It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D and more!

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Episode transcription with links:

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.

Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.

A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.

HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.

Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups,

There were no differences between groups or concerns in other safety measures, including hypoglycemia.

https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex

Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health.

Stelo users will start seeing the features this week. The AI is modeled after Google Cloud's Vertex AI and Gemini models. We'll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare.

BTW this press release is the first time I've seen what seems to be a new slogan for Dexcom – Discover What You're Made Of.

https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing

Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention.

Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company.

The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.

Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges.

This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.

https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html

Can we add treating sleep apnea to the list of applications for terzepatide? That's the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea.

Eli Lilly said there was nearly a 20% reduction in weight among those in the trials.

The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year.

https://www.aol.com/popular-weight-loss-drug-could-131507702.html

Health Canada okays Tandem's tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors.

Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7's 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4.

Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025.

To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca.

https://www.businesswire.com/news/home/20241210731189/en/Tandem-tslim-X2-Insulin-Pump-Now-Compatible-with-Dexcom-G7-CGM-in-Canada

A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps.

The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision.

Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps.

In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million.

A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe's Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea.

The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet's trade secrets.

Insulet CEO Jim Hollingshead said the company is "extremely pleased with the jury's verdict." EOFlow did not immediately respond to a request for comment.

https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/

A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds.

Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions.

Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care.

https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes

New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable.
In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them.

We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support.
For more information, please visit: https://lnkd.in/gTDhnDc4

I'm also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2.

https://www.medscape.com/viewarticle/icymi-top-10-diabetes-endocrinology-stories-2024-2024a1000n6u?&icd=login_success_email_match_fpf

That's it for the last In the News of 2024! Don't miss out episode next week with a look ahead to what we're watching in 2025.

I'm SS I'll see you back here soon…

Pharma & Biotech

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