In the News... Spray insulin tested, Dexcom T2D sensor submitted, A1C period pads... and more!

It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Vertex pauses their stem cell transplantation trials after a patient death, spray insulin is tested, learning more about Dexcom's sensor for type 2, measuring A1C through menstrual blood and more!

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Episode transcript:

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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Our top story this week…

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Vertex Pharmaceuticals, Inc. has paused a study of stem cell–derived, fully pancreatic islet cell replacement therapy (VX-880) following two patient deaths.

Neither death is related to the therapy itself - called VX-880 – according to the company. Vertex says they plan to share full data soon. In the study that was paused, 14 patients with type 1 received infusions of VX-880 and standard immunosuppression. After 90 days, 13 of the patients have an A1C under 7 without using exogenous insulin.

This was the study that made a big splash in the New York Times in late 2021 with the headline “A Cure for Type 1 Diabetes?” and featuring Brian Shelton among others. Shelton is one of the two patients who have died.

 

https://www.medscape.com/viewarticle/vertex-pauses-islet-cell-study-after-patient-deaths-2024a10000oe

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Early days but researchers in Norway are testing an insulin body spray.

Patients squirt the insulin directly on to their inner forearm, where skin tends to be thinner, allowing easier absorption. Within minutes, it gets absorbed into the bloodstream.

This joins other research on skin patches packed with micro-needles that punch tiny and reportedly painless holes in the skin to let insulin seep through.

The spray contains insulin and propylene carbonate, a chemical often used in cosmetic skin creams to help them penetrate the outer layers of the skin.

In this case, it’s hoped the chemical — attached to insulin in the spray droplets — will help the hormone seep as far as the tiny blood vessels that lie beneath the surface of the skin, where the hormone will then get absorbed into the bloodstream.

 

InsuLife, the Norwegian company developing the body spray, is setting up a trial involving 12 patients with type 1 diabetes to see how different doses of the spray compare with injected insulin in controlling blood-sugar levels. It is used just before a meal, like injected insulin.

 

The clinical trial was set up after a study involving five people found the spray reduced blood sugar levels by about 20 per cent after a meal.

https://www.dailymail.co.uk/health/article-12965203/insulin-spray-arm-diabetes-jab-Hope-sight-millions.html

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The FDA clears the Qvin’s Q-Pad™ A1c Test System which uses menstrual blood to get an A1C result.

The kit is intended for the collection of menstrual blood samples by individuals 18 years of age and older using the Q-Pad, a pad with an embedded blood collection strip (Q-Strip). Each kit includes 2 Q-Pads, a return sample container, and a stamped mailing pouch.

The FDA clearance was based on data from a clinical validation study that included 198 participants. Samples were collected using the Q-Pad Kit and were returned to the laboratory by mail. To provide the reference sample, a venous blood draw was performed on participants by a phlebotomist. An analysis of both samples demonstrated that the clinical performance of the Q-Pad test system in measuring HBA1c was equivalent to the traditional method of blood testing.

https://www.empr.com/home/news/fda-approved-q-pad-test-system-uses-menstrual-blood-to-measure-hba1c/

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Learning more about Dexcom’s upcoming CGM designed for people with type 2 who don’t use insulin. It’s to be called Stelo and they’ve submitted to the FDA with an eye on a late summer launch. I was at the announced last June – this is a system that will have very few alerts and alarms.. Stelo looks a lot like the G7 but will have different software and will last for about 15 days per sensor.

https://www.theverge.com/2024/1/11/24034098/dexcom-stelo-cgm-diabetes-health-tech-ces-2024

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Tandem Diabetes Care's t:slim X2 Insulin Pump Automated Insulin Delivery System is now the first to incorporate the Abbott FreeStyle Libre 2 Plus Sensor for users in the United States. The FreeStyle Libre 2 Plus sensor is a modified version of the FreeStyle Libre 2 sensor cleared in 2023 by the US Food & Drug Administration for use with automated insulin delivery (AID) systems.

The move follows Tandem's December announcement of integration with the recently available 10-day Dexcom G7 sensor.

https://www.medscape.com/viewarticle/tandem-insulin-pump-system-integrates-libre-sensor-2024a10000iq?form=fpf

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If you use Omnipod 5 with an Android, there’s a software update you need to do. The FDA has issued a Class one correction recall. due to a software error that occurs when the user enters a bolus amount less than 1 unit without putting a leading zero before the decimal point.

This recall is not a product removal and users should have already received an alert that won’t let them use the app until they do the software update.

https://www.fda.gov/medical-devices/medical-device-recalls/insulet-corporation-recalls-omnipod-5-android-app-due-software-error#:~:text=Reason%20for%20Recall,zero%20before%20the%20decimal%20point.

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Embecta continues to move ahead with its insulin patch pump.. submitting a 510(k) premarket filing to the FDA for its proprietary insulin patch pump.

This is a disposable pump for people with type 2 diabetes. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study.

Henry Anhalt, chief medical officer, says nine out of 10 people with diabetes live with type 2 diabetes. However, Anhalt says the majority of automated insulin delivery systems cater to those with type 1 diabetes. Embecta aims to offer more options and tools to the broader diabetes care community, he says.

 

https://www.drugdeliverybusiness.com/embecta-submits-insulin-patch-pump-fda/

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Update on insulin prices.. as a few prices changes went into affect at the beginning of the year. So, what took effect this month was that Sanofi followed suit with Eli Lilly and Novo Nordisk to implement this cap on insulin co-pays at $35 that took effect January 1.

And that comes after the provisions of the Inflation Reduction Act capped insulin for people on Medicare at $35. The Medicare cap is automatic and part of policy. For everyone with commercial insurance, the cap is voluntary from the companies. For those without government or private insurance, the picture is more complicated. If your insulin is still more than $35 per month, ask your pharmacist for coupons or check out getinsulin dot org.

https://www.pbs.org/newshour/show/new-law-caps-insulin-prices-for-some-with-diabetes-but-cost-remains-high-for-millions

 

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Commercial

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Young adults who reported higher stress during their teenage years to adulthood were more likely to have high blood pressure, obesity and other cardiometabolic risk factors than their peers who reported less stress, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association.

Cardiometabolic risk factors often occur together and are a significant cause of cardiovascular disease. These include obesity, Type 2 diabetes or prediabetes, high cholesterol and high blood pressure, researchers noted.

In 2020, cardiometabolic diseases, including cardiovascular diseases and Type 2 diabetes, were the most prevalent chronic health conditions and collectively accounted for nearly a quarter of all deaths in the U.S., according to the American Heart Association statistics. In 2023, the American Heart Association noted the strong connections among cardiovascular disease, kidney disease, Type 2 diabetes and obesity, and suggested redefining cardiovascular risk, prevention and management.

 

https://finance.yahoo.com/news/childhood-stress-linked-higher-risk-100000670.html

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Shout out to NBC News for a great story they did recently on LADA – featuring two women who have both been on this podcast. Dr. Phyllisa DeRoze and Mila Clark were both first misdiagnosed with type 2 before they got a correct diagnosis of LADA. I’ll link up the NBC story along with our chats with both women.. thanks to Mila for giving me a mention as one of the voices in the diabetes community who made her think was she had might not be type 2.. but could be LADA.

https://www.nbcnews.com/health/diabetes/diagnosed-type-2-diabetes-may-different-form-disease-rcna132571

 

 

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