In the News... Vertex buys Viacyte, Tandem mobile bolus begins roll out, a One Drop sensor and more!

Top stories in this news this week: Stem cell research Vertex company buys Viacyte, another company looking at stem cells for a functional cure for T1D, some tslim users are getting access to Tandem's new mobile bolus feature, One Drop shows a "health sensor" on its website, a study shows that screening for type 1 at very young ages could help detect most cases 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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Our top story this week, Vertex buys Viacyte! For context, Vertex is the company that got all the headlines last fall – big article in the New York Times for a stem cell therapy that brought one person with type 1 off insulin completely. The FDA put them on hold but lifted that just last week. Vertex previously acquired Dr. Doug Melton's Semma.
Viactye is the company featured in the documentary "The Human Trial" - they're using CRISPR technology to keep the body from rejecting their stem cells. Both companies technology does NOT require immunosuppressive drugs and both say they are working toward a functional cure. Some experts are saying this will speed up that effort while critics worry that it eliminates the competitive aspect of the race. Sernova is still one separate company that has shown stem cell therapy can work.. I’ve got requests out to Viacyte to talk to us about all of this, so stay tuned.
https://investors.vrtx.com/news-releases/news-release-details/vertex-acquire-viacyte-goal-accelerating-its-potentially?fbclid=IwAR15qlFSBsBR89blzXymyIGL3tW5C64QtdHpwq7a5fdjmv2q6JmfoTIpm-k
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If we widely screened kids for type 1 at certain ages, a new study suggests, it would identify most of those who go on to develop it by their teen years. These researchers looked at screening for the type 1 autoantibodies at ages 2 and 6. This included nearly 25-thousand children from Europe and US. One issue in this study, funded by JDRF, all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher. It also included almost exclusively kids of northern European ancestry.
https://www.medscape.com/viewarticle/976992
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Tandem bolus by phone is slowly rolling out. This week, the T:Connect app was updated in the The t:connect app was updated and emails started arriving for those notified they were part of the early release groups. I did see some reports of people not yet getting the email but seeing the update in their portal so be sure and check. Mobile Bolus is reportedly available for those using Control IQ and Basal IQ. It’s worth noting that for those outside the US there really is no timeline, but Tandem has previously said they’re going to replace t:connect with a new system that will debut outside the US first. By the way, I got my email this morning, but Benny is still at camp for three more weeks so it'll be a bit before we do the update!
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Interesting look at teens and young adults with type 1.. the early morning psychosocial state may explain a proportion of their daily variance in time in range. The study included 88 participants aged between 14 and 26 years, 56-percent of whom were women. This is tough to quantify but they had the participants complete an engagement prediction survey and set a diabetes management goal for the day when they woke up, and also completed an evening survey. These questions were about mood, motivation, control beliefs, social support, stress, general health, self-esteem, and perceived need for assistance.

Of note, lower morning glucose levels correlated with measures of good sleep, high motivation, and good health, whereas higher morning glucose levels were associated with illness and feeling the need for support.
https://www.medwirenews.com/diabetes/morning-mindset-daily-glucose-fluctuations-young-people-diabetes/23255450
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Good catch by our friend Nerdabetic over on Twitter.. One Drop plans to enter what they’re calling the continuous health sensing market with a daily disposable, minimally invasive biosensor in development. They say this is designed to provide greater flexibility and insights for people living with diabetes compared to blood glucose monitor (BGM) fingersticks alone. The availability of our continuous health sensor is subject to receipt of clearance or approval from the U.S. Food and Drug Administration. Pending regulatory approval and commercial adoption, we believe integrating the One Drop health sensor with our existing digital solution, One Drop Premium, should augment proven outcomes and yearly cost savings for members living with diabetes and other chronic conditions.
https://onedrop.today/blogs/blog/bgm-vs-cgm?utm_source=twitter&utm_medium=social-organic&utm_campaign=social-campaign_jul-2022&utm_content=blog
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Navitus Health Solutions, which is owned by Costco & SSM Health – has joined CivicaScript as a founding member. CivicaScript was created in 2020 to bring affordable versions of common but high-priced generic medicines to market. Earlier this year they announced they would be adding insulin to that list, but it likely won’t be available for at least two years. This partnership would seem to insure the lower cost insulin will be available at Costco pharmacies, which you don’t have to have a membership to use.

https://www.businesswire.com/news/home/20220713005349/en/Navitus-Health-Solutions-Joins-CivicaScriptTM-to-Further-Availability-of-Lower-Cost-Generic-Medications/?fbclid=IwAR0vBF0YlCo9ZJ-9Yd0nLag_Mjuf8s4YpnR9IJVudvVGDR1Rj508HSd_kXw
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Right back to the news in a moment but first As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It’s a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. 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. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy Sign up at T1DExchange.org slash Stacey (that’s S-T-A-C-E-Y).
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The Food and Drug Administration received more than a thousand comments—mainly from diabetes patients and their family members—in response to draft cybersecurity guidance. These are for staff to use when processing submissions from medical-device manufacturers.

“Please do not let medical device manufacturers use cybersecurity as a pretense to prevent me from accessing my OWN devices,” reads one entry from a sample of the comments FDA posted to the docket on the guidance.

Howard Look, CEO of Tidepool is quoted in some of the article around this. Tidepool provides software that allows patients to see their data and better manage the disease. And supporters are working to make Tidepool Loop the first FDA approved app for more convenient automated insulin delivery.
“Following best practices for cybersecurity does not need to imply blocking patient users from accessing their own data or controlling their own devices,” the comments read. “Tidepool asserts there is a risk that the FDA guidance will be interpreted or misinterpreted to suggest restriction of access by the patient user is appropriate or encouraged. The FDA can mitigate this risk by clearly stating a patient user’s access to and use of their own device can be considered authorized access, and should not be considered a cybersecurity threat.”
With a 90-day public comment period ending Thursday, the FDA will now begin the process of finalizing cybersecurity guidance for its pre-market submissions, according to a notice in the Federal Register.

https://www.nextgov.com/cybersecurity/2022/07/diabetes-patients-flood-fda-comments-cybersecurity-medical-devices/374020/
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Congrats to the team over at Divabetic Podcast – which celebrates 12 years this month! Divabetic was inspired by the late R&B legend, Luther Vandross, and founded in 2005 by his long-time assistant, Max “Mr. Divabetic” Szadek. It’s now a national nonprofit organization that uses highly engaged, non-traditional virtual programs, videos and podcasts to promote prevention, early action and education. Congrats to Max and the entire team!
https://divabetic.org/about-us/
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Next week you’ll hear from the folks at Diabetes Wise – that’s a website to help you choose diabetes technology.. they’ve added information for doctors – this may help you educate your heathcare providers on why you want the pump or cgm system that you do.. the long format episode out right now is all about campviews, a new system that lets diabetes camps see every camper’s CGM all at once.
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.