https://www.breakthrought1d.org/news-and-updates/two-new-trials-baricitinib-to-delay-t1d/

Insulet is taking diabetes awareness into the workplace. Having found 79% of people with diabetes have faced bias or misunderstanding at work, the medtech giant is rolling out a range of resources intended to trigger changes in how workplaces approach the condition.

Lots going on for Diabetes Awareness month.. some notables.. Insulet's "The Day Diabetes Showed up to Work" campaign. based on a survey of almost 10,000 people 79% of people with diabetes have faced bias or misunderstanding at work,.

Almost 90% of people with diabetes surveyed reported experiencing barriers at work due to their condition, and more than 40% of people with diabetes and caregivers said they have workplace-related anxiety tied to the metabolic disease. Around one-quarter of respondents reported fears that diabetes could limit opportunities or lead to workplace discrimination and judgment, and a similar proportion of people said they conceal their condition.

https://www.fiercepharma.com/marketing/widespread-workplace-challenges-people-diabetes-spark-insulet-campaign

New directive issued by the Trump administration could mean people seeking visas to live in the U.S. might be rejected if they have certain medical conditions, including diabetes or obesity.

The guidance, issued in a cable the State Department sent to embassy and consular officials and examined by KFF Health News, directs visa officers to deem applicants ineligible to enter the U.S. for several new reasons, including age or the likelihood they might rely on public benefits.

The guidance says that such people could become a "public charge" — a potential drain on U.S. resources — because of their health issues or age.

The cable's language appears at odds with the Foreign Affairs Manual, the State Department's own handbook, which says that visa officers cannot reject an application based on "what if" scenarios, Wheeler said.

The guidance directs visa officers to develop "their own thoughts about what could lead to some sort of medical emergency or sort of medical costs in the future," he said. "That's troubling because they're not medically trained, they have no experience in this area, and they shouldn't be making projections based on their own personal knowledge or bias."

Immigrants already undergo a medical exam by a physician who's been approved by a U.S. embassy.

https://www.npr.org/2025/11/12/nx-s1-5606348/immigrants-visas-health-conditions-trump-guidance

SAN DIEGO---Nov. 14, 2025—DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing,

today unveiled 16 new diabetes advocates to represent people living with diabetes globally as part of

Dexcom's World Diabetes Day campaign.

The advocates – ranging from ages six to 68, spanning various types of diabetes, and hailing from four

continents and five countries – were selected from 1,000 open call submissions based on their

experiences advocating for people with diabetes in their communities. While each person's experience

with diabetes is unique, they share a common passion for advocacy – and use of Dexcom's glucose

biosensing technology.

"Through advocacy, I strive to show others, especially children and newly diagnosed patients, that

diabetes is not a limitation but an opportunity to grow stronger, inspire resilience and pursue ambitious

goals," said Maria Alejandra Jove Valerio, one of Dexcom's new advocates. "What began as a diagnosis

at age seven has grown into a lifelong mission to uplift others."

This effort represents the first time Dexcom has sourced voices from the broader diabetes community

specifically for its World Diabetes Day campaign, reinforcing Dexcom's history of and commitment to

giving real people with diabetes a platform to share their story on a global stage.

Through engaging, editorial-style portraits and deeply personal stories, the campaign highlights each

advocate's personal experience with diabetes, what misconceptions about diabetes they'd like to dispel

and how they want to inspire others with diabetes to discover what they're made of.

To prepare for the spotlight, the group of advocates met in Los Angeles for a World Diabetes Day

photoshoot which included a surprise visit from Grammy-nominated artist, actor, producer and Dexcom

Warrior Lance Bass and author, producer, actress and Stelo*Ambassador Retta. This visit offered the

advocates an opportunity to exchange stories and personal perspectives on the meaning of diabetes

advocacy and how they live it each day.

Behind the lens at the shoot was another member of the diabetes community—photographer Tommy

Lundberg who lives with Type 1 diabetes.

