It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: a new insulin pump gets FDA approval, once-weekly basal insulin for type 2 gets through another trial, New Jersey caps insulin prices for some, possible link between ability to chew and glucose control, a landmark diabetes study moves on to aging and T1D, JDRF Children's Congress and more!
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Please visit our Sponsors & Partners - they help make the show possible!
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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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by AG1. AG1 helps you build your health,
foundation first.
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Our top story, Tandem’s Mobi Pump is approved. The FDA cleared the tiny pump for people with diabetes ages six and up. Tandem says mobie is fully controllable from a mobile app and is the world’s smallest durable AID system. It still has a button on the pump to dose and holds 200 units. You use the same infusion set as the current Tandem pumps and Mobi uses Control IQ. Limited release planned for late this year and fully available early 2024.
https://www.drugdeliverybusiness.com/fda-clears-tandem-mobi-automated-insulin-pump/
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Learning more about a newly approved therapy for type 1 diabetes called Lantidra. Two safety and efficacy studies found that 21 participants who took Lantidra did not need to administer themselves insulin for a year or more. Twelve of those participants did not need to take insulin for up to 5 years, and 9 did not need insulin for over 5 years.
Lantidra is an allogeneic (donor) pancreatic islet cellular therapy. In other words, Lantidra uses cells taken — or isolated — from human organ donor pancreases. “In [a] subsequent process, the insulin-producing islets are purified from the rest of the pancreatic tissue using a density gradient. Once the islets are isolated, purified, and put for a short time in cell culture, the cell preparation is infused into the liver of the recipient,” he explained.
https://www.medicalnewstoday.com/articles/fda-approves-first-cellular-therapy-for-type-1-diabetes-what-does-it-do#How-does-islet-cellular-therapy-work?
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Once weekly basal insulin for type 2 gets through another trial. After 26 weeks of treatment and five weeks of follow-up, patients on weekly insulin icodec had significantly larger improvements in their HbA1C than those using daily insulin. Both groups had an extremely low rate of adverse events. These researches say next step is FDA evaluation.
https://www.utsouthwestern.edu/newsroom/articles/year-2023/july-weekly-insulin-found-safe.html
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That’s the idea behind Fractyl Health’s treatment for type 2 diabetes—which could also be used for weight control. The Lexington, Massachusetts-based biotech company is in the early stages of developing a one-time gene therapy intended to lower blood sugar and body weight using the same mechanism as semaglutide. “You have this problem where you need to stay on therapy for efficacy,” says Harith Rajagopalan, a cardiologist by training and CEO and cofounder of Fractyl Health. “That’s the Achilles heel.” The company wants to deliver an artificial gene to the pancreas that continuously produces the GLP-1 hormone so there’s no need for weekly injections. The approach, called gene therapy, uses inactivated viruses to carry a therapeutic gene to pancreatic cells. (Viruses are used because of their natural ability to deliver genetic material to cells.) The company is aiming to begin an initial human trial by the end of 2024
https://www.wired.com/story/a-one-time-shot-for-type-2-diabetes-a-biotech-company-is-on-it/
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Gov. Phil Murphy signed three bills into law Monday aimed at cutting the high cost of prescription drugs in New Jersey.
The new laws will cap how much residents will pay for some popular medications such as insulin, prevent pharmacy benefit managers from engaging in practices that make drugs more expensive, and create a panel that will monitor prices set by pharmaceutical companies. One measure (S1614) would cap the cost of insulin, epinephrine auto-injector devices and asthma inhalers for state and local public workers enrolled in the State Health Benefits Program, the School Employees’ Health Benefits Program and other state-regulated plans. For a 30-day supply, insulin will cost $35, EpiPens $25 and asthma inhalers would be capped at $50, according to the bill. The law takes effect next year.
https://www.nj.com/politics/2023/07/new-laws-to-stem-high-cost-of-prescription-drugs-in-nj-were-just-signed-by-gov-murphy.html
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The European Medicines Agency (EMA) said on Tuesday it has extended its probe into Novo Nordisk's (NOVOb.CO) diabetes drugs Ozempic and weight-loss treatment Saxenda, following two reports of suicidal thoughts, to include other drugs in the same class.
The agency began its review on July 3 after Iceland's health regulator flagged the reports of patients thinking about suicide and one case of thoughts of self harm after use of Novo's drugs.
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-extends-ozempic-probe-include-other-drugs-2023-07-11/
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We often hear that diabetes can lead to problems with your teeth.. but one researcher says it might be the other way around. A University at Buffalo researchers says there is a notable correlation between chewing functionality and blood glucose levels in people with type 2.
Specifically, he found that patients with T2D who maintain a full chewing ability exhibit significantly lower blood glucose levels compared to those with compromised chewing function. The thinking here is that chewing stimulates the body in all sorts of ways, including releasing hormones that help you feel fuller and help in digestion. More studies are expected.
DOI: 10.1371/journal.pone.0284319
https://scitechdaily.com/the-surprising-connection-between-chewing-and-type-2-diabetes/
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The next step of the landmark Diabetes Control and Complications Trial will focus on aging with type 1 diabetes.
The original randomized DCCT clinical trial results, published September 30, 1993, in the New England Journal of Medicine, proved that early intensive glycemic control was the key to preventing or slowing the progression of long-term eye, kidney, and nerve complications of type 1 diabetes. Subsequently, EDIC has yielded many more major findings including that early tight glycemic control also reduces cardiovascular risk and prolongs survival in type 1 diabetes.
subsequent EDIC data also have suggested that it is never too late to initiate intensive glycemic control
Together, DCCT and EDIC — both funded by the National Institutes of Health at 27 sites in the United States and Canada — have changed the standard of care for people with type 1 diabetes Prior to the DCCT, between 1930 and 1970, about a third of people with type 1 diabetes developed vision loss and one in five experienced kidney failure and/or myocardial infarction. Stroke and amputation were also common, DCCT/EDIC chair David M. Nathan, MD, said while introducing the symposium.
"All of the advances in care of type 1 diabetes have developed because this study demonstrated that it was important — continuous glucose monitoring (CGM), new insulins, better [insulin] pumps…I think the most profound finding is that mortality in our intensively treated cohort is the same as in the general population. That says it all," Nathan told Medscape Medical News.
https://www.medscape.com/viewarticle/994221
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Commercial – AG1
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Today, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, urged members of the Senate Appropriations Committee to renew the Special Diabetes Program (SDP) and support policies to ensure insulin is available at an affordable and predictable price. Opened by U.S. Senator Patty Murray (D-WA) and led by U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), the hearing took place during the 2023 JDRF Children's Congress, a biennial event that brings over 160 kids and teens living with T1D face-to-face with lawmakers and top decision-makers. The youth delegates traveled to Washington, D.C. from across the country and JDRF's international affiliates in the United Kingdom, Australia, the Netherlands, and Canada.
The SDP has accelerated the pace of T1D research through a long-term investment of funding at the National Institutes of Health. The program has led to significant scientific breakthroughs, including Tzield, the first disease-modifying treatment for T1D, which can delay the onset of the disease by over two years. Without Congressional action, the SDP will expire at the end of September.
"The Special Diabetes Program has fundamentally changed what it means to live with diabetes, put new life-changing therapies in our hands, and brought us closer to cures," said Aaron Kowalski, Ph.D., JDRF CEO. "We must keep this momentum going so we can capitalize on the progress to date and realize cures. However, until we have cures, people need access to affordable insulin. JDRF urges Congress to pass the bipartisan INSULIN Act of 2023, which will establish a $35 per month insulin copay cap for people with commercial insurance and includes other provisions that would make insulin more affordable for everyone, regardless of insurance status."
Dr. Kowalski was joined at the hearing by Dr. Griffin Rodgers, Director of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, who provided testimony on the scientific value of the SDP, and Jimmy Jam, award-winning producer, songwriter, musician, member of the Rock & Roll Hall of Fame, and T1D parent.
"My son Max, who is now in his twenties, was just two years old when he was first diagnosed with type 1 diabetes. Late nights working on music became late nights working on music and waking up my son to test and manage his blood sugar levels," said Jimmy Jam. "Type 1 diabetes should be one of those things we can all agree on. Diabetes doesn't care if you're a Democrat or a Republican. We can all agree that there should be research to improve the lives of those with diabetes. We can all agree that insulin should be affordable for all who need it."
Two 2023 JDRF Children's Congress delegates shared their T1D experience with the committee:
Maria Muayad: 10-year-old Maria is from Maine and is a member of her school's civil rights club and math challenge group. Every November, Maria, and her mother, Golsin, give blue ribbons to the staff at her school in honor of National Diabetes Awareness Month.
Elise Cataldo: 15-year-old Elise lives in New Hampshire and is passionate about educating those around her about life with T1D and tries to use things like pump site changes and blood sugar checks as opportunities to help others learn.
Following the hearing, the 2023 JDRF Children's Congress delegates continued their advocacy by meeting with lawmakers in their Capitol Hill offices.
https://www.prnewswire.com/news-releases/2023-jdrf-childrens-congress-delegates-urge-lawmakers-to-support-type-1-diabetes-research-and-access-to-affordable-insulin-301874927.htmlXX
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A 23-year-old with type 1 diabetes has broken the record for circumnavigating Britain in a kayak after paddling 2,000 miles in 40 days. Dougal Glaisher beat the previous record by 27 days.
Glaisher was diagnosed with type 1 diabetes at the age of 19 shortly after winning the Oban Sea Kayak race in Scotland, when he had blurred vision and struggled to recover his energy.
The expedition was to raise money for the UK-based charity Action4Diabetes and Glaisher livestreamed his blood sugar
On Tuesday he was well stocked with a bunch of bananas and a stash of cereal bars lashed to his boat. But in remote areas it was more challenging. Around the islands off Scotland he ran out of freeze-dried meals and survived on porridge for several days. He also sourced drinking water from streams.
. It is the first time anyone has used a surfski – a kayak that you sit on top of – to paddle around the country.
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On the podcast next week.. I sat down with Dexcom’s new Chief Commercial officer to talk about their announcements from this week about the type 2 market and other features important to people with type 1. Our last epoisde is all about Kickass Healthy LADA
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: FDA approval for a pancreatic islet cell therapy to treat type 1, stem cell research moves ahead, big news from the ADA Scientific Sessions about what's next for medications like Mounjaro and a pill form of semaglutide. Dexcom announces a sensor for people with type 2 who don't use insulin, Libre moves ahead with Ketone monitoring and more.
