In the News... Generic GLP-1, All-in-one sensor and infusion set, 365-day CGM, T1D & Roblox and more!

Diabetes Connections | Type 1 Diabetes

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The Eversense CGM could soon be approved for one year of continuous use, the first generic GLP-1 medication is launched, a new company tauts and all-in-one sensor and pump infusion set, a new diabetes accessory in the Roblox game, and more!

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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark

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The first ever generic GLP-1 medication will soon be available in the US. It’s a generic of Victoza, originally approved by the FDA in 2010 for diabetes, is part of the same class of drugs that includes Ozempic and Mounjaro.

Liraglutide is Glucagon-like peptide-1 receptor agonists (otherwise known as GLP-1s or GLP-1 RAs) are a class of incretin drugs that mimic the body’s natural hormones to help treat diabetes and obesity.

However, the popularity of the drugs has spiraled out of control at times, leading to shortages and supply chain issues in the US and abroad. The arrival of a GLP-1 generic drug provides reasons to be hopeful for doctors and patients alike, but there are also caveats.

Couple of caveats - liraglutide is injected once daily (vs. weekly) and many doctors say it doesn’t work as well for as many people as semaglutide and terzepatide. No confirmation on the price Two other generic options are being developed and could launch in December 2024. Patents for newer GLP-1 medications like Ozempic and Wegovy won’t expire until several years down the road

https://www.healthline.com/health-news/victoza-generic-glp1-drug-available

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Senseonics plans to launch a 365-day sensor in the U.S. in the fourth quarter of this year. A one-year Eversense CGM could be a game changer for the company.

In 2024, Senseonics expects to more than double U.S. new patient starts and increase the global installed base by around 50%. The growth is built on the current 180-day version of Senseonics’ implantable Eversense CGM.

Eversense’s 180-day sensor can need calibrating twice a day, something Senseonics CEO Tim Goodnow said “has been a competitive disadvantage.” Users calibrate the 365-day sensor once a week.

Senseonics is in talks with insulin pump manufacturers about integrating its Eversense CGM with their devices but has yet to commit to a timeline for finalizing an agreement.

https://www.medtechdive.com/news/senseonics-365-day-cgm-2025-sales/719717/

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People who take Ozempic or Wegovy may have a higher risk of developing a rare form of blindness, a new study suggests. Still, doctors say it shouldn’t deter patients from using the medicines to treat diabetes or obesity.

Last summer, doctors at Mass Eye and Ear noticed an unusually high number of patients with non-arteritic anterior ischemic optic neuropathy, or NAION, a type of eye stroke that causes sudden, painless vision loss in one eye.

The condition is relatively rare — up to 10 out of 100,000 people in the general population may experience it — but the doctors noted three cases in one week, and each of those patients was taking semaglutide medications.

The risk was found to be greatest within the first year of receiving a prescription for semaglutide.

The study, published Wednesday in the medical journal JAMA Ophthalmology, cannot prove that semaglutide medications cause NAION. And the small number of patients — an average of about 100 cases were identified each year — from one specialized medical center may not apply to a broader population.

The ways that semaglutides interact with the eyes are not entirely understood. And the exact cause of NAION is not known either. The condition causes damage to the optic nerve, but there is often no warning before vision loss.

For now, patients who are taking semaglutide or considering treatment should discuss the risks and benefits with their doctors, especially those who have other known optic nerve problems such as glaucoma or preexisting visual loss, experts say

https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-ozempic-linked-with-sight-threatening-eye-disorder-study-2024-07-03/

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We got some updates at ADA about the over the counter CGMS Dexcom Stelo and Abbot’s Libre. Dexom plans a late august launch of stelo, which you’ll order from their website – it won’t be physically in stores.

Abbott also plans to sell its wellness-oriented Lingo device this summer through an e-commerce website. That’s a sensor that’s been available in other coutnires for a while, but was recently okayed in the US. It’s not meant for people with diabetes. The Libre Rio is designed or adulst with type 2 who don’t use insulin. No timing yet on that product’s launch.

Neither Abbott nor Dexcom have disclosed pricing for the upcoming products.

https://www.medtechdive.com/news/abbott-dexcom-over-the-counter-cgm-launch/719928/

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Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration.

Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.

Omnipod 5 is currently cleared in the U.S. for people with Type 1 diabetes. Insulet hopes to expand the pump to people with Type 2 diabetes, with an expected launch in early 2025.

