In the News... Insulin copay cap revived? G7 timeline pushed back, once weekly basal insulin and more!

Get caught up on the news and headlines around the diabetes community! The top stories in the last seven days: Senate Republicans nixed an insulin copay cap, but Democrats say they will revisit this issue in a few weeks, Dexcom pushed back their G7 timeline in the USA after the FDA asks for changes, once weekly basal insulin moves forward in trials. Plus, Beyond Type 1 is back in the NYC Marathon and much 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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The copay cap on insulin may come back before the Senate in a few weeks. Senate Majority Leader Charles Schumer say he’ll bring tht issue back up.. after Republicans blocked it in a sweeping climate, inflation and health care package passed by the Senate on Monday. Speaking on MSNBC’s “The Rachel Maddow Show.” Schumer said, “We’re going to come back and make them vote on that again.” Seven Republicans still voted with all 50 Democrats, three short of the 60 votes needed, and it is possible more Republicans would support it if it came up as a standalone measure. It’s not clear if this would again be a copay cap or in fact a cap on the actual price of insulin for all, including the uninsured.
https://thehill.com/policy/healthcare/3594003-schumer-senate-will-vote-again-on-35-insulin-cap-after-gop-blocked-it/

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Dexcom is pushing back the timeline for a U.S. launch the G7. That’s after the FDA raised questions about the device’s software during a review. This has something to do with how the G7 and it’s smartphone apps deliver alarms to users. Looks like maybe a limited release in the 4th quarter of this year and full rollout in 2023 if there aren’t any other hiccups. As you likely know, the G7 is nearly 60-percent smaller than the G6, it’s transmitter and sensor all in one and has a much shorter warmup period. It’s been approved in Europe since March.

https://www.fiercebiotech.com/medtech/dexcom-resubmit-g7-glucose-monitor-software-fda-review-pushing-back-us-launch
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One type of once-a-week basal insulin gets the go ahead to move forward with clinical trials in the US. Gan & Lee Pharmaceuticals says it’s investigation drug called GZR4 is more stable with less day to day variation than once a day basal insulin. There are a few of these weekly insulins in trials, none yet approved. Gan & Lee is also doing trials of the drug in China where they are already a big player in the insulin market.
https://www.ganlee.com/detail/668.html
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Good news for Senseonics, makers of the Eversense implantable CGM. Shares were up on second quarter earnings and future expectations. I don’t generally report on stock market moves of diabetes companies, but the past few years have been a bit iffy for Senseonics and there was speculation on whether this CGM option might not be available in the US. They partnered with Ascensia Diabetes Care and got the six month approval for Eversense earlier this year.
https://www.massdevice.com/senseonics-stock-q2-2022/
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A new call for comments to the FDA but the deadline is TODAY august 15 at midnight eastern time. I’m going to read directly from a post by Joanne Milo in the CGM in the Cloud off topic group. Joanne’s been a guest of the show and leads the loop and learn group – she writes. “We have until August 15, 2022 to provide comments on FDA changes to the way CGM display and alarm systems are regulated. This has implications for remote monitoring and automated insulin delivery systems, both commercial and DIY.
We request your assistance in helping the FDA and device providers (FDA considers software for treatment of disease to be a device) understand the benefits of real-time CGM access and the risks we carry by not having ubiquitous real-time access to our diabetes device data.
We hope you will choose to spend a moment to add your voice to the #WeAreNotWaiting chorus.
They provide some text which I’ll link up in the show notes as well as the links to this post and the FDA comment portal.
https://www.regulations.gov/commenton/FDA-2018-N-1910-0047?fbclid=IwAR2WAtGl3vjTUonamNdlBtAu_pg2-xQOVy8bSqG2peLCUz2eq8R8OgLqtHQ
https://www.facebook.com/groups/CGMITCOFFTOPIC
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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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Team of 50 individuals living with type 1 diabetes will raise awareness and funds for their chronic illness

SAN MATEO, Calif., (Aug. 3, 2022) – Going the extra mile this year, global diabetes nonprofit Beyond Type 1 was named an Official Charity Partner for the 2022 TCS New York City Marathon, taking place on November 6. Beyond Type 1 will be among the 500 official charity partners providing thousands of runners the opportunity to run in the world’s most popular marathon.

This year’s Beyond Type Run team includes nearly 50 runners across the United States, Canada, Ecuador and Australia, who are raising awareness and funds for type 1 diabetes as ambassadors for Beyond Type 1, showcasing how they live beyond their diagnoses and supporting crucial efforts and programs for others affected by this condition. First-time Marathon Runner Kyle Banks, known for his tour with the Broadway cast of The Lion King, is the team captain.

“The Beyond Type Run team displays the ultimate resilience and strength as they run the marathon. If it weren’t for the team jerseys or the technology attached to their bodies, you’d never know they were living with a chronic illness,” said Beyond Type 1 CEO Deborah Dugan. “We are grateful to them for helping us raise awareness, and we thank all of our sponsors for their generous support and donations to the team.”

Since 2017, Beyond Type 1 has had roughly 150 people with type 1 diabetes run the TCS New York City Marathon through the New York Road Runners (NYRR) Official Charity Partner Program.

“The TCS New York City Marathon serves as one of the world’s largest fundraising platforms supporting hundreds of charities and philanthropic efforts,” said Christine Burke, Senior VP of Strategic Partnerships, NYRR. “We are very proud to support Beyond Type 1 and the incredible impact they have made to the diabetes community as they raise important funds to support people with diabetes.”

The NYRR Official Charity Partner Program offers an opportunity for nonprofit organizations to raise funds to support their missions and services. Participating charities can offer guaranteed entry to runners who fundraise on their behalf.

Since its inception in 2006, the TCS New York City Marathon Official Charity Partner Program has raised more than $400 million for more than 1,000 worthy nonprofit organizations across the globe. Prior to the start of the official program, the New York City Marathon had served as an outlet for individual philanthropic runners since the 1980s.

https://beyondtype1.org/beyond-type-1-nyc-marathon-2022/
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Morgan Shepard book Morgan Shepherd
So happy to announce my book “ T1D Looks Like Us! A Type 1 Diabetes Story” is now available to order! I am so excited to share this piece of my heart with you ❤️ Rose was diagnosed with Type 1 Diabetes (T1D) when she was seven years old. Now she is nine and at times feels lonely because she doesn't know any other kids with T1D. With help from her mom, Rose meets people from all over the world who also live with T1D and have their own unique stories to share!

This book is intended to spark conversations about empathy, differences, and self-compassion. Through the text children will learn not only about Type 1 Diabetes but also about the diversity of people who are living bravely with T1D. The book is perfect for newly diagnosed children, siblings, and classrooms that have a student living with T1D.
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Next week I’m talking to the folks at Patients For Affordable Drugs about the bill that passed the Senate this week. The insulin copay cap was removed, but what does it really mean for medication prices? The episode out right now is our special 500th episode where I’m interviewed by news anchor Cristina Frank, who hosts the morning show at WMTW in Maine lives with type 1.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.