Avsnitt
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For the first time, you can buy a continuous glucose monitor over the counter, no prescription needed. This summer we went from no CGMs available this way, to now having two. This week we’re talking about the Dexcom Stelo with the company’s COO Jake Leach. We’ll talk about Stelo and get an update on G7 features including Dexcom’s plans to address concerns over Geofencing, and issues that can potentially arise if you travel outside your home country.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
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Reach out with questions or comments: info@diabetes-connections.
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It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: Dexcom CGM is worn in space, two over-the-counter CGMs are now available, a large new study looks at potential dietary causes of type 1, and researchers are looking at a gel version of GLP-1 medications.
Find out more about Moms' Night Out
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
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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Astronauts on the Polaris-Dawn mission are wearing the Dexcom G6 CGM.
Polaris Dawn launched this week with astronauts wearing the G6 to better understand the effects of spaceflight on human health. The crew intends to conduct research to advance human health on Earth and the understanding of health during long-duration spaceflights.
“This health research-driven mission marks another first for Dexcom, with our industry-leading CGMs being worn by astronauts in outer space,” said Jake Leach, EVP and COO at Dexcom. “We are thrilled to play a role in building a future where people with diabetes are empowered to accomplish anything they set their minds to–including the possibility of exploring outer space–without being held back by their condition.”
Over five days in space, the Polaris Dawn crew plans to conduct around 40 scientific experiments. That includes several aimed at better understanding the effects of spaceflight on glucose health. Labront, a platform assisting health researchers in collecting and analyzing physiological data, is collaborating with Dexcom. It plans to provide advanced analytics for the data collected by the crew.
According to a news release, the mission expects to explore how microgravity, fluid shifts, and blood flow restriction exercises impact glucose regulation.
https://www.drugdeliverybusiness.com/dexcom-cgm-outer-space-polaris-dawn/
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There are now two OTC CGMs.. Dexcom launched Stelo a few weeks ago and now Abbott says Lingo is for sale. They’re both available on the companies’ websites, cost about the same, but you can opt to buy only one Lingo where Stelo comes in pairs. Lingo is meant for people without diabetes – it’s a health bio sensor. Abbott has another CGM called Libre Rio meant for people with type 2 who don’t take insulin. Not a lot of details about what the real difference are here – likely just in the software – No word on when Rio will be available.
https://www.cnbc.com/2024/09/05/-abbott-launches-its-first-over-the-counter-continuous-glucose-monitor-in-the-us.html
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Warning about flying with an insulin pump – And I want to be clear here because I’m sure you’ll see some scary headlines. This is really about pressure emergencies in planes. For the study, researchers tested 26 insulin pumps in a hypobaric chamber programmed to mimic the atmospheric changes during a normal commercial airline flight.
“The drop in cabin pressure during ascent may lead to a slight increase in insulin delivery as a result of the formation of air bubbles which displace excess insulin out of the cartridge,” Fan said in a meeting news release. “A slight reduction in insulin delivery is also possible during descent as the increasing air pressure dissolves the air bubbles, sucking insulin back into the pump.”
People on insulin pumps could be in real trouble in the event of rapid decompression of the cabin at altitude, researchers said. In that case, the pumps could deliver an insulin overdose -- dropping blood sugar levels so much that there’s a significant risk of hypoglycemia, results show.
These researchers recommend disconnecting and reconnect at take off and landing, but that’s not going to help if there is emergency rapid decompression. As always, be prepared with emergency glucagon and low snacks and supplies.
https://www.healthday.com/health-news/diabetes/flying-could-upset-insulin-pump-function-for-type-1-diabetics
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Lilly moves forward with it’s version of once weekly basal insulin. Clinical trials show it can help control both Type 1 and Type 2 diabetes as well as daily basal injections do. However, in those with type 1 diabetes, there was an increased risk for hypoglycemia.
This is the same issue with Novo Nordisk’s Awiqli insulin – approved in Canada but not in the United States.
https://www.upi.com/Health_News/2024/09/11/weekly-insulin-injections-effective-diabetes-weekly/8711726068680/
https://www.medscape.com/viewarticle/once-weekly-insulin-looks-good-t2d-risk-seen-t1d-2024a1000gh8
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Eating what seems like really healthy foods could be associated with a higher risk of developing type 1 diabetes. New study shows that eating fruit, oats and rye in childhood is associated with a higher risk of developing type 1 diabetes (T1D). Eating berries, however, is linked to lower odds of developing the condition.
What triggers the immune system's attack is unknown but is thought to involve a combination of a genetic predisposition and an environmental trigger such as a virus or foodstuff.
T1D, the most common form of diabetes in children, is increasing worldwide. The number of cases worldwide is projected to double in just 20 years, from 8.4 million in 2021 to 17.4 million by 2040. Finland has the highest incidence of T1D globally, with 52.2 cases per 100,000 children under the age of 15 – more than five times higher than in the 1950s.
