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!
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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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In the news is brought to you by the T1D Exchange, 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
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
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!
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