In the News... Teplizumab approved, Twitter mess for Lilly, Medtronic 7-day infusion set launches, and more!

It’s in the News.. the top diabetes stories of the past seven days. This week, the first drug to prevent T1D for any length of time is approved, Eli Lilly takes a financial hit from a Twitter impersonation stunt, Medtronic's 7-day pump infusion set is ready for consumers, Dexcom's G7 gets great reviews from older folks and educators for ease of use, a new study about light at night and diabetes and more!

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population.
https://t1dexchange.org/stacey/
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And by my new book “Still The World's Worst Diabetes Mom: More Real Life Stories of Parenting a Child With Type 1 Diabetes” available on Amazon in paperback and for kindle.
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Our top story  this week, the US U.S. Food and Drug Administration approves teplizumab, the first drug to delay the onset of type 1 diabets. We’ve been following this for a long time and I’ll ink up our previous interviews with Provention Bio, the company that makes it. The brand name will be Tzield (teplizumab-mzwv) and it’s an injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

 

Tzield is administered by intravenous infusion once daily for 14 consecutive days. Lots of questions here and we’ll follow up with an interview and more as soon as I can.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes

https://diabetes-connections.com/delaying-a-t1d-diagnosis-the-fda-considers-teplizumab/

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Our top story this week – the kerfuffle over on Twitter where a couple of accounts spoofed Ely Lilly. The insulin makers stock tanked 6% over just one day late last week, wiping billions of dollars from its market cap. On Nov.10, someone pretending to be Lilly’s corporate account tweeted: “We are excited to announced insulin is free now.” You may know that Twitter under new owner Elon Musk was verifying any account with any name for just 8-dollars. Another verified but fake Lilly account tweeted profanities and taunted people who use insulin with higher pricing, again, also fake. Other major insulin makers Sanofi and Novo Nordisk were also caught up in the crossfire, with their stock prices dipping and questions over the high cost of insulin back in the headlines.
In the understatement of the year, Lilly CEO David Ricks said – quote – “it probably highlights that we have more work to do to bring down the cost of insulin for more people”
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Mice with diabetes appeared cured after transplantation of insulin-secreting pancreatic islet cells, according to a Stanford Medicine study. The animals’ immune systems were coaxed to accept the donated cells prior to transplantation through a three-pronged process that could be easily replicated in humans, the researchers said. No immune-suppressing treatments were necessary after the transplant to prevent rejection of the foreign islet cells. The technique, which builds on earlier work at Stanford Medicine, may open the door to a new type of organ transplant that doesn’t require an immunologically matched donor or years on immune-suppressing medication. The difference here is that they do two transplants.. first doing a partial blood stem cell transplant which makes the new pancreas cells recognized as the body’s own and less likely to be rejected. Long way to go here, but promising idea.
https://med.stanford.edu/news/all-news/2022/11/islet-transplant-diabetes.html
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The first and only 7-day infusion set is ready to go.. after approval more than a year ago – in September of 2021, Medtronic says customers can now order the Medtronic Extended for the 600 and 700 series pumps.

In clinical studies of the Medtronic Extended infusion set, study participants observed a decrease in the number of times an infusion set needed to be changed by 50% and the number of infusion set failures associated with high glucose levels was lowered.3,4 Study participants using the Medtronic Extended infusion set commented on the new infusion set being more comfortable to wear compared to their previous infusion sets and were happy with the longer wear feature in helping reduce the overall burden of insulin pump therapy.3,4