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by the T1D Exchange a nonprofit organization dedicated to improving outcomes for the entire T1D population.
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Big week of news following the 2023 ADA Scientific Sessions conference. What follows is just the tip of the information iceberg, so please follow the links in the show notes to much more.
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Top story though isn’t from ADA – but a new FDA approval.. for a pancreatic islet cell therapy to treat type 1. It’s called donislecel, developed from cadaver donors and giving as a single infusion straight into the liver. Immunosuppression is required to maintain cell viability, just as it is required to support a transplanted kidney or other organ.
Approval was based on what seems to be a very small study – 30 people with type 1 who had hypoglycemic unawareness and who received between one and three infusions of donislecel. After one year, 11 people did not need to dose insulin.. 10 stayed that way for more than five years. But five people in the study were not able to stop dosing insulin at all. This method is different from what Vertex and Sernova are trying to do with stem cell therapy.
https://www.medscape.com/viewarticle/993854
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Vertex moves forward on their clinical trial of islet stem cell therapy. All six patients treated with VX-880 had undetectable fasting C-peptide (endogenous insulin secretion) at baseline, a history of recurrent SHEs in the year prior to treatment and required an average of 34.0 units of insulin per day. Following treatment, all six patients demonstrated endogenous insulin secretion, improved glycemic control as measured by HbA1c, improved time-in-range on continuous glucose monitoring, and reduction or elimination of exogenous insulin use. Two patient are completely insulin independent after one year – with an A1C of 5.3 compard to 8.6 at baseline.. the other 6.0 with a 7.6 at baseline – again the ”after” number is without taking insulin.
As a result of these safety and efficacy data in Parts A and B, the independent data review committee has recommended moving to Part C of the trial, which allows for concurrent dosing of patients at the full target dose of VX-880.
https://www.businesswire.com/news/home/20230623446641/en/Vertex-Presents-Positive-VX-880-Results-From-Ongoing-Phase-12-Study-in-Type-1-Diabetes-at-the-American-Diabetes-Association-83rd-Scientific-Sessions
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Sernova also reports good results with their cell pouch system. Five of the six patients who have completed implantation continue to experience insulin independence for periods ranging from six months to more than three years. The sixth patient only recently completed the protocol-defined islet transplants.. so no results yet. There is a second group testing a larger cell pouch.
https://www.drugdeliverybusiness.com/sernova-interim-data-cell-pouch-system/
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Big news from ADA about all of the type 2 and obesity drugs you’ve likely heard about.. here are some headlines:
SURMOUNT-2 clinical trial evaluating tirzepatide – brand name Mounjaro - for weight loss in adults with obesity or overweight and type 2 diabetes.
Average weight loss was 15.7% at the highest dose, with many other health benefits such as lower A1C levels; reduction in waist circumference, and body mass index; and improvements in cardiometabolic disease risk factors such as lipid levels, cholesterol, and blood pressure.
That 15 percent weight loss was about 34 pounds and the a1c reduction for half of those in the study went down to 5.7 which is considered nondiabetic. Mounjaro is currently approved for type 2 and the FDA could approve Mounjaro regardless of diabetes status later this year.
https://diatribe.org/new-lilly-trial-results-show-big-weight-loss-results-positioning-mounjaro-obesity-drug-approval
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A study called PIONEER looks at oral semaglutides – some calling it the Ozempic pill. When compared to other anti-diabetic medications such as Jardiance, Januvia and Victoza, people taking the oral semaglutide say 1% or or more reduction of HbA1c compared to those treated with other anti-diabetic medicines. They also were more like to achieve a 5% or more reduction of body weight. Note: this was not a study comparing a semaglutide pill with the same type of injection.
https://www.news-medical.net/news/20230607/Oral-semaglutide-outperforms-other-medications-in-type-2-diabetes-treatment-significantly-reducing-HbA1c-and-body-weight.aspx
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And look for two additional new drugs to treat obesity in the next few years.. orforglipron, is easier to use and to produce, and it will probably be cheaper than existing treatments. The second, retatrutide, has an unprecedented level of efficacy, and could raise the bar for pharmacological obesity treatment.
Orforglipron and retatrutide both mimic hormones produced by the lining of the gut in response to certain nutrients. These hormones help to slow the passage of food through the digestive tract and lower appetite by acting on receptors in the brain — both effects that reduce people’s desire to eat and help them to lose weight. Orfoglipron is a non-peptide molecule that researchers say is easy to produce and is a pill.. a lower price is anticipated for this one. Retratritude looks like it could help people lose even more weight than Mounjaro.
https://www.nature.com/articles/d41586-023-02092-9
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Dexcom announces a new product in the US – coming in 2024 – designed for people with type 2 who don’t use insulin. This will be built on the G7 hardware, but with different software and a 15 day sensor.
CEO Kevin Sayer also announced that the G7 will be able to share data direct to the apple watch
https://www.businesswire.com/news/home/20230623025076/en/Global-Continuous-Glucose-Monitoring-Pioneer-Dexcom-Reveals-New-Plans-to-Bring-Sensing-Technology-to-Millions-More
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Abbott will partner with Weight Watchers - people who have been prescribed one of Abbott’s FreeStyle Libre 14-Day or FreeStyle Libre 2 sensors and who are using the WeightWatchers diet plan to see their CGM data directly in the WeightWatchers app.
This is also a study where Abbott will launch two pilot programs directed at using CGM data to help people with Type 2 diabetes adjust and manage their dietary habits, regardless of whether they’re on insulin therapy.
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A little bit more news about Abbott’s dual glucose and ketone sensor under development. Announced a last year’s ADA, the company says it’s moving forward through R&D
Separately from the Type 2 CGM push, Taub also offered an update on the dual glucose ketone sensor that’s currently under development at Abbott and that the company first announced at last year’s ADA conference. The sensor will be aimed at catching rising ketone levels as early as possible to help avoid cases of diabetic ketoacidosis. An Abbot executive says – quote - “There’s so much that we stand to learn about ketones because there hasn’t been a continuous sensor for them before, so there’s really very little we know about the evolution of ketones “
https://www.fiercebiotech.com/medtech/ada-abbott-pushes-widespread-cgm-use-type-2-diabetes-weightwatchers-ada-collabs
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Commercial
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Beta Bionics has received FDA 510(k) clearance for the compatibility of the Fiasp Pumpcart prefilled insulin cartridge with the iLet automated insulin-delivery system.
The iLet is a bionic pancreas that fully automates 100% of all user insulin doses, providing users with the choice of three insulins, Novolog; Humalog; and Fiasp Pumpcart.
The device eases diabetes management in everyday life and almost eliminates the expertise that has been required in the past to set up and manage a traditional insulin pump. In May 2023, Beta Bionics was awarded FDA approval for the iLet device.
The iLet manages glucose levels with just a meal announcement and is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.
All that is required for set-up is the user’s weight. While there is a need for carbohydrate awareness, no carb counting is necessary. Bolusing, correction factors, insulin-to-carb ratios, and pre-set basal rates are also unnecessary.
Beta Bionics president and CEO Sean Saint said: “Beta Bionics has been working tirelessly to create an insulin delivery system that offers less burden and more convenience for the type 1 community. Since launching last month, the iLet bionic pancreas is now available and clinics and users are being trained on its simple design and easy management features.
“When Fiasp Pumpcart prefilled cartridges are available, users will save time not having to manually fill cartridges and will have more choice for their diabetes management.”
https://www.medicaldevice-network.com/news/beta-bionics-gains-fda-clearance-for-prefilled-insulin-cartridge/
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Oura – the ring that tracks your sleep – will start sending info to three CGM info companies.. January, Supersapiens and Veri. All three of these companies provide software based off of the Libre CGM. These companies will now be receiving sleep scores and other biometric data from Oura so they can see how these measurements affect users’ glucose levels and overall health.
https://www.forbes.com/sites/andrewwilliams/2023/06/27/oura-smart-ring-can-be-used-to-help-monitor-blood-sugar/?sh=2520116c2b10
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Just a fun fact here – there is a Facebook group called type 1 diabetics for 50 plus years. And it looks like this week they passed over 1500 members.
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On the podcast next week.. I sat down with Dexcom’s new Chief Commercial officer to talk about their announcements from this week about the type 2 market and other features important to people with type 1. Our last epoisde is all about Kickass Healthy LADA
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: FDA warning about compounded versions of semaglutides like Wegovy and Ozempic, new research on what people with diabetes who start Go Fund Me campaigns are asking for, Tandem's CEO gives an update on Dexcom G7 and Libre integration, follow-up on the French Open player denied insulin on the court, and more!
Here's more info about Mom's Night Out: https://bit.ly/DMomsNightOut
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Moms Night Out! Treat yourself to some time away with other moms who get it!
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The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain the same ingredients as the prescription products and may not be safe or effective.
Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn’t say what the problems were. The trouble is that those versions, often sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in people.
As of May, Ozempic and Wegovy remain on the FDA’s list of drug shortages. When drugs are in short supply, compounding pharmacies are permitted to produce versions of those medications.
Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said.
https://time.com/6284497/fda-warning-ozempic-wegovy/
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ZVHER-ehv pronounce https://www.youtube.com/watch?v=u8spdvgpIzs
French Open organizers reversed their initial decision denying Alexander Zverev access to insulin injections on the court. Initially they said he’d have to do his injections during off-court bathroom breaks, something players are limited to only two of. Zverev has lived with type 1 since he was three years old? And apparently there were complaints after he injected himself during his fourth-round match. Zverev said he was told it didn’t look right when he injected himself on the court. “This is not a clever take because if I don’t do it, my life will be in danger. But they said it looks weird,” he said.
And it prompted a response from type 1 diabetes research charity JDRF. In an open letter, the charity said: “We would like to emphasise that insulin administration is an essential aspect of type 1 diabetes management, and it should be treated with the same respect and understanding as any other medical intervention.
“It is critical that athletes with diabetes, like Mr. Zverev, are given the necessary accommodations and support to effectively manage their condition while competing. This includes the ability to administer insulin when required, as recommended by their healthcare professionals.”
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Many people with diabetes in the United States have turned to crowdfunding to pay their medical bills, even though a quarter of patients sampled had insurance, according a new study by Duke University researchers.