5,674 children (3,010 boys and 2,664 girls) with genetic susceptibility to T1D were followed from birth to the age of six. Food records completed by their parents repeatedly from the age of three months to 6 years provided information on the entire diet.
The 34 food groups covered the entire diet and, when they were all factored in, several foods were associated with a higher risk of developing T1D.
To the best of our knowledge, this is the first time a child's entire diet has been considered at the same time."
The results show that the more fruit, oats or rye children ate, the more their risk of T1D increased. In contrast, eating strawberries, blueberries, lingonberries, raspberries, blackcurrants and other berries appeared to provide protection against T1D. The more berries a child ate, the less likely they were to develop T1D.
Oats, bananas, fermented dairy products (such as yogurts) and wheat were associated with an increased risk of islet autoimmunity, whereas cruciferous vegetables, such as broccoli, cauliflower and cabbage, were associated with decreased risk.
It is, however, too early to make any dietary recommendations. The researchers are quick to point out that they don’t really know the “why” here. Could be the food itself, could be pesticides, and until the results are replicated they urge parents not to change their child’s diet.
https://www.news-medical.net/news/20240909/Eating-fruit-oats-and-rye-in-childhood-may-increase-type-1-diabetes-risk.aspx
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Researchers in France have developed a once-a-month hydrogel-based delivery system for semaglutide, significantly simplifying diabetes and weight management
Semaglutide, marketed as Ozempic, Rybelsus, and Wegovy, is a GLP-1 receptor agonist that helps to regulate blood sugar levels and promote weight loss. This medication is especially effective in managing type 2 diabetes and is available in both injectable and oral forms. Semaglutide enhances the body’s natural ability to control blood glucose and reduce appetite, providing a dual approach to treatment.
The new hydrogel delivery platform uses two innovative degradable polymers that are chemically bound to one another to form a gel, but allow slow, sustained release of soluble peptides over 1 to 3 months. How do you slow release a gel? With an injection. It goes under the skin. This is still in animal studies, so we’re a ways off from human clinical trials.
https://scitechdaily.com/new-semaglutide-hydrogel-say-goodbye-to-weekly-shots-for-diabetes-and-weight-loss/
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Edgepark Commercial
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Embecta has received clearance from the Food and Drug Administration for its first insulin patch pump.
The device can be used by people with Type 1 or Type 2 diabetes and worn for up to three days. It includes a 300-unit insulin reservoir.
Embecta said Tuesday it plans to develop a closed-loop version of the pump for automated insulin dosing that it will submit to the FDA in the future using the Tidepool Loop algorithm.
Earlier this summer, Insulet received FDA clearance to offer its Omnipod 5 pump to people with Type 2 diabetes. Diabetes tech firms have focused on Type 2 in recent years as insurance coverage improves.
https://www.medtechdive.com/news/embecta-gets-fda-nod-for-insulin-patch-pump/725904/
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An artificial intelligence (AI)–driven voice algorithm showed "excellent agreement" with the American Diabetes Association (ADA) risk test in detecting adults with type 2 diabetes (T2D), research presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting revealed.
The AI model detected T2D with 66% accuracy among women and 71% in men, and there was 93% agreement with the questionnaire-based ADA risk score, demonstrating comparable performance between voice analysis and an accepted screening tool.
The Colive Voice project includes volunteers from all over the world; however, the current study was restricted to adults from the United States, both with and without T2D,
"This first proof of concept was limited to English speakers, and further research will need to enroll more diverse populations, in terms of languages and sociodemographic background," he said.
"This study represents a first step toward using voice analysis as a first-line, highly scalable T2D screening strategy," the authors concluded.
"The next studies will have to demonstrate the robustness of our approach in diverse populations and also include people living with prediabetes," Fagherazzi said. "If proven reliable, we expect such technology to be available in the next 5-10 years. Then, it could be deployed easily at scale in millions of smartphones worldwide and reduce undiagnosed diabetes cases."
https://www.medscape.com/viewarticle/ai-voice-analysis-diabetes-screening-shows-promise-2024a1000ggw
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Join us again soon!
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Saknas det avsnitt?
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Jaime Ferrer was diagnosed with type 1 at age three.. and this summer was drafted into Major League Baseball by the Minnesota Twins. I caught up with him to ask him your questions about works out, playing with a pump, how he managed the college recruitment process, and more. He’s a great kid and this was a fun one.
I should note that many of you know Jamie’s mother Mila Ferrer. She’s been blogging about her family’s experience for a long time, does a lot of work with Beyond Type 1 and is an advocate for the Latino diabetes community. I’ve had the pleasure of working with her on some of the past Beyond Type 1 projects.
Jaime was drafted by the Twins this summer and he’s currently practicing and playing with their minor league team Fort Myers Mighty Mussels. He is also part of the Tandem Diabetes Ambassador program.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Follow Jaime Ferrer on Instagram
Joint interview with Jaime and Mila Ferrer
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
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Reach out with questions or comments: info@diabetes-connections.
