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Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide's impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment. ESSENCE Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial. In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023. At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the newly published findings from the CATALYST trial, a prospective, observational study establishing the prevalence of hypercortisolism among individuals with difficult-to-control type 2 diabetes (T2D). CATALYST enrolled 1057 adults with T2D and suboptimal glycemic control (HbA1c, 7.5–11.5%) despite treatment with ≥2 glucose-lowering agents. All participants underwent a 1-mg overnight dexamethasone suppression test (DST), and common confounders were excluded. Hypercortisolism—defined as a post-DST cortisol level >1.8 µg/dL—was identified in 23.8% of participants, with even higher rates among those with cardiac disease (33.3%) or on ≥3 antihypertensives (36.6%). Adrenal imaging revealed abnormalities in about one-third of affected individuals. Isaacs and Bellini emphasized how striking it is that such a high proportion of patients met criteria for hypercortisolism, a condition historically considered rare. The trial challenges that perception, revealing that clinical features like persistent hyperglycemia and hypertension—despite optimized therapy—could reflect underlying endocrine dysfunction. They noted that neither A1c nor body mass index (BMI) alone predicted elevated cortisol, although medication intensity and comorbid conditions did. The conversation explored how the recognition of hypercortisolism could alter clinical management. Future studies will assess whether targeted treatments—such as cortisol-lowering pharmacotherapy, including mifepristone (Korlym), or adrenal surgery—can reduce medication burden, improve glycemic control, and lower cardiovascular risk. Isaacs and Bellini pointed out that many patients with hypercortisolism present without the classic phenotype, underscoring the importance of broader screening criteria. Looking ahead, they called for greater awareness among clinicians to consider screening in patients on intensive diabetes and blood pressure regimens who still fail to reach therapeutic goals. Identifying and treating hypercortisolism could open a new pathway to improving outcomes in this population. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:01 Catalyst Trial Overview and Introduction 00:01:37 Patient Criteria and Initial Findings 00:04:18 Implications and Next Steps 00:05:23 Adrenal Imaging and Cardiac Disorders 00:07:22 Clinical Implications and Future Research 00:09:13 Demographic Differences and Future Directions

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the top-line results from the ACHIEVE-1 trial evaluating orforglipron—an investigational, once-daily oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Eli Lilly—for adults with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Isaacs and Bellini emphasized the clinical significance of orforglipron's Phase 3 data in the ACHIEVE-1 trial, which demonstrated substantial reductions in A1c (1.3–1.6%) from a baseline of 8.0% and notable weight loss averaging 16 pounds (7.9%) at the highest dose over 40 weeks. Impressively, more than 65% of participants achieved an A1c below 6.5%, meeting the American Diabetes Association (ADA)'s target for diabetes control. The hosts highlighted the convenience advantage of orforglipron compared to oral semaglutide, which has strict dosing requirements. Oral orforglipron can be taken without food or water restrictions, potentially increasing adherence and reducing treatment burden. They also noted the drug's favorable safety profile, with gastrointestinal side effects similar in type and incidence to existing GLP-1 RAs, and no hepatic safety signals observed in the trial. Beyond glycemic control, Isaacs and Bellini discussed the broader implications for obesity treatment, pointing to the drug's potential utility in weight management, pending regulatory submission. They explored the possibility of using injectable GLP-1 RAs for initial weight loss followed by oral maintenance with orforglipron—potentially lowering costs and improving access. The conversation touched on the upcoming ACHIEVE trial series, which will explore orforglipron in head-to-head comparisons with other agents, its use in insulin-treated T2D, and future indications including cardiovascular risk and kidney disease. While optimistic, the hosts stressed the need for cardiovascular outcomes data to confirm orforglipron's safety and potential benefits in this domain. If confirmed, they suggested orforglipron could become a cornerstone oral therapy for T2D and obesity. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:01 Discussion on OR for GLP-1 Receptor Agonist 00:02:13 Potential Impact and Patient Preferences 00:03:59 Safety and Market Potential 00:05:13 Cost and Transition Options 00:06:32 Future Trials and Side Effects 00:08:55 Cardiovascular Outcome Data and Conclusion

In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, are joined by Rifka Schulman-Rosenbaum, MD, director of inpatient diabetes at Long Island Jewish Medical Center and co-author of Establishing Screening Programs for Pre-symptomatic Type 1 Diabetes: Practical Guidance for Diabetes Care Providers, a new paper in the Journal of Clinical Endocrinology and Metabolism. With Bellini as a co-author of the piece, experts explored the increasing clinical and operational momentum behind screening for pre-symptomatic type 1 diabetes (T1D) and what it takes to implement effective programs in real-world settings. The conversation centers on the rationale and logistics behind identifying individuals in stages 1 and 2 of T1D—autoimmune stages characterized by multiple islet autoantibodies before clinical onset. With the availability of teplizumab (Tzield), a disease-modifying therapy shown to delay progression to stage 3 of T1D, the importance of early detection and standardized screening protocols has become more urgent. Schulman-Rosenbaum outlined how her work on the JDRF Breakthrough T1D initiative led to the development of actionable guidance aimed at frontline diabetes care providers. She highlights barriers to implementation—such as limited provider awareness of T1D staging and screening protocols—and details her institution's ongoing efforts to educate primary care clinicians and endocrinologists, including distributing screening handouts and creating streamlined workflows using dot phrases and dedicated follow-up slots. The discussion emphasizes targeted screening for high-risk groups, such as first- and second-degree relatives of individuals with T1D and patients with autoimmune diseases like Hashimoto's or celiac. Schulman-Rosenbaum emphasized the opportunity for endocrinologists to screen these patients directly during routine care and the utility of a centralized handout to guide test ordering and family engagement. Drawing from their paper, experts outlined practical steps for launching autoantibody screening programs: nominating a program champion, forming an implementation team, and embedding screening into existing clinical systems. Experts stressed the importance of using appropriate ICD-10 codes for insurance coverage and referenced a diagnostic coding table in their publication. Schulman-Rosenbaum also addressed the widespread issue of misdiagnosis, particularly in adults mistakenly classified as having type 2 diabetes, and outlines best practices for using antibody and C-peptide testing to refine diagnosis. She detailed her hospital's approach to inpatient screening, noting an increased use of autoantibody testing and follow-up coordination for patients with suspected T1D or latent autoimmune diabetes in adults (LADA). Finally, the episode highlighted how to monitor individuals who test positive for a single antibody or exhibit mild dysglycemia, noting that many fall outside established risk categories. Experts called for more research in this area and advocate for individualized monitoring strategies based on clinical risk, family history, and emerging glucose patterns—often using continuous glucose monitoring (CGM) data. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00:00 Introduction 00:02:18 Inspiration Behind the Paper 00:04:12 Challenges in Implementing T1D Screening 00:07:32 Educating Providers and Overcoming Barriers 00:09:32 Addressing Misdiagnosis of Diabetes 00:12:01 Inpatient Screening Practices 00:16:13 Support and Resources for Patients with Positive Antibodies 00:20:01 Conclusion and Final Thoughts

