It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: FDA approves the first fast-acting biosimilar insulin in the US, Tandem issues warning, DOJ stands up for remote monitoring in schools, GLP1 use protects against dementia, and more!

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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.

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We’ve got the first and only biosimilar FDA approved and moving to market. Kirsty – insulin aspart, which is a biosimilar to Novolog will be available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.

KIRSTY has been available in Europe and Canada since 2022. This same company makes Semglee, the first biosimilar for long acting?

Sales of Insulin Aspart in the United States were approximately $1.9 billion in 2024, according to IQVIA.

https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html

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Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated insulin pumps.

In a July 22 notice, the San Diego-based company warned of pumps that may exhibit a higher rate of speaker failure. During normal use, the insulin pump software monitors current flowing through the speaker during use. Measurements that fall within a pre-determined range indicate a functioning speaker. Meanwhile, measurements falling outside the range indicate a speaker failure.

 

When the measurements land outside the expected range, the system declares a malfunction, referred to as “Malfunction 16.” If the pump declares this malfunction, insulin delivery will stop and the pump will no longer be operational. Malfunction 16 terminates communication between the pump and continuous glucose monitor (CGM), as well as the t:slim mobile app.

 

If not addressed, the issue can lead to hyperglycemia, which can result in hospitalization or medical intervention. The company reports 700 adverse events and 59 reported injuries to date, with no reports of death.

 

Tandem identified that certain speaker versions have a higher rate of Malfunction 16 events due to a wiring issue within the speaker. Users can continue using their pump but with added precautions because Malfunction 16 can occur at any time. They should use the t:slim mobile app with push notifications turned on so the app alerts them if the malfunction occurs, the company said.

 

Additionally, Tandem intends to release a software update aimed at enhancing the early detection of speaker failure. The update also introduces persistent vibration alarms to help reduce potential safety risk. Tandem plans to notify affected pump users when it makes the update available.

https://www.drugdeliverybusiness.com/tandem-warns-insulin-pump-speaker-malfunction/

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BIG WIN! The DOJ protects T1D rights again! The US Attorney's office for the Western District of Washington State reached a settlement with a public school district that once again confirms remotely monitoring students’ CGMs is a reasonable accommodation that schools must provide to comply with the Americans with Disabilities Act. If its true for one state its true for all states under federal law!

If your local schools still refuse to remotely monitor CGMs of their students, provide them with this letter to compel them to FOLLOWT1Ds and FOLLOW Federal Laws. If they still refuse contact us!

https://followt1ds.org/

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new study finds people taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin users.

Past studies show that people who have type 2 diabetes — a chronic condition where the body does not use its insulin properly — are at a higher risk of developing dementia.

The study found that when comparing the neuroprotective abilities of two diabetes medications — metformin and glucagon-like peptide-1 receptor agonists (GLP-1 agonists) — participants taking GLP-1 agonists had a significantly lower cumulative risk of developing dementia, when compared to metformin.

 

https://www.medicalnewstoday.com/articles/glp-1s-may-offer-better-dementia-protection-than-metformin

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Front office changes coming to Dexcom.  CEO Kevin Sayer will step down  & give the reins to current Chief Operating Officer Jake Leach. Scheduled for January 1, 2026, Leach will also join Dexcom’s board of directors where Sayer will remain  executive chairman.

One of our frequent guests here.. Leach has worked at Dexcom for 21 years. He served as chief technology officer from 2018 to 2022 before he was named COO in late 2022. He was given the title of president in May.

https://www.medtechdive.com/news/dexcom-ceo-change-kevin-sayer-jake-leach/756382/

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A major international study has revealed that many children and young adults in Sub-Saharan Africa who are diagnosed with type 1 diabetes (T1D) may actually have a different, non-immune-based form of the condition. Unlike the traditional autoimmune version of T1D, this form appears to develop without the immune system attacking the insulin-producing cells. This finding could significantly reshape how diabetes is diagnosed and treated across the region, potentially leading to more precise care and better health outcomes.

The researchers found that many young people in Sub-Saharan Africa diagnosed with T1D often don’t have the usual markers in their blood (called islet autoantibodies) typically seen in people with T1D in other parts of the world. Specifically, 65% of participants with T1D in this region did not have islet autoantibodies.