In the United States, more than 40% of patients with diabetes struggle to pay their medical bills. Among those patients, more than half — 56% — have either delayed or foregone care entirely, Caroline E. Sloan, MD, MPH, a primary care physician at Duke University School of Medicine, and colleagues wrote. One estimate suggested that the average patient who is dependent on insulin and has insurance spends about $4,800 every year on physician visits, supplies, medications, hospitalizations and lost wages — the equivalent to 15% of the median U.S. per capita income.
They evaluated 313 GoFundMe campaigns describing patients’ medical situations, expenses and fundraising goals. The researchers included an oversampling of type 1 diabetes campaigns so they could have roughly even proportions of type 1 and non-type 1 diabetes campaigns “and ensure a wide breadth of experiences.”
Sloan and colleagues found that the median fundraising goal was $10,000, the median amount raised was $2,600, and just 14% of campaigns reached their goal.
Additionally, 25% of fundraisers had insurance, but 49% of those who did have insurance said their out-of-pocket costs were still too high. Fewer than 10% requested money specifically for insulin; 48% of direct medical expenses were not directly related to glucose control.
When it came to characteristics of campaigns for types of diabetes, they found that 21% of total campaigns — almost all of which were campaigns for type 1 diabetes — requested money for diabetic alert dogs. Campaigns not for type 1 diabetes mentioned indirect medical expenses more often than campaigns for type 1 diabetes: 63% vs. 34%.
“Thirty-five percent of patients with type 1 diabetes started fundraising campaigns for diabetic alert dogs, which cost about $15,000 and are not covered by insurance because of high variability in effectiveness,” the researchers wrote. “Clinicians who learn of a patient’s intent to purchase a dog could redirect them toward proven management strategies, such as continuous glucose monitors.”
https://www.healio.com/news/primary-care/20230613/patients-with-diabetes-are-increasingly-turning-to-gofundme-to-pay-medical-bills
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United Healthcare will now cover the Eversense E3 CGM System for people with type 1 diabetes and people with type 2 who use insulin. That’s as of July 1. The Eversense E3 CGM is inserted just under the skin and stays there for six months.
UnitedHealthcare is the largest health insurance company in the United States
https://finance.yahoo.com/news/senseonics-announces-unitedhealthcare-coverage-eversense-110000925.html
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operational and commercial goals we set for this year,” CEO John Sheridan said in a call with investors on Wednesday afternoon.
That confidence is helped along in particular by the company’s plans for a spate of product expansions and launches later this year.
“Overall, there’s an enthusiasm at Tandem as we approach being able to offer another wave of innovative products to the diabetes community,” Sheridan said. “With these launches, we’ll be building upon our reputation for offering high-quality products and services that reduce the burden of diabetes management.”
Among those launches will be the integration of Dexcom’s G7 continuous glucose monitor sensor and Abbott’s FreeStyle Libre 2 and 3 into Tandem’s t:slim X2 insulin pump system, which Sheridan said would make Tandem’s device “the first FDA-cleared insulin pump integrated with multiple CGM sensors.”
Those additions will come in the form of free, remote software updates, per the CEO, with the first updates slated to begin rolling out in the coming quarters. For each of the three integrated CGMs, Tandem will perform “internal walkabout testing” before adding them to its t:slim system in scaled launches first in the U.S. and then internationally; the process has already begun for Dexcom's G7 and Abbott's Libre 2 sensors, with the Libre 3 on track to be a “fast follow-up” after the previous model’s U.S. launch this fall.
Sheridan suggested that a “meaningful number of customers” could be using a G7-connected t:slim pump by the third quarter, while the FreeStyle Libre version of the tech should reach that same nebulous milestone in the fourth quarter
Alongside the upgrades to its t:slim X2 pump, Tandem is also eyeing an upcoming launch for its new Mobi pump, which is still under FDA review. The pump is about half the size of the t:slim models and can be completely operated via a smartphone app.
“Our dialogue with the agency remains constructive as we work through the process of FDA review and responding to questions,” Sheridan said. “In the meantime, we continue to prepare for its launch in the second half of the year.”
https://www.fiercebiotech.com/medtech/tandem-plots-h2-launch-slimmed-down-insulin-pump-dexcom-and-abbott-cgm-integration
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Researchers at Washington University School of Medicine in St. Louis have identified a process in immune cells that links vitamin D deficiency during pregnancy to an increased risk of Type 2 diabetes in those born from those pregnancies. The research is published June 13 in the journal Nature Communications. Some theories of disease suggest that conditions in utero may have irreversible, lifelong consequences in offspring. The new study's principal investigator, Carlos Bernal-Mizrachi, MD, said that could be happening to the children of mothers who don't have adequate levels of vitamin D during pregnancy.
https://www.news-medical.net/news/20230613/Vitamin-D-deficiency-during-pregnancy-linked-to-an-increased-risk-of-Type-2-diabetes-in-offspring.aspx
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In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I’ve taken the best elements from those events and created a brand new experience. We’re going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D.
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Update on non invasive glucose monitoring.. Know Labs says they’re in the next stage of their Bio-RFID sensor. Lots of behind the scenes and lab advancements here from what I can tell. But they release says:
For 2023, Know Labs remains focused on external validation of its technology and contributing to its growing body of peer-reviewed evidence, which can be found at www.knowlabs.co/research-and-validation. The company will make further refinements to the Gen 1 Device as it works toward realizing its vision for the KnowU and UBand and bringing an FDA-cleared product to the marketplace.
https://www.businesswire.com/news/home/20230607005237/en/Know-Labs-Completes-Build-of-Portable-Generation-1-Prototype-for-Non-Invasive-Glucose-Monitoring
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Dexcom focuses on mental heath during the UK Diabetes Awareness Week. They’ve released a new study showing 84% of people surveyed agree having diabetes can negatively impact mental health. Their news release goes on..
To honor the strength and resilience of the diabetes community, and to promote mental health and connection, Dexcom is encouraging people with diabetes - and their friends and family - to strike a #DexcomWarriorPose by hosting a day of free puppy yoga classes at Puppy Yoga London in Hoxton, London this Saturday 17 June.
https://www.businesswire.com/news/home/20230612005039/en/New-Study-Shows-That-84-of-People-With-Diabetes-Struggle-With-Mental-Health1
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On the podcast next week..
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
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It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Lilly becomes the first of the big three insulin makers to settle a class action lawsuit over pricing, the FDA approved Beta Bionics' iLet system, oral meds trialed for T2D seem to work as well as Ozempic injectable, Lego adds a T1D "friend" to their line and a big win for an American Ninja Warrior competitor with T1D.
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by VIVI Cap Keeps your insulin at the exact right temperature, even in extreme heat or cold.
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Our top story,
Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit accusing the company of overpriced its insulin. As part of the settlement, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. That’s three months after Lilly said it would cut insulin prices to that level.
The lawsuit was filed in 2017, against insulin makers Lilly, Novo Nordisk and Sanofi. Plaintiffs claimed the companies joined in an “arms race” to raise list prices of their meds while the “real” price to pharmacy benefit managers remained constant or in some cases dipped.
Price increases of insulins that previously cost $25 per prescription were pushed up to $450, the suit said. The increases, taken in “lockstep,” were “astounding and inexplicable,” according to the class action lawsuit. Novo and Sanofi have yet to settle this case.
https://www.fiercepharma.com/pharma/eli-lilly-inks-settlement-long-running-insulin-pricing-lawsuit
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The FDA is changing its draft guidance for industry regarding Antidiabetic Drugs and Biological Products. It’s been 15 years since an update. Topics covered in the draft guidance include:
Hemoglobin A1c (A1C), a measure of average blood sugar, remaining an acceptable primary efficacy endpoint
The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C.
The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development. The FDA will be accepting comments on the guidance until August 24, 2023.
https://www.appliedclinicaltrialsonline.com/view/fda-on-track-to-updates-diabetes-efficacy-endpoints-guidance
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The iLet bionic pancreas from Beta Bionics gets FDA approval for people with type 1 age 6 and up. This is a unique system in that it starts with only the user’s weight and requires meal announcements – no carb counting – to automate blood sugar. It will launch with the Dexcom G6 CGM. You’ll hear from the company CEO this Tuesday in our next episode where we do a deep dive into the system.
https://www.medicaldevice-network.com/news/beta-bionics-fda-insulin-pump/
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Researchers had observed an increased incidence of type-1 diabetes cases during the COVID-19 pandemic. Now, a new study has confirmed the link and established a temporal association between the development of type-1 diabetes in children and infection with the SARS-CoV-2 virus.
The new study published in Jama Network was the first research that used data, which indicated if the type-1 diagnosed children previously had COVID-19 infection.
The researchers found the likelihood to develop type-1 diabetes increased by 57% in children who had a confirmed COVID-19 infection, compared to those who did not have the infection.
https://www.medicaldaily.com/covid-19-infection-increases-incidence-type-1-diabetes-children-study-469854
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New oral medication from Pfizer seems to stack up well next to Ozempic for weight loss. New study looked at people with type 2 found danuglipron when given twice a day, lowered blood sugar in patients at all doses and reduced body weight at the highest dose after 16 weeks.
The weight loss with danuglipron is of a similar magnitude to that observed in the mid-stage data for Novo Nordisk's semaglutide, known as Ozempic when used for diabetes and Wegovy for obesity.
The treatments, including Pfizer's danuglipron, belong to a class of drugs that mimic the gut hormone glucagon-like peptide-1 (GLP-1), which works by suppressing appetite and were initially developed to treat type 2 diabetes.
Pfizer is also testing another oral diabetes drug, lotiglipron, which is given once daily and has said it plans to initiate late-stage development of only one of the two candidates.
The company believes an oral therapy could appeal to patients who want to avoid injections.
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-diabetes-drug-reduces-weight-similar-novos-ozempic-2023-05-22/
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Artificial intelligence (AI) algorithms used to screen for and predict type 2 diabetes may be racially biased, which could perpetuate health disparities, according to a study published last week in PLOS Global Public Health.
Risk prediction models for type 2 diabetes have shown promise in bolstering early detection and clinical decision-making, but the researchers pointed out that these models can bias the decision-making process if risk is miscalibrated across patient populations.
The research team found that the Framingham Offspring Risk Score underestimated type 2 diabetes risk for non-Hispanic Black patients, but overestimated risk for their white counterparts.