It's finally Long Beach Grand Prix week, and Conor Daly has a brand new livery just in time for the famed event. He joins co-host Chase Holden to chat about the Mannkind-sponsored Juncos Hollinger 76 entry he'll be piloting this weekend, as well as what listeners should expect to see when IndyCar hits the track. The race has been lengthened to 90 laps this season, which Conor explains will unlock new opportunities for strategy. Drivers and teams will also be dealing with a similar tire selection to the St. Pete season opener, which showed favorable results. The guys make their podium picks for the race and chat about the other latest news around the IndyCar paddock.In celebration of the 40th anniversary of his 1985 Indianapolis 500 victory, IndyCar legend Danny Sullivan joins the program. He fills listeners in on his journey from Louisville, Kentucky to the famous Jim Russell Driving School in England, which sent him on the path of formula racing. After a brief stint in Formula One in 1983, Danny would return Stateside and take his place in the CART paddock. In 1985, Danny completed the famous “spin and win” at the Brickyard, which has become one of the most iconic moments in the history of the race. He chats with Conor and Chase about what life was like on the grid back then and what the victory did for his life and career.

Video Version Only on HCPLive! In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explored two key trial updates in type 2 diabetes (T2D) care at the American College of Cardiology (ACC) 2025 Annual Scientific Sessions. SOUL Trial SOUL, a double-blind, placebo-controlled, event-driven trial, was designed to assess the cardiovascular effects of oral semaglutide (Rybelsus) in patients with T2D and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). A total of 9650 patients aged ≥50 years were enrolled across 450 centers in 44 countries. Analyses showed oral semaglutide (Rybelsus) was linked to a 14% reduction in major adverse cardiovascular events (MACE) in high-risk patients with T2D. This reduction included the incidence of cardiovascular (CV) death, myocardial infarction (MI), or stroke compared to placebo (HR, 0.86; 95% CI, 0.77 to 0.96; P = .006) over a median follow-up of 47.5 months. A 26% reduction in non-fatal MI was the primary driver of benefit, while safety findings identified gastrointestinal adverse events as more common with oral semaglutide. Based on these results, Novo Nordisk announced plans to pursue regulatory approval for a label expansion of oral semaglutide to include MACE risk reduction in adults with T2D and established CV disease. STRIDE Trial STRIDE, a double-blind, randomized, placebo-controlled trial initiated in 2020, assessed the effects of semaglutide 1.0 mg (Ozempic) on functional outcomes, including walking distance, in patients with T2D and peripheral artery disease (PAD). Conducted across 112 sites in 20 countries, the trial randomized 792 patients to receive semaglutide or placebo for 52 weeks. Analyses showed semaglutide use was associated with improvements in maximal walking distance, quality of life, and ankle-brachial index (ABI). SOUL met its primary endpoint, with semaglutide favoring the ratio from baseline in maximum walking distance at 52 weeks (1.21 [interquartile range, 0.95–1.55] vs 1.08 [0.86–1.36]), with an estimated treatment ratio (ETR) of 1.13 (95% CI, 1.06–1.21; P = .0004). At week 57, the improvement in walking distance was higher with semaglutide (ETR, 1.08; P = .038). Quality-of-life scores (VascuQoL-6) at week 52 were significantly higher in the semaglutide group (median difference, 1.00; P = .011), as were improvements in pain-free walking distance (ETR, 1.11; P = .0046). Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Editor's Note: In this episode, there was an error in the discussion about the new dosing for Rybelsus in the SOUL trial. The corrected information is that the 14 mg dose is now 9 mg with the new formulation, due to improved absorption. The full corrected statement is: “Instead of 3 mg, the new dose is 1.5 mg; instead of 7 mg, it's 4 mg; and instead of 14 mg, it's 9 mg.”

Tonight, on a Monday night edition of Trackside with Curt Cavin and Kevin Lee, they talk about Robert Wickens returning to the driver’s seat to compete in the IMSA WeatherTech Sports Car race this weekend at Long Beach. They later look forward and preview this weekend’s Acura Grand Prix of Long Beach and talk about who looks good and not. They also talk a little about tonight’s NCAA Men’s Basketball Tournament championship game between Florida and Houston. Later, they talk about some new looks for this weekend's race, with Conor Daly driving a new MannKind livery, Marcus Armstrong with Root Insurance, and Nolan Siegel with Onsemi. Later in the first hour of the show, they talk about the reopening of the Indianapolis Motor Speedway Museum and talk more about Jay Frye going to Rahal Letterman Lanigan Racing as their team president. They also talk about NASCAR competing at Darlington Raceway yesterday with their throwback weekend, and they talk about if IndyCar would ever do a throwback weekend. To wrap up wrap up the first hour of the show, they talk about the passing of Shigeaki Hattori over the weekend after a car accident in North Carolina. They also talk about the passings of Jersey Johnny Cimasko and Maurice Kessler. To start the second hour of the show, they talk about Curt’s official induction in the Indiana Sportswriters and Sportscasters Association Hall of Fame. They later talk about the update on the newest IndyCar chassis coming in 2027 or 2028. They also talk about Tony Kanaan getting some testing laps in case if Kyle Larson has to skip the Indianapolis 500 for rain. Later in the second hour of the program, they answer fan questions from X, such as if there could ever be a return to Japan. They also talk about parking for the Indy 500 which has sold out. Then to wrap up another addition of the show, Kevin talks with Jackson Lee as he competed at Mid-Ohio for the World Racing League as he breaks down his weekend with crazy weather conditions and being teammates with Brian Till. See omnystudio.com/listener for privacy information.