When the researchers compared this data to studies in the U.S., they found a smaller but significant proportion (15%) of Black participants diagnosed with T1D had a similar form of diabetes found in Sub-Saharan Africa – characterized by negative autoantibodies and a low T1D genetic risk score.

 

However, white Americans with T1D showed the typical autoimmune pattern, even if they didn’t have detectable autoantibodies, their genetics still pointed to autoimmune diabetes.

 

“The identification of this T1D diabetes subtype in Sub-Saharan African populations and among individuals of African ancestry in the U.S. suggests a potential ancestral or genetic link,” Dabelea notes. “These findings highlight the need to consider alternative etiologies in this group and a deeper understanding of the underlying mechanisms may provide important insights for future prevention and treatment strategies.”

 

 

https://scitechdaily.com/new-diabetes-subtype-discovered-in-africa-challenges-global-assumptions/

 

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Formal recognition for the specialty of Diabetology.

 

Diabetology is the specialty focused on the full continuum of diabetes care — encompassing diagnosis, treatment, prevention, technology integration, education, and cardiometabolic management. While it intersects with endocrinology, primary care, and public health, diabetology is uniquely defined by its depth and focus on diabetes alone.

 

 

 

The American College of Diabetology (ACD) is the national professional organization representing clinicians who specialize in diabetes care. ACD advances clinical excellence and education to improve the lives of those affected by diabetes.

https://www.businesswire.com/news/home/20250725766248/en/American-College-of-Diabetology-Announces-Formal-Taxonomy-Classification-for-Diabetology

 

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Tidepool announces cloud-to-cloud integration with Abbott’s FreeStyle Libre portfolio. From the release:

This integration allows people living with diabetes using the FreeStyle Libre portfolio to connect their data to their Tidepool account seamlessly. For healthcare providers, this means more comprehensive insights and streamlined workflows, with FreeStyle Libre systems data flowing continuously into the Tidepool Data Platform.

https://www.tidepool.org/blog/abbott-freestyle-libre-integration-launched

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Stelo dexom ai food

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With high drug prices remaining an ongoing concern for U.S. politicians, Roche is considering following in the footsteps of some of its peers with a direct-to-consumer (DTC) model to cut out the middlemen.

 

 

About 50% of the money spent on drugs in the U.S. healthcare system goes straight to PBMs instead of the companies that create the medicines, Roche CEO Thomas Schinecker called out in a press conference on Thursday.

 

Bringing the drugs directly to the consumer could be a solution to positively impact pricing for patients “without destroying innovation,” Schinecker added on a separate Thursday call with investors, noting that the company has discussed the matter with the U.S. government and its Department of Health and Human Services.

The pricing talks come after President Donald Trump inked a “Most Favored Nation” executive order in May, aiming to tie U.S. drug prices to lower prices in other developed nations. The plan was quickly called out by industry voices such as the PhRMA trade group, which labeled it a “bad deal” for U.S. patients.

https://www.fiercepharma.com/pharma/roche-weighing-direct-consumer-drug-sales-ease-us-drug-pricing-woes-cut-out-pbms-ceo-says

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SAB BIO secures substantial $175M financing to advance T1D therapy with impressive investor lineup and extended cash runway until 2028.

Most critically, this financing fully funds the pivotal Phase 2b SAFEGUARD study evaluating SAB-142 for delaying progression of autoimmune Type 1 diabetes in newly diagnosed patients. By extending the cash runway into mid-2028, SAB has effectively eliminated near-term financing risk and provided clear visibility through this crucial clinical trial and potential commercialization preparation.

Participation from strategic investor Sanofi, along with new investors RA Capital Management, Commodore Capital, Vivo Capital, Blackstone Multi-Asset Investing, Spruce Street Capital, Forge Life Science Partners and Woodline Partners LP, and existing investors Sessa Capital, the T1D Fund, and ATW Partners

 

 

 

 

https://www.stocktitan.net/news/SABS/sab-bio-announces-oversubscribed-175-million-private-fwsf2t91ek4z.html

 

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In a landmark 14-year study, researchers have found that artificially sweetened drinks raise the risk of developing type 2 diabetes by more than a third, significantly higher than those loaded with sugar. It challenges the long-standing perception of diet drinks being a healthier alternative and suggests they may carry metabolic risks of their own.

