In the News.. Tzield approved for toddlers, generic Ozempic, Omnipod & Tandem updates, T1D Barbie honored... and more!

It's In The News - where we bring you the top diabetes stories and headlines happening now. This week, Tzield approved down to age one and over, Omnipod trials for fully closed loop, Tandem approved for pregnancy, Eversense 365 launches in Europe, generic Ozempic in Canada, an award for the T1D Barbie and more. 

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Okay.. our top story this week:

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The U.S. Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) for use in children in stage 2 type 1 diabetes (T1D) ages one and older. The approval expands the previous indication from those aged eight and above and was granted under a priority review process.

This decision is supported by one-year data from the PETITE-T1D Phase IV study, which evaluated the safety and pharmacokinetics of Tzield in children under eight years old.

Tzield was approved for use in individuals 8+ in stage 2 T1D in 2022. Since then, we have been working to expand the eligible population. This expansion effort includes individuals in stage 3 T1D, who can preserve endogenous insulin production for longer when they take Tzield and, most notably today, children in stage 2.

https://www.breakthrought1d.org/news-and-updates/tzield-approved-for-children-ages-one-and-older-in-stage-2-t1d/

 

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Big write up in the journal Pediatrics about screening for type 1. Citing the 2025 ADA Standards of Care in Diabetes, the opinion piece talks about how to engage the greater healthcare community.  It says:

We aim to encourage the development of strategies to emphasize the importance of T1D early detection, integrate screening into routine health care encounters, and support implementation of T1D screening. Pediatricians and other primary care clinicians are well positioned for greater collaboration with the multidisciplinary team, ensuring early detection, timely intervention, and improved outcomes.

https://publications.aap.org/pediatricsopenscience/article/2/2/1/207272/Type-1-Diabetes-Screening-in-Pediatrics-Putting?autologincheck=redirected

 

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More info about GLP-1 drugs and people with type 1. New study shows off label use did not lead to DKA or pancreatitis in a large 1-year single-center study.

Moreover, GLP-1 agonist use in people with T1D was associated with lower overall rates of hospitalization, as has occurred in type 2 diabetes

Although GLP-1 agonists are not approved by the FDA for T1D management, off-label adjunctive use has risen for those with obesity.

Semaglutide was the most commonly-used GLP-1 (65.5% of GLP-1 users) followed by tirzepatide (23.5%). The rest were using the older-generation drugs: liraglutide or dulaglutide. Lots more information to come on type 1 and glp 1-s in upcoming studies.

https://www.medscape.com/viewarticle/use-glp-1s-type-1-diabetes-not-linked-increased-dka-2026a1000d56

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Health Canada ‌​has approved the first generic ​version of ​Danish ⁠drugmaker ⁠Novo ‌Nordisk's Ozempic drug.

In January 2026, the Canadian patent for Ozempic will expire, paving the way for cheap generic versions of the semaglutide injections that help regulate blood sugar levels and appetite.

Health Canada said this generic, like existing products, is indicated to be used for the "once-weekly treatment of adult patients with Type 2 diabetes to manage blood sugar levels."

With three generics on the market, Tadrous said the price could drop to about $100 or less, depending on their dose.

Health Canada said it's currently reviewing eight other generic submissions by different companies and expects to make a decision on these in the next few weeks and months.

https://www.cbc.ca/news/health/ozempic-generic-health-canada-9.7180566

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 Insulet has enrolled the first participant in a pivotal study for its fully closed-loop (FCL)A automated insulin delivery (AID) system for type 2 diabetes (T2D

 The participants are between 18 – 75 years of age, living with T2D and using insulin (basal-bolus or basal-only). The Company received Investigational Device Exemption (IDE) approval in March 2026 from the U.S. Food and Drug Administration (FDA).

The Company plans to submit a 510(k) filing to the FDA in 2027 and launch its FCL AID system for T2D in 2028.

 

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insulet Corporation (PODD) has initiated a voluntary recall of certain lots of its Omnipod 5 insulin delivery Pods in the U.S. after detecting that some devices had a manufacturing defect that causes insulin leakage.

 

Patients using the affected devices could risk experiencing high blood glucose levels due to insufficient insulin delivery, the Acton, Massachusetts-based MedTech disclosed in a statement late Thursday.

The company has already notified the FDA about the recall, which it said will affect nearly 1.5% of Omnipod 5 pod units it manufactures annually. The customers were advised to immediately seek a product replacement at no cost if a Pod from a defective lot is currently in use.

https://www.msn.com/en-us/money/companies/insulet-recalling-certain-defective-omnipod-insulin-delivery-devices/ar-AA1YyslT?apiversion=v2&domshim=1&noservercache=1&noservertelemetry=1&batchservertelemetry=1&renderwebcomponents=1&wcseo=1&bundles=feat-es2020-c

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Tandem Diabetes Care (Nasdaq:TNDM) gets FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy.

The FDA cleared the company’s Control-IQ AID technology for use in what they call: pregnancy complicated by type 1 diabetes mellitus. Tandem says t:slim X2 and Mobi are the first and only commercially available AID systems cleared for use during pregnancy in the U.S.

https://www.drugdeliverybusiness.com/tandem-fda-clearance-aid-pregnancy-t1d/

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Tandem also issued an urgent medical device correction for a software problem with its Mobi insulin pumps. The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. We told you about this back in October when Tandem sent a letter to customers notifying them of the fault and instructing them to update their pump software as soon as possible. The FDA now issued a class one recall, the most serious type.