The ARIC Model and PRT overestimated risk for both groups, but to a greater extent for white patients.
Research like this highlights that while data analytics and AI approaches may help find gaps in chronic disease management and care, racial disparities are still a major obstacle to achieving health equity for diabetes patients.
A 2021 study of city-level data revealed significant disparities in diabetes mortality rates across the United States.
The analysis sourced data from the 30 largest cities in the US and demonstrated that mortality rates were higher for Black individuals than for white individuals. Disparities were also found to be up to four times larger in some cities compared to others, with Washington, DC experiencing the highest rates of diabetes mortality inequities.
https://healthitanalytics.com/news/potential-racial-bias-found-in-type-2-diabetes-risk-prediction-models
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1 in 3 adults with Type 2 diabetes may have undetected cardiovascular disease. Elevated levels
However, mildly elevated concentrations of of two protein biomarkers that indicate heart damage may be an early warning sign of changes in the structure and function of the heart, which may increase the risk for future heart failure, coronary heart disease or death.
Researchers analyzed health information and blood samples for more than 10,300 adults collected as part of the U.S. National Health and Nutrition Examination Survey from 1999 to 2004. Study participants had reported no history of cardiovascular disease when they enrolled in the study.
One-third (33.4%) of adults with Type 2 diabetes had signs of undetected cardiovascular disease, as indicated by elevated levels of the two protein markers, compared to only 16.1% of those without diabetes.
https://medicalxpress.com/news/2023-05-adults-diabetes-undetected-cardiovascular-disease.html
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VIVI CAP
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MTV Documentary Films has acquired worldwide rights to Pay or Die, a film about Americans living with diabetes who face a cruel choice: pay the “extortionate” cost of insulin charged by pharmaceutical companies or risk death.
Scott Alexander Ruderman and Rachael Dyer directed and produced the documentary, which premiered in March at SXSW. MTV Documentary Films plans a theatrical release later this year, followed by a debut on streaming platform Paramount+.
Those personal stories in the film stretch across the country. “From a mother-and-daughter struggling to rebuild their lives after spending their rent money on insulin, to a young adult diagnosed with Type 1 diabetes during the COVID-19 pandemic, to a Minnesota family thrust into the national spotlight when their 26-year-old son dies from rationing his insulin, Pay or Die highlights this devastating struggle to survive while living with diabetes.”
https://deadline.com/2023/05/pay-or-die-mtv-documentary-films-acquisition-directors-scott-alexander-ruderman-rachael-dyer-news-1235382566/
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Katie Bone win the “American Ninja Warrior Women’s Championship” — not only claiming the title but a cash prize of $50,000. She donated $5,000 to the Juvenile Diabetes Research Foundation and Pumped NM.
Bone has not only appeared on three iterations of the competition series, but is also a nationally-ranked rock climber.
While not the youngest competitor anymore, she was the shortest standing at 5 foot, 2 inches. She’s been making waves since competing in “American Ninja Warrior Jr.” in 2020.
To train for the event during the pandemic, her father built a ninja course in their backyard.
During that competition, Bone, who was diagnosed with Type 1 diabetes at 11 years old, competed with both her insulin pump and glucose monitor on her arms.
Being on the show also presents Bone with the opportunity to be an ambassador for Type 1 diabetes awareness and representation.
Bone says Type 1 diabetes didn’t end her life, it just changed it.
“I hope I inspire a little kid to wear their pump on their arm,” Bone said. “It makes everything that you do that more amazing.”
In February, Bone competed at the USA National Women’s Team Climbing trials in Austin, Texas.
During her fourth climb, she fell.
“Katie heard four pops,” Tammy Bone said. “She tore her ACL and both sides of her meniscus. This was a moment she was preparing for all her life and it got put on pause.”
Bone had surgery and has been getting physical therapy in Colorado. The family returned Monday night to New Mexico after being away for three months.
Bone still has her eyes on the Olympics, though the road to recovery may take some more time.
“I don’t need easy, I just need possible,” she said.
https://www.abqjournal.com/2602750/17-year-old-new-mexico-ninja-warrior-katie-bone-takes-the-title-in-womens-championship-competition.html
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Today LEGO has revealed the first wave of Friends sets for 2023, bringing in a new cast of characters and an update to the branding with a new logo. A new LEGO Friends television series will also accompany the new sets. LEGO’s annual Play Well study revealed that 3 out of 4 children felt there were not enough toys with characters that represent them, so LEGO is aiming to bring more diverse representation to Heartlake City that’s inclusive of not just various ethnicities and genders, but also disabilities and neurodivergence. LEGO says the 2023 sets and series will feature characters with limb difference, Downs Syndrome, anxiety, vitiligo, and even pets with disabilities, including a blind dog and a dog with a wheelchair. She has a CGM printed on her arm and even has a printed phone tile showing her blood sugar. Her name is Hannah and she’s in 41744 Sports Center
https://www.brothers-brick.com/2022/10/27/lego-friends-reveals-5-sets-for-2023-with-diverse-characters-to-better-represent-children-news/
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On the podcast next week.. Beta Bionics CEO Sean Saint. Last week I MedT 780G
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: The US Senate grills insulin makers about keeping the price where it is, two studies look at the impact of faster-acting insulins, a new study looks out temperature and insulin storage, researchers examine CGM access and health outcomes, and more
Check out Moms' Night Out with three new dates on the calendar!
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Moms Night Out - Treat yourself to some time away with other moms who get it. Our next stops this fall in Providence, RI and Frisco TX.
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Our top story this week, big Senate hearing on insulin.. The three insulin makers recently cut their list prices by around 70%. The Senate Committee on Health, Education, Labor and Pensions pressed industry leaders and all three – Lilly, Novo Nordisk and Sanofi - committed to “keeping their drugs affordable,”
But asked whether the companies would no longer raise prices on their existing insulins, only Lilly sai yes. The Sanofi and Novo Nordisk chiefs did not.
Sen. Markwayne Mullin, R-Oklahoma, called PBMs “the fox guarding the henhouse,” going after the executives for essentially “rebating themselves." He said the situation “isn’t working for America.”
“This committee is going to stay on this issue," Senator Bernie Sanders said Wednesday. "We need profound change in the industry and in PBMs."
https://www.fiercepharma.com/pharma/bernie-sanders-led-senate-committee-holds-pharma-chiefs-and-pbm-execs-feet-fire-insulin
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Not a big difference between fast-acting insulin aspart and standard insulin. New study using hybrid closed-loop insulin delivery system found that faster acting Fiasp did not offer any additional glycemic benefits compared with standard insulin aspart – Novolog - and participants had more cases of hyperglycemia with ketosis with the Fiasp.
The study cohort had a baseline HbA1c of 7.2% and a time in range of 63.9% at the start of the trial. Of the cohort, 76% was using a hybrid closed-loop insulin delivery system at enrollment.
There were no cases of severe hypoglycemia or DKA during either intervention.
https://www.healio.com/news/endocrinology/20230508/time-in-range-similar-with-fastacting-vs-standard-insulin-for-young-kids-with-diabetes
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On the other hand, people with type 2 diabetes saw more time in range with faster acting insulin. These were adults with type 2 on basal bolus MDI along with CGM. The insulins here with Lyumjev and humalog.
https://link.springer.com/article/10.1007/s13300-023-01400-w
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New study confirming that insulin doesn’t have to be refrigerated as strictly at package instructions. These researchers took 6 different bands and types of insulins and stored them – quote - unopened for 1–4 months in non-refrigerated conditions in a real-world setting during the summer in India, all compared with control samples of each insulin, which remained refrigerated.
Insulin vials were stored in watertight bags. Bags were placed in either an open plastic container stored on a high shelf or in a cupboard, or in clay pots with a separate water compartment. All storage containers were placed in shaded areas The temperature was measured every 15 min by electronic data loggers. The mean maximum temperatures were between 86 and 94 degrees. Most of the insulin stayed fine for two months and much of it for four months. Every study I talk about is linked up at this episode’s homepage at d-c dot com with more specifics.
https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00028-1/fulltext?fbclid=IwAR1J2Y2JLZNHTvlPwtCo7t-wA60zhFMRvx2DEc7sujaFOX1pKc_-RbjhnL0
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Not so shocking conclusion that increasing access to CGMs – regardless of ethnicity and insurance status – can improve outcomes.
Despite higher rates of complications among T1D youths from lower-income backgrounds, diabetes technology is 50% lower among this group. Youths with public insurance have frequent interruptions to CGM access, which are associated with worsening HbA1C trends. Implicit biases and willingness to recommend diabetes technology to youths from underrepresented backgrounds are likely additional contributors to these disparities, according to authors.
Authors concluded the results demonstrated in the study suggest equitable access to CGM soon after T1D diagnosis could be a first step to improve HbA1C for all youths, but acknowledge this access alone is, “unlikely to eliminate disparities entirely.” The authors add broader societal strategies to address structural drivers of disparities in diabetes care are required.
https://www.contemporarypediatrics.com/view/equitable-access-to-glucose-monitoring-improves-hba1c-levels
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Interesting reminder that the seemingly obvious answer isn’t always the right one comes from cataract research..
Cataracts—the clouding of the lens of the eye—are the number one cause of blindness worldwide and are a common complication of type 2 diabetes. The current hypothesis behind diabetic cataract development is coined “the sugar hypothesis” and suggests that high blood sugar—a hallmark of diabetes—precedes cataract development. The working assumptions underlying the sugar hypothesis describe higher levels of glucose in the lenses of people with diabetes convert to a sugar alcohol molecule called sorbitol, which induces structural changes to the lens of the eye that precede cataract development. While unproven, researchers rarely investigate this theory further due to cataracts’ treatable nature.
Now, after some animal studies, it looks like the damage actually starts
before blood glucose rises above normal. The reseahres say it’s still too early to tell what’s going on but they hope ore study will bring the medical community a step closer to understanding the cellular mechanisms underlying the origins of diabetic complications during the pre-diabetic stage of the disease. Then, they say, they can search for ways to better prevent them.
https://scitechdaily.com/sweet-deception-sugar-hypothesis-of-diabetic-cataract-development-gets-an-eye-opening-reality-check/
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Very large study shows that GLP1 receptor agonists—a class of diabetes medications that include Trulicy and Ozempic —are associated with fewer major adverse cardiovascular events than another type of diabetes drug older veterans with no prior heart disease. The second drug type is DPP4 inhibitors with brand names like Januvia and Nesina.