The FDA has not yet cleared any automated insulin delivery systems for people with Type 2 diabetes, Insulet said. The company has a basal-only insulin pump, called Omnipod Go, that was cleared for people with Type 2 diabetes last year, but it does not connect to other devices.

Even though Omnipod 5 is not currently indicated for Type 2 diabetes, doctors prescribe it for their patients with full reimbursement since the pharmacy channel doesn’t distinguish between Type 1 or Type 2 patients, J.P. Morgan analyst Robbie Marcus wrote in a research note on Sunday.

https://www.medtechdive.com/news/insulet-omnipod-5-type-2-diabetes-study/719644/

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In the keynote address at the American Diabetes Association annual conference, FDA Commissioner Dr. Robert Califf expressed concerns about the rising rates of diabetes in the U.S.

Though revolutionary medications and technologies for diabetes and weight loss continue to emerge, these treatments are vastly underused.

The silver lining lies with type 1 diabetes therapies, which are showing great promise in clinical trials.

“For the larger epidemic of type 2 diabetes, we’re failing right now,” Califf said. “I don't say that lightly.”

A huge problem, Califf said, is access. While most health insurance plans cover medical devices and medications for diabetes, without insurance, costs add up quickly. Ozempic, for example, costs nearly $1,000 per month without insurance. Studies have found that regardless of insurance status, roughly 26% of Americans skipped or delayed treatment due to cost.

https://diatribe.org/diabetes-management/fda-commissioner-says-were-failing-people-type-2-diabetes

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Embecta presented two abstracts at the American Diabetes Association Scientific Sessions last weekend making the case for its insulin patch pump for Type 2 diabetes. The company submitted the device for Food and Drug Administration clearance in late 2023.

The diabetes device company developed a patch pump with a larger insulin reservoir that can hold up to 300 units.

Embecta, which is better known for making equipment such as pen needles and insulin syringes, has been developing its first patch pump. The company found that a device with a larger insulin reservoir could provide longer wear times and fewer disposable patches.

https://www.medtechdive.com/news/embecta-insulin-patch-pump-volume-american-diabetes-association/719779/

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Pump/CGM sensor in one

The niaa signature patch pump, shown with a watch displaying current blood sugar level

The niaa signature patch pump has a manual bolus button and is part of an in-development AID system.

Swiss technology maker Pharmasens demonstrated a new semi-reusable tubeless patch pump and glucose sensor in the same compact device, called the niia signature, which the company says can be worn for five days.

The top of the device, which includes Bluetooth connectivity and the electronic and mechanical parts to control the pump, separates from the disposable 300-unit reservoir along with the adhesive used to attach the device to the body via a steel cannula. A small button on the device allows manual bolusing. The company says an AID system will manage the device, controlled by smartphone.

PharmaSens' simpler basal-bolus patch pump, the niia essential, was submitted for FDA approval in late December. Availability of the niia signature AID system has yet to be announced.

https://diatribe.org/diabetes-technology/diabetes-technology-display-ada-2024

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Edgepark Commercial

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New international consensus statement offers guidance on the care and monitoring of people who are at high risk for type 1 diabetes (T1D). This is all about screening and testing for islet autoantibodies.

These individuals are classified as: At risk or Stage 0 (single autoantibody or transient single autoantibody), Stage 1 (two or more autoantibodies with normoglycemia), and Stage 2 (two or more autoantibodies with dysglycemia but without symptoms and not yet meeting diagnostic criteria for Stage 3 clinical T1D).

The document was presented on June 24, 2024 in a 90-minute symposium at the American Diabetes Association's annual Scientific Sessions and published simultaneously in both Diabetes Care and Diabetologia.

"This is not guidance around who to screen or when to screen. This is guidance for the hundreds of thousands of people around the world who have participated in screening, mostly through research programs, and have been identified with positive autoantibodies and need care in the clinical setting," panel co-chair Anastasia Albanese-O'Neill, PhD, APRN, CDCES, of Breakthrough T1D, told Medscape Medical News.

The recommendations also include when to start insulin, and how to provide education and psychosocial support to individuals and family members of those given the early-stage T1D diagnosis.

https://www.medscape.com/viewarticle/experts-advise-early-risk-monitoring-type-1-diabetes-2024a1000bpo

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Roblox has added a diabetic option, complete with insuli pen and Dexcom

You can find it in the marketplace

JDRF – now breakthrough t1d – started a world in roblox a couple of years ago as well

Roblox is a super popular online game that a lot of kids play.

https://www.roblox.com/games/5823990610/Breakthrough-T1D-World

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FFL next week!

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