In the News.. COVID-19 & T1D, Ozempic Pill Progress, FDA to Consider Afrezza for kids, Faster Insulin, "Beyond Misconceptions," and More

n the News.. COVID-19 & T1D, Ozempic Pill Progress, Faster Insulin, "Beyond Misconceptions," and More It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: A new study looks at the link between COVID-19 and very young children, Lilly moves ahead with their Ozempic oral pill, ultra-rapid insulin clears another hurdle, Beyond Type 1 launches a new campaign and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: [email protected] Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX https://www.scientificamerican.com/article/advances-in-type-1-diabetes-science-and-tech/ This article is part of "Innovations In: Type 1 Diabetes," an editorially independent special report that was produced with financial support from Vertex. XX More evidence linking COVID 19 to type 1 diabetes.. but still exactly why is a mystery. During the COVID-19 pandemic, there was an unexpected increase in the number of cases of type 1 diabetes in Sweden, particularly among children under 5 and young adult men. The infection accelerated the onset of diabetes among children between the ages of 5 and 9. The researchers looked at data from a 17-year period on the incidence of type 1 diabetes among all people under the age of 30 in Sweden. In addition, they compared the risk of developing diabetes among 720,000 individuals with positive COVID-19 tests against a control group of 3.5 million people. The findings are published in the journal Diabetologia. The number of diabetes cases increased by 12% in 2021 and 9% in 2022 compared with previous years. In 2023, the number of cases was back to a normal level. Despite this, the researchers cannot distinguish a clear connection between COVID-19 infection and diabetes, except for children between 5 and 9 years old. They had an increased risk of type 1 diabetes about one month after a COVID-19 infection even though their total risk did not increase. "However, it's clear that the COVID-19 vaccine can be ruled out as a cause of the increase in diabetes cases. The recommendation for the age group where we saw the strongest increase was not to get vaccinated. In addition, other studies on adults have shown that vaccination reduces the risk of developing type 1 diabetes after a COVID infection." https://medicalxpress.com/news/2025-10-diabetes-young-people-pandemic.html XX A new gene therapy approach aimed at protecting people with type 1 diabetes from developing diabetic kidney disease—a serious and common complication of the condition, has shown promising results in a University of Bristol study. Findings from this new study, published in Molecular Therapy, demonstrated a 64% reduction in a damage indicator for kidney disease, paving the way for a potential new treatment. The study, explored the potential of delivering a protein called VEGF-C directly into kidney cells. Previous studies have shown VEGFC could protect against kidney disease as it helps keep blood vessels in the kidney filter healthy, repairing early signs of diabetes-related kidney damage. https://medicalxpress.com/news/2025-10-gene-therapy-kidney-disease-diabetes.html XX The FDA has agreed to consider Afrezza inhaled insulin for children and teens. The company said in August that it submitted a supplemental Biologics License Application (sBLA) for Afrezza in the pediatric population and it's been assigned a decision deadline date of the end of May, 2026. Afrezza first recieved FDA approval for adults (age 18 and up) in June 2014 https://www.drugdeliverybusiness.com/fda-accepts-application-mannkind-inhaled-insulin-kids/ Update on inhaled insulin for kids.. in the open-label, randomized, phase 3 INHALE-1 clinical trial Afrezza demonstrated safe and effective replacement for rapid-acting meal insulin in children with type 1 diabetes (T1D and demonstrates comparable glycemic control to injected rapid-acting insulin. The INHALE-1 clinical trial assessed the safety and efficacy of Afrezza among children and adolescents with T1D, including a total of 230 patients aged 4 to 17 years. Researchers used basal injected insulin and randomly assigned inhaled insulin or rapid-acting analogue for meals, evaluating the change in hemoglobin A1c levels at 26 weeks. After completing 26 weeks of randomly assigned treatment with either Afrezza or rapid-acting insulin injections combined with basal insulin, participants continued receiving the inhaled insulin until week 52 for an extension phase to evaluate the safety and