In the News.. Inhaled Insulin Approved for Kids, CGM + Ketone Monitor, Food Coloring & Diabetes Study, Device Recalls and more!

It's in the News! The top diabetes stories and headlines happening now. Top stories this week include: Afrezza inhaled Insulin is Approved for Kids, CGM + Ketone Monitor gets European approval, Food Coloring & Diabetes Study, Device Recalls include Omnipod and Dexcom, Beta Bionics shares more about their patch pump, ADA conference info and more!

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Episode transcripts:

Welcome! I’m your host Stacey Simms and this is an In The News episode.. where we bring you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes.

ADA starts this week – safe travels to those of you heading to New Orleans. We’ll be covering remotely so please follow on social – make sure to Like the FB page or join the group. We’ve got a wrap up episode planned for this podcast as well as some indepth interviews with the newsmakers from the conference.

I will see some of you next week in Chicago. We have a couple of seats left for our Club 1921 dinner on June 10^th in Northbrook – this is a FREE dinner for HCPs and patient leaders – all about screening for T1D. More info on the website under the events tab.

Okay.. our top story this week:

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Afrezza inhaled insulin is now approved for kids and teens. The FDA okayed MannKind’s afrezza for children 6 and older with type 1 and type 2 diabetes.

MannKind says its proprietary Technosphere drug delivery platform enables the rapid absorption of insulin into systemic circulation.

This follows FDA approval earlier this year for an update that revises recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens.

MannKind also completed enrollment in February for a study evaluating the initiation of Afrezza therapy shortly after type 1 diabetes diagnosis in pediatric patients.

 

The company said it made Afrezza available for eligible patients for $35 or less per month.

Desmond Schatz, professor of pediatrics at the University of Florida College of Medicine, said:

“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary. With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.”

Lots more to come on this – we’re working on a bonus episode with one of the pediatric endos who worked on the clinical trials that led to this approval – hopefully have that out later this week.

https://www.massdevice.com/mannkind-fda-approval-inhaled-insulin-children/

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FDA has agreed to consider a new drug for the treatment of adults with type 1 and chronic kidney disease.

Finerenone (fy-near-uh-known) is currently approved in the US for adults with CKD associated with type 2 diabetes and for adults with heart failure with left ventricular ejection fraction of 40% or greater.

Chronic kidney disease (CKD) is present in over one-third of adults with diabetes, and because it’s such a serious condition, interventions are needed to reduce its incidence and help people live a long and prosperous life.

https://www.docwirenews.com/post/fda-grants-priority-review-to-finerenone-snda-for-type-1-diabetes-associated-ckd

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Abbot gets European approval for the world's first dual glucose‑ketone sensing technology for people with diabetes. They’re calling this Libre Duo and Libre Duo 10 Day, and it’s designed to continuously measure glucose and ketone levels every minute. Abbott plans to begin launching Libre Duo systems in select European countries later this year.

Libre Duo delivers up to 15 days of wear and will be offered to adults ages 18 and older. Libre Duo 10 Day offers up to 10 days of wear and is intended for people ages 2 and older.

Abbott is also working with leading pump companies to allow automated insulin delivery (AID) systems to connect with the sensors.

https://abbott.mediaroom.com/2026-05-27-Abbott-secures-CE-Mark-for-worlds-first-dual-glucose-ketone-sensing-technology-for-people-with-diabetes

 

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Huge recall for Omnipod. Insulin says a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery  with specific lots of its Omnipod 5, Dash and Eros pods. Insulet said the scope of this action reaches approximately 7 million pods. This issue is separate from the March recall that affected certain Omnipod 5 lots.

According to the Acton, Massachusetts-based company, some of its affected pods may have a small tear in the tubing (cannula) just above the skin. This tear lands between the pod and the point where the cannula enters the body. If this occurs, insulin may leak outside of the device instead of being fully delivered into the body as intended. This may lead to under-delivery of the therapeutic.

 

Individuals using an affected pod may notice wetness on the skin or pod adhesive or detect the smell of insulin. However, some cases may prove difficult to detect and go unnoticed.

Of the approximately 7 million pods included in the action, approximately 60% have been consumed or are expired. The pods affected by the correction represent approximately 8.5% of the 2025 global Omnipod pod prodcution.