Video Version Only on HCPLive! In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, reflect on major announcements and product updates from the Advanced Technologies & Treatments for Diabetes (ATTD) 2025 annual conference. The conversation opens with insights into Medtronic's new Simplera CGM, emphasizing its single-use, disposable design and fully disposable on-body form factor. The hosts highlight improvements over previous iterations, such as the absence of an inserter and a more streamlined adhesive system. Although accuracy data have yet to be released, Medtronic has initiated a pivotal trial, and expectations are high for competitive MARD performance. They then turn to Tandem Diabetes Care's Tandem Mobi pump, recently launched in the US market. The pump's compact size and phone control interface are praised for improving convenience and discretion. Bellini underscores how Mobi shifts the paradigm for pump wearability, with early feedback from patients indicating high satisfaction. Later, the hosts discuss Beta Bionics' insulin-only iLet Bionic Pancreas system, which has expanded availability in the U.S. They review recent clinical updates and ongoing efforts to integrate real-world user data. The system's unique algorithm, which doesn't require manual carb counting or standard pre-programming, continues to generate interest across clinical settings. Additional topics include anticipated innovation from Lilly's new pump platform, the competitive implications for CGM integration, and an emphasis on patient-centered device design. The episode closes with Isaacs and Bellini reflecting on the rapid evolution of diabetes technology and how practitioners can stay current with emerging tools and evidence-based practices. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Editor's Note: Control-IQ+ technology is cleared by the FDA for use in adults with type 2 diabetes in the United States, as of February 25, 2025. The podcast episode erroneously positioned the indication as forthcoming. On March 18, 2025, Tandem Diabetes Care announced the commercial launch, making Control-IQ+ available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes.

Video Version Only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center speak with Laurel Messer, PhD, RN, senior director of medical affairs at Tandem Diabetes Care, about the latest advancements in Control-IQ+, the company's next-generation automated insulin delivery (AID) technology. With clearance received from the US Food and Drug Administration (FDA) in February 2025, Tandem announced on March 18, 2025, that the Control-IQ+ hybrid closed-loop algorithm is now available for use in adults with type 2 diabetes (T2D) aged ≥18 years alongside people with type 1 diabetes (T1D) aged ≥2 years. Enhancements to the algorithm included a broader weight range (20–440 lbs) and insulin dosing parameters (5–200 units), representing a more inclusive algorithm. In this episode, Messer highlighted other new features in the updated algorithm, such as temp basal rate adjustments for exercise or illness and an extended bolus option of up to eight hours, which enhances flexibility in insulin management during meals. Messer also emphasized that Control-IQ+ offers a unique advantage: the ability to fine-tune correction factors, allowing providers to tailor insulin delivery for improved glycemic control. With the AutoBolus feature, Control-IQ+ predicts and corrects hyperglycemia every hour, significantly benefiting individuals who struggle with consistent mealtime bolusing. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Important Safety Information: RX ONLY. Indicated for patients with type 1 diabetes, 2 years and older and for patients with type 2 diabetes, 18 years and older. BOXED WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds, as those are the required minimum values needed for Control-IQ+ to operate safely. Safety info: tandemdiabetes.com/safetyinfo.

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss a pair of recently published studies examining the use of diabetes technology in adults with type 2 diabetes. SECURE-T2D A single-arm prospective study conducted at 21 US clinical centers, SECURE-T2D assessed the impact of automated insulin delivery (AID) on glycemic control in adults with type 2 diabetes using insulin for at least 3 months. The study enrolled 305 participants (mean age, 57 years; 57% female), with a diverse racial and ethnic representation, including 24% Black and 22% Hispanic or Latino. Following a 14-day standard therapy phase, participants used the Omnipod 5 AID system for 13 weeks. HbA1c decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (mean difference, -0.8 percentage points; 95% CI, -1.0 to -0.7; P

Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore the updated American Diabetes (ADA) 2025 Standards of Care, focusing on therapeutic advancements in diabetes management. Hosts discussed the significant changes to treatment algorithms and new guidance designed to enhance outcomes for people with diabetes and related conditions. One of the major updates discussed is the expanded flexibility in the treatment algorithm for type 2 diabetes (T2D) and chronic kidney disease (CKD), including glucagon-like peptide-1 receptor agonists (GLP-1 RA), such as semaglutide, as an alternative to patients who may not tolerate sodium-glucose co-transporter 2 (SGLT2) inhibitors. Isaacs and Bellini emphasized the complementary benefits of combining these therapies, particularly for kidney protection and glucose management. The episode also highlighted updates on the use of GLP-1 RAs for patients with obesity-related heart failure with preserved ejection fraction (HFpEF), underscoring the evolving role of these medications beyond glucose lowering. The discussion then shifted to the introduction of recommendations for metabolic dysfunction-associated steatotic liver disease (MASLD) and steatohepatitis (MASH). GLP-1 RAs, dual GLP-1/GIP agonists, and combinations with pioglitazone are now recognized as promising treatment options to mitigate these risks. Hosts delved into the importance of identifying disease severity using FIB-4 scores and how these guidelines aim to address the rising prevalence of fatty liver disease among people with diabetes. Another noteworthy update focused on screening for type 1 diabetes (T1D), particularly in first-degree relatives of individuals with the disease. Isaacs and Bellini review the new staging framework, which classifies T1D progression into three distinct stages, and the inclusion of ICD-10 codes for accurate diagnosis. They also discussed the role of teplizumab (TZIELD) in delaying disease progression in individuals aged ≥8 years and what this could represent for early intervention. With practical insights and real-world applications, this episode provided a comprehensive look at how these updates from the ADA's 2025 Standards of Care will shape therapeutic decision-making and improve care for people with diabetes. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:00 Updates to 2025 ADA Standards of Care 03:06 GLP-1 Agonists and SGLT2 Inhibitors Combination Therapy 04:34 Heart Failure Stratification and Obesity-Associated Heart Failure 07:04 Introduction of Liver Disease into Algorithms 10:28 Screening for Type 1 Diabetes and New Guidelines 13:57 Guidelines for Pre-Symptomatic Type 1 Diabetes 17:35 Nutrition and Medication Adjustments 20:45 Vitamin D Monitoring and Supplementation 22:12 ADA Standards of Care App