effectiveness of Afrezza with continued use.1,2 https://www.pharmacytimes.com/view/inhaled-insulin-demonstrates-comparable-safety-lung-function-and-efficacy-to-injectable-insulin-in-type-1-diabetes XX Eli Lilly released the results of two new Phase 3 trials of an experimental GLP-1 pill that the company says could become a "foundational treatment" for type 2 diabetes. The Indianapolis-based drugmaker plans to submit global regulatory applications for orforglipron in the treatment of type 2 diabetes next year. The company said it will seek approval of the drug as an obesity medication by the end of 2025. Lilly is trying to build on the success of its Mounjaro/Zepbound franchise by offering patients a pill instead of an injection. But the company is trailing behind rival Novo Nordisk in developing an oral alternative, and data released so far has raised some skepticism among investors. A study released in August showed that orforglipron could help patients lose an average of about 12% of their body weight. Wall Street had been expecting more; Lilly's injectable drug Zepbound produced weight loss of as much as 21%, and Novo Nordisk has achieved 15% weight loss percentages for both oral and injectable versions of its Wegovy medication.   https://www.fiercebiotech.com/biotech/eli-lillys-orforglipron-bests-farxiga-padding-oral-glp-1-case-pair-phase-3-diabetes-wins   XX XX UF Health Cancer Center researchers have found a surprising culprit behind common health problems such as obesity, diabetes and fatty liver disease: silent genetic glitches in the blood system that occur naturally as people age. The findings, published in the Journal of Clinical Investigation, mean that in the future, simple blood tests could be developed to identify people most at risk early on, helping prevent chronic illnesses and cancer through strategies like diet or lifestyle changes. As people age, stem cells in the bone marrow that produce blood cells gradually accumulate mutations in their DNA. Most mutations don't cause any issues, but sometimes blood stem cells with a mutation can start crowding out their peers. Called clonal hematopoiesis, this condition affects about 10% of older people and is associated with an increased risk of blood cancers like leukemia. It's also linked to a higher risk of obesity and diabetes. But the prevailing thinking was that obesity and related conditions promoted blood cell changes, not the other way around. The new study reverses that. The implications could be far-reaching, particularly as obesity has now overtaken smoking as the most significant and preventable risk factor for cancer. The team is studying how the mutations drive disease. Next, they plan to test how drugs like those commonly used to treat diabetes and new popular weight loss drugs might help reverse or prevent diseases caused by blood cell changes. https://medicalxpress.com/news/2025-10-hidden-blood-mutations-obesity-diabetes.html XX A new ultra rapid insulin continues to move forward. A phase 3 clinical trial of BioChaperone Lispro (liss-pro) conducted in China found it safe and effective compared with Humalog along with a significant reduction of the rise of blood glucose after a test meal.     These results complete and confirm the positive outcomes previously obtained with THDB0206 injection in people with Type 2 Diabetes It combines Adocia's proprietary BioChaperone® technology with insulin lispro, the active ingredient in the standard of care, Humalog® (Eli Lilly).   This innovative formulation acts significantly faster https://pharmatimes.com/news/ultra-rapid-insulin-shows-promise-in-phase-3-trial-for-type-1-diabetes/   Poor blood sugar control in adolescent patients with type 1 diabetes (T1D) may be associated with a higher risk of neuropathy in adulthood, according to recent research from the University of Michigan.1 The study included children diagnosed with T1D between 1990-1992 who were recruited into the Cognition and Longitudinal Assessment of Risk Factors over 30 Years cohort study in Australia. Investigators collected HbA1c from medical records, and microvascular complications were assessed through self-reports, clinical screenings, retinal photographs, and urinary albumin-creatinine testing.3   A total of 30 children were recruited from the original cohort with a mean diagnosis age of 2.9 years. After an average of 29.7 years (standard deviation [SD]: 3.9 years), 33% of participants (n = 13) developed neuropathy, 63% (n = 19) developed diabetes-related eye disease, and 10% (n = 3) developed neuropathy.3 Mean HbA1c estimates