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Traveling with diabetes gives you enough to think about – especially traveling internationally: preparing, packing, going through airport security. But if you travel out of your country – not just the US – with your Dexcom G7, you also have to be aware of something called geofencing. If something goes wrong with your phone or your app.. getting it back is going to be an issue. We’ll talk about how this works, why it’s in place, and what you can do about it.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
More from Dexcom
More from Loop & Learn: https://www.loopnlearn.org/g7-geofence/
Stacey's free travel guide and packing list: https://bit.ly/DiabetesCxnsTravel
Previous episode with Dexcom's Jake Leach
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.
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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!
Find out more about Moms' Night Out
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
Facebook (Page)
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
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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Edgepark Commercial
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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!
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Medtronic and Abbott are joining forces – and we have questions. The announcement that Abbott will create a new CGM, based on the Freestyle Libre, exclusively for Medtronic comes just as Medtronic gets FDA approval for it’s newest sensor. So why the team up? Why now? And what will all this look like for the person using these systems? We’re talking to both companies.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
Facebook (Page)
Instagram
Twitter
Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.
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It’s hard to believe that a generation ago, doctors were still telling newly diagnosed people that they shouldn’t play sports with type 1 diabetes. My guest – Chris Bright – is not just an example of how wrong that thinking was and is.. he’s actively now helping others pursue their dreams with T1D. Chris was diagnosed as a child back in 1999 and is the founder of The Diabetes Football Community. Chris shares his early challenges, how his mother’s experience with type 1 affected their family, and what he wants you all to know about playing any sport with diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
Facebook (Page)
Instagram
Twitter
Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.
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It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A weekly basal plus semaglutide is in the works, but not for the US right now, Tandem updates it's app recall, liver targeted insulin study, a weird walking story, and Lance Bass educates about LADA.
Find out more about Moms' Night Out
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
Facebook (Page)
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
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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Novo Nordisk moves ahead with a new combination: once-weekly insulin icodec and semaglutide. Called IcoSema, Novo plans to submit for approval in Europe, Canada, Japan and Australia but NOT the US.
As we told you earlier this summer, icodec – once weeky basal insulin – was not approved by the US FDA.
Semaglutide is the molecule underpinning Novo’s immensely popular GLP-1 drugs Ozempic and Wegovy. Icodec has been approved as Awiqli in places like Europe, Canada, Japan and Australia but was snubbed by the FDA last month.
The FDA has left the door open for another application, but Novo says they don’t expect to iron it out this year.
In studies, the combination worked well to lower A1C for people with type 2 and they lost weight. They also had fewer lows.
https://www.fiercepharma.com/pharma/corrected-after-icodec-rejection-novo-nordisk-wont-file-application-once-weekly-insulin-and
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An update from Tandm on their app recall. Back in March they notified users of the recall because of an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience even after an updated version of the app was released.
Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release.
Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at [email protected] or (877) 801-6901.
https://www.businesswire.com/news/home/20240812040222/en/Tandem-Diabetes-Care-Provides-Update-on-March-2024-Nationwide-Recall-of-tconnect-Mobile-App-for-iOS-Devices
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If you are an adult who has type 1 diabetes, you may be eligible to participate in a trial examining the impact of an investigational liver-targeted insulin on blood glucose control, A1C, and nighttime lows.
This study is researching whether administering a liver-targeting insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro), will improve glycemic control.
HDV-L insulin is designed to act on the liver to enhance glucose storage and decrease the frequency of severe hypoglycemia in individuals requiring insulin. It is not currently approved for use.
For this trial, researchers are recruiting roughly 230 adults with type 1 diabetes aged 18-79 who are on multiple daily injections (MDI).
This study is recruiting in California, Colorado, Florida, Georgia, Illinois, Indiana, New York, North Carolina, Ohio, and Texas. To enroll or learn more about this study, contact Todd Hobbs, MD at Diasome Pharmaceuticals at [email protected] or call 216-780-9324.
Clinical Trials Identifier: NCT06238778
https://diatribe.org/diabetes-research/new-study-tests-liver-targeted-insulin-type-1-diabetes
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Sanofi is investing heavily to boost insulin production. They opened a new facility in Germany for the basal insulin Lantus and they announced they will invest over one billion dollars to expand production capacity in France.
Sanofi’s considerable investment in insulin production is especially important given that other insulin companies appear to be focusing their efforts on production of GLP-1 medications like Mounjaro and Ozempic, rather than insulin. This has left some patients worried that Novo Nordisk and Lilly will leave them behind to pursue more lucrative products for weight loss, especially after Novo Nordisk decided to discontinue the basal insulin Levemir.
https://diatribe.org/diabetes-medications/sanofi-build-new-state-art-insulin-plant
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Hoping to talk to Abbott and Medtronic soon about their partnership announced earlier this month. The companies announced that Abbot will create an integrated continuous glucose monitor that works only with Medtronic’s diabetes technology and be sold exclusively by Medtronic.