Apparently, the clinical trials showing cardiovascular benefits for these drugs were conducted in people who already had heart disease, so these researchers wanted to see if it would help those who did not. 100-thousand US veterans were included in this study.
The median patient age was 67 years, and the median diabetes duration was 8.5 years. The researchers included variables such as age, sex, race, body mass index, blood pressure, laboratory values like hemoglobin A1c, and history of prior illnesses in the statistical analysis.
https://medicalxpress.com/news/2023-05-diabetes-drugs-adverse-cardiac-events.html
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Ascensia expands it’s Eversense PASS, a Payment Assistance and Simple Savings program designed to enhance affordability and access to the Eversense E3 CGM System. Under the new and improved program, more people with diabetes will be eligible for assistance paying for the system, which now includes increased savings for eligible first time users.
Eligibility for the program has now been extended to all commercially insured people with diabetes across the country, including those who do not have coverage for the Eversense E3 system from their insurance provider.
Eversense is an implanted CGM that lasts six months and has a removable smart transmitter.
https://www.prnewswire.com/news-releases/ascensia-diabetes-care-expands-payment-assistance-and-simple-savings-program-for-eversense-e3-cgm-system-301818639.html
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Right back to the news, but first, I want to tell you about Moms Night Out! In the 16+ years since my son was diagnosed with type 1, I have attended dozens of diabetes conferences and events. Now I’ve taken the best elements from those events and created a brand new experience. We’re going to have lots of diabetes technology for you to see and learn about, stress-relieving social time where you can meet other moms just like you, and speakers who will leave you feeling energized and ready to face the challenges of parenting a child with T1D. We had the first of these in January – I didn’t realize it was the first I actually expect it to be a one and done – but it went to so well and the reaction was so good from moms around the country that I deided to keep going. Our next stops are Frisco TX and Providence RI, back to Charlotte in Feb and more cities to come in 2024. Join us – check out the very top of diabetes-connections dot com or click on the event tab.
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Garmin today announced expanded region availability of the Dexcom Connect IQ apps. Available for a wide range of Garmin smartwatches, the Dexcom Connect IQ app3 provides people with diabetes with a secondary way to view their glucose levels, right from their wrist.
Connect IQ is the app platform for Garmin wearables, bike computers, and outdoor handhelds
https://www.garmin.com/en-US/newsroom/press-release/wearables-health/people-with-diabetes-can-now-view-dexcom-cgm-data-on-their-garmin-smartwatch-or-cycling-computer/
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On the podcast next week.. Neil Greathouse is a familiar face on social media – posting every day as “The Betes.” I’ll catch up with Neil to talk about what motivated this every day connection – he has a real job not in diabetes – and more. Last week I spoke with The Marvelous Mrs Maisel’s Austin Basis about managing T1D on set and off.
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: after a long wait, the FDA approves Medtronics 780G and lifts their warning letter, Omnipod GO for people with type 2 gets approved, a look at insulin in pill form, a new way to treat overnight low blood sugars and lots more!
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by the T1D Exchange, make your voice heard and drive research that matters
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Buckle up there is a LOT going on
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Medtronic’s Minimed 780G AID system gets FDA approval. This is for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders on May 15, 2023. Users of the current MiniMed 770G will be eligible for free remote software upgrades.
The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the UK since 2021. The biggest difference from other systems is that it can automatically administer bolus correction insulin doses every 5 minutes. It will also automatically adjust basal insulin The insulin pump's infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL.
In the pivotal US trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia.
https://www.medscape.com/viewarticle/991091
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U.S. Food and Drug Administration (FDA) lifted Medtronic’s warning letter sent in December 2021.
The resolution of the warning letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems. All regulatory restrictions associated with the warning letter have been resolved.
https://finance.yahoo.com/news/medtronic-diabetes-resolves-warning-letter-203000188.html
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FDA also approved Omipod GO, for people with type 2 who take daily injections of long acting insulin. Insulet says “Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes”
Omnipod GO is a standalone system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It’s tubeless and waterproof just like a regular Omnipod but it’s offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. It has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.
The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections. If a patient becomes insulin-intensive, meaning they require both basal and bolus insulin, the transition to another Omnipod product would be seamless.
Omnipod GO will have its US launch sometime next year.
https://www.businesswire.com/news/home/20230424006026/en/Insulet-Announces-FDA-Clearance-of-Omnipod-GO%E2%84%A2-a-First-of-its-Kind-Basal-Only-Insulin-Pod-Further-Simplifying-Life-for-People-with-Type-2-Diabetes
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Senseonics says the first pediatric study participant has received an Eversense 365-day CGM insertion.
The E3 180 day implantable CGM got FDA approval in February last year.
Dr. Francine Kaufman, Senseonics CMO, said expanding to a pediatric population represents a “priority” for the company. Positive results could further extend the company’s reach across the global diabetes community, she added.
The company also intends to utilize study data to submit for an integrated CGM (iCGM) designation in 2023. Senseonics holds an FDA investigational device exemption (IDE) to expand the trial to pediatric patients. These patients — between 14 and 18 years old — first enrolled in the second quarter of 2023.
https://www.drugdeliverybusiness.com/senseonics-first-pediatric-cgm-insertions/
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Baqsimi gets a new home. Amphastar Pharmaceuticals is buying the Glucagon nasal spray from Lilly in a deal worth up to $1.08 billion dollars. Launched in 2019, Baqsimi saw worldwide sales worth $139.3 million in 2022, the companies said. You may remember that Lilly had acquired Baqsimi from Locemia Solutions in 2015. The drug has an active compound glucagon, a form of a hormone produced in the pancreas that stimulates glucose production
https://www.reuters.com/markets/deals/eli-lilly-sell-low-blood-sugar-drug-amphastar-2023-04-24/
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The FDA recently cleared a new experimental drug for type 1 diabetes to begin a phase 2 clinical trial. If approved, the drug would be the first therapy to specifically address low blood sugar at night. We’ve talked about this.. Zucara Therapeutics is testing an oral medication currently known as ZT-01 will attempt to restore the body’s natural ability to respond to low blood sugar levels. Researchers will evaluate the ability of the drug to blunt hypoglycemia caused by insulin in type 1 diabetes.
This phase 2 clinical trial follows positive results from the company’s earlier phase 1 study which included 18 participants with type 1 diabetes who received the treatment. Of these 18, 16 (89%) had a meaningful increase in glucagon production after being given ZT-01, with no serious health events during the trial.
https://diatribe.org/drug-prevent-nighttime-lows-approved-enter-clinical-trials
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The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.
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Australian scientists have designed a new way to swallow insulin, in a pill form. The design also has potential uses for delivering other protein drugs, such as antibiotics and cancer treatments. Insulin is made of smaller versions of proteins called peptides. Previous attempts to develop an orally administered insulin have found that the severe pH levels in the gastrointestinal tract degrade the peptides, causing the drug to lose its function.
To get around this problem, the scientists encapsulated the insulin in a lipid-based nanomaterial placed inside an enteric capsule. In animal studies, long acting insulin was absorbed better than fast acting. They say long way to go, but an interesting start.
https://newatlas.com/medical/new-insulin-capsule-game-changing-diabetics/
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A new proof of principle study demonstrates the accuracy of Know Labs’ proprietary Bio-RFID™ sensor in quantifying different analytes in vitro, proving a 100% accuracy rate in these tests. The full study is currently undergoing the peer-review publishing process.
“Proof-of-principle studies are critical in demonstrating Bio-RFID’s accuracy for non-invasive methods of medical diagnostics. This was an essential step toward achieving our goal of delivering the first FDA-cleared, truly non-invasive glucose monitoring device to the market”
Know Labs’ technology platform, Bio-RFID, uses electromagnetic energy in the form of radio waves to non-invasively capture molecular signatures, which can be converted into physiologically meaningful information and insights. While the technology is proven to accurately measure several analytes inside and outside the body, the first application of this technology is aimed at non-invasive glucose monitoring.
This study did not include people but researchers say it’s an important step on the way.
https://www.businesswire.com/news/home/20230421005095/en/Know-Labs-Demonstrates-Accuracy-of-Non-Invasive-Bio-RFID-Technology-with-Proof-of-Principle-Study
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Moms Night Out – new cities include Providence, RI, Frisco, TX and Charlotte NC. more info here
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On the podcast next week.. Dexom's Jake Leach brings us up to date on some G7 updates as well as new Medicare coverage for people with type 2. Last week's episode was with the first US commercial pilot with type 1, Pietro Marsala.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Abbott recalls Freestyle Libre readers (not the sensors, see below for more information), Medicare expands CGM coverage for more people with type 2, a new study looks at the transition for children with T1D to adults and why patients aren't being served well during that time, and much more!
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Athletic Greens AG1 by Athletic Greens is daily nutrition made really simple.
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If you’ve got an Abbott Libre reader – check it for a huge recall. The company is issuing a class one – that’s the most serious -recall of all readers distributed in the U.S. from November 2017 to February 2023, totaling more than 4 million devices.
The recall is due to the potential overheating, sparking, or fire that may occur when the readers are charged with non-Abbott adapters or USB cables, or when they are damaged or exposed to liquids. Abbott-provided USB cables and power adapters limit the current to safely charge the battery, whereas third-party cables and adapters may allow much higher power, increasing the risk of fire.
Abbott has reported 206 incidents related to this issue, including at least seven fires and one injury, but no deaths. I’ve got the phone number to call and more information in the show notes at d-c dot com.
This recall only applies to those using the external reader device, not those using their smartphone.
Contact Information
Users with questions about this recall should contact Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time, excluding major holidays.
https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash
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A big policy change coming next week - The Centers for Medicare and Medicaid Services will expand continuous glucose monitor coverage to more people with type 2 diabetes. That starts April 16th, this Sunday if you’re listening as the episode first drops.
The expanded coverage applies to people using a basal only routine, as well as others who have a history of what has been classified as “problematic hypoglycemia.” Bottom line for those with type 2 – check with your doctor to see if a CGM is now covered
October.https://diatribe.org/medicare-expands-cgm-continuous-glucose-monitor-coverage-type-2-diabetes
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Montana lawmakers are considering a bill that would require insurance companies to cover CGMs for people with Type 1 and Type 2 diabetes.
