[Diabetes-Talk] Fwd: Recent FDA approvals you should know about!

Patricia Maddix pmaddix at comcast.net
Thu Aug 25 18:18:47 UTC 2022


See below the forwarded message regarding four of the diabetes related devices that have received FDA approval in just the last eight months. Things in the diabetes field are moving at lightning speed and it is very exciting.
Patricia



Sent from my iPhone

Begin forwarded message:

> From: "Sanjoy Dutta, Ph.D., Chief Scientific Officer, JDRF" <Communications at content.jdrf.org>
> Date: August 25, 2022 at 10:48:16 AM PDT
> To: pmaddix at comcast.net
> Subject: Recent FDA approvals you should know about!
> Reply-To: "Sanjoy Dutta, Ph.D., Chief Scientific Officer, JDRF" <reply-fec5177375620c7b-664_HTML-14380484-514009018-25009 at content.jdrf.org>
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> Hey there JDRF Community,
> 
> We’ve been making incredible progress in our research for type 1 diabetes (T1D) treatment and cures, and today we’re sharing a roundup of exciting recent U.S. Food and Drug Administration (FDA) decisions and what they mean for our community. When a therapy receives FDA authorization, it is the culmination of years of work—from an initial idea to securing funding, conducting research and clinical trials, and applying for authorization—so we want to celebrate these approvals with you, as these advances will help improve the lives of people with T1D, and thank you for all you do to advance T1D research and advocacy through JDRF. Only a select few receive FDA authorizations—that makes it all the more special!
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> Thanks to dedicated supporters like you, JDRF is able to fund groundbreaking studies and the development of new therapies and technologies that improve the lives of individuals with T1D, no matter their age or race or ethnicity. We’re grateful to have you moving our work forward and moving us closer to a world without this disease.
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> Without further ado, here’s the good news for our community coming out of the FDA:​
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> A Fourth Artificial Pancreas System
> The Insulet Omnipod​ 5® is the world’s first tubeless, wearable artificial pancreas system authorized by the FDA for individuals ages 2 and older. A group of JDRF-funded researchers created an algorithm, which was eventually licensed by Insulet Corporation that led to the development of Omnipod 5. JDRF started the Artificial Pancreas Project over 15 years ago to ensure people with T1D have better, more innovative ways to manage their T1D until there are cures.
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> Bolus Insulin Dose from Your Smartphone
> This past spring, Tandem Diabetes announced the FDA clearance of bolus insulin dosing from their t:connect® mobile app. This means individuals with the Tandem t:slim X2™ pump will be able to administer their bolus remotely from their smartphone—a game changer for those who keep their insulin pump in hard-to-reach places. Throughout the years, JDRF has tirelessly supported research to develop better therapies that make it easier for people to manage their T1D.
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> New Continuous Glucose Monitoring Technology
> In May, the FDA cleared the Abbott FreeStyle Libre® 3 continuous glucose monitor (CGM) for people ages 4 and up—adding another option for personal monitoring devices. CGM technology has revolutionized the treatment and management of T1D. JDRF has played a pivotal role in the development of CGM technology—including funding a landmark study in 2008 that demonstrated its benefits.
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> Advances in Long-Term Implantable CGM
> Early this year, the FDA approved Senseonics Eversense® E3, the first long-term implantable CGM system with new enhancements that extends its use for up to 6 months. This approval gives people with T1D another way to reap the benefits of CGM technology. JDRF funded the development of an early Senseonics prototype, which later advanced into the Eversense technology we know today!
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> JDRF will continue to monitor the field and push for meaningful technological advancements—and we won’t ever stop fighting for affordability, choice, coverage, and cures on our path to a world without T1D.
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> If you’re able to make a donation today, you can help fund the next breakthrough in treatments and cures.
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> Thank you for all you do,
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> Sanjoy Dutta, Ph.D.
> Chief Scientific Officer, JDRF
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> Donate
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