Along with announcing the partnership, Medtronic said Wednesday it received FDA approval for its Simplera CGM, which does not require fingersticks or overtape, unlike the company’s previous sensors.
The Simplera Sync sensor, which is designed to work with Medtronic’s automated insulin delivery algorithm, is under FDA review separately.
https://www.medtechdive.com/news/abbott-medtronic-partnership-automated-insulin-delivery/723600/
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Researchers have developed a novel computer algorithm that can predict various diseases like diabetes or stroke, just by analysing the colour of the human tongue with 98 per cent accuracy.
The imaging system developed by Middle Technical University (MTU) and the University of South Australia (UniSA) in Australia can diagnose conditions such as diabetes, stroke, anaemia, asthma, liver and gallbladder issues, Covid-19, and other vascular and gastrointestinal diseases.
"The colour, shape, and thickness of the tongue can reveal a litany of health conditions," said Ali Al-Naji, adjunct Associate Professor at MTU and UniSA.
The paper published in Technologies describes how the system analyses tongue colour to provide real-time diagnoses, demonstrating that AI can advance medical practices significantly.
The breakthrough was achieved through a series of experiments using 5,260 images to train machine-learning algorithms to detect tongue colour.
Researchers received 60 tongue images from two teaching hospitals in the Middle East, representing patients with diverse health conditions. The AI model matched tongue colour with the correct disease in nearly all cases.
https://www.ndtv.com/world-news/new-algorithm-analyses-tongue-to-predict-diabetes-stroke-with-98-accuracy-6327124
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Big roundup article from the UK Guardian all about 6 projects all around smart insulin. Not a lot new here, but it caused a lot of chatter. I’ll link it up – good summary of all of the research happening in the space right now. Glucose-responsive insulin is the idea that you could give one injection and the insulin would respond to the rise and fall of glucose levels without further action by the person.
https://www.theguardian.com/society/article/2024/aug/11/scientists-hail-smart-insulin-responds-changing-blood-sugar-levels-real-time-diabetes
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Edgepark Commercial
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Lance Bass (like glass) continues to keep the public posted on his recent LADA diagnosis. The boy band singer showing his IG audience more about what’s also called diabetes 1.5 and explaining how he was first diagnosed with type 2.
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Ok, brace yourself – I promise this is a real story. The Fart Walk is actually good for you. Ok.. stay with me. This is really just a great silly reframing of something we all know, and I couldn’t resist putting it in here. A wellness influencer put this out – you may have seen it – claiming the after dinner stroll can limit your risk of type 2 diabetes. A lot of studies confirm that – along with it having benefits if you already have diabetes. The flatulence part – or a release of gastric pressure – is also a known benefit of moving more after meals. So it’s funny, farts are always funny, but if it gets more people to walk after they eat I’m all for it.
https://people.com/fart-walk-benefits-what-is-it-type-2-diabetes-8694630#:~:text=Wellness%20influencer%20Mairlyn%20Smith%20has,of%20day%20you%20do%20it
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Join us again soon!
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This week, when it’s stormy out – most of us head inside. But there are those who just can’t wait for big storms and extreme weather so they can head out to track and learn from it. Jen Walton is a storm chaser and photographer who lives with type 1. We’ll talk about how her diagnosis as an adult helped kick off her long-delayed dream to chase, how she prepares and manages with T1D on board, and how she’s encouraging other women and girls to share her passion for extreme weather.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Jen Walton's Instagram
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I spent a lot of this summer at diabetes conferences and the top question I got from parents was: how did we make Benny so independent with his T1D? But there are some things I’ve learned that may make it easier for you. I’ll explain my parenting pivot to Customer Support with the release of this excerpt from "Still the World's Worst Diabetes Mom"
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When Gary Hall Jr was diagnosed with type 1 diabetes in 1999 his doctors told him to give up competitive swiming and drop out of the 2000 Olympics. Instead, he charged ahead and became the first person with T1D to take home an Olympic Gold Medal. Hall won Gold in Sydney in 2000 and again in Athens in 2004, adding to the medals he’d won in 1996 before his diagnosis.
Stacey caught up to Gary at this summer’s Friends for Life Conference and asked him how he got past what his doctors told him. He also shared what he tells newly diagnosed families today.
This interview first aired in July 2021
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
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We're hearing more and more about prevention of type 1 diabetes. There’s some big news on that front – just last week Diamyd Medical got fast track designation for it’s medication to stave off T1D for people who carry a particular gene – a gene that about 40-percent of people with type 1 have. Diamyd is recruiting for some big clinical trials – we’ll find out who’s eligible, where you have to go and what you to have to do, and the reasons why there’s an awful lot of hope around this.
