In the News... Hurricane aid, Medtronic recall, Mounjaro supply update, stem cell T1D success... and more!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Hurricane aid for people with diabetes, Medtronic safety warning, stem cell updates for type 1, new study about teens and young adults with type 1, and Ryan Reed returns to racing.

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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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Hurricane Insulin efforts

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Medtronic has notified customers that battery issues with its Minimed 600 and 700 series insulin pumps could cause the devices to stop delivering insulin significantly sooner than expected.

A “low battery pump” alert, intended to signal up to 10 hours of remaining battery life, may be displayed on the device even if much less time is left. Medtronic told customers they could contact the company to determine the need for a replacement pump.

Medtronic said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S., from January 2023 to September 2024, potentially related to the issue.

Pump models including the Minimed 630G, 670G, 770G and 780G systems are affected by the notice.

https://www.medtechdive.com/news/Medtronic-Minimed-insulin-pumps-recall-battery-life/729019/

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A woman has undergone a stem-cell therapy made from her own cells, to treat her type 1 diabetes.

Researchers in China discovered the woman did not need to use insulin 75 days after the procedure, and that the stem-cell derived islet cells she was injected with had been engrafted inside her abdomen.

the case is the first of its kind, and two more people have been enrolled in the clinical trial in China since, researchers involved in the study told Medical News Today.

Other stem-cell based therapies for type 1 and type 2 diabetes are also currently in development and in trials.

For this case study, researchers based in Tianjin First Central Hospital, Nankai University, Tianjin, China took fat cells from a 25 year-old woman with type 1 diabetes, and chemically induced them to behave as pluripotent stem cells, a type of cell that can develop into other types of cell.

They then used these to create islet cells, which typically exist in the pancreas and create insulin, a hormone that regulates levels of glucose (sugar) in the bloodstream.

The patient in this case study had previously had two liver transplants and a failed pancreas transplant due to complications that had arisen due to her diabetes.

The induced islet cells made from the patient’s own cells were then injected between the skin and abdominal muscles. Researchers discovered that these successfully engrafted in the patient, including growing their own vasculature.

Before the procedure she produced enough insulin to reach her target glycemic range 43.18% of the time, and 4 months later this increased to 96.2% of the time. She was also shown to have lower glycated hemoglobin, which indicated long-term systemic glucose levels at a non-diabetic level.

 

https://www.medicalnewstoday.com/articles/stem-cell-therapy-reverses-type-1-diabetes-in-groundbreaking-case-study

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The state of Texas is accusing major pharmacy benefit managers and drug companies of colluding to raise the cost of insulin.

 

Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs Optum Rx, Express Scripts and CVS Caremark through a quid pro quo agreement.

PBMs then give preferred status on its standard formularies to drugs with the highest list prices, the state said.

Insulin costs $2 to produce and could be purchased for $20 in the 1990s but now costs up to $700, the Office of the Attorney General of Texas wrote in a news release.

The filing goes so far as to describe a LinkedIn group these executives would use to discuss insulin pricing tactics.

The Federal Trade Commission (FTC) recently sued Optum Rx, Express Scripts and Caremark for rising insulin prices and anticompetitive practices. The PBMs reject the FTC’s findings. Drug manufacturers were not included in the lawsuit.

Texas’ lawsuit also noted the consolidation in the PBM market, arguing it gives PBMs a “disproportionate amount of market power.” Nearly 40 PBM entities have now been consumed by UnitedHealth Group, Cigna and CVS Caremark.

https://www.fiercehealthcare.com/payers/texas-sues-pbms-manufacturers-over-insulin-conspiracy

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Canadian teens and young adults living with diabetes face double the risk of hospitalizations and emergency room visits compared with younger children with the condition, say doctors suggesting changes to how care is organized for affected families.

In the October issue of the journal The Lancet Diabetes and Endocrinology, Dr. Meranda Nakhla, a pediatric endocrinologist at the Montreal Children's Hospital, and her team used Quebec health administrative data to estimate the risk of gaps in regular diabetes care for complications in children under 10, and adults up to age 23.