Insulet says it has sufficient supply to replace affected pods. It expects no disruption to product availability. The company said it has notified the FDA and all other relevant regulatory authorities of its action.

 

The full list of affected pod lots can be found here.

https://www.massdevice.com/insulet-another-omnipod-5-recall-dash-eros/

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Dexcom is warning that certain scrapped glucose sensors have been stolen and resold.

Dexcom said it has not received any reports of severe adverse events associated with the stolen product. One lot of scrapped devices carries a risk of infection for sensors that are not properly sterilized, and another lot had an elevated internal testing failure rate, meaning users would have an increased risk of having no sensor readings available.

Dexcom said the affected sensors were stolen during the destruction process and then sold by third parties. The company routinely scraps sensors that do not meet its standards. The sensors are sent to a third-party vendor for destruction and recycling.

 

Dexcom said it traced sales of the stolen devices to Pharmsource, which is not an authorized Dexcom distributor but supplies some independent pharmacies and U.S. durable medical equipment distributors. Because of this, pharmacies that purchase products from Pharmsource should review their inventory, Dexcom said.

 

People with sensors from the affected lots should not use those sensors and can call customer support to request replacements. Dexcom has set up a website to help users check if their devices are affected.

https://www.medtechdive.com/news/dexcom-warns-of-scrapped-glucose-sensors-being-resold/821139/

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Beta Bionics plans to debut its first insulin patch pump by the end of the second quarter of 2027, subject to Food and Drug Administration clearance.

The device, called Mint, would be compatible with Beta Bionics’ interoperable automated glycemic controller, a software that allows for the pump to automatically adjust insulin delivery based on readings from a glucose sensor.

Beta Bionics first unveiled the prototype for Mint last year at the American Diabetes Association’s Scientific Sessions. The device is expected to have a similar size and wear time, at three days, to Insulet’s patch pumps on the market. It would have a 200-unit insulin reservoir.

 

Mint differs by containing a mix of reusable and disposable components. Beta Bionics plans to make the device exclusively available in the pharmacy channel, building on its existing agreements for its current iLet insulin pump.

Beta Bionics is one of several diabetes tech companies developing patch pumps to compete with market leader Insulet. Tandem Diabetes Care and Medtronic spinoff MiniMed have also announced planned patch pumps. Tandem said it plans to file a 510(k) submission this quarter for a tubeless version of its small, durable pump, and Medtronic plans to submit its patch pump to the FDA this fall.

 

https://www.medtechdive.com/news/beta-bionics-to-launch-its-first-insulin-patch-pump-to-compete-with-insulet/821091/

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CVS puts Zepbound back on it’s coverage list – with it’s Caremark PBM. They also added Foundayo, Lilly’s obesity pill. CVS had dropped Lilly’s Zepound last summer but kept competitor Wegovy. It’ll be back at Caremark October first.

All three of the nation's largest pharmacy ⁠benefit managers ​now cover Lilly's full obesity medicine portfolio.

https://www.reuters.com/legal/litigation/cvs-brings-back-coverage-lillys-obesity-drug-zepbound-2026-05-28/

 

More to come, including a new benefit from metformin for women, something new from Tidepool, big news for T1D in Austalia and more..

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A new study suggests that higher long-term exposure to food colouring additives — including both synthetic and natural colourings commonly found in processed foods and beverages — may be associated with an increased risk of developing type 2 diabetes. Researchers analyzed data from more than 108,000 adults in the French NutriNet-Santé cohort between 2009 and 2023, following participants for a median of just over eight years. During that time, 1,131 participants developed type 2 diabetes. The study found that people with the highest intake of total food colouring additives had a 38% higher risk of developing type 2 diabetes compared with non- or low-consumers.

 

Several specific additives were linked to increased risk, including caramel colouring additives such as total caramel (E150 family), plain caramel (E150a), sulphite ammonia caramel (E150d), and beta-carotene (E160a). Additional associations were observed for curcumin (E100), anthocyanins (E163), paprika extract (E160c), lutein (E161b), and cochineal-derived colourings (E120). “Our findings revealed positive associations between widely consumed food colouring additives and type 2 diabetes incidence,” the authors wrote, adding that further research is needed to better understand the mechanisms behind the findings and whether food colouring regulations should be reevaluated.

https://www.medscape.com/viewarticle/use-common-food-colours-tied-high-type-2-diabetes-risk-2026a1000hes

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Big news for Australia – their Therapeutic Goods Administration (TGA) approves Tzield. Tzield is now approved in Australia to delay the onset of stage 3 (or clinical) T1D in people aged eight years and older with stage 2 T1D – the early, pre-symptomatic stage of the condition, where changes in blood glucose levels have begun but insulin therapy is not yet required.