My guest this week is Elna Narula, US Site Relations and Patient Recruitment Lead at Diamyd Medical. Her daughter was diagnosed with type 1 more than 30 years ago. Elna was already working in healthcare and she became a diabetes educator.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
More info about Diamyd
Learn about the studies and recruitment here
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Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
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It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A new study looks at insulin needs in men vs women, updates on stem cell transplants and a new look at COVID 19 and T1D plus a fully implantable CGM is announced. We'll also tell you about a T1D athlete drafted to the MLB. Lots more in this week's episode, full transcipt below.
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Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
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Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
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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 the news is brought to you by Edgepark simplify your diabetes journey with Edgepark
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Do men and women have different insulin requirements? A new study conducted across Europe says yes – women overall need less. Published in the Journal of Diabetes Science and Technology this looked at over 9,000 adults with type 1 diabetes using data from patients using the Diabeloop Generation 1 (DBLG1) hybrid closed-loop pump system.
In this study, women needed 14-percent less insulin overall than men. These researchers say these findings have important implications for the practical management of insulin therapy and highlight the necessity of considering gender as a crucial factor in diabetes treatment. The treatment guidelines provided by American and European Diabetes Societies do not currently have gender-specific recommendations for insulin-weight ratios.
The co-founder and Chief Scientific and Technical Officer for Diabeloop. “This study also highlights the capacity to discover new insights from big-data analysis of real-world data.”
*Insulin Requirements According to Gender and Weight in a Population of 9036 Adult Persons With Type 1 Diabetes Using Closed-Loop Insulin Delivery, https://doi.org/10.1177/19322968241252366).
https://www.theglobeandmail.com/investing/markets/markets-news/GetNews/27419187/diabeloop-study-reveals-significative-gender-differences-in-insulin-requirements-for-type-1-diabetes-patients/
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New drug therapy in those lucky diabetic mice boosted insulin-producing cells by 700% over three months, effectively reversing the disease.
Scientists at Mount Sinai and City of Hope have been able to grow new beta cells in the body, in a matter of months.
The therapy involved a combination of two drugs: one is harmine, a natural molecule found in certain plants, which works to inhibit an enzyme called DYRK1A found in beta cells. The second is a GLP1 receptor agonist. The latter is a class of diabetes drug that includes Ozempic,
The researchers tested the therapy in mouse models of type 1 and 2 diabetes.. The signs of the disease quickly reversed, and stayed that way even a month after stopping the treatment.
The results are intriguing, but of course being an animal study means there’s still much more work to be done before it could find clinical use. So far, harmine alone has recently undergone a phase 1 clinical trial in humans to test its safety and tolerability, while other DYRK1A inhibitors are planned for trials in humans next year.
https://newatlas.com/medical/diabetes-reversing-drug-boosts-insulin-producing-cells/
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Stem cell–derived beta-cell replacement therapy continues to show benefit in people with type 1 diabetes at a high risk for severe hypoglycemia. New info from Vertex shows that of a total 17 patients who received a full dose of their investigational allogeneic stem cell–derived, fully differentiated pancreatic islet cell replacement therapy (VX-880), three, thus far, have achieved the primary study efficacy endpoint of elimination of severe hypoglycemic episodes with A1c < 7% at 1 year and the secondary endpoint of insulin independence.
Others are on the same trajectory, Piotr Witkowski, MD, PhD, professor of surgery at The University of Chicago, Chicago, said at the recent American Diabetes Association (ADA) 84th Scientific Sessions. In his presentation, Witkowski also provided details about the deaths of two study participants that the company had announced in January 2024, neither of which were related to the VX-880 product.
In fact, there have been no severe adverse events related to the product itself, with most due to either the infusion procedure or the immunosuppression. "These data highlight the curative potential of VX-880 in people living with type 1 diabetes and support further evaluation of VX-880 toward pivotal development," Witkowski said.
For now, patients selected for the study are those who experience frequent severe hypoglycemia deemed to be a greater risk to the patient than that of immunosuppression.
However, Ahn pointed out, "With VX-880, the obvious fly in the ointment is the need for immunosuppression which carries significant risk…There are multiple solutions being proposed, but we are still waiting for data as promising as the initial Vertex data is on that front."
https://www.medscape.com/viewarticle/stem-cell-derived-islets-continue-show-benefit-t1d-2024a1000cx1
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Still lots of COVID studies coming in about type 1. A German study suggests COVID 19 may speed up progression of existing but presymptomatic T1D in kids.
These researchers had been screening and following children in an early presymptomatic stage of type 1 diabetes for several years. They noticed an increase in the numbers of Incidence of clinical type 1 diabetes nearly doubled after the pandemic started.
"We know that the virus can infect the pancreatic islets so it could be causing damage or change in the beta cells that make insulin," said Ziegler when discussing possible mechanisms behind this association. "Second, there is generalized inflammation during the infection and there may be a stimulation of the immune response. Third, there could be metabolic stress from the infection that affects the beta cells that make insulin.