Additionally, use of the Medtronic Extended infusion set is estimated to result in annual costs savings of insulin of up to 25% due to a reduced number of infusion set and reservoir changes that result in unrecoverable insulin, as well as plastic waste reduction of up to 50%.
https://www.prnewswire.com/news-releases/medtronic-launches-worlds-first-and-only-infusion-set-for-insulin-pumps-that-doubles-wear-time-up-to-7-days-in-us-301677790.html
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Recall for omnipod. This is an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. No serious injuries have been reported, but insulet has received reports tht the omnipod 5 controller chargting port or cable is discoloring or even melting due to excess heat. Customers are instructed to called insulet or login to an fda site. I’ll link up all of that info in the show notes.
at 1-800-6).
Additional informati41-2049, which is available 24 hours a day, 7 days a week. Alternatively, Omnipod 5 users can utilize the FDA’s MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htmExternal Link Disclaimer), by regular mail, or by fax (1-800-FDA-0178on, including instructions to customers to mitigate risk, can be found on the Company’s website at www.omnipod.com/insulet-alertsExternal Link Disclaimer.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller
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Small study shows that using the Dexcom G7 is easier for older adults to insert and use. Results indicate that G7 CGM system required half as many steps to set up and deploy as the G6 system, with the system’s system usability scale survey scores indicating excellent usability.
The current study was launched to better understand ease of use and task burden of uptake of Dexcom’s G7 CGM system. To do so, investigators designed their study as a formal task analysis with the intent of identifying the number and complexity of tasks associated with deployment of the G7 CGM system compared to the fifth- and sixth-generation systems in adults aged 65 years or older. A cohort of 10 older adults with no prior CGM experience and 10 CDCESs were recruited for inclusion in the investigators’ formal task analysis. This analysis assessed ease of use among CDCESs through a survey after hands-on insertion and initiation of the system. For older adults in the study, ease of use was assessed using system usability scale (SUS) survey scores.

In the post-test survey and SUS survey given to older adults, no responses lower than neutral were recorded and the SUS score for setup and insertion of the G7 system was 92.8, which investigators noted was reflective of an excellent usability rating.
https://www.endocrinologynetwork.com/view/study-finds-dexcom-g7-set-up-is-easier-requires-fewer-tasks-for-older-adults-than-previous-generations
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Control IQ for people with type 2 works well and is safe. New study from Tandem Diabetes Care shows people with type 2 spent 3.6 hours a day long in target range after switching to the tslim x2 pump / Dexcom system from multiple daily injections or basal insulin only
https://www.medtechdive.com/news/tandem-pump-dexcom-CGM-Type-2-diabetes/636448/
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New program from Walgreens to help give more people access to information and diabetes services. Walgreens is teaming up with its Health Corners and third-party clinics to offer free A1C and blood glucose testing and diabetes education during November, Diabetes Awareness Month. For participating locations, visit Walgreens.com/FreeDiabetesScreening and I’ll link that up. Walgreen is the largest provider of continuous glucose monitors including the Dexcom G6 and FreeStyle Libre 2 which track glucose levels all day and night – fewer finger sticks required.

7. Affordable care options and tools including Walgreens Prescription Savings Club and Find Rx Coverage which offer insulin savings programs and affordable, predictable copayments on select insulins. Walgreens Find Care provides access to in-person and virtual healthcare expertise from the comfort of one’s home.
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Sleeping in a room exposed to outdoor artificial light at night may increase the risk of developing diabetes, according to a huge study of nearly 100,000 Chinese adults.
People who lived in areas of China with high light pollution at night were about 28% more likely to develop diabetes than people who lived in the least polluted areas.
We told you about a study published earlier this year that showed Sleeping for only one night with a dim light, such as a TV set with the sound off, raised the blood sugar and heart rate of the young people during the sleep lab experiment.
These researchers caution that any direct link between diabetes and nighttime light pollution is still unclear, however, because living in an urban area is itself a known contributor to the development of diabetes

https://www.cnn.com/2022/11/14/health/night-light-pollution-diabetes-sleep-wellness/index.html

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Researchers are recruiting 20,000 children for a trial to try to identify those at high risk of developing type 1 diabetes.

If left undiagnosed or untreated, the condition can lead to life-threatening complications.

The trial, led by the University of Birmingham, could mean access to new treatments for children at high risk.

The researchers say it may also offer insights that could make screening for type 1 diabetes a possibility.

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Type 1 diabetes is an autoimmune condition where the immune system attacks and destroys cells in the pancreas which produce insulin.

Insulin is crucial because it moves energy from food from the blood to the cells of the body - without it, the body cannot function properly.

Approximately 29,000 children in the UK currently have type 1 diabetes, out of a total of about 400,000 people. For them, managing the condition involves injecting insulin and testing blood glucose levels regularly.

The condition is very different to type 2 diabetes, which is often linked to poor diet or an unhealthy lifestyle.

The organisers want children aged three to 13 to sign up for the trial, which will analyse their blood - through finger prick and vein tests - for autoantibodies.

These are linked to the development of type 1 diabetes. Those with two or more autoantibodies have an 85% chance of having the condition within 15 years, and are almost certain to develop it in their lifetime.

