In the News... FDA hints on D-tech timeline, Libre 2 app approved, interchangeable insulin and more!

It's "In the News..." the only LIVE diabetes newscast! Top stories this week: FDA hints on 2021 D-tech timeline, the Freestyle Libre 2 app is approved, interchangeable insulin to cost less, an "astonishing" type 2 teen study and a big fall-off in use of metformin in people with type 2.

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This week I was on the road, at the Podcast Movement convention. Sorry about the setting! Back in the home studio next week.

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Episode Transcription below:

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.  I’m on the road – again! This time I’m at podcast movement a big convention going on in Nashville.. so apologies if the audio and video are a little bit off but I think we’re good enough. And As always, I’m going to link up my sources in the Facebook comments – where we are live – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more when you have the time.

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In the News is brought to you by Real Good Foods! Excited to have them back as a sponsor – we’re big fans. Real Food You Feel Good About Eating.

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Our top story this week… a brief comment about diabetes devices at the FDA might give a hint to some timelines we’re all watching. FDA Center for Devices and Radiological Health head Jeffrey Shuren says COVID-19 remains a source of uncertainty.

"Goal is to be back to normal as we roll into 2022," Shuren said. "But there are a lot of variables that could impact that… don't know if we'll get hit with another tsunami of submissions for full marketing authorization for a lot of the COVID products. Getting back on track, everything is moving for the diabetes submissions."

Products in front of the FDA expected by year’s end: Medtronic’s 780G and Zeus CGM, Insulet’s Omnipod 5, Tandem’s bolus by phone and it’s expected that Dexcom’s G7 will be submitted soon.

https://seekingalpha.com/news/3715640-fda-devices-head-says-progress-being-made-on-diabetes-devices-backlog

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The FDA did clear one diabetes product this past week.. Abott’s Freestyle Libre 2 iOS app. The Libre 2 hardware was approved last year.. this is the app for Apple phones.. it gives users optional real time high and low alarms – still have to scan to see the actual values. It updates every minute – only CGM that does – and it lets caregivers remotely monitor. Freestyle Libre 2 has a 14 day wear.. no exact date on when the App will be available or when it’ll be available for android users.

 

https://finance.yahoo.com/news/abbotts-freestyle-libre-2-ios-130000861.html

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Other side of the coin, Abbot will pay $160 million to resolve claims that two of its units submitted false claims to Medicare.

The Justice Department said free glucose monitors were provided to get patients to order more testing supplies, and the companies routinely waived copayments. They were also accused of charging Medicare for ineligible patients and for more than 200 patients who were actually dead.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-says-abbott-units-pay-160-mln-resolve-alleged-false-medicare-claims-2021-08-02/

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Back to the FDA.. for the first time, they’re allowing a less expensive brand name insulin to be substituted for the original. Semglee – approved last year – is basically the same as Lantus but it’s a lot less expensive. Semglee is now is the first-ever to earn the “interchangeable” designation Trusted Source, meaning it’s fully approved to be substituted for Lantus at the pharmacy. No need to get permission from the doctor.

This is the second copycat of Lantus; the first was Eli Lilly’s Basaglar, launched in 2016.

There is some new branding and labeling needed here, so expect a relaunch of Semglee by the end of this year.

FYI the pens are a little different even if the insulin in them is the same. It’s always a good idea to know what your doctor is prescribing and what your pharmacist is giving you.. even if it costs less.

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Big new studies focusing on children and teens with type 2 diabetes.. showing how different the disease can be in younger people.

The studies, published July 29 in the New England Journal of Medicine, showed that within 15 years of a Type 2 diabetes diagnosis, 60% of participants had at least one diabetes-related complication, and nearly a third of participants had two or more.

These Texas researchers call it astonishing and say it appears type 2 in youth is much more aggressive than in older people.

These researchers say more treatment options are needed for younger people because lifestyle changes don’t seem to be enough. The study also showed a lot of families don’t have regular access to medication or health care providers. They say it was a diverse study representative of teens and kids in the US.

https://medicalxpress.com/news/2021-08-young-adults-complications-diabetes.html

 

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More to come, including new about people with diabetes who stop taking a very commonly prescribed medication..  but first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible.

Real Good Foods! We’ve been fans for a long time – Benny especially likes their ice cream. Real Good Foods makes delicious food you’ll feel good about eating; high in protein, grain free and always made from real, nutrient dense ingredients. The labels are easy to read – because the ingredients aren’t chemicals and fillers. Whether it’s waffles or burrito bowls or stuffed chicken or the pizza that started it all.. I think you’ll really love Real Good Foods. Learn more with the link in the FB comments or as always at d-c dot com.

Back to the news…

 

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Interesting research using artificial intelligence to catch diabetes eye issues earlier – when they’re easier to treat.

Changes in the blood vessels in the retina cause diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in US adults. There are several studies and institutes looking at the use of A-I here, but these folks at the Indiana University School of Optometry say they’re using information that is often ignored for diagnosis and it’s making a big difference.

The National Institutes of Health’s National Eye Institute funded the work.

https://www.futurity.org/biomarkers-diabetic-retinopathy-blindness-vision-2604812/

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Nearly half of adults prescribed metformin after a new diagnosis of type 2 have stopped taking it by 1 year.

The fall off is most dramatic during the first 30 days. These researchers say it didn’t matter how long the prescription was written for and most who discontinued still had A1C’s high enough to still need glucose lowering medication.

They say as physicians quote - A lot of times we're quick to prescribe metformin and forget about it...Physicians might write a script for 3 months and three refills and not see the patient again for a year...We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they're getting early diabetes education."

https://www.medscape.com/viewarticle/955893

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That’s In the News for this week.. if you like it, please share it! And quick note this is our 400^th episode. I’ve been busy with some behind the scenes stuff and it caught up to me! A huge thank you to all of you.. incredible support from this community. Six years and 400 episodes is an accomplishment that I’ve only reached because of you.

And join me wherever you get podcasts for our next episode -Tuesday –  I’m talking to Eoin Costello the host of his own diabetes podcast – about staying active or starting getting more fit with type 1. This week’s interview – the one that’s out right now – is a look at the features of Omnipod 5 – the newest hybrid closed loop system in front of the FDA.

Thanks and I’ll see you soon