during adolescence (9% [74.9 mmol/mol]; 95% CI, 8.6-9.3 [70.5-78.1]) were substantially higher than childhood (8.2% [66.1 mmol/mol]; 95% CI, 7.8-8.5 [61.7-69.4]; P Ultimately, although they noted other potential influences for future complication risks, investigators determined that adolescent hyperglycemia leads to higher neuropathy risk in adulthood, regardless of preexisting childhood control. The team urges adolescent glycemic management, noting that patients with adolescent hyperglycemia may require more support in transitioning to adult care. https://www.hcplive.com/view/adolescent-hyperglycemia-in-type-1-diabetes-may-increase-adult-neuropathy-risk XX Blue Circle Health has expanded to five more states: Massachusetts, Connecticut, Pennsylvania, Virginia, and Kentucky! This will bring the total number of states served to 16 and we are planning additional expansion prior to the end of the calendar year. Free, expert clinical care, education, and support for adults living with type 1 diabetes Blue Circle Health is a nonprofit organization with a 6-month program for adults 18+ living with type 1 diabetes. We offer free, personalized, virtual clinical care, education, and support — thanks to generous funding from The Leona M. and Harry B. Helmsley Charitable Trust. As a reminder, the program is currently active in 11 other states: Alabama, Louisiana, Mississippi, Florida, Missouri, Iowa, Ohio, Vermont, New Hampshire, Maine, and Delaware to adults 18+ with type 1 diabetes! https://www.bluecirclehealth.org/ XX O'Reilly Automotive Inc. is suing major pharmacy benefit managers (PBMs) and insulin manufacturers, alleging collusion to inflate insulin prices. The lawsuit accuses CVS Caremark, Express Scripts, Optum Rx, Eli Lilly, Novo Nordisk and Sanofi of violating the RICO Act. O'Reilly claims the companies conspired to control insulin prices, leading to increases of up to 1000%. O'Reilly Automotive Inc. provides health benefits to approximately 45,000 members O'Reilly is requesting treble damages — three times the amount of actual damages — as well as restitution and damages available under state laws, punitive damages and to recover the costs of its suit. https://www.news-leader.com/story/news/health/2025/08/07/oreilly-automotive-sues-insulin-producers-prescription-managers-inflating-prices/85528977007/ XX Nobel Prize   XX On social media, Tandem Diabetes Care (Nasdaq:TNDM) said the launch of a new integration for its insulin pump system is near. "It's almost here! The t:slim X2 insulin pump integration with the FreeStyle Libre 3 Plus sensor, the world's smallest continuous glucose monitor, is coming soon," Tandem wrote on LinkedIn.   Tandem announced that it was pairing its t:slim X2 automated insulin delivery system with Libre 3 Plus in June. At the time, the company said it had already initiated an early access program for integration in the U.S. with plans to scale availability in the second half of 2025.   On Tandem's website, it says the pump will integrate with the FreeStyle Libre 3 Plus "by the end of 2025."   The pending rollout would provide the latest pairing of automated insulin delivery (AID) and continuous glucose monitor (CGM) technologies between the companies. They announced the integration of FreeStyle Libre 2 Plus CGM into the t:slim X2 insulin pump in January 2024. Just last week, the companies announced the future pairing of Tandem systems with Abbott's under-development dual glucose-ketone sensor.   Abbott's FreeStyle Libre 3 Plus is the company's latest-generation CGM designed for insulin pump integration. Its readings every minute can help insulin pumps adjust to users' needs. The system also offers a 15-day wear time.   t:slim X2, powered by Control-IQ+ technology, has an advanced hybrid closed-loop automated insulin delivery feature. It predicts and helps prevent high and low blood sugar. Control-IQ leads to improved time in range throughout the day and night. Tandem unveiled the next-generation algorithm earlier this year. https://www.drugdeliverybusiness.com/tandem-abbott-libre-3-coming-soon/ XX New campaign from Beyond Type 1 about smashing misconceptions about all types of diabetes featuring a video with Nick Jonas. I was really happy to see that this is a video that uses a lot of humor as well as a bunch of real life amazing people with type 1 who aren't all celebrities. You'll probably recognize a few and some have been on the podcast. Very well done and worth sharing. https://www.youtube.com/watch?v=SnJQocFIutY https://beyondtype1.org/go-beyond-misconceptions-stigmas-diabetes/