In the News.. Omnipod 5 approved for type 2, bright light at night diabetes link, Zepbound price cut, and more!

Diabetes Connections Type 2

It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: The FDA approved Omnipod 5 for people with type 2 who use insulin, Dexcom's Stelo, the first over the counter CGM, is now on sale. more evidence that bright light at night may increase the risk of diabetes, a price cut for Zepbound, 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.

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In a first for any automated insulin delivery system, The FDA clears Omnipod 5 for people with type 2 diabetes.

The new indication is based on data from the real-world multicenter SECURE-T2D trial of a racially diverse group of 305 adults with type 2 diabetes who were taking insulin. About half were also taking a glucagon-like peptide-1 (GLP-1) receptor agonist. Use of the Omnipod 5 resulted in a significant A1c reduction from 8.2% at baseline to 7.4% at 13 weeks (P < .001), with no differences in outcome by GLP-1 receptor agonist use.

Some doctors are already prescribing the Omnipod 5 off-label to some of their patients with type 2 and other types of diabetes. Private insurance will typically cover it, although prior authorization is often required. Medicare Part B requires certification of C-peptide deficiency for coverage of insulin pumps.

This new indication is likely to increase uptake of the Omnipod 5 into primary care, where the vast majority of people with type 2 diabetes are managed.

https://www.medscape.com/viewarticle/fda-clears-omnipod-5-system-type-2-diabetes-2024a1000fld

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For the first time, you can get a CGM over the counter, with no prescription. Dexcom began selling Stelo this week.. intended for people with Type 2 diabetes who don’t take insulin, although it can be used by people without diabetes. It costs 99 dollars for a one-time order of two sensors or $89 dollars for a monthly prescription.

Stelo is a 15-day sensor based on Dexcom’s other glucose monitors. The main difference from prescription products is in what information users get through the app. Stelo flags glucose spikes, provides information on time-in-range goals, and includes meal and activity logging. The intent is to reveal how food, exercise and sleep can affect a person’s glucose levels.

Competitor Abbott plans to launch two over-the-counter CGMs: one called Lingo, for people without diabetes, and one called Libre Rio, for people with diabetes who don’t use insulin. It has not yet priced either sensor.

Abbott said it plans to debut its competing Lingo device this summer. The company has not said when it will launch its Rio CGM.

https://www.medtechdive.com/news/dexcom-sells-stelo-over-the-counter-cgm/725310/

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You’ll soon be able to get vials of Lilly’s popular weight loss drug, Zepbound, from a direct to consumer website, at a lower cost. This is still nearly 400 dollars a month for the lowest dose $550 for the next lowest and it will come in vials, not pens.

Lilly and Novo have been struggling to make enough of their obesity medications to meet soaring demand, especially keeping up the pen supply.

Lilly's medicines are now listed as available by the U.S. Food and Drug Administration, though they are not yet off the FDA's official shortage list where they have been most of the year.

I haven’t seen this mentioned in any of the reporting but.. if it’s coming in a vial, you have to use a syringe to inject. Not much of a barrier to this group listening.. but pens have made using drugs like this much easier for a lot of people and I worry that going back to syringes is better for these companies than the patients.

Zepbound is terzepatide, the same mediation as in Mounjaro. The latter is approved for people with type 2 diabetes, so this could be a way for some people to better access Mounjaro which is very hard to come by.

https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-launches-single-dose-vials-zepbound-weight-loss-expand-us-supply-2024-08-27/

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In a few months the US govermet will announce the list of 15 moe drugs they’ll negotiate Medicare prices for.. and Ozempic is a top candidate. This is speculation from Wall Street analysts but I think worth watching. All the drugs on their prediction list have been on the market since at least 2017 and are among those that the Medicare health program spends the most on.

Under President Joe Biden's signature Inflation Reduction Act (IRA), prices for 10 highly popular prescription drugs used by Medicare will be cut by 38% to 79% in 2026. The industry has fought the negotiation program, saying it will stifle innovation.

Government researchers predict that the use of diabetes drug Ozempic for weight loss would raise the U.S. deficit over the next 10 years at its current price. Medicare spent over $4.6 billion on the drug in 2022.

https://www.reuters.com/business/healthcare-pharmaceuticals/ozempic-wall-streets-list-2027-medicare-drug-negotiations-2024-08-23/

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Type 2 diabetes and prediabetes are associated with accelerated brain aging, according to a new study from Karolinska Institutet in Sweden published in the journal Diabetes Care. The good news is that this may be counteracted by a healthy lifestyle.