Breakthrough T1D Australia Chief Executive Officer, Sydney Yovic, said the approval represented a transformational moment for Australians affected by T1D.

https://newshub.medianet.com.au/2026/05/landmark-approval-of-tzield-in-australia-ushers-in-a-new-era-of-delay-for-type-1-diabetes/155036/

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https://www.theatlantic.com/health/2026/05/diabetes-pregnancy/687324/

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A common diabetes drug may hold great potential to help with aging, even if scientists aren't exactly sure why. According to a study, the drug metformin doesn't just help patients to effectively manage their type 2 diabetes. it may also give older women a better chance of living to 90.

Scientists in the US and Germany used data from a long-term US study of postmenopausal women.

 

Records for a total of 438 people were selected – half of whom took metformin to treat diabetes, and half of whom took a different diabetes drug, sulfonylurea.

 

While there are some caveats and asterisks to the study, those in the metformin group were calculated to have a 30 percent lower risk of dying before the age of 90 than those in the sulfonylurea group.

The study used age 90 as the marker for 'exceptional' longevity.

However, scientists aren't yet sure that the drug extends lifespan, especially in humans – which is part of the reason for this study.

RCTs could follow further down the line to dig deeper into these results, the researchers suggest. In the meantime, as the global population continues to skew older, studies continue to find ways to keep us healthier for longer and reduce damage to the body as we age.

https://www.sciencealert.com/a-common-diabetes-drug-is-linked-with-exceptional-longevity-in-women
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The American Diabetes Association® (ADA) will host the 2026 Scientific Sessions from June 5-8 in New Orleans. The ADA's Scientific Sessions is the world's largest diabetes meeting, convening an expected audience of over 12,000 leading physicians, scientists, researchers, and healthcare professionals from around the globe. The premier diabetes meeting, which is also offered virtually, will feature the latest scientific findings in diabetes and obesity, where leading experts and peers will share findings in research for prevention, care, and cures at the Ernest N. Morial Convention Center.

Key themes will include:

Advancing obesity and metabolic health:

Prevention, early detection, and disease modification:

Improving cardiometabolic outcomes:

Transforming care through innovation and access: New research will highlight how technology, artificial intelligence, and implementation strategies are reshaping diabetes care—reducing treatment burden, expanding access, and enabling more person-centered care.

Advancing beta cell replacement and cure strategies:

Fostering innovation: On Saturday, June 6, from 4:30-6:00 p.m., the Innovation Challenge, which debuted in 2023, invites emerging companies to pitch novel ideas to improve the lives of people living with diabetes. A panel of judges, with input from a live audience, determines which contestants will earn a private audience with potential funders.

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Tidepool, the nonprofit leader advancing innovation in diabetes technology, announced that Tidepool+ Direct Connect is now available through the Epic Showroom. Built on SMART on FHIR, Direct Connect brings interactive diabetes device data directly into Epic workflows, helping clinicians use patient data during routine care.

“Tidepool has always focused on making diabetes data more accessible and actionable,” said Brandon Arbiter, CEO. “We’re excited to empower clinicians using Epic with insightful, intuitive patient data that fits directly into their encounter workflow so they can use it to improve care in the moment it matters.”

 

Tidepool+ Direct Connect supports scalable deployment across Epic-enabled health systems. This architecture enables faster, more intuitive rollouts, enhancing Tidepool’s existing EHR integration capabilities.

 

Direct Connect is part of Tidepool’s ongoing work to improve how clinicians can use timely and relevant diabetes device data during patient visits to help drive better health outcomes.

 

The feature is now available in the Connection Hub of the Epic Showroom.

 

https://www.businesswire.com/news/home/20260527780274/en/Tidepool-Launches-in-Epic-Showroom-to-Bring-Diabetes-Device-Data-into-the-Point-of-Care

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