To dive into this topic, youth were identified in the German Fr1da-screening program from 2015 to 2023. All patients had presymptomatic diabetes defined as persistent, confirmed positive results for two or more islet autoantibodies. Their progression was monitored at 3- to 6-month intervals. Clinical type 1 diabetes was defined according to American Diabetes Association
COVID infection was either self-reported via the family or identified with SARS-CoV-2 antibodies were confirmed in blood samples collected at study visits.
Vaccination against COVID-19 may be one way to protect presymptomatic type 1 diabetes youth from progression, Ziegler added. She said her group is currently testing whether COVID-19 vaccination can reduce new-onset, presymptomatic type 1 diabetes in a clinical trial of children with genetic risk factors for the condition.
https://www.medpagetoday.com/endocrinology/type1diabetes/111084
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The FDA says no – for now - to Novo Nordisk's weekly insulin. This has been approved in Canada and should be available there shortly. But the FDA says it wants more information related to the manufacturing process and the type 1 diabetes indication to complete the review.
Novo said it does not expect to be able to fulfil the requests this year, and that it will work closely with the FDA regarding the next steps.
The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1 diabetes due to risks of low blood sugar.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-novo-nordisks-weekly-insulin-2024-07-10/
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A couple of weeks ago we spoke to the attorneys taking on CGM monitronig in schools. They’ve helped a family in Connecticut and set a precdent. A child with autism and diabetes was not getting reasonable accommodations under the federal Americans with Disabilities Act in a public preschool program. I’ll link up the press release from the DOJ but this family wasn’t getting any support and it just wasn’t safe. The lawyers here tell me the ruling and settlement is just going to help them going forward as they try to make schools complient with CGM as a reasonable accomodatin.
https://www.justice.gov/usao-ct/pr/aba-therapy-provider-make-changes-comply-americans-disabilities-act
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Ozempic could lower the risk of dementia and a range of other mental problems compared with other existing treatments for patients with diabetes. What’s more, researchers found that Ozempic cut nicotine dependence in those patients.
This study relied on medical records from more than 100,000 U.S. diabetes patients, including more than 20,000 who were prescribed semaglutide between December 2017 and May 2021.
After a year, patients who took Ozempic had a 48% lower risk of developing dementia than those on Januvia. The risk in Ozempic patients was also 37% lower than those who took Glucotrol and 9% lower than those on Jardiance.
Notably, previous research has determined that diabetes patients are at a greater risk of developing dementia.
But the authors emphasized that the analysis is observational. The results need to be replicated in a controlled trial that assigns patients to randomly take Ozempic and the other drugs, according to Dr. Max Taquet, another Oxford clinical lecturer and senior study author.
https://www.cnbc.com/2024/07/16/healthy-returns-ozempic-may-lower-dementia-risk-nicotine-use.html
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Edgepark Commercial
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The Omnipod 5 with Dexcom G7 integration is now available through select pharmacies with full availability expected in the fall.
The System uses new Pods that are compatible with both Dexcom G6 and G7, but the prescription code will stay the same as the current Omnipod 5 Pods. This means the community will have similar insurance coverage and access to what they have with Omnipod 5 today.
If you're looking to start on Omnipod 5 and you're currently using Dexcom G7, your doctor will need to send a prescription for both the Omnipod 5 Intro Kit and Omnipod 5 Pods, compatible with Dexcom G6-G7, to ASPN Pharmacies.
You can learn more at https://www.omnipod.com/innovation/dexcom-g7.
If you are already using Omnipod 5, you will get the new Pods compatible with Dexcom G6 and G7 through your Pod refills. You do not need a new prescription. The week of July 29th, you will receive a free software update for the Omnipod 5 App to your Controller or compatible Android smartphone which is needed to use the System with Dexcom G7. Accept the update. We recommend you continue to use your current Omnipod 5 Pods and Dexcom G6 supplies until the new Pods compatible with Omnipod 5 with Dexcom G6-G7 are available at your preferred pharmacy.
We'll email our users when the new Pods are available in most pharmacies.
You can learn more at
https://www.omnipod.com/innovation/new-compatible-devices
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Big promises about long-term implantable blood glucose monitor from a company called Focus. They say they’re partnering with Glucotrack to quote - transform how people with diabetes interact with their condition.
They’re not calling this a CGM – rather it’s a CBGM, continuous blood glucose monitor because it will measure glucose levels in blood, not in interstital fluid like CGMs do. They company says this is a fully subdermal location, with no external wearable. In preclinical studies, the CBGM has a MARD of 4.7% at day 90. That is MUCH lower than CGMs on the market – Dexcom and Libre are in the low 8s right now. BUT.. it hasn’t been fully tested in people yet. Human clinical trials are set to start later this year.
https://www.drugdeliverybusiness.com/focus-collaborates-glucotrack-implantable-cbgm/
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Big congrats to Jamie Ferrer (Chy-may Fer-rare)
On Monday, Ferrer’s dream was realized when the Twins selected the Florida State outfielder in the fourth round (No. 126 overall) during Day 2 of the MLB Draft. Minnesota vice president of amateur scouting Sean Johnson said the club had its eyes on Ferrer since high school.