"Directing this photoshoot was nothing short of inspiring. Each of these advocates has a unique an

On what would have been the 100th birthday of its visionary founder Alfred E. Mann, MannKind Corporation (Nasdaq: MNKD), in partnership with Alfred E. Mann Charities and The Diabetes Link, announced the launch of the Centennial Al Mann Scholarship. The new program will distribute $100,000 in scholarship funds to support at least 10 young adult students living with diabetes as they pursue higher education in life sciences.

Launched in Diabetes Awareness Month, the scholarship program honors Alfred E. Mann's enduring legacy of innovation, philanthropy, and his lifelong commitment to improving the quality of human life through medical advancement. Deeply passionate about giving back, Mr. Mann believed that his success should continue to serve humanity long after his passing, a belief that lives on through this initiative.

Each scholarship recipient will be awarded up to $10,000, distributed in annual installments of $2,500 throughout the course of their studies. Depending on the length of their degree program, recipients may receive between two and four installments (up to the full $10,000 per student). The first awards will be made for the 2026 academic year.

"Al Mann dedicated his life to helping people with serious medical conditions live longer, healthier lives. This scholarship is a reflection of that spirit," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "By supporting students living with diabetes who are pursuing careers in the life sciences and adjacent fields, we're honoring Al's legacy and investing in the future of innovation and care. This program is about giving back to the community we serve and empowering the next generation to carry forward Al's mission of making a meaningful difference in people's lives."

Alfred E. Mann Charities and MannKind will partner with The Diabetes Link to launch the program to serve young adults (aged 18-22) living with either type 1 or type 2 diabetes with their higher education goals. Those eligible will include incoming freshmen and current students pursuing 2- or 4-year degrees. The application window will open in early 2026, and for those interested in receiving notifications, an early interest form is available. More information about the scholarship will be shared on thediabeteslink.org.

"We're honored to partner with MannKind to expand access to higher education for young adults with diabetes," said Manuel Hernández, Chief Executive Officer of The Diabetes Link. "At a time when the cost of college continues to rise, this scholarship helps ease the financial burden and carries forward the spirit of Al Mann, whose vision and legacy continue to inspire us."

Mr. Mann was MannKind's Chairman of the Board from 2001 until his passing in February 2016 and served as Chief Executive Officer from November 2003 until January 2015. Driven by a desire to improve lives and fill unmet medical needs, for more than six decades he founded 17 companies and developed breakthrough medical devices, including insulin pumps, cochlear implants, cardiac pacemakers and retinal prostheses. In 1997, Mr. Mann saw the potential of a dry powder insulin formulation to change the way diabetes is treated and invested nearly $1 billion to help bring Afrezza® (insulin human) Inhalation Powder to market.

About MannKind

MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

About Alfred E. Mann Charities, Inc.

Alfred E. Mann Charities, Inc. became active in 2016, following the passing of the organization's benefactor, Alfred E. Mann. Throughout his life, Al was passionate about philanthropy and was dedicated to prolonging and improving the quality of human lives through innovation in the fields of healthcare and the use of medical devices. It was important to Al that his success and assets continue to better human lives even after his own passing.

Alfred E. Mann Charities, Inc. (formerly known as Alfred E. Mann Family Foundation) has similarly placed its primary focus on healthcare and medical innovation, as our organization believes this is where we can have the greatest impact on humanity and human health throughout the world. Alfred E. Mann Charities, Inc. is also dedicated to promoting arts, culture, education, and community development across Los Angeles and throughout the world in order to best serve people and this planet.

Learn more at aemanncharities.org.

About The Diabetes Link

The Diabetes Link is the only national nonprofit organization dedicated to empowering young adults living with diabetes. Founded by and for young adults, The Link serves this community through peer support, leadership opportunities, and practical, evidence-based resources designed for real life. Its network of campus and community chapters, active online community, and robust Resource Hub help young adults navigate the transitions of early adulthood while managing diabetes. The organization envisions a future where every young adult living with diabetes has

Genetics & Genomics

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Gene Therapy

Genetic Testing

Precision Medicine

Rare Disease