House Bill 758 has broad support from lawmakers, but it faces opposition from insurance companies and some providers. That opposition focuses on the cost, whether a CGM is medically necessary at all stages of diabetes, and the possibility that CGM manufacturers will raise their prices if there is an insurance mandate.
Blue Cross and Blue Shield of Montana, the state’s largest insurer, estimates the bill, if passed, would cost the organization nearly $5 million a year. The BCBS spokesperson also says ““These things are a convenience,”
https://khn.org/news/article/montana-potential-bill-insurance-covering-continuous-glucose-monitor/
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Short-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk for heart failure hospitalization among patients with type 2 diabetes (T2D), according to a Danish registry study.
Among over 300,000 patients with T2D, short-term use of NSAIDs was associated with a relative 43% increased risk of a first-time heart failure hospitalization in the subsequent 28 days. NSAIDs increased the risk of heart failure even more in type 2 diabetics who were 80 or older (78%) or who had high blood sugar levels (68%), the results showed. Those who'd never used an NSAID before had the worst reaction, with their heart failure risk nearly tripling. However, heart failure was not associated with using NSAIDs in people with well-controlled diabetes and normal blood sugar levels.
https://www.medpagetoday.com/cardiology/chf/103936
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New study from Boston Children’s Hospital shows the transition from child to young adult managing type 1 is a pretty fraught time.
routine outpatient care for type 1 diabetes decreased between ages 16 and 24. At the same time, emergency room visits to treat the condition increased for that age group.
The study raises the concern that young adults lack a “medical home” with an endocrinologist and instead may be seeking routine care such as insulin prescription refills from an emergency department (ED), Garvey says. If anything, the research supports the idea that endocrinologists should have an integral role in diabetes management for young adults, she says, and illustrates how specialized care may prevent the need for acute care in hospitals.
The data here showed that annual endocrinologist visits declined from 2.3 per year at age 16 to 1.5 per year by age 24. This data stands out, Garvey says, because previous research has shown endocrinologists are the main providers of type 1 diabetes care for most young adults with the condition.
These researchers hope the study can serve as a launching point for endocrinologists to assess how they can help young adults better manage type 1 diabetes
https://answers.childrenshospital.org/self-care-of-diabetes/
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The past few years have seen numerous advances in the understanding of how type 1 diabetes develops and how to manage it, yet the global disease burden remains high, according to a review article published April 5 in The Lancet.
The authors cite data related to diabetes control in youth and adults from the T1D Exchange demonstrating that only 21% of adults with type 1 diabetes have an A1c (a blood test that reflects a 90-day sugar average) of 7.0 or lower.
While type 1 diabetes is the third most common disease of childhood, there should be greater awareness of adult onset of the disease. The paper references data from the UK Biobank indicating that up to 40% of type 1 diabetes diagnoses occur in people over age 30.
, the paper notes that racial and ethnic disparities persist and insulin pump usage is lowest at 18% among non-Latinx Black populations compared with 72% among non-Hispanic white people and 40% among Hispanic populations.
The paper also reports that inhaled insulin – brand name Afrezza - has demonstrated a fast onset of action, improving the ability to control glucose after meals.
https://medicalxpress.com/news/2023-04-global-diabetes-burden-high-advances.html
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A research team led by the University of Michigan Health Department of Neurology followed more than 120 patients who underwent bariatric surgery for obesity over two years after the procedure. They found that all metabolic risk factors for developing diabetes, such as high glucose and lipid levels, improved outside of blood pressure and total cholesterol, according to results published in Diabetologia.
Investigators also found that patients two years removed from bariatric surgery showed improvements in peripheral neuropathy, a condition marked by damage to the nerves that go from the spinal cord all the way to the hands and feet.
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Obesity is the second leading risk factor for peripheral neuropathy after diabetes, which affects more than 30 million Americans.
https://medicalxpress.com/news/2023-04-bariatric-surgery-reverse-diabetes-complications.html
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As of April 12, 2023, Panbela Therapeutics has officially begun their Phase II double-blind, randomized study to assess the effectiveness and safety of CPP-1X-T for recent onset type 1 diabetes (T1D). The study will involve enrolling 70 patients across six different centers in the United States, with Indiana University leading the trial. The first patient has already been enrolled, which has led to a boost in the company’s stock prices.
Panbela Therapeutics is a clinical-stage biopharmaceutical company that specializes in developing innovative therapies for cancer patients and those with other urgent medical needs. They have recently completed a clinical trial of ivospemin, a treatment for locally advanced or metastatic pancreatic cancer. The company also acquired Cancer Prevention Pharmaceuticals in June 2022, a clinical-stage biopharmaceutical company that focuses on developing therapies to prevent cancer and rare diseases.
CPP-1X-T is one of the drugs that Panbela Therapeutics is currently developing. This drug has shown potential complementary activity with the FDA-approved treatment for pancreatic cancer and is being evaluated for the treatment of T1D in the Phase II clinical trial. The company’s shares have been fluctuating in recent months due to various factors, including the progress and results of their clinical trials.
https://beststocks.com/panbela-therapeutics-begins-phase-ii-clinical/
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Type 1 Diabetes Conference & Community
For people living with type 1 diabetes of all ages where they can find:
Information, Motivation, And Inspiration To Thrive With Type 1 Diabetes
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The book!
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On the podcast next week.. Jisel Parra was diagnosed as a teenager and it couldn’t have gone worse – they didn’t prescribe insulin initially, she struggled with getting the right and with her mental health.. but now she makes medical jewelry and tags with her company A Tad Too Sweet. I’m excited for you to hear her story. Last week, Dr. Bryce Nelson on Tzield.
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Insulin-maker Sanofi lowers its prices and also acquires Provention, clinical trials begin on an out-patient surgery that could help treat type 2 diabetes, a swimmer DQ'd for the tape on his CGM gets the systemic changes he'd pushed for and more!
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Episode Transcription:
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Athletic Greens ● AG1 is way more than greens.
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Provention Bio’s been in a news a lot lately after the approval of Tzield to delay the development of type 1. Now French insulin-maker Sanofi has agreed to acquire it. The deal builds on an existing co-promotion agreement and gives Sanofi full ownership of the drug. Sanofi makes long acting Toujeo and Lantus.
Interestingly, Sanofi has said they’re gong to stop further work on type 2 diabetes and obesity drugs.
They also joined Novo Nordisk and Eli Lilly in dropping the price of insulin in the US.
https://www.reuters.com/markets/deals/frances-sanofi-acquire-us-based-provention-bio-29-bln-2023-03-13/
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Insulin pricing staying in the news as Senators Bernie Sanders and Cori Bush introduced legislation to cap the price at 20-dollars. They point out the recent prices cuts don’t apply to everyone and are still at the whim of the manufacturers.
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California signs up with Civica Rx to produce its own insulin and sell it at an affordable price. The $50 million investment will allow California to produce insulin to be sold at prices capped at $30 per vial and $55 for a box of five prefilled pens, Civica Rx said (PDF) in a release. The agreement is part of the state’s CalRx Biosimilar Insulin Initiative.
Utah-based Civica Rx is a nonprofit, social welfare manufacturer of generic drugs. This is a long way off.. Civica Rx still needs to gain approval for its biosimilar versions of Sanofi’s Lantus (gargline), Eli Lilly’s Humalog (lispro) and Novo Nordisk’s Novolog (aspart).
The cost of insulin would be same for all patients regardless of their insurance situation
https://www.fiercepharma.com/manufacturing/california-invests-50m-partner-civica-rx-insulin-manufacturing
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Millions of Americans with diabetes have cheered as drugmakers slashed the price of insulin, the lifesaving medication that treats the chronic disease.
But those lower prices, which came amid government pressure to cap insulin costs and more competition from generics and biosimilars, are only one part of the cost of treating the disease, which causes elevated blood sugar that can damage the heart, eyes and kidneys if untreated.
Over-the-counter medical supplies to monitor glucose levels and administer medications can make up the largest portion of a patient’s costs. A 2020 JAMA Internal Medicine report found that children and adults with private health insurance spent more out-of-pocket on diabetes-related supplies than on insulin A person with diabetes who uses insulin typically spends $4,882 a year on treatment if they have insurance. Of that, $3,992 is spent on supplies, according to an analysis by GoodRx, or more than 80% of the annual expense of managing the disease
https://www.usatoday.com/story/money/personalfinance/2023/03/19/cost-diabetes-supplies-worse-than-insulin/11472381002/
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New trial of a technique to slow the progression of type 2 diabetes. It’s a simple outpatient surgery conducted in the early stages of diagnosis.
The procedure targets the doo-oh-DEE-num duodenum, the first section of the small intestine just past the stomach. This organ plays a key role in digestion, including regulating insulin and blood glucose levels. In patients with type 2 diabetes, the cells that line the duodenum have become damaged, and the trial’s hypothesis is that removing these cells helps healthy ones to grow back, improving the regulation of blood glucose levels.
Patients in the clinical trial would undergo an endoscopy to insert a device into the doo-oh-DEE-num duodenum, which removes those dysfunctional cells with a series of electrical pulses. The procedure itself is only minimally invasive – it takes about an hour, it’s conducted under a general anaesthetic and the patient is discharged the same day.
Early results seem encouraging. Patients who have undergone the procedure in recent months have already seen their blood glucose levels drop. BTW if you live near L-A they’re still recruiting for this. You have to have a type 2 diagnosis and not yet need insulin injections.
https://newatlas.com/medical/diabetes-prevent-slow-progression-procedure-clinical-trial/
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Another study showing automated insulin delivery systems work well and are safe, this one the Tandem Control IQ in little kids. That’s only approved right now for kids as young as six.. this study looked at children ages two to six. The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared to no change with standard care.
Standard care here meant either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
https://www.medscape.com/viewarticle/989673
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Follow up! Two years ago we told you about Ethan Orr, a Colorado high school swimmer disqualified at a state meet because of the tape over his CGM. Orr’s family filed a complaint with the department of justice and the US Attorney in Colorado took up the case. They weren’t seeking any financial damages, just a change in policy, which they got. The changes include allowing medical tape with documentation, a way to evaluate requests from students with disabilities who might need reasonable modifications of rules, and a way for refs or coaches to seek on the spot reasonable modifications.
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“I knew I’d have to fight my disease to swim, but I never imagined I’d have to fight discrimination to swim,” Ethan said, according to the news release from the law firm.