“Recently, I was in Orlando at a conference called, “Friends for Life with CWD [Children with Diabetes],” and we had an event that was a sports day. … Kids would come up to me and either them or their families would ask me how I dealt with this [or that],” Ferrer said. “And seeing their faces light up whenever I said I was diagnosed at three and I played college baseball. … You hear people tell you no and that you can’t do this because you have Type 1 diabetes … So why not inspire as many people as I can?”
“I’m super proud of being a Type 1 athlete, and it’s something that I’ll never shy away from talking about or showing off my insulin pump because it’s who I am and it’s something that I’ve had to deal with my entire life.”
https://www.mlb.com/news/jaime-ferrer-selected-no-126-overall-by-twins-in-2024-mlb-draft
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This week, I think it’s fair to say that we all struggle with insurance issues. Diabetes – or any chronic condition – increases the hoops we jump through, the expense and the stress. I’m talking to Emily Adams an employee benefits consultant to get some advice about how to navigate. Emily thought she knew the system pretty well, but then her daughter was diagnosed with type 1 and she learned on a personal level how complex our system is.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
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When my son was diagnosed with type 1 more than 17 years ago, the day he’d leave home seemed very far away, but also something we knew we needed to plan for. Well, Benny finished his Freshman year of college – he goes to school 300 miles away – and he’s here to talk about it. We answer your questions about how it went, how he managed, how I managed and what’s next.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Previous episodes with Benny
Previous episodes with Lea
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
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Learn about Dexcom
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Check out VIVI Cap to protect your insulin from extreme temperatures
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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!
Find out more about Moms' Night Out
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
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Learn about Dexcom
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Reach out with questions or comments: [email protected]
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 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!
Join us again soon!
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Stacey sits down with Dexcom’s CEO for an in-person interview at ADA Scientific Sessions. Dexcom made a little bit of news at the conference, but it’s a less-trumpeted replacement policy that had you all asking a lot of questions. We’ll go through the latest news, updates, sensor issues, and a peek into the future with Dexcom’s CEO Kevin Sayer.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
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Reach out with questions or comments: [email protected]
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DIY Pioneer Dana Lewis was diagnosed with something called EPI – exocrine pancreatic insufficiency a couple of years ago. She’d never heard of it and was shocked to find out diabetes is considered a common co-condition. In fact, 20-30 percent of people with diabetes can end up with EPI. EPI can cause a lot of discomfort and stomach issues – and health issues if left untreated. Of course, Dana jumped in, publishing a review of studies and now- creating studies of her own. She’ll explain what she’s doing, why she needs your help, and more about this condition that doesn’t get much attention.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Find your Exocrine Pancreatic Insufficiency Symptom Score using Dana Lewis's new tool: https://danamlewis.github.io/EPI-PEI-SS/
Learn more from Dana here
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
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It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: South Africa runs out of insulin pens - and why this could happen anywhere, once-weekly insulin is approved in Canada, update on Omnipod 5 with Dexcom G7 rollout, more older people are getting type 1 but more people are living longer with it, CGM at the Olympcs and more!
Find out more about Moms' Night Out
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
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Facebook (Group)
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Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
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 the news is brought to you by Edgepark simplify your diabetes journey with Edgepark
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Quick note – the American Diabetes Association Scientific Sessions is this weekend. That means new research studies will be released, technology announced, and likely lots of news will be made. I’m recording this before the conference starts – if there’s enough going on we may have an additional In the News next week.
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Our top story right now…
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No more insulin pens for South Africa.. .as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs. Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen.
Novo Nordisk’s drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A month’s supply of Ozempic in the United States costs about $1,000, far more than insulin.
Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound.
Novo Nordisk is continuing to supply human insulin in vials to South Africa, where more than four million people live with diabetes, but pens are considered much easier to use and more precise.
The vial system was phased out for most South Africans in 2014. But recently, South Africa’s National Department of Health instructed clinicians that they should teach patients how to use vials and syringes of insulin instead of pens.
I posted about this already and said this is a canary in the coal mine and everyone going to ADA should be asking Novo and Lilly about this. GLP medications are fantastic but insulin cannot be left behind.
https://www.nytimes.com/2024/06/19/health/insulin-pens-south-africa-ozempic-wegovy.html
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Once a week basal insulin – for type 1 and type 2 – comes to Canada. Novo Nordisk announced that it’s version of insulin icodec will be available starting June 30th. They are calling it.. Awiqli – I promise I didn’t make that up. Canada is the first country to get the product.
Awiqli works as a time release of insulin over the course of a week. It is more expensive. And Canada's Drug Agency, which assesses drugs and recommends whether they should qualify for reimbursement under public drug plans, is still doing the math here. No word on private insurers coverage yet.