 

"With adolescents and young adults, [the complication]  tends to be more related to an insulin omission and maybe just feeling burnt out from having diabetes and just not wanting to deal with it," Nakhla said. "They may stop taking insulin and a day later end up in the emergency room with diabetic ketoacidosis."

Part of the challenge, Nakhla said, is for parents to take a step back from managing all aspects of their child's diabetes to a more supportive role that allows the child to have more autonomy.

What's new about the Quebec findings is they highlight how gaps in diabetes care visits start at a younger age than previously looked at, said Dr. Rayzel Shulman, a pediatric endocrinologist at Toronto's Hospital for Sick Children.

Since the brains of adolescents and young adults aren't fully developed, planning ahead, thinking about the consequences of their actions and controlling impulses differs from their parents.

As part of an ongoing study, Shulman's team uses text messages to send adolescents and young adults appointment reminders as well as monthly diabetes messages. They recently added an artificial intelligence chat bot programmed with answers from trusted sources.

https://www.cbc.ca/news/health/diabetes-pediatric-1.7345526

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A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs.

 

On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lily, had a manufacturing capacity that “can meet the present and projected national demand.”

 

 

With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association (OFA) represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders.

 

The OFA and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the FDA on Monday, alleging the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”

 

“Ignoring evidence that the shortage persists, FDA removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” said their complaint.

 

The evidence that the plaintiffs cited for the shortage persisting was that the FDA noted in its announcement that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”

 

Eli Lilly made a similar statement after the shortage was declared over, saying, “Patients’ experiences looking for a particular dose of medicine in their local pharmacies may vary. The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. ”

https://thehill.com/policy/healthcare/4922234-trade-group-sues-fda-over-ending-mounjaro-zepbound-shortage/

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New project in Europe to provide data to enable more people with diabetes who use insulin to work as commercial pilots and air traffic controllers.

The European Union Aviation Safety Agency project focuses mainly on pilots and air traffic controllers, but the data being collected will apply to cabin crew and passengers with diabetes as well

 

currently only three countries in Europe — the United Kingdom, Ireland, and Austria — allow them to obtain a license that enables them to fly commercially, under a strict protocol that was first launched by the UK Civil Aviation Authority in 2012. The Irish Aviation Authority joined in 2015, and Austro Control followed in 2016.

 

 

https://www.medscape.com/viewarticle/eu-program-aims-ensure-safety-pilots-who-use-insulin-2024a1000ia6

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Edgepark commercial

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The two-time Xfinity Series winner was competing at Talladega in McAnally-Hilgeman Racing’s No. 91 truck for his first start of the season. The last time Reed drove in a NASCAR event came last fall at Las Vegas Motor Speedway in the Xfinity Series, and his most recent Truck start came in the spring of 2021 at Darlington Raceway.

 

“I couldn’t stop making mistakes early on,” Reed said. “The truck was so fast. I think more than anything I’m really proud of myself for being able to get out there and make aggressive pushes and be able to kind of rise to the occasion.”

 

See also

Grant Enfinger Wins Talladega, Advances to Championship 4

Despite the speed, Reed’s truck burst into flames shortly after crossing the finish line. Reed said he stared at the door of teammate Christian Eckes while he crossed the line in the middle of a multi-truck pileup.

 

 

“Gosh, we could go anywhere we wanted today,” Reed told Frontstretch. “I made a lot of mistakes, but we put ourselves in position at the end. I hate that Bill [McAnally] has torn up race trucks.”

 

Friday marked Reed’s sixth start in the past six years in Truck and Xfinity equipment, something Reed said might have added some doubt.

 

“When you’re sitting on the couch every weekend, you think you can do it,” he reflected. “I remember I used to race every single weekend, I know how to get around these plate tracks, but you don’t know, right?

 

“It’s really gratifying to come off the couch and remind myself, like ‘hey I can still do this,’ at least at superspeedways. I think I can do it at other tracks too.”

 

 

The day ended in a combination of a career-best Truck Series finish and a ball of fire for Ryan Reed in his return to NASCAR Craftsman Truck Series competition on Friday (Oct. 4).

 

https://frontstretch.com/2024/10/04/ryan-reed-scores-career-best-finish-in-truck-series-return/

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