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.
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Check out VIVI Cap to protect your insulin from extreme temperatures
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Sign up for our newsletter here
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Learn more about everything at our home page www.diabetes-connections.com
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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.
LADA is a form of diabetes that is often mistaken for type 2 but needs to be treated much more like type 1. As you can imagine, getting the diagnosis wrong is dangerous. This week's guest, Jacqueline Haskins, says she got lucky. A friend said her symptoms sounded more like Latent Auto Immune Diabetes in Adults than like Type 2.
Jacqueline is the author of Kick Ass Healthy LADA where she shares research, advice and her own story. She’s an aquatic biologist and an award winning author.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Here are our earlier episodes around LADA
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
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Sign up for our newsletter here
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Learn more about everything at our home page www.diabetes-connections.com
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Katie Bone is the youngest ever American Ninja Warrior Women’s National winner! She is also a nationally ranked rock climber and has her eyes on the Olympics. Katie was diagnosed with type 1 at age eleven and is now seventeen. We talk about her big win, a recent injury and what she’s looking forward to next. She also answers a lot of your questions about managing T1D during training and competitions.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
More about Katie here: https://katiebone.com/
Watch Katie's NInja Warrior win: https://www.youtube.com/watch?v=i3Jlvc3OwLw
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
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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Medications like Ozempic, Wegovy and Mounjaro are getting a lot of attention. What are they? How can they help people with type 1 and type 2? Should you think about taking one? After all, the weight loss component alone sounds amazing.
This week, Stacey talks with Dr. Steve Edelman, who lives with type 1 and heads up Take Control of Your Diabetes – TCOYD – a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. We go through the science behind these medications, who might think about taking them, and whether they live up to the hype.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
More info about GLP-1 medications here
Dr. Edelman's "Buongiorno" Mounjaro video here
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
The newly FDA-approved iLet Bionic Pancreas is the most hands-off automated insulin delivery system to be commercially available. At set up, all you enter is your weight and the only interaction with the pump is to announce meal size, no carb counting.
Stacey talks with Beta Bionics CEO Sean Saint. We go through this pump system in lots of detail, talk about future plans – yes we’ll talk dual chambered pump which is the original design here - and get a little philosophical about the idea behind a hands off system.. especially for those of us used to being much more in the driver’s seat.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
More about Beta Bionics: https://www.betabionics.com/
Our previous episodes about the iLet here: https://diabetes-connections.com/?s=ilet
One of many write ups of clinical trials with the iLet system: https://www.nejm.org/doi/full/10.1056/NEJMoa2205225
Stacey mentioned our episode with ConvaTec about infusion sets: https://diabetes-connections.com/the-seven-day-infusion-set-is-here-whats-next-from-convatec-infusion-care/
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
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.