An FDA advisory board recently passed on approving weekly basal for people with type 1, saying the risk of low blood sugar was too great. But the full FDA hasn’t yet weighed in.
https://www.ctvnews.ca/health/world-s-first-weekly-insulin-injection-coming-to-canada-in-2-weeks-manufacturer-says-1.6929321
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The prevalence of people over 65 living with type 1 diabetes went up 180% in the past 30 years, a new study finds. That’s an increase of 1.3 million people over 65 in 1990 with the disease to 3.7 million in 2019, the authors noted in a study published on June 12 in The BMJ. Data included people from 204 countries and territories from 1990 to 2019.
Dying from type 1 diabetes slipped by about 1% every year since 1990, the data also showed. The mortality for people 65 and up went down by 25% during the three decades covered in the study.
The most rapid prevalence was in North Africa and the Middle East, and Western Europe, and the slowest increase in prevalence was in North America. All 21 regions around the world had an increased prevalence of type 1 diabetes in people over 65.
The disease no longer contributes to a reduced life expectancy for many people due to medical care improvements, say these researchers.
https://www.mcknights.com/news/report-type-1-diabetes-prevalence-in-older-adults-nearly-triples-since-1990s/
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Hearing more about the limited rollout of Omnipod 5 with the Dexcom G7. This was announced in February but just seems to really be getting underway. A few people have received emails that people new to the system will be getting this first.. but that at the end of July current users will get a controller update so they can use G7 with the current pods. We’ll have more on this soon – I don’t have a link for you - but thanks to all of you who sent me those emails very much appreciate it.
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New life possible for Korean insulin pump EOPatch– this is a competitor to the Omnipod. A court has killed an injunction that meant the company, EOFlow, could not bring the patch pump to the US. Last year, the court initially granted that injunction and Medtronic backed out of an acquisition plan. No word yet from Medtronic if that deal is back on.. or if another company may work to bring EOFlow to the US.
https://news.bloomberglaw.com/business-and-practice/ban-against-insulin-pump-patch-sales-reversed-by-federal-circuit
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The CeQur Simplicity patch is now FDA-cleared for up to 4 days of wear. This is a mechanical patch pump that replaces fast-acting injections. This is an extension from 3 days to four.. now each patch replaces up to 12 injections making it the longest wearable insulin delivery patch. The company says that can be 1000 fewer shots a year. Marketed mostly to people with type 2 diabetes who use insulin, the company says nearly 90% of patients using CeQur Simplicity reported following their insulin regimen better as compared to multiple daily injections.(4) The patch is clinically proven to improve glycemic control, with patients achieving significantly improved A1C and time-in-range (TIR) goals.(5,6)
https://www.prweb.com/releases/cequr-simplicity-a-wearable-mealtime-insulin-delivery-device-obtains-fda-clearance-for-4-days-of-wear-to-further-simplify-diabetes-management-302173938.html
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A warning from Roche which says “dangerous counterfeits” of its diabetes medical devices ended up for sale on Amazon. Roche accused manufacturers and sellers based in India of selling counterfeit versions of test strips for its Accu-Chek glucometers. This is part of a federal lawsuit. Roche said the counterfeit test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche’s registered U.S. trademarks and fake expiration dates.
After the suit was filed, a judge granted Roche’s request for a temporary restraining order to stop the defendants from selling the counterfeit products. The Amazon stores that were offering the products for sale appear to have been taken down.
Amazon is not a defendant in the case, but Roche claims that as part of the alleged scheme all of the counterfeit products sent to the U.S. were stored at Amazon warehouses across the country, including in Brooklyn.
https://www.cnbc.com/2024/06/10/roche-counterfeit-diabetes-medical-devices.html
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Edgepark Commercial
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Summer Olympics this year may be a showcase for CGMs. Abbott is sponsoring a Dutch long distance running, he’ll be wearing the Libre. Other athletes are using the CGMs in training and may wear as allowed in their sports. There isn’t a lot of proof yet that these devices make a big difference for people without diabetes.. but high level athletes are looking for any edge possible. Expect to hear a lot more about this in the lead up to the Olympics July 26th.
https://learningenglish.voanews.com/a/olympic-athletes-turn-to-diabetes-technology-in-medal-chase/7653234.html
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Join us again soon!
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Scott Strumello has lived almost 50 years with type 1. Diagnosed as a child in the 70s, he found the online community and started blogging. Scott has a unique perspective – with a background in finance and consulting, he’s a reliable source of what’s happening in earnings calls, legislation, and the business of diabetes. We have a great talk about what’s coming in terms of biosimilars, the role of PBMs and some legal action that may happen this year.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Stacey's webinar with Breakthrough T1D Mountain West Chapter
The Breakthrough T1D announcement video
Find out more about Moms' Night Out - registration is open for Denver and Philadelphia!
Please visit our Sponsors & Partners - they help make the show possible!
Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)
Omnipod - Simplify Life
Learn about Dexcom
Edgepark Medical Supplies
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
Drive research that matters through the T1D Exchange
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Facebook (Group)
Facebook (Page)
Instagram
Twitter
Check out Stacey's books!
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: [email protected]
- Visa fler