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! Video Version only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore the updated American Diabetes (ADA) 2025 Standards of Care, focusing on technology advancements in diabetes management. The discussion highlighted significant advancements and updated recommendations in diabetes care, particularly surrounding continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems. In particular, hosts pointed to stronger ADA recommendations for CGM use, including for individuals with type 2 diabetes (T2D) not on insulin therapy, and emphasized the importance of CGM for all patients on insulin therapy to reduce hypoglycemia risks. They also touched on the potential of over-the-counter CGMs to guide medication adjustments and lifestyle changes for prediabetes and T2D. A notable topic is the ADA's revised stance on open-source AID systems, explicitly asking clinicians to support and guide patients who use these open-source systems. In particular, the organization recognized its potential to improve outcomes and urged providers to understand the underlying algorithms as they continue to advance. Isaacs and Bellini also highlighted the role of CGM and AID systems during pregnancy, emphasizing the early initiation of technology to achieve personalized glycemic targets and optimize outcomes. The discussion expanded on the seamless integration of CGM during hospital discharge programs, as well as ADA recommendations that AID systems become the preferred insulin delivery method for people with type 1 diabetes (T1D), with growing support for their use in T2D on basal or multiple daily insulin injections. They addressed challenges such as Medicare restrictions on pump coverage for T2D, and insurance denial of test strips for CGM users, emphasizing the critical need for test strips as backups during CGM failures. Their conversation also zeroed in on the ADA's new guidance on allowing insulin pump use during hospitalization when clinically appropriate. Bellini stressed the importance of patient independence and education, advocating for hospitals to enable pump use if patients or caregivers can manage them. Hosts underscored the importance of patients bringing sufficient supplies to hospitals, as most facilities do not stock them. Throughout the episode, Isaacs and Bellini emphasized the transformative potential of diabetes technology, urging clinicians to embrace and adapt to advancements to better support patients. They advocated for empowering individuals to manage their care, educate healthcare providers, and push for policy changes that improve access, equity, and outcomes in diabetes management. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Key Episode Timestamps 00:01 Introduction, Updates on CGM for Type 2 Diabetes 03:14 Support for Open Source AID Systems 09:14 Improved Guidelines for AID and Pregnancy 13:34 Early Initiation of CGM and AID 18:46 Advocacy for CGM and Test Strips 21:52 Insulin Pumps During Hospitalization 25:35 Conclusion

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Allison Evert, MS, RD, CDCES, and Savitha Subramanian, MD, co-authors of a recent publication on the evolving role of registered dietitian nutritionists (RDNs) in incretin-based therapies and obesity care, titled "Incretin-Based Therapies and Lifestyle Interventions: The Evolving Role of Registered Dietitian Nutritionists in Obesity Care". The conversation explores how combining GLP-1 receptor agonists with lifestyle interventions can enhance long-term outcomes in diabetes and obesity management, focusing on the integral role of RDNs in addressing medication adherence, side effects, and patient education. Evert and Subramanian highlight key findings from their paper, including strategies for mitigating side effects such as nausea, constipation, and diarrhea, which contribute significantly to high discontinuation rates during the first year of therapy. They stress the importance of counseling patients on appropriate dietary adjustments to prevent nutrient deficiencies and muscle loss during rapid weight loss, recommending an emphasis on protein intake and nutrient-dense food choices. The discussion also delves into the practical challenges of integrating RDNs into care teams, particularly in systems with limited resources. To address this gap, the authors provide actionable tools in their paper, including figures and resources to guide clinicians in patient education and medication management. The hosts and guests agree that team-based care, including the use of pharmacists, advanced practice providers, and clinical protocols, is critical to improving outcomes and ensuring the long-term success of these therapies. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Gigliotti L, Warshaw H, Evert A, et al. Incretin-Based Therapies and Lifestyle Interventions: The Evolving Role of Registered Dietitian Nutritionists in Obesity Care. J Acad Nutr Diet. Published online November 7, 2024. doi:10.1016/j.jand.2024.10.023

Video version only on HCPLive! In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, speak with Eran Atlas, chief executive officer of DreaMed Diabetes, on the evolution and current functionality of his company's automated insulin technology, originally developed within a prominent diabetes treatment center in Israel, and now integrated with Medtronic's 780G system. Atlas Described how DreaMed Diabetes started focusing on automated insulin delivery but has expanded into developing a comprehensive digital care platform. This platform, called endo.digital, is designed to optimize insulin therapy for people with diabetes using AI-driven algorithms. It can gather data from various devices, including continuous glucose monitors (CGMs) and insulin pumps, analyze it, and offer tailored insulin recommendations to providers, which can be automatically integrated into the patient's medical records. Atlas further explained how the platform supports both insulin pump users and those on multiple daily injections (MDI). Hosts discussed how this algorithm could detect potential issues, such as incorrect carb ratios, missed insulin doses, or improper basal insulin adjustments, and subsequently provide actionable recommendations for providers. These insights are aimed at improving the quality of care and increasing accessibility to expert care for people with diabetes, especially in settings where endocrinologists are not readily available. Currently, the system is FDA-cleared to work with glucose data and doesn't require direct insulin data input, as it can infer insulin events from glucose trends. The company's platform is currently deployed in multiple health systems, including the Yale University health system and Boston Children's Hospital, with a focus on increasing its reach to primary care providers. Atlas indicated one key benefit of the platform is its ability to save providers significant time by automating documentation and visit summaries, which has already resulted in hundreds of hours saved in health systems. Looking forward, Atlas described how DreamMed Diabetes is expanding its offerings, including working on solutions for basal-only insulin patients and enhancing the platform's capabilities to include other diabetes therapies, such as GLP-1 medications. Atlas emphasized the company's mission to improve care access and outcomes, particularly in underserved populations. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Episode Highlights 0:00 Introduction and Background of DreaMed Diabetes 1:46 Current Functionality and Features of DreaMed Diabetes Platform 4:44 Algorithm Capabilities and Insights 7:06 Cloud-to-Cloud Integration and User Engagement 9:37 Onboarding Process and Data Analysis 21:00 Financial Benefits and Budget Neutrality 25:31 Future Enhancements and Broader Applications