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Today, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, presented the inaugural Mary Tyler Moore Awards to three women leaders in Congress who have been instrumental in the fight against T1D. U.S. Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus, were honored alongside Representative Diane DeGette (D-CO), co-chair of the Congressional Diabetes Caucus, for their longstanding support of the T1D community. The ceremony, held during JDRF's annual Government Day, honored the legacy of screen icon Mary Tyler Moore, who was diagnosed with T1D at the age of 33. As international chairman of JDRF from 1984 to 2017, Moore used her influence to bring government, scientists and people living with diabetes together to further T1D advocacy and innovation.
JDRF (PRNewsFoto/JDRF)
JDRF (PRNewsFoto/JDRF)
One of Moore's most significant achievements as JDRF international chairman was increased Congressional funding for the Special Diabetes Program at the National Institutes of Health that has accelerated the pace of type 1 diabetes research. This long-term investment in diabetes research has led to significant scientific breakthroughs including Tzield, the first disease modifying treatment for T1D which can delay the onset of the disease by over two years. JDRF Government Day volunteers, more than 175 T1D advocates from across the country, will encourage members of Congress to renew the Special Diabetes Program when they visit lawmakers later today on Capitol Hill.
https://finance.yahoo.com/news/jdrf-presents-inaugural-mary-tyler-110000226.html
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On the podcast next week..
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That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: learning more about Lilly's plan to lower the price of some insulins, Abbott's Libre 2 and Libre 3 get FDA approval to work with automated insulin delivery systems like Control IQ and Omnipod 5, Medicare expands coverage of CGMs for people with type 2, an old blood pressure medication shows promising results in a T1D study, and more!
Please visit our Sponsors & Partners - they help make the show possible!
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:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
Episode transcription:
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by Athletic Greens
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Insulin prices
https://www.statnews.com/2023/03/06/eli-lilly-insulin-medicaid-rebates/
Drugmaker Eli Lilly & Co.
on Wednesday said it will cut prices of its most commonly prescribed insulins by 70% and cap monthly out-of-pocket costs at $35 at certain retail pharmacies for people who have private insurance.
Lilly will list its Lispro injection at $25 a vial effective May 1 and slash the price of its Humalog and Humlin injections by 70% starting in the fourth quarter.
The announcement comes amid growing federal pressure to lower the cost of insulin. The Inflation Reduction Act capped insulin prices for Medicare beneficiaries at $35 per month but did not protect people with private insurance or who don’t have coverage from higher prices.
Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week.
The company was about to run into a Medicaid penalty for raising the price of it’s drugs faster than the rate of inflation.
https://www.cnbc.com/2023/03/01/lilly-cuts-insulin-prices-70percent-cap-prices-at-35-per-month-for-private-insurance.html
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The FDA has cleared Abbott's Freestyle Libre 2 and Libre 3 continuous glucose monitors (CGM) for integration with automated insulin delivery (AID) systems. These devices have also been cleared for younger children, extended wear time, and for use during pregnancy.
The FDA on March 6 cleared Abbott’s Freestyle Libre 2 and Freestyle Libre 3 CGM for use with automated insulin delivery (AID) systems.
AID systems connect a CGM, insulin pump, and smartphone to automatically adjust insulin dosing in real-time in response to changing glucose levels. These systems have been demonstrated to help many people with diabetes improve their time in range and reduce the time spent thinking about managing glucose each day.
With this new clearance from the FDA, Libre 2 and 3 CGMs and the connected smartphone app will soon integrate with insulin pumps to adjust insulin dosing.
Freestyle Libre 2 and Libre 3 CGMs were previously cleared for use by people with diabetes ages 4 and older. Freestyle Libre 3, cleared in the United States in May 2022, is compatible with both iOS and Android smartphones. Among several upgrades made from Libre 2, Libre 3 no longer requires users to manually scan their device with their smartphone to see glucose levels – data is sent to the mobile app automatically.
In the announcement, Abbott said the device has also been cleared for an extended wear time of 15 days, for use by children as young as age 2, and for use during pregnancy by women with type 1, type 2, or gestational diabetes.
Current users of Libre CGMs should note that the devices available now cover people with diabetes ages 4 and older, can be worn for 14 days, and are not cleared for use during pregnancy. According to Abbott, the modified Libre 2 and 3 sensors will be available in the U.S. later this year.
https://diatribe.org/fda-clears-freestyle-libre-2-and-3-use-automated-insulin-delivery
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Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services.
The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note.
Dexcom and Abbott Laboratories had expected coverage to start in mid-year.
In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people with non-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.
“At first glance, it seems that the finalized CMS language is broader and no longer includes daily insulin language,” Marcus wrote.
The policy change could open up a bigger opportunity for broader coverage by commercial insurers over the next year or two, he added.
Currently, just 25% of people with Type 2 diabetes who are intensive insulin users (taking multiple shots per day) use a CGM. Covering people who take basal (daily) insulin could double the U.S. market opportunity of about 2 million people with Type 1 diabetes and 2 million people with Type 2 diabetes who are intensive insulin users, a group currently covered by CMS, Marcus wrote.
https://www.medtechdive.com/news/Medicare-CGM-coverage-Dexcom-abbott-ABT-DXCM/644019/
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Bigfoot Biomedical receives FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts.
Last month Bigfoot sold its closed-loop automated insulin delivery (AID) system technology to Insulet. CEO Jeffrey Brewer said he has confidence in the makers of the omnipod to utilize Bigfoot’s “great asset” in its focus on simplicity and ease of use for pump users.
He said the limited rollout generated “great data” to support Bigfoot Unity in the type 2 population. That includes ease of use, especially for people who might not be tech-savvy.
The big focus for Bigfoot Biomedical, Brewer explained, remains the pharmacy channel. He said the company is currently in discussions with Express Scripts, Optum and CVS to utilize their wide reach. Brewer said that getting an agreement with one or more of those companies will enable a more broad launch this year.
By wrapping the insulin delivery around CGM, Bigfoot Biomedical believes it can address the type 2 market in a new way.
https://www.massdevice.com/bigfoot-biomedical-next-steps-diabetes-management/
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Although the use of diabetes technology has increased across all racial and ethnic groups, inequities persist, according to research published in the Journal of Endocrinology & Metabolism.
In the United States, race and ethnicity have been associated with inequities in diabetes treatment and outcomes. Non-Hispanic Black and Hispanic indi- viduals with type 1 diabetes (T1D) have higher hemoglobin A1c (HbA1c), higher rates of severe hypoglycemia and dia- betic ketoacidosis, and are more likely to visit emergency departments and hospitals than individuals with T1D who identify as non-Hispanic White.
Researchers used a version of Optum’s deidentified Clinformatics Data Mart to select Medicare Advantage beneficiaries with T1D between January 1, 2017, and December 31, 2020.
Investigators found that overall, use of an insulin pump, a CGM, both insulin pump and CGM, and either insulin pump or CGM increased during the 4-year study period
When evaluating the data by racial and ethnic group, investigators found that the prevalence of each outcome did increase; however, “within each annual cohort and outcome, there were significant differences between racial/ethnic groups,” with gaps in prevalence between White individuals and individuals of other races and ethnicities remaining “generally increase[ing] or remaining stable” between 2017 and 2020.
When evaluating data from the 2020 cohort, there were significant differ- ences noted in the use of insulin pump and/or CGM technology based on demographic and socioeconomic factors.
According to the researchers, the “persistent inequities” in diabetes technology access found in the current study have implications “not only for patients and providers, but also for health care systems and policymakers” and require multiple policy changes to improve equitable access.
https://www.drugtopics.com/view/racial-ethnic-inequities-persist-in-diabetes-care
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The CLVer study tested whether improved blood glucose control using a hybrid closed loop insulin pump (also known as an automated insulin delivery or AID system) and/or verapamil preserves beta cell function one year after diagnosis.. The trial showed that verapamil, but not better blood glucose control, improved beta cell function over the year-long study.
In October, the FDA approved the drug Tzeild (teplizumab) for people with diabetes antibodies but who did not yet have type 1 diabetes. This therapy was the first approved medicine to delay the onset of type 1 diabetes by an average of 2 years.
The CLVer study offers further hope for researchers by showing that another medication can have additional impact in type 1 diabetes, and lays the groundwork for further study. By seeing preserved c-peptide levels in the study participants, the trial demonstrated that taking verapamil improved beta cell function.
Additionally, although AID users had greater time in range of 78% compared to non-users’ 64%, which is a 3.4 hour/day difference, the trial found that AID did not provide a significant improvement in insulin secretion.
This study was partially funded by JDRF
“Safe, effective therapies are urgently needed to delay disease progression in people recently diagnosed with type 1 diabetes,” said Dr. Sanjoy Dutta, chief scientific officer at JDRF. “This is the second trial showing that verapamil, a cheap and widely used blood pressure medication, can preserve beta cells in the new onset period. The CLVer trial moves us one step closer to our goal of having disease modifying therapies widely available for people with type 1 diabetes.”
https://diatribe.org/impressive-results-show-verapamil-preserves-insulin-producing-cells-newly-diagnosed-type-1-diabetes
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Some advances in cell transplantation to treat type 1:
Vertex gets FDA clearence for their application to study VX-264, a stem cell-derived, pancreatic islet cell therapy encapsulated into an immunoprotective device with the potential to treat type 1 diabetes (T1D). The VX-264 program does not require the use of immunosuppression, which may broaden the population of people with T1D that this investigational therapy could reach. This clearance means they can begin clinical trials.
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Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.
While they are working towards not using immunosuppression, the patients in the current trial do still require immunosuppression to start after implantation of the Cell Pouch SystemTM
https://www.businesswire.com/news/home/20230308005894/en/Vertex-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-VX-264-a-Novel-Encapsulated-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes
https://finance.yahoo.com/news/sernova-announces-initial-islet-transplantation-120000700.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAH6NwHdjldrxbueuanlpUGXou6yHP2dKNpYXN31GEMLWCyhkJkgwlhn9ScIDMTX5GGtf5V242uN3EvZzFtTd56z0YZaQgOss37DT2dksdasEONxWa7OOdgnWvDlwUd0-s2RPyMTPi1sw8z08CK6DUMLIrrA6dmCDZeozlwos_CDB
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Two classes of drugs prescribed off-label for some patients with Type 1 diabetes can provide significant benefits but also come with health concerns, according to a study by UT Southwestern Medical Center researchers. The findings, published in The Journal of Clinical Endocrinology & Metabolism, provide a rare view of real-world use of these medications, which are growing in popularity among patients with Type 1 diabetes as adjuvants to insulin.