'A simple test could have saved my son'
Parth Narendran, professor of diabetes medicine, and Dr Lauren Quinn, clinical research fellow at the University of Birmingham, said there was a need to explore if screening children for type 1 diabetes in the UK would be possible in the UK.

"Screening children can reduce their risk of DKA (diabetic ketoacidosis) at diagnosis around fivefold and can help them and their families settle into the type 1 diagnosis better," they said.

DKA is a life-threatening complication of type 1 which can occur when diagnosis does not happen quickly.

Rachel Connor, director of research partnerships at JDRF UK, which is co-funding the study, said new drugs that target the immune system were progressing through trials.

"We are demonstrating that it is possible to delay the need for intensive insulin treatment in those most at risk. When these drugs become available in the UK, we need to be ready to use them straight away," she said.

Dr Elizabeth Robertson, from Diabetes UK, which also funded the study, said: "Extra years without the condition means a childhood no longer lived on a knife-edge of blood sugar checks and insulin injections, free from the relentlessness and emotional burden of type 1 diabetes."
https://www.bbc.com/news/health-63622084
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New study on pancreas transplants. These researchers say Up to 90% of people who received a pancreas transplant enjoy freedom from insulin therapy and the need for close glucose monitoring. Biggest drawback is having to take immunosuppressants for the rest of their life. The number of pancreas transplants has declined in recent years. New paper this week in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Another downside is that this isn’t a long-term cure.. the paper says the median graft survival is around eight years and the transplanted pancreas does not always work well, so the patient might not be completely insulin-free. However, I do believe that the combined kidney/pancreas transplant should be considered for all patients with type 1 diabetes with an indication for a kidney transplant.”

https://www.healthline.com/health-news/type-1-diabetes-the-benefits-and-limitations-of-a-pancreas-transplant
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Medtrnoic sending emails out regarding the CareLink™ Software outages. .
For most of our customers, we were able to resolve the issue relatively quickly through an application fix that took effect when individuals logged out and then logged back into their CareLink™ accounts (reminder of these recommended actions available here). But we know this was not the experience for all, and for some of you the experience was extremely frustrating and lasted longer. Medtnoic is still working to resolve the issue for some customers. They stress this was not because of a security breach but don’t give further details.
https://app.medtronicdib.mdtpatient.com/e/es?s=357929245&e=822474&elqTrackId=b0ce7494b5bd47ad9b9c672c71086a1c&elq=3155b86a3ca045f0a2e27c182f392387&elqaid=7514&elqat=1&fbclid=IwAR1XYIdfEFpkUrdk-yTk6WKSvlsdncJBNrSy_OpdeuJhHXD2zi78WnxaSG8
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Women with polycystic ovary syndrome (PCOS) were found to be at higher risk for developing type 2 diabetes over a 30-year period, according to new research presented at the 2022 American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo, and described in an article at Healio.

PCOS is a hormonal disorder that causes enlarged ovaries containing small fluid-filled sacs, and it can have painful symptoms. Hormonal changes related to PCOS can also have effects throughout the body — including effects related to diabetes. One study estimated that nearly one in five adolescent girls with type 2 diabetes also has PCOS, although the nature of the link between PCOS and diabetes is still not fully understood. Many scientists believe, though, that insulin resistance — when tissues in the body become less sensitive to insulin, which is a large part of the disease process in type 2 diabetes — also plays a role in the development of PCOS. There is also evidence that correcting the hormonal imbalances seen in PCOS may reduce the risk of developing type 2 diabetes. A recent study showed that taking oral birth control pills as a treatment for PCOS reduced the risk for type 2 diabetes.
https://www.diabetesselfmanagement.com/news-research/2022/11/16/polycystic-ovary-syndrome-linked-to-higher-risk-for-type-2-diabetes/
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Back to the news in a moment but first..
The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
The registry is now available on the T1D Exchange website and is simple to navigate, mobile and user-friendly. For more information or to register, go to www.t1dregistry.org/stacey
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SAFE TRAVELS to all en route to San Francisco for the Fall 2022 #Diabetes Mine #Innovation Days. Can't wait to see u all in person! Nov 17 and 18
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On the podcast next week.. My daughter Lea talks about siblings and type 1. Last week was all about Eversense E3 and the future of long-term CGM sensors.
Listen wherever you get your podcasts
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.