Video Version only on HCPLive!  In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center explore the increasing focus on the connection between obesity and diabetes, including the latest advancements in glucagon-like peptide-1 (GLP-1) receptor agonist therapies, the use of inhaled insulin, and the recent addition of hypercortisolism to the “Ominous Octet”, creating the “Noxious Nine.” Although obesity rates in the US have been rising steadily globally, hosts pointed to a recent CDC report reporting a slight decrease in obesity rates. They suggest that this may be partially attributed to the impact of GLP-1 drugs, which have become increasingly popular in managing obesity and related metabolic disorders, including type 2 diabetes (T2D). With these drugs continuing to show promising results, the hosts express optimism about their potential to reduce obesity and improve long-term patient health outcomes. Their conversation shifted to a detailed discussion of the INHALE-1 trial, which evaluated the effectiveness of inhaled insulin in children with type 1 diabetes (T1D) and T2D. The trial, designed to evaluate the non-inferiority of inhaled insulin compared to traditional subcutaneous injections, found that inhaled insulin provided similar efficacy without significant differences in lung function or hypoglycemia occurrence. Isaacs and Bellini highlighted the implications of these findings, emphasizing that inhaled insulin could offer an alternative treatment option for pediatric patients, particularly those who struggle with needle phobia or the burden of multiple daily injections (MDIs). The episode concluded with a deep dive into the Catalyst study, which explored the use of mifepristone in patients with T2D complicated by hypercortisolism. The second phase of the Catalyst trial found a significant reduction in HbA1C levels, showing a 1.5% decrease in patients treated with mifepristone compared with the placebo group. Isaacs and Bellini discussed the potential clinical applications of these results, particularly for patients with difficult-to-control diabetes who may have an underlying hormonal issue contributing to their condition. Overall, hosts encouraged clinicians to consider hypercortisolism in their differential diagnosis for patients with challenging diabetes cases, noting the promise that mifepristone could offer as an adjunctive treatment. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Video Version Only on HCPLive! In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore recent advancements in incretin-based therapies, highlighting their transformative potential for diabetes management and weight loss. The episode opens with a detailed discussion on Amgen's maridebart cafraglutide (MariTide; AMG-133), an investigational antibody peptide conjugate offering remarkable efficacy for obesity and overweight in Phase 2 trial data. At 52 weeks, participants without type 2 diabetes (T2D) experienced an average weight loss of ~20% with MariTide treatment without a weight loss plateau, while those with T2D achieved up to a ~17% average reduction without a plateau. The hosts underscored the potential impact of this type of therapy, particularly in addressing adherence challenges posed by the more frequent dosing schedules of current options. Hosts cited the potential safety concerns, but noted that AMG-133 could represent a significant step forward in managing obesity and related metabolic disorders. The conversation then shifted to a head-to-head comparison of two leading incretin therapies for obesity: tirzepatide (Zepbound) and semaglutide (Wegovy). Tirzepatide emerged as a frontrunner in the SURMOUNT-5 trial, contributing to a mean body weight reduction of 20.2% versus 13.7% achieved with semaglutide. Isaacs and Bellini discuss how these findings might influence clinical decision-making, emphasizing the importance of tailoring treatment plans to individual patient needs. They also touch on the practical implications of these therapies in both obesity and diabetes care, given the growing prevalence of these conditions. In the final segment, Isaacs and Bellini addressed a critical safety issue: the proliferation of non-FDA-approved compounded glucgaon-like peptide-1 (GLP-1) receptor agonists. The American Diabetes Association (ADA) released a statement warning against these unregulated formulations due to concerns over safety, quality control, and potential adverse effects. Despite the growing popularity of compounded versions as a lower-cost alternative, the hosts stressed the importance of prioritizing patient safety. They advised clinicians to steer patients toward evidence-based, FDA-approved therapies that have undergone rigorous testing and demonstrated consistent efficacy and safety profiles. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Mannkind releases info about it's Afrezza pediatric studies, Dexcom launches AI tech with Stelo, Health Canada approves Tandem/Dexcom G7, diabetes drug may help sleep apnea, an app in development to help drivers with T1D 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  Edgepark Medical Supplies 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: 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: info@diabetes-connections.com 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 Mannkid expects to talk to the FDA about Afrezza inhaled insulin for pediatric approval early in 2025. The company just announced six-month results from its Phase 3 INHALE-1 study of kids aged 4-17 with type 1 or type 2 diabetes comparing either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin. A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing. HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, There were no differences between groups or concerns in other safety measures, including hypoglycemia. https://www.medscape.com/viewarticle/inhaled-insulin-benefits-kids-diabetes-too-2024a1000nex   XX Dexcom announces the use of AI for its Stelo platform. The company says the new Dexcom GenAI platform will analyze individual health data patterns to reveal a direct association between lifestyle choices and glucose levels while providing actionable insights to help improve metabolic health. Stelo users will start seeing the features this week. The AI is modeled after Google Cloud's Vertex AI and Gemini models. We'll hear more about this in January – Dexcom will be part of a panel at the Consumer Electronics Show about AI and healthcare. BTW this press release is the first time I've seen what seems to be a new slogan for Dexcom – Discover What You're Made Of. https://www.businesswire.com/news/home/20241217011997/en/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing XX Staying with Dexcom, users report that the geofencing issue we reported on seems to be resolved. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. With the latest iOS and Android G7 apps, this seems to be resolved. This is according to the folks in the DIY community who first brought it to my attention.   XX Interesting insulin development to watch. Egypt approves EVA Pharma's insulin drug products, which is a collbaration between Eli llly and EVA, an Egyptian company. The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.   Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges. This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030. https://www.prnewswire.com/news-releases/lilly-and-eva-pharma-announce-regulatory-approval-and-release-of-locally-manufactured-insulin-in-egypt-302333269.html     XX Can we add treating sleep apnea to the list of applications for terzepatide? That's the generic for Zepbound and Mounjaro. Phase 3 study shows that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea. Eli Lilly said there was nearly a 20% reduction in weight among those in the trials. The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year. https://www.aol.com/popular-weight-loss-drug-could-131507702.html   XX Health Canada okays Tandem's tslim X2 with Dexcom G7 and G6 making it the first and only insulin pump in Canada that is integrated with both Dexcom sensors. Now, t:slim X2 users in Canada can experience even more choice when it comes to CGM compatibility, along with the option to spend more time in closed loop with Dexcom G7's 30-minute sensor warm-up time, faster than any other CGM on the market.3 In addition, t:slim X2 users who pair Dexcom G7 with an Apple smartwatch4 can see their glucose numbers directly from their watch without having to access their pump or smartphone4. Tandem will email all in-warranty t:slim X2 users in Canada with instructions on how to add the new compatibility feature free of charge via remote software update. t:slim X2 pumps pre-loaded with the updated software will begin shipping to new customers in early January 2025.   To check coverage and start the process of getting a Tandem insulin pump, please visit tandemdiabetes.ca. https://www.businesswire.com/news/home/20241210731189/en/Tandem-tslim-X2-Insulin-Pump-Now-Compatible-with-Dexcom-G7-CGM-in-Canada XX A federal jury on Tuesday awarded Insulet $452 million in its patent skirmish with EOFlow over insulin patch pumps. The jury awarded Insulet $170 million in compensatory damages from EOFlow and an additional $282 million in exemplary damages for willful and malicious misappropriation. A judge has not yet entered a judgment on the decision. Insulet filed a lawsuit in the U.S. District Court for the District of Massachusetts in 2023, claiming EOFlow copied patented components of its Omnipod insulin pumps. In October 2023, the Massachusetts district court issued a preliminary injunction against EOFlow. Following that decision, Medtronic called off plans to buy EOFlow for about $738 million.   A federal appeals court later overturned the preliminary injunction, and EOFlow resumed selling its devices in Europe. The company recently defended against a separate injunction filed by Insulet in Europe's Unified Patent Court, according to Korea Biomedical Review, an online English newspaper based in Seoul, South Korea.   The Massachusetts jury found this week that EOFlow and CEO Jesse Kim, as well as two of three former Insulet employees who were named as defendants in the lawsuit, misappropriated Insulet's trade secrets.   Insulet CEO Jim Hollingshead said the company is “extremely pleased with the jury's verdict.” EOFlow did not immediately respond to a request for comment. https://www.medtechdive.com/news/insulet-eoflow-jury-verdict-patent-lawsuit/734745/ XX A tele-education program for health care providers who treat people with diabetes resulted in significant improvements in patient outcomes, including better blood sugar levels and increased use of medical devices to manage the disease, a University of Florida study finds. Led by researchers in the UF College of Public Health and Health Professions and the UF College of Medicine, the program used the Extension for Community Health Care Outcomes model, which has been adopted worldwide to train clinicians who treat patients with a variety of conditions. Known as Project ECHO, this is one of the first to demonstrate patient benefits for the program in a large, randomized trial. The findings appear in the journal Diabetes Care. https://ufhealth.org/news/2024/clinician-training-program-leads-to-better-outcomes-for-patients-with-diabetes XX New app under development to make driving safer for people with diabetes. Diabetes Driving Pal says it will use CGM data and guide you while you are driving without any annoying alerts. Guidance/suggestions will be on your car dashboard so that you don't have to look at phone and it will be very individualized and actionable. In a study last year, ~70% of people have reported (5% reported accident) to have at least one low blood sugar while driving and most reported that CGM alerts were not enough to protect them. We are hoping to start beta testing in a few months. We are trying to raise the fund to develop this product. We need your support. For more information, please visit: https://lnkd.in/gTDhnDc4 XX I'm also going to link to the top ten most read diabetes and endocrinology stories of 2024 from Medscape. This is almost all GLP-1 related.. and mostly for people with type 2. https://www.medscape.com/viewarticle/icymi-top-10-diabetes-endocrinology-stories-2024-2024a1000n6u?&icd=login_success_email_match_fpf XX That's it for the last In the News of 2024! Don't miss out episode next week with a look ahead to what we're watching in 2025. I'm SS I'll see you back here soon…

Video Version only on HCPLive! In celebration of the podcast surpassing 100 episodes, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down for a special edition episode with Irl Hirsch, MD, professor of medicine at the University of Washington. Discussion within the episode reflects on continuous glucose monitoring (CGM) and its revolutionary impact on diabetes care as well as its transformative history, beginning with its introduction by MiniMed in 1999. Hirsch recounts his first CGM experience and how it fundamentally changed his approach to managing hypoglycemia and diabetes complications. The conversation transitions to pivotal milestones, such as the JDRF CGM study and the push for Medicare coverage, which advanced CGM accessibility and integrated it into diabetes care standards. Hirsch also highlights the evolution of CGM technology, including the adoption of factory calibration, non-invasive sensors, and over-the-counter options, while addressing challenges like patient misconceptions about device accuracy. The trio also explore CGM's potential beyond glucose monitoring, including ketone detection, that could revolutionize diabetes management and broader healthcare applications. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.Relevant disclosures for Hirsch include Abbott Diabetes Care, Roche, Hagar, Tandem, and Mannkind. Chapters: 00:00 - Start 01:37 - Early Experiences with CGM 07:44 - Early Resistance and Advocacy  14:33 - Impact of CGM Advances 25:32 - Emerging Metrics and Biomarkers Beyond A1C 31:01 - Future Directions in Glucose Monitoring

In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, take a deep dive into 3 pieces of news related to diabetes management and incretin therapies, including the BPROAD trial, tirzepatide in heart failure with preserved ejection fraction with obesity, and an NHANES analysis suggesting more than 50% of US adults qualify for semaglutide. BPROAD Presented at the American Heart Association (AHA) Annual Scientific Sessions 2024, BPROAD examined the effects of 120 mmHg vs 140 mmHg blood pressure goals among a cohort of 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. With a follow-up period lasting up to 5 years, the trial's primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Upon analysis, results suggested the mean SBP levels in participants at the 4-year visit were 120.6 mmHg in the intensive treatment group and 132.1 mmHg in the standard treatment group. Those receiving the intensive treatment regimen experienced a 21% lower relative risk of major cardiovascular events during the follow-up period, compared with those on standard treatment (HR 0.79; 95% Cl, 0.69 to 0.90; P

Launched on November 14, 2024 to celebrate World Diabetes Day, this episode tackles a flurry of recent news and updates related to semaglutide (Ozempic/Wegovy/Rybelsus), including Novo Nordisk declaring an end to the shortage of the drug, which began in early 2022. In the episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the latest developments in GLP-1 receptor agonists, with a particular focus on semaglutide. They begin by examining topline results from the SOUL trial, which demonstrated a 14% reduction in major adverse cardiovascular events with oral semaglutide (Rybelsus) in patients with established cardiovascular disease. According to hosts, this finding may expand options for patients who prefer oral medications over injections, although they emphasize proper administration techniques to maximize efficacy. The conversation then turns to new data presented at Obesity Week, showcasing oral semaglutide's effectiveness in weight loss for higher doses—25 and 50 mg—demonstrating 14% weight loss at 25 mg. They also highlight semaglutide's impact in specific comorbidities in recent trials, with use eliciting a significant reduction in osteoarthritis pain and potential benefits for kidney disease, even in patients without diabetes. Isaacs and Bellini discuss the SELECT trial results, where semaglutide showed a reduced rate of hospitalizations and adverse events, suggesting an anti-inflammatory benefit that could further support its use in managing obesity and type 2 diabetes. The episode concludes with a call to payers to support wider coverage, given the compelling data on reduced hospitalization and improved patient outcomes. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore the recent updates surrounding GLP-1 receptor agonists, particularly focusing on long-term tirzepatide (Mounjaro/Zepbound) data and the current status of GLP-1 shortages. The hosts begin the episode by highlighting the FDA recently reported a stabilization in the GLP-1 supply, may reduce the use of compounded, unapproved versions of these drugs, which the FDA now cautions against in the absence of official shortages. Turning specifically to tirzepatide, the hosts discuss findings from the SURMOUNT-1 trial, now with a 3-year follow-up, which demonstrated sustained weight loss for doses up to 20% in patients with obesity. Additionally, tirzepatide showed a 94% reduction in progression from prediabetes to type 2 diabetes, which hosts highlight as a promising outcome given the increasing diabetes prevalence. The hosts anticipate further research that could reveal even longer-term benefits, especially as tirzepatide continues to show positive outcomes in sleep apnea and heart failure metrics. Isaacs and Bellini encourage clinicians to consider tirzepatide's sustained metabolic effects and urge a continued focus on personalized medicine as more data emerges. They conclude with a call to stay informed as GLP-1 research progresses, with the potential for further applications in chronic disease prevention and treatment. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