In the first longitudinal study of its kind, led by Monash University, researchers tracked 36,608 participants over an average period of 13.9 years to assess how both sugar-sweetened beverages (SSBs) and artificially sweetened beverages (ASBs) impacted health outcomes. The self-reported health data, from the Melbourne Collaborative Cohort Study, was drawn from participants aged 40 to 69 years at the time of recruitment.

 

What they found was that drinking just one can of artificially sweetened soda increased the risk of developing type 2 diabetes by 38%, compared to people who didn’t consume these drinks at all. For those consuming the same amount of sugary drinks, the risk was 23% higher.

This suggests there's more than obesity at play. The researchers believe this result is due to an independent metabolic effect, possibly gut microbiome disruption or a change in glucose metabolism.

 

While the study didn't identify which artificial sweeteners were at play,

 

Evidence suggests that artificial sweeteners can alter the composition and function of gut bacteria, leading to glucose intolerance – a precursor to type 2 diabetes. And that some sweeteners may trigger insulin release, desensitize metabolic responses over time, or confuse the body’s glucose regulation system – even without actual sugar in the picture.

 

Another hypothesis is that regular exposure to the kind of intense sweetness that artificial products deliver may condition the body to anticipate sugar calories that never come, affecting appetite regulation, insulin sensitivity and broader metabolic pathways. However, the authors suggest that how sweeteners affect the gut microbiota and glucose regulation are the most likely drivers of increased diabetes risk.

 

https://newatlas.com/diet-nutrition/one-drink-diabetes-risk/

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After months of deliberation, information gathering and public testimony, a state board unanimously agreed Monday that two common medications for type-2 diabetes and other conditions appear to pose an affordability challenge to the state and Marylanders.

 

The state Prescription Drug Affordability Board approved two resolutions saying that prescription drugs Jardiance and Farxiga likely pose an “an affordability challenge for the state health care system” and the state should look for ways to bring down those costs.

 

Health care advocates call the long-awaited resolution an “important first step” in the process in bringing down prescription costs for those on the state’s health plan.

 

 

 

That milestone has been years in the making. Created in 2019 by the General Assembly, the Prescription Drug Affordability Board was slow to launch due in part to a veto from former Gov. Larry Hogan (R) amid pandemic-induced economic uncertainty in 2020 that delayed the board’s formation.

The board also cited out-of-pocket costs for consumers and state and local spending on those drugs as indicators that there may be an affordability challenge.

 

The board will now look at options to address the potential affordability challenge, which could include setting an upper payment limit on those drugs. But it’s not clear when the state will see cost savings.

 

That said, some members of the health care system and the pharmaceutical industry say that policies such as upper payment limits could weaken access to life-saving drugs. Others say that the board has not engaged enough viewpoints from the health care industry.

https://marylandmatters.org/2025/07/29/state-board-determines-two-type-2-diabetes-drugs-may-be-unaffordable/

 

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One year after it was revealed that Chrissy Teigen and John Legend’s son, Miles, was diagnosed with type 1 diabetes, Teigen is revealing how she’s making her son feel more included.

Teigen first opened up about her 7-year-old son’s diagnosis after she and her two oldest kids, Miles and 9-year-old daughter Luna were at the 2024 summer Olympics cheering on Simone Biles.

Teigen posted a photo of Miles and Luna holding up a sign. Also visible in the picture was the insulin pump on Miles’ arm.

Now, Teigen is sharing some insight into how she’s making Miles more comfortable with having type 1 diabetes, including giving LeBron James’ Barbie doll type 1 diabetes as well.

In a video shared on Instagram, Teigen is seen taking the T1D Barbie, removing her insulin pump and gluing the pump onto LeBron James’ Barbie. “Turning T1D Barbie into T1D Lebron James for my son,” Teigen captioned the video, revealing James is Miles’ hero.

41 million followers

https://www.yahoo.com/lifestyle/articles/chrissy-teigen-gives-lebron-james-154608782.html