Type 1 diabetes is universally treated with insulin injections. However, explained Dr. Lingvay, because only a fifth of patients with Type 1 diabetes in the U.S. achieve the blood sugar control that the American Diabetes Association recommends, doctors are increasingly prescribing medications known as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and/or sodium-glucose cotransporter-2 inhibitors (SGLT2is) to help patients reach this goal.
Furthermore, both classes of medications have been shown in patients with Type 2 diabetes to decrease the risk of cardiac and renal events and help promote weight loss, effects that also would greatly benefit patients with Type 1 diabetes. However, the risk-benefit ratio of these medications has not been fully vetted in this patient population.
In fact, both classes of drugs have been associated with increased risk of severe hypoglycemia and DKA when used in patients with Type 1 diabetes. Because both positive and negative effects of GLP-1RAs and SGLT2is were shown in strictly regulated clinical trials, their real-world effects have been unclear.
To examine their efficacy, Dr. Lingvay, along with colleagues Khary Edwards, M.D., a former Endocrinology fellow at UTSW, and Xilong Li, M.B.A., Senior Database Analyst at UTSW, searched medical records for Type 1 diabetes patients treated at UT Southwestern who used any GLP-1RAs and/or SGLT2is for at least 90 days before Oct. 31, 2021. Their search turned up 104 patients: 65 who had used GLP-1RAs exclusively, 28 who had used SGLT2is exclusively, and 11 who had used both either concurrently or sequentially.
After a year of use, patients on GLP-1RAs had significant reductions in weight, glycated hemoglobin A1C (a three-month average measure of blood sugar), and total daily dose of insulin. SGLT2i users had significant reductions in hemoglobin A1C and basal insulin, a baseline dose delivered outside of meals.
However, SGLT2i users were about three times more likely than GLP-1RA users to experience DKA. Just over a quarter of patients taking either class of drugs stopped due to side effects such as gastrointestinal problems.
The study authors say these results suggest both types of drugs can be beneficial to patients with Type 1 diabetes, but close monitoring is required. Specifically when using SGLT2is, extreme caution is advised in selecting patients with the lowest risk of DKA, performing detailed education about the risk of DKA, and ensuring careful monitoring to prevent its occurrence.
https://www.utsouthwestern.edu/newsroom/articles/year-2023/february-type-1-diabetes.html
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Athletic Greens
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COVID-19 patients who took the diabetes drug metformin for two weeks after a diagnosis were less likely to develop long COVID-19 symptoms, according to results from a clinical trial.
The trial enrolled about a thousand participants who were symptomatic with a COVID-19 infection for less than a week. Participants were randomly selected to receive a placebo or one of three drugs: metformin, ivermectin or fluvoxamine.
About 6 percent of people who took metformin later developed long COVID-19, as determined by a medical diagnosis. In the placebo group, 10.6 percent of participants developed long COVID-19.
This meant that overall people who took metformin were 42 percent less likely to develop long COVID-19 compared to people who got the placebo.
The authors also note that the beneficial effect is potentially stronger for people who started taking metformin less than four days from symptom onset compared to people who started the medication four or more days after their first symptoms. The participants who received the two other drugs, ivermectin and fluvoxamine, did not see any benefits in terms of preventing long COVID-19.
https://thehill.com/policy/healthcare/3889797-diabetes-drug-proves-beneficial-in-preventing-long-covid-in-clinical-trials/
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Great article..
https://www.nytimes.com/2023/03/03/sports/baseball/garrett-mitchell-brewers.html
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On the podcast next week.. Ginger Vieira, author and diabetes advocate. Our last episode was with a family whose son was treated with Tzield to delay his T1D diagnosis.
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Dexcom G7 is now available in the United States, Insulet buys assets from Bigfoot and another California company, new studies about cannabis and type 1 and COVID and diabetes, different predictors of type 2 in women and men, plus scholarships for T1D students.
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Episode Transcription:
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by T1D Exchange dedicated to improving outcomes for the entire T1D population
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Our top story. Today’s the day. February 17th is the day Dexcom’s G7 becomes available in the United States. Now.. whether you can get it still depends on your insurance, your doctor – a new prescription is needed – and the availability at your pharmacy. Whether you want to get it may depend on if you use a compatible pump system – the G7 will NOT work with Tandem’s CIQ or Omnipod 5 for several more months. The G7 will be accessible to all Medicare patients with diabetes who meet the eligibility criteria as of today.. so no wait there. Much more to come on the launch I’m sure..
https://investors.dexcom.com/news/news-details/2023/Dexcom-G7-Continuous-Glucose-Monitoring-System-Will-Be-Available-to-Medicare-Beneficiaries-at-Launch/default.aspx?fbclid=IwAR0cKhAv5C8TMZ8v8f98rlhnvBQ0JkFj3SLRyc7RdMeOAO3_Tpl95cKNX20
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People who’ve had Covid-19 have a higher risk of developing diabetes, and that link seems to have persisted into the Omicron era, a new study finds.
Mounting evidence suggests Covid-19 infections are tied to a new diagnosis of diabetes, though it’s not clear whether this relationship is a coincidence or cause-and-effect. Big study here, 23,000 adults who’d had Covid-19 at least once.
The raw data showed that people who’d had Covid-19 had higher risks of being diagnosed with diabetes, high cholesterol and high blood pressure after their infections.
But when the researchers adjusted those numbers to account for the benchmark diagnosis, only the risk of diabetes remained significantly elevated. Covid-19 increased the odds of a new diabetes diagnosis by an average of about 58%.
The new study is notable because it adds recent data, said Wander, who was not involved in the research. It also used strategies to try to address shifts in health care during the pandemic.
Another strength of the study was that it included people who were diagnosed between March 2020 and June 2022, so it was able to estimate the risk even after the Omicron variant swept through the US.
https://www.cnn.com/2023/02/14/health/covid-diabetes-risk-study/index.html
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Insulet making a couple of interesting acquisitions.. $25 million in assets from Automated Glucose Control LLC in California. And the same amount $25 million of assets from Bigfoot Biomedical. AGC and Insulet have had a partnership since 2016 which mostly involved the algorithm that led to Omnipod 5. Bigfoot has also claimed patents regarding more hands-off insulin delivery,
The acquisition effectively doubles Insulet’s IP portfolio, Eric Benjamin, the company’s executive VP of innovation, strategy and digital products, said in a press release.
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Dr. Halis Akturk and colleagues began noticing patterns among people with T1D in Colorado hospital emergency departments (ED) after cannabis was legalized in the state. They have since conducted several nationwide retrospective studies on those living with T1D that also use cannabis, including hospitalization records and T1D Exchange Registry participant surveys. They found that T1D participants had repeated return visits to the ED in the following weeks, and DKA was frequently misdiagnosed.
Based on that research, Dr. Akturk’s team has recently developed a key to differentiating between DKA and a new syndrome that mimics DKA, one they’ve named HK-CHS: Hyperglycemic Ketosis-Cannabis Hyperemesis Syndrome.
To treat HK-CHS, your care team will typically increase fluids, treat the high blood glucose with insulin, and balance your electrolytes, or anion gap. You will be advised to stop using cannabis until the symptoms resolve. These treatments will bring your blood glucose levels back into target range and get your gut moving again, which will ease the nausea and vomiting. Depending on your dose, frequency, and duration of use, symptoms may take several days to several weeks to resolve.
https://t1dexchange.org/cannabis-t1d-risks/
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About two thirds of people with type 1 diabetes in the United States have overweight or obesity, nearly the same proportion as Americans without diabetes, new nationwide survey data suggest. What's more, among people with overweight or obesity, those with type 1 diabetes are less likely to receive lifestyle recommendations from healthcare professionals than those with type 2 diabetes, and are less likely to actually engage in lifestyle weight management activities than others with overweight or obesity, with or without type 2 diabetes.
"the lack of evidence for safe, effective methods of diet- and exercise-based weight control in people with type 1 diabetes may be keeping doctors from recommending such methods," these researchers say.
"Large clinical trials have been done in type 2 diabetes patients to establish guidelines for diet- and exercise-based weight management, and we now need something similar for type 1 diabetes patients."
https://www.medscape.com/viewarticle/988199
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New research showing men and women have different risk factors when it comes to type 2 diabetes.
In healthy women, low serum level of the adipose tissue protein adiponectin was an independent strong predictor of type 2 diabetes and prediabetes in the future. In healthy men, instead, low serum level of the liver protein IGFBP-1, was an independent strong predictor of type 2 diabetes and prediabetes This means that these proteins, which are measures of insulin sensitivity in adipose tissue (adiponectin) and liver and muscle (IGFBP-1), can predict whether one has a high risk of getting type 2 diabetes in 10 years.
A previous study performed in Shanghai in 2016 showed gender differences in the same direction. In men with prediabetes the risk of future type 2 diabetes was significantly reduced if they increased their physical activity and muscle mass . In contrast, the same study showed that women with prediabetes must avoid increasing waist circumference and abdominal obesity or reducing large waist circumference to prevent type 2 diabetes.
https://medicalxpress.com/news/2023-02-women-men-shown-factors-diabetes.html
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Tempramed/ VIVI Cap
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2023 Diabetes Scholars applications are now open! If you're a high school senior living with type 1 diabetes in the US, you can apply to get money for college.
https://diabetesscholars.org/apply-now/?fbclid=IwAR2txFmkmxp9qoMf5ZkKX0f83oxj3aOr69rCXeqozRDxq7Dt94e9QdBQrjg
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On the podcast next week.. Diatech Diabetes is a medical device company based out of Memphis, TN committed to changing the way infusion set failure detection is done with our infusion set failure detection system, SmartFusion. The last episode is with Dr Phyllisa Deroze all about explaining to your child when you, the parent, have diabetes.
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
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The T1D Exchange Registry is a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. The platform is open to both adults and children with T1D living in the U.S. Personal information remains confidential and participation is fully voluntary. Once enrolled, participants will complete annual surveys and have the opportunity to sign up for other studies on specific topics related to T1D. The registry aims to improve knowledge of T1D, accelerate the discovery and development of new treatments and technologies, and generate evidence to support policy or insurance changes that help the T1D community. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy.