On social media, Neil Greathouse is better known as “The Betes.” He posts daily about diabetes on social media. It’s a lot of work – and not his real job. I wanted to know why this is important to him. What is he hoping to accomplish?
There is so much to Neil’s story – he’s become a diabetes educator – and he’s an open book – he’ll share about going into DKA not too long ago, a failed marketing effort with a big diabetes company and much more.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
My first conversation with Neil, from 2017: https://diabetes-connections.com/neil-greathouse-t1d-instagram-inspiration/
Please visit our Sponsors & Partners - they help make the show possible!
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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: 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
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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
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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 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.
Actor Austin Basis has a juicy role in this final season of The Marvelous Mrs. Maisel; he plays Alvin, the head writer on the show within the show. Basis was diagnosed with type 1 at age nine back in the 1980s. It was a time before home blood glucose meters, let alone pumps and CGMs.
He shares how he manages T1D during auditions and on the set and of course we talk about Mrs. Maisel! I had questions about the fashion, the plot, all night shoots and how this final season ends.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
My first episode with Austin Basis from 2018: https://diabetes-connections.com/actor-austin-basis-and-the-kinetix/
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
Medicare has now expanded coverage for CGM use among people with type 2, in part because of studies by companies like Dexcom. We’ll talk about those findings and learn more about the US release of the G7.
Dexcom Chief Operating Officer Jake Leach gives us information on app updates, talks about CGM for people with type 2 and gestational diabetes, pump integration for the G7, smoothing – and what that means – and a lot more.
More info about CGM and Medicare:
From ADCES: http://www.radiomiw.com/press.html
Dexcom Medicare coverage info: https://www.dexcom.com/en-us/g6-g7-medicare
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Moms' Night Out is back! Three cities are on the schedule: Learn 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
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.
Long thought an impossible, development people with type 1 diabetes are now working as commercial airline pilots. The very first to be certified in the US , Pietro Marsala says he decided to forge ahead while working as a flight instructor, taking inexperienced student pilots up while he was in control.
Pietro will share what happened next, how a mountain of data gradually won of skeptics, his in flight diabetes routine and what he’s up to now. You might be a passenger on his next flight!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Follow Pietro on Instagram: https://www.instagram.com/flytype1/?hl=en
FAA requirements for pilots who dose insulin: https://www.faa.gov/ame_guide/dec_cons/disease_prot/itdm
More about Pietro Marsala: https://www.healthline.com/diabetesmine/first-commercial-pilot-type-1-diabetes
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
Jisel Parra had a rocky start with diabetes – as a teen her type 1 was initially misdiagnosed and she struggled with support and mental health. But she found ways to find community and gradually started to thrive with T1D. These days, Jisel runs A Tad Too Sweet, which makes trendy medical bracelets. She has a career outside of diabetes and has two children.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
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: 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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Athletic Greens
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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.
Dr. Bryce Nelson is one of the first doctors in the country to administer the new Tzield to delay the onset of type 1. He’s been involved with TrialNet, identifying those who have the genetic markets for T1D and says that research was exciting but frustrating because they had no treatment. Now, they're looking at a possibly new way of talking about T1D.
Dr. Nelson is the Chief of Endocrinology at Children’s Hospital of Richmond at VCU
Dr. Nelson takes us through the process of using Tzield – which was researched under the name teplizumab – from identifying the patient, to treatment to what happens next. His first patient, William Troutman, is a North Carolina teenager. William's mom joined me a few weeks ago to tell their side of the story.
Listen to our episode with Amanda Troutman: https://diabetes-connections.com/delaying-a-t1d-diagnosis-with-tzield-a-deep-sigh-of-relief-for-a-little-while/
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
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This week… one of the oldest diabetes companies is looking ahead – Once part of BD, makers of needles and syringes, Embecta is now working on new technology like a patch pump. I’m talking to CEO Dev Kurdikar about moving the company forward, while still serving the patient community that relies on their established technology.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
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Dr. Maureen Michele is a pediatrician whose daughter had already survived a cancer diagnosis, when she was later diagnosed with 1 diabetes. In fact, Dr. Michele knew enough to test for T1D, so mom and daughter found out together, in the school bathroom. The family is now on the other side of what she calls this overwhelming chaos.. and what they’ve learned can help others..
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Maureen's Book: Reclaiming Life
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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: 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!
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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 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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Athletic Greens
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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.
When the FDA cleared the 3 FreeStyle Libre 2 and FreeStyle Libre 3 (iCGM) system sensors for integration it meant a big leap forward to interoperability. For the first time in the US, insulin pumps can work with two different sensors.. Libre and Dexcom. This week, Stacey talks to Dr. Jordan Pinsker, medical director for Tandem Diabetes Care, about the upcoming Libre integration, the Mobi pump that's in front of the FDA right now, and much more. Dr. Pinsker has extensive experience with automated systems – he’s been there since close to the beginning and we talk about the long process to bring them to market, how they’re changing lives and what is still yet to come.
More about the Libre approval: https://beyondtype1.org/freestyle-libre-aid-clearance/
More about Dr. Pinsker: https://www.tandemdiabetes.com/providers/bio/jordan-pinsker
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
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Ginger Vieira is here to talk about her new book – she’s written on everything from pregnancy with diabetes to exercise to her new series of children’s books. But she’s such a well-versed advocate, I had to ask her about her work at the T1D Exchange and all about her use of Afrezza. Why does she love it so much and what does she want you to know about using inhaled insulin?
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
More about Ginger: https://www.gingervieira.com/
Diabetes Doodles: https://diabetesdoodles.com/
Please visit our Sponsors & Partners - they help make the show possible!
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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: 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
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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 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.
AND
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.
Last fall, Tzield was approved to delay type 1 diabetes in people predicted to develop it. This week, I’m talking one of the first families to use what used to be called Teplizumab for their son, as a regular patient, outside the clinical trials. How exactly does this all work? Who’s eligible and how do you cover the enormous financial cost?
Amanda Troutman talks about why they went through this process with her son, William. Their whole family was tested for the genetic markers after their daughter, Jenna, was diagnosed in 2020.
As always, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Our previous episodes on Tzield: https://diabetes-connections.com/?s=teplizumab
More about the Troutman family: https://www.vcuhealth.org/news/north-carolina-teen-among-first-in-us-to-receive-new-diabetes-drug
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Dexcom’s G7 has been available in the US for less than two weeks, but the company continues to look ahead. Part of the future? Their Type Zero group – which created Tandem’s Control IQ – is working on a truly closed loop system.
Chief Operating Officer Jake Leach spoke to Stacey from the recent ATTD Conference. Of course we also asked a bunch of your G7 questions and had a more in-depth discussion about CGM monitoring for people without diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
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Reach out with questions or comments: info@diabetes-connections.com
Infusion sets have always seems like the weak link of pumping for us. What good is the best algorithm and state of the art pump and CGM if the way it all attaches to the body is no good? New information shows infusion failures happen more than you may think. John Wilcox's company, DiaTech Diabetes, has an infusion set failure detection system. He’s going to explains what that is, how it works and what you can do with the sets you have right now to make them more effective
More here: https://diatechdiabetes.com/
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
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It’s In the News, a look at the top 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.
When you’re a parent with diabetes, your kids often learn about diabetes before they can read or write. They know you might beep or take shots or wear a CGM and they often become diabetes helpers in serious circumstances. This week, Dr. Phyllisa Deroze talks about why she wrote a new book “Diabetes Helpers.” Dr. Deroze began blogging at DiagnosedNOTdefeated.com almost immediately after being diagnosed with diabetes in 2011. The following year she founded Black Diabetic Info; a website dedicated to helping close gaps of cultural incompetence around diabetes information.
Amazon link to Diabetes Helpers
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Our previous episode with Dr. Deroze about how diabetes is misrepresented in media:
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
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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
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Learn more about everything at our home page www.diabetes-connections.com
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Tandem Diabetes has made some big moves recently, acquiring two new companies – one makes infusion sets, the other a patch pump called Sigi, and their tiny Mobi pump is in front of the FDA right now. We’re finding out how it may all come together from Tandem’s EVP and Chief Strategy Office Elizabeth Gasser. We talk about how these acquisitions have changed Tandem’s road map – you may remember they released that look into the future last year – G7 integration, software updates and a lot more.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
2022 Episode with Tandem, includes links to the original 5-year road map
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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It’s In the News, a look at the top stories and headlines from the diabetes community happening now. This week, Dexcom sets a US release date for the G7, we find out whether Tandem will be a Tidepool Loop partner now that Insulet and Medtronic are out, Omnipod Eros to be discontinued, a new study says there's a better age to test kids for type 1, a new smart insulin pen sensor can also be used to track dosing of GLP-1 medications, a new twist in the Faustman study of the TB vaccine to treat diabetes, the Sims 4 update brings CGMs to the game and more.
Links and transcript below
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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 VIVI Cap – confidence on the go that keeps your insulin protected in hot or cold
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Learning a bit more about the Tidepool pump partnership, at least who it won’t be. When Tidepool Loop approval was announced last month, it came without the original pump partners, Omnipod and Medtronic. CEO Howard Look said they do have a pump partner but that they’re not ready to announced yet. I spoke to Tandem for next week’s episode and they say its’ not them. Quote “That’s not part of our roadmap, it’s not an integration we’re working on.”
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Insulet announces it will discontinue the original Omnipod system. In a letter to healthcare professionals, the company says the system, referred to as Eros or Omnipod Classic will be discontinued at the end of this year. It’s no longer available to new patients and existing customers will be transitioned to Dash or Omnipod 5. I’ll link up the letter in the show notes.
“Dear healthcare professionals,
We have made the decision to discontinue the original omnipod insulin management system in the us after December 31 2023. This system is often referred to omnipod eros or omnipod classic.
Insulet will continue to support the omnipod system throughout this year to allow existing patients ample time to transition to newer omnipod technology such as Omnipod dash or Omnipod 5. please note this product is no longer available for new patients in the US. After December 31, 2023 Insulet will not be able to guarantee the availability of the omnipod system supplies. “
https://www.facebook.com/photo/?fbid=10225188520677483&set=a.1253748061199
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Civica continues to move ahead with more affordable insulin, announcing that Ypsomed will make and supply their pens. Civica plans to produce three insulin biosimilars priced at no more than $30 per vial and no more than $55 for a box of five pen cartridges. Contingent on FDA approval, Civica anticipates that its insulins will be available for purchase beginning as soon as 2024.
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New study shows screening kids at risk for type 1 diabetes only once – at age ten – is very effective in detecting the condition by the age of 18. These researchers also say “Almost no one” who is islet autoantibody negative at age 10 years despite a high familial risk for type 1 diabetes will develop clinical diabetes by the age of 18. Full study published in the Lancet.
https://www.medwirenews.com/diabetes/age-10-years-optimal-type-1-diabetes-screening-point/23957596
https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00350-9/fulltext?fbclid=IwAR2kRNyGg6lnq3ZWsFkXnCvkeNiisg9mE2bbN_OnGiLrUpcHKXAaff3OkE4
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The nonprofit public health advocacy group the Physicians Committee issued a formal complaint that a recent CBS "60 Minutes" segment was a promotion for Novo Nordisk’s obesity drug, Wegovy, that was dressed up as a news segment.
The Washington, D.C.-based group has filed a complaint with federal bodies alleging that the CBS "60 Minutes" segment that aired on New Year’s Day breached the FDA’s “fair balance” rules for drug ads.
The Committee said in a release that the feature failed to talk about alternatives to the drug or about other weight-loss methods; that only experts “paid by Novo” were used in the program; and that the piece used overly promotional language.
This has caused Wegovy supply issues for Novo which, coupled with manufacturing problems, only deepened bumps in production last year for the drug and led to an official shortage of the drug in 2022.
A spokesperson for Novo Nordisk told Fierce Pharma Marketing: “Novo Nordisk did not provide any payment or sponsorship to CBS 60 Minutes for their reporting on obesity as part of a news segment that aired on January 1, 2023, and we did not control any of the content or have any role in identifying or selecting the doctors and patients featured in the news segment.”
https://www.fiercepharma.com/marketing/health-group-lambasts-novo-nordisk-60-minutes-paid-news-program-weight-loss-med-wegovy
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Some researchers have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants. This is part of the Faustman study of the BCG vaccine. Some recent research suggests that the vaccine, first administered in 1921, also may protect against Covid-19 and respiratory diseases because of its broad effects on the immune system. The lead investigators of the pediatric trial are proceeding with the study, but N.Y.U. Langone’s abrupt withdrawal could potentially jeopardize its viability if they are unable to collect data on the children at the N.Y.U. site.
An earlier study by the scientists at Massachusetts General found that two doses of B.C.G. vaccine reduced blood sugar levels to near normal in a very small group of adults with Type 1 diabetes. Other studies of B.C.G., using different versions of the vaccine and following Type 1 diabetes subjects for varying periods of time, have yielded mixed results.
The lead investigator of the trial, Dr. Denise Faustman, director of the immunobiology laboratory at Massachusetts General Hospital, said that N.Y.U.’s withdrawal was a serious deviation from trial protocol that may call into question the final results.
https://www.nytimes.com/2023/01/20/health/diabetes-bcg-nyu.html
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A new smart insulin pen sensor can also be used to track dosing of GLP-1 medications. Brand names for GLP-1 medications include Trulicity and Ozempic. This device, called Mallya, attaches to the injector and connects it to a mobile app. It’s already cleared in Europe and should be available in the US in the next few months.
The device is compatible with most popular insulin pens, including Lilly’s Kwikpen, Sanofi’s Solostar, and the Novo Nordisk FlexPen. Biocorp also announced that it has partnered with Novo Nordisk, Sanofi, and Roche Diabetes Care to improve Mallya’s current design moving forward.
According to the Mallya website, the device’s lifespan is two years before a replacement is needed, and in no way does it change the way that users operate their insulin pen. The device can be charged via USB and, with average use of three to four injections per day, requires charging once a month. Also, for those who have different pens for multiple types of insulin, the app can connect multiple Mallya devices, one for basal insulin and another for bolus, for instance.
https://diatribe.org/fda-clears-smart-injector-pen-device-mallya
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Tempramed/ VIVI Cap
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New features popped up this week in the latest version of The Sims – after an update, players can opt for their characters to wear a CGM – Libre or Dexcom
Freestyle Libre in the Sims 4 game. Search for CGM or Libre
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The Jonas Brothers officially have a star on the Hollywood Walk of Fame.
On Monday, Nick, Joe and Kevin Jonas were honored during a ceremony on Hollywood Boulevard where their careers as musicians were celebrated. Their star was dedicated in the category of Recording and the trio was introduced by Monte and Avery Lipman of Republic Records, Ryan Tedder and writer and producer Jon Bellion.
While the brothers still maintain their own separate projects -- Nick Jonas is set to produce and star in the upcoming film "Foreign Relations," Joe Jonas recently starred in the film "Devotion," and Kevin Jonas hosts the ABC series "Claim to Fame" -- they continue to make music together and are slated to release new songs this year.
The group closed out Monday's ceremony by announcing big news about their upcoming new album, which will be released in May. They also said they'll be going on tour again.
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On the podcast next week.. Tandem Diabetes with an update on their road map announced last year. They’ve since acquired a patch pump company and one that makes infusion sets. A lot to catch up on! This past week’s long format episode is with Tidepool Loop, a deep dive into what was approved with CEO Howard Look
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
The US FDA has approved Tidepool Loop, an app designed to automate insulin dosing. Born out the do-it-yourself, "we are not waiting" movement, it has designs and features not in the first wave of commercial automated systems like Omnipod 5 and Tandem’s Control IQ. CEO Howard Look talks to Stacey about what was approved here and what Tidepool Loop is all about.
If you’ve followed this story closely, you’re going to be surprised to learn about a few changes that have happened along the road to approval.. and to learn the questions that Tidepool will have to answer next.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Learn more about Tidepool: https://www.tidepool.org/
Our previous episodes with Howard Look:
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Learn more about everything at our home page www.diabetes-connections.com
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How are those New Year's resolutions going? By this time, it’s possible you’ve given up. But maybe it's just that you’ve set your goals a little too high.
This week, Stacey talks to Ben Tzeel, Founder of Your Diabetes Insider, Registered Dietitian, Certified Diabetes Care & Education Specialist, Certified Strength & Conditioning Specialist. Ben also lives with type 1. We’re going to talk about how to make the changes you want in a way that helps you stick with it. AND he’s going to share some of his experience in a trial where he ate – no joke – about four thousand calories at one meal!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
It’s In the News, a look at the top stories from the diabetes community from the last seven days. This week: Cost Plus pharmacy starts putting out feelers about insulin, asking people to take part in a pilot program, EO Flow looks at the US market for their new patch pump, quite a few new studies about type 2 diabetes drugs, a study about slowing down type 1 in kids and much more!
Learn more about the T1D exchange and drive research that matters! www.t1dexchange.org/stacey
Join the Diabetes Connections Facebook Group!
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Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
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In the news is brought to you by The T1D Exchange - Help drive research that matters.
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Possible new player in the US Patch pump business. EO Flow has submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. EO Flow is based in California and has launched the pump in South Korea. The company also has FDA breakthrough device designation on an integrated artificial pancreas. The website says EOPancreas is a wearable disposable artificial pancreas system that integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion. They’re looking for a US partner for the pump and hope to launch in 2024.
http://www.eoflow.com/eng/eopatch/eopatch_010100.html
https://www.drugdeliverybusiness.com/eoflow-submits-insulin-patch-pump-fda-clearance/
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Your time in range before getting a COVID vaccine may predict your body’s response. This was a small study, 25 patients with type 1 who received two doses of a COVID vaccine. Researchers followed the group two weeks before before and six months after the shots.
Main outcome measures: The primary exposure and outcome measures were pre-vaccination glucose control, and antibody response after vaccination, respectively. Patients meeting the recommended pre-vaccination glucose targets of TIR (≥70%) and TAR (≤25%), developed stronger neutralizing antibody titres (p < 0.0001 and p = 0.008, respectively), regardless of HbA1c. highlighting a role for well-controlled blood glucose in vaccination efficacy.
https://pubmed.ncbi.nlm.nih.gov/36611249/
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New study in kids with type 1 seems to show that the drug golimumab – brand name Simponi – can help preserve beta cell function. This is the Tiger study which included people ages 6 to 21 years old with T1D and given either the drug or a placebo for 52 weeks the off the drug for another year. The group taking the drug used less insulin and had a higher c peptide level in the time after the medication stopped, indicating that there was a difference.
https://diabetesjournals.org/care/article-abstract/doi/10.2337/dc22-0908/148228/Two-Year-Follow-up-From-the-T1GER-Study-Continued?redirectedFrom=fulltext
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New study confirming what a lot of you already know, Metformin failure in people with type 2 diabetes is very common, particularly among those with high A1c levels at the time of diagnosis.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three US clinical sites found that over 40% experienced metformin failure. This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications. "These results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy," they add in their article published online in the Journal of Clinical Endocrinology and Metabolism.
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi's Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.
https://www.medscape.com/viewarticle/986994
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The FDA has approved a label update for semaglutide that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes. The brand name here is Wegovy. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form.
https://www.pharmacytimes.com/view/fda-approves-label-update-for-semaglutide-allowing-use-as-first-line-option-for-adults-with-type-2-diabetes
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Merk says it’s diabetes drugs Januvia and Janumet have become contaminated with a potential carcinogen.. and it can resolve the problem by the end of the year. The company submitted a report to the U.S. Food and Drug Administration (FDA) and other regulators. The impurity arose mostly during storage, as well as during manufacturing, Bloomberg News said. The FDA said in August certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were contaminated with a possible carcinogen.
https://www.bloomberg.com/news/articles/2023-01-17/merck-mrk-ready-to-remove-cancer-linked-chemical-from-diabetes-drugs-in-2023
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Researchers studying new methods for improving blood sugar control in type 2 diabetes have discovered an old class of antipsychotic drugs may offer clues to a novel kind of treatment for hyperglycemia. While the researchers propose the old drugs could be directly repurposed to treat diabetes, they could also be slightly modified to more specifically target blood sugar control.
The class of drugs, known as (DPBPs), were developed back in the 1960s and are still used today. The researchers say they “They all improve blood sugar control by preventing the muscle from burning ketones as a fuel source.”
Because the DPBP drugs are already approved medicines the researchers hope to quickly move to proof-of-principal human trials. This would establish whether these preclinical findings are reproducible in human patients.
The new study was published in the journal Diabetes.
https://newatlas.com/medical/old-antipsychotic-drugs-new-class-diabetes-treatment/
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Another study showing an AID system works well for people with type 2. Scientists from University of Cambridge set up a small study, no surprise, the closed loop system did a lot better than standard injection therapy – people stayed in target range 66-percent of the time versus 32-percent with shots. That was an additional 8 hours a day of time in range.
https://www.medicalnewstoday.com/articles/type-2-diabetes-artificial-pancreas-may-soon-be-an-option
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Dexcom gives us a little more information about the G7. I interviewed Kevin Sayer for this week’s long format interview and he says the G7 will launch in the US during this first quarter.. so by the end of March. He also gave a more pessimistic view for interoperability with Tandem and Omnipod than we’ve heard – with Tandem end of summer early fall and Omnipod 5 next year. It’s up to those companies, not Dexcom.
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T1D Exchange
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On the podcast next week.. how are those new year’s resolutions going? If you haven’t kept them up, maybe you tried to do too much at once? Nutritionist Ben Tzeel joins me to talk about how to get back on track.
I mentioned last week’s episode with Dexcom CEO Kevin Sayer. We talk about the G7 launch and lots more, including their plans for the type 2 community and moving into “health”
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.