We just released a bonus episode all about Tanem – tubeless mobi and what else is in the pipeline. You can listen to that wherever you are listening to this.. it’s the episode just before this one.

https://www.medtechdive.com/news/tandem-recalls-mobi-insulin-pumps-over-software-malfunction/818260/

 

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Switching CGMs didn’t make a measurable difference for adults using MiniMed’s pump system. In a real-world analysis presented at the International Conference on Advanced Technologies & Treatments for Diabetes, researchers found that CGM metrics for patients who switched from the Guardian 4 sensor (MiniMed) to Instinct by Abbott were able to maintain a time in range of greater than 75%.

“When it comes to the automated insulin delivery system ... I think the sensor matters less and the system matters more,” Viral N. Shah, MD, professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at Indiana University Center for Diabetes and Metabolic Diseases, said during a presentation. “Having a different sensor with the system, I think the [glycemic] outcomes will still be what you want.”

I’m including this because the headline here seemed to indicate no CGM makes a difference, but this study only looked at two.

https://www.healio.com/news/endocrinology/20260401/switching-cgm-sensors-does-not-impact-glycemic-outcomes-with-automated-insulin-delivery

 

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Vitamin D supplementation may help delay or prevent disease progression in people with prediabetes.. in people who have specific variants in their vitamin D receptor gene. This was found after a second look at large study where researchers found vitamin d really did make a difference.. a second look with people who had a specific gene variation had much better results.

“More research is needed to see if there are other factors that are associated with risk reduction.”

https://www.medicalnewstoday.com/articles/vitamin-d-supplements-help-prevent-type-2-diabetes-right-gene-variants

 

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Senseonics (Nasdaq:SENS) announced today that it initiated the first European launch of its Eversense 365 continuous glucose monitor (CGM).

The launch comes a few months after the company picked up CE mark for the long-term, implantable CGM in January.

Eversense 365 is the world’s first 365-day CGM system. It also holds clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems, like the Sequel Med Tech twiist system.

The company said it made Eversense 365 available to the first patients in Sweden. It plans to bring the sensor to Germany, Spain and Italy in the coming weeks

https://www.drugdeliverybusiness.com/senseonics-launches-eversense-365-europe/

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A machine learning model can improve genetic prediction of type 1 diabetes by as much as 10%, show results from a University of California, San Diego study.

 

The researchers used the machine‑learning model T1GRS to improve on a gold standard polygenic genetic risk score used to predict who is likely to develop the condition called GRS2.

The GRS2 polygenic risk score has been widely tested and can be used to predict newborns who are at high risk of developing type 1 diabetes. While early prediction can’t necessarily stop the disease it can help to prevent emergencies like diabetic ketoacidosis at diagnosis, allow families time to prepare and could allow use of therapies to delay onset of the condition.

In this study, Gaulton and colleagues carried out a genome‑wide association study in 20,355 people with type 1 diabetes and 797,363 non‑diabetic Europeans, as well as a further analysis around the MHC region in 10,107 diabetic and 19,639 nondiabetic individuals.

https://www.insideprecisionmedicine.com/topics/molecular-dx/machine-learning-tool-helps-improve-type-1-diabetes-prediction/

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Sen. Mark Warner (D-Va.) said Monday that he will return to the upper chamber this week after taking time off for the death of his daughter, Madison.

 

The Virginia senator wrote on the social platform X, “As we remember our incredible daughter, Maddy, my family has been deeply touched by the outpouring of support we’ve received. Thank you to everyone for your kind words.” Madison Warner, 36, died earlier this month after a decades-long battle with juvenile diabetes and other health issues. Mark Warner and his wife, Lisa Collis, wrote in a statement last Monday that they were “heartbroken beyond words” by their daughter’s passing.

 

On Monday, the former Virginia governor said his daughter “was a deeply empathetic and engaged person” and that “as recently as the day she passed, she was full of ideas and suggestions” for him, including how he could improve his social media presence.

 

“She used to say to me: ‘Dad, you have the power — you have to use it.’ She pushed me to make the most of my position, to use my seat in the Senate to help people in meaningful ways,” he added.

 

 

 

“If I can find any solace during this time, it’s that I have the enormous privilege to serve Virginians and the responsibility to keep working for a better, more just world in Maddy’s name.”

 

Warner concluded, “I look forward to returning to the Senate this week and continuing that essential work.”

 

Madison Warner is survived by two younger sisters.

 

 

An estimated than 2.1 million Americans, including about 314,000 children and adolescents younger than age 20, have diagnosed type 1 diabetes as of March — which is what juvenile diabetes is commonly called — according to the CDC’s National Diabetes Statistics Report.

 

An estimated 11 million U.S. adults have undiagnosed diabetes, the report notes.

 

Symptoms of type 1 diabetes include feeling more thirsty than usual, urinating a lot, bed-wetting in children who have never done so, feeling very hungry and losing weight without trying, according to the Mayo Clinic.

https://thehill.com/homenews/senate/5851605-mark-warner-diabetes-death/

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Mattel, Inc. and Breakthrough T1D just won a Gold Halo Award for Best Cause Product Initiative for the launch of the first Barbie with T1D.

 The Halo Awards recognize the most outstanding corporate social impact efforts over the past year.