Type 2 diabetes is a known risk factor for dementia, but it is unclear how diabetes and its early stages, known as prediabetes, affect brain aging in people without dementia. Now, a comprehensive brain imaging study shows that both diabetes and prediabetes can be linked to accelerated brain aging.

The study included more than 31,000 people between 40 and 70 years of age from the UK Biobank who had undergone a brain MRI scan (magnetic resonance imaging). The researchers used a machine learning approach to estimate brain age in relation to the person's chronological age.

Prediabetes and diabetes were associated with brains that were 0.5 and 2.3 years older than chronological age, respectively. In people with poorly controlled diabetes, the brain appeared more than four years older than chronological age. The researchers also noted that the gap between brain age and chronological age increased slightly over time in people with diabetes. These associations were attenuated among people with high physical activity who abstained from smoking and heavy alcohol consumption.

https://medicalxpress.com/news/2024-08-healthy-lifestyle-counteract-diabetes-brain.html

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Another study showing the link between bright light at night and a higher risk of developing type 2. This study in the journet Lancet

In the large modeling study, the research team investigated whether personal light exposure patterns predicted the risk of diabetes using data from approximately 85,000 people and around 13 million hours of light sensor data.

The participants – who did not have type 2 diabetes – wore devices on their wrists for one week to track their light levels throughout the day and night.

They were then tracked over the following nine years to observe whether they went on to develop type 2 diabetes.

“Light exposure at night can disrupt our circadian rhythms, leading to changes in insulin secretion and glucose metabolism,” he says.

Having more exposure to light at night (between 12:30 am and 6:00 am) was linked to a higher risk of developing type 2 diabetes, and this was true regardless of how much light people were exposed to during the day.

The research accounted for other factors associated with type 2 diabetes, such as lifestyle habits, sleep patterns, shift work, diet, and mental health.

Even after taking these factors into account, the findings showed that getting more light at night was still a strong predictor of developing diabetes.

https://scitechdaily.com/scientists-discover-simple-and-cheap-way-to-reduce-your-risk-of-diabetes/

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Is there a link between voice pitch and glucose levels? And is it strong enough to one day perhaps lead to non-invasive glucose monitronig?

Klick Labs published a new study in Scientific Reports today—confirming the link

In "Linear Effects of Glucose Levels on Voice Fundamental Frequency in type 2 diabetes and Individuals with Normoglycemia," researchers investigated how blood glucose levels influence the frequency of the voice in 505 participants across three glycemic statuses—non-diabetic, prediabetic, and type-2 diabetic.

Participants were fitted with continuous glucose monitors (CGMs) and recorded their voices multiple times daily for two weeks. The analysis revealed a linear relationship where an increase in CGM glucose levels corresponded to an increase in the fundamental frequency in the voice.

The lead author says,

"Whereas current glucose monitoring methods are often invasive and inconvenient, voice-based glucose monitoring could be as easy as talking into a smartphone, which could change the game for the estimated 463 million people around the world living with type 2 diabetes."

Klick Labs' latest research marks another step forward in its ongoing commitment to advancing the detection and management of diabetes using voice tech and machine learning. Their October 2023 study in Mayo Clinic Proceedings: Digital Health demonstrated that voice and AI can screen for type 2 diabetes with high accuracy.

https://medicalxpress.com/news/2024-08-diabetes-links-blood-glucose-voice.html#google_vignette

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Earlier this year we talked to the teenager behind a free bolus calculator. The FDA took T1D1 down, when they and Apple started cracking down on health tools without regulatory approval. Drew Mendalow has been working to bring it back and we have an update:

He says, “Over the last two years, we have been tirelessly working to complete our FDA premarket submission. Thanks to contributions by the T1D community, we were able to complete the preparations needed for the Human Factors Study. The trial itself is the last, vital piece needed before we can submit the app to the FDA.

Now, we're thrilled to announce that the team at Dexcom has graciously offered to run the study for us!”

It’s a big deal – kudos to Dexcom and to Drew. We’ll let you know when T1D1 is back in the app store.

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Join us again soon!