This episode spotlights news in diabetes technology from the latter half of October 2024. In the episode, hosts breakdown updates from multiple companies related to continuous glucose monitoring and insulin delivery. A brief overview of announcements covered in the episode by hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, can be found below: Abbott's FreeStyle Libre 3: On October 30, 2024, Beta Bionics Inc announced the integration of the iLet Bionic Pancreas with Abbott's FreeStyle Libre 3 Plus sensor. According to hosts, the new compatibility broadens choice for patients and offering flexibility in CGM usage. Additionally, this sensor has also been approved for use during MRI and CT scans, eliminating the need to remove the device, which adds convenience for patients requiring frequent imaging. Integration with Tidepool: On October 28, 2024, Tidepool announced a new data integration with Abbott. With this integration, the Libre 3 now connects with Tidepool, allowing data from multiple CGMs to be consolidated in a single platform, streamlining data review for clinicians and patients and reducing training requirements. Omnipod 5 for iOS: on October 29, 2024, Insulet Corporation announced the full market release of its Omnipod 5 App for iPhones in the US. Now available for iPhone users (using Dexcom G6), the update allows features like preset meal settings, a valuable tool for patients who use flexible carb counting approaches. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

On September 17, 2024, Ascensia Diabetes Care and Senseonics announced the US Food and Drug Administration's (FDA) clearance of the Eversense 365 system for people with type 1 and type 2 diabetes aged 18 years or older—the world's first 1-year continuous glucose monitor (CGM). A fully implantable, long-term CGM option, the Eversense 365 offers a 12-month sensor survivability and implantable sensor, which allow for fewer data interruptions, less waste, and lessened burden on quality of life, according to the release from Ascensia and Senseonics. Other features highlighted by the companies include a silicone-based adhesive that can be changed daily, a removable transmitter that can be taken on and off without wasting a sensor or adding a warmup period, and on-body vibration alerts to keep patients notified when away from their phone. Ascensia and Senseonics also pointed out Eversense 365 had been cleared as an integrated CGM system, which allows for integration with compatible medical devices, including insulin pumps as part of an automated insulin delivery system. “Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, president of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics' ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.” In this special edition of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Hansen joins hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, for a deep dive into the Eversense 365 and what clearance means for people with diabetes. During the episode, key points of discussion include the product's features like reduced calibrations, the convenience of the transmitter's USB charging, and its suitability for active patients. During the discussion, Hansen emphasizes the role of patient choice in design and future direction for Eversense. Hansen notes Eversense is currently working to expand inserter networks and pursue pump partnerships, with future goals to include a fully implantable sensor without a transmitter. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Campbell P. FDA clears Eversense 365, marking First 1-year CGM option in diabetes. HCP Live. September 18, 2024. Accessed October 15, 2024. https://www.hcplive.com/view/fda-clears-eversense-365-marking-first-1-year-cgm-option-in-diabetes. Senseonics. Eversense 365 receives FDA Clearance: The World's first one year CGM. Senseonics. September 17, 2024. Accessed October 15, 2024. https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174. Key Timestamps and Highlights 00:00 - Introduction and Guest Introduction 02:04 - Overview of Eversense 365 07:20 - Details on the Transmitter 08:44 - Patient Candidate and Use Cases 13:55 - Medicare Coverage and Integration with Insulin Pumps 17:01 - Future Goals and Patient Choice 28:38 - App and Remote Patient Monitoring

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, take a deep dive into their experience with the Dexcom Stelo. The Dexcom Stelo is the first FDA-cleared over-the-counter glucose sensor. Cleared by the FDA on March 05, 2024, the Stelo is indicated for use by anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Dexcom announced availability of the device via Stelo.com on August 26, 2024. In a previous episode, Isaacs an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Bellini, provide insight to their experiences with the system after the first 24 hours of use. In this episode, describe their continual experience with the device itself as well as the app. During the episode, hosts discuss the app setup process, which differentiates between users with and without diabetes, setting appropriate target glucose ranges. Later, the hosts praise the app's educational "nuggets" and the spike detection feature, which prompts users to reflect on potential causes of glucose changes. Bellini notes her appreciation of the app's ability to ask questions about real-time glucose fluctuations, highlighting how this could provide valuable insights to consumers, and Isaacs calls attention to the app's 15-minute data updates, though the underlying data is available every 5 minutes. Later in the episode, hosts discuss some of the early drawbacks of the system. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss US availability of the Abbott Lingo and Embecta's announcement of US Food and Drug Administration (FDA) clearance for their tubeless patch pump with a 300-unit insulin reservoir. Abbott Lingo Availability On September 05, 2024, Abbott announced US availability of their over-the-counter continuous glucose monitoring system, the Lingo. Designed for consumers 18 years and older not on insulin, is priced at $49 for 1 biosensor worn for up to 14 days or $89 for 2 biosensors. The announcement of availability comes less than 2 weeks after Dexcom announced the availability of the Stelo and less than 3 months after Abbott announced the FDA clearance of the Rio and Lingo systems. Editor's note: During this episode, hosts reference a 15-day wear time for this system, the Lingo can be worn for up to 14 days, according to Abbott. Embecta Approval On September 03, 2024, Embecta Corporation announced the US FDA had granted 510(k) clearance for their disposable patch pump for insulin delivery for use in adults who require insulin to manage diabetes. Including both 1 and type 2 diabetes within this indication, the FDA clearance means patients will have access to a tubeless patch pup boasting a 300-unit insulin reservoir designed based on feedback from people with type 2 diabetes and healthcare providers. According to the company, the 300-unit insulin reservoir will offer a distinct advantage compared to other systems, citing a recent study finding a reservoir of this size would meet the needs of 64% of adults with T2D for three-day wear, while a 200-unit reservoir would only meet the needs of 38% of that same population. In their announcement, Embecta pointed out patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

This episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, our second related to the Association of Diabetes Care and Education Specialists (ADCES) 2024 annual meeting, spotlights new data and perspectives from the meeting brought forth by pharmaceutical and diabetes technology companies. Check out our first episode related to ADCES 2024. A large theme of the episode is discussion around data and interactions with Lexicon, which announced the resubmission of a New Drug Application for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control among adults with type 1 diabetes and chronic kidney disease. According to the FDA, the agency considers the resubmission a complete response to its 2019 letter regarding sotagliflozin for type 1 diabetes.1 For this application, the FDA has assigned a Prescription Drug User Fee Act review date of December 20, 2024. On August 21, 2024, Lexicon Pharmaceuticals announced the FDA's intention to host an advisory board meeting regarding this application.2 Of note, sotagliflozin (Inpefa) has received approval in heart failure for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors in May 2023.3 Following this, the conversation between hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, shifts to a discussion on Medtronic's collaboration with Abbott, with the hosts praising this partnership as a strategic move to improve sensor technology for patients. The episode then highlights the innovative educational approach to learning about the Sequel Twiist, with Sequel hosting a jeopardy-style game to engage attendees in learning about their upcoming pump product. Finally, the hosts explore the Diabetotech certificate program, which offers in-depth education on various diabetes technologies, and emphasize the importance of continuous learning and unbiased educational resources in the rapidly evolving field of diabetes management. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

Today we are discussing Afrezza with Michael Castagna, CEO of MannKind. Screen It Like You Mean It Eversense CGM Learn about the Medtronic Champions This BetterHelp link saves 10% on your first month of therapy Try delicious AG1 - Drink AG1.com/Juicebox I Have Vision Use code JUICEBOX to save 30% at Cozy Earth  Get Gvoke HypoPen CONTOUR NextGen smart meter and CONTOUR DIABETES app Learn about the Dexcom G6 and G7 CGM Go tubeless with Omnipod 5 or Omnipod DASH * Get your supplies from US MED  or call 888-721-1514 Learn about Touched By Type 1 Take the T1DExchange survey *The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.  A full list of our sponsors  How to listen, disclaimer and more Apple Podcasts> Subscribe to the podcast today! The podcast is available on Spotify, Google Play, iHeartRadio, Radio Public, Amazon Music and all Android devices The Juicebox Podcast is a free show, but if you'd like to support the podcast directly, you can make a gift here or buy me a coffee. Thank you! Disclaimer - Nothing you hear on the Juicebox Podcast or read on Arden's Day is intended as medical advice. You should always consult a physician before making changes to your health plan.  If the podcast has helped you to live better with type 1 please tell someone else how to find the show and consider leaving a rating and review on Apple Podcasts. Thank you! The Juicebox Podcast is not a charitable organization.  

On the final episode of The Rob and Eritrea Show of 2023, the gang wraps up the highs, the lows, and a whole lot more: * Some of their favorite moments from the forty-three episodes published in 2023 * Being the #1 podcast on Spotify wrapped for some of our listeners and some other surprising stats * Hosting four first-time events, some virtual, some in person, some local, some not * Our expanding collaboration and relationship with the North Texas Food Bank * Making it to the Top 20 of the DCB Innovation Challenge and what we learned during that process * Cementing the mission of DDT in 2023 at the CWD conference as a team * A bit about our 2024 programming and what more is on the horizon As we close out the year and reflect on all the work we put in, we are truly grateful to each and everyone one of you who gets anything out of these episodes. We couldn't do it without you! Big shoutout and Thank you to some of our sponsors this year: Medtronic, Mannkind, Xeris, Insulet, SkinGrip, Diabetes Link, Swoon, Belay, and more! Happy Holidays and see you in 2024!

It's not often that we get to talk to the partners that help us to be able to create this podcast. On this episode, Rob talks to the CEO of MannKind Corporation, Michael Castagna. They discuss: * Being a doctor of pharmacy and then getting an MBA at a top-tier school * Working on the HIV drug that became the first once-a-day one pill regimen * Becoming a CEO of a pharma company could expand his ability to help more people * Having doubts in self-confidence from being a kid who grew up in poverty * Being an expert in two fields * Inhaled insulin still not being widely known * Becoming a patient himself * The legacy of Alfred Mann and the continued mission to help patients * Mission to help patients vs. the money going to middlemen * What's coming up for MannKind in 2024 o More tools and options for patients Like he said in the episode, if you have access issues - you can get help here to find a doctor or you can email him directly at mcastagna@mannkindcorp.com

Have you wanted to enter the mind of an up and coming CEO? Sitting down with Dr. Michael Castagna was a pleasure. You will learn so much about how to grow into the industry side of pharmacy and he really sheds light on a very different side of pharmacy and healthcare. He has been thriving in the pharmaceutical industry and has been around specialty pharmacy for the past 25 years. I know I took notes on his books that he recommends. Find him on LinkedIn!

This special #sponsored episode features Stargirl herself, Brec Bassinger! This episode is sponsored by Mannkind, and is part of Diabetics Doing Things ongoing partnership with Mannkind. If you want to see Brec in Stargirl, it's streaming in all places that stream the CW including HBOMax. Season 3 is out now. In this episode, Rob and Brec talk about: How they both have January diagnoses in DFW area children's hospitals Balancing diabetes with a Superhero's schedule Life on set The importance of friends with diabetes Becoming an advocate and spokesperson Favorite reality TV…hint: it's Selling Sunset Which celebrity they'd challenge to a pickleball match And MORE We want to hear from you. Send your questions, comments, queries, and general diabetes concerns to THE MAILBAG at mailbag@diabeticsdoingthings.com!

In this episode, hosts are joined by the associate director of Medical Affairs and Medical Education at MannKind for a special edition episode from ATTD 23 that focuses on use of inhaled insulin and future research plans for MannKind.

REMINDER: This podcast should not be considered medical advice. Please speak to your doctor to determine whether Afrezza is right for you.I am thrilled to release this episode with Michael Castagna PharmD, CEO of MannKind. MannKind is the maker of Afrezza, the inhaled insulin. Listen back to Episode 25 released on May 18, 2022 (link below) if you want my initial impressions of Afrezza. As you may have gathered from listening to this podcast, I'm a huge fan of Afrezza. It has completely changed how I manage my diabetes and it has greatly simplified my daily routine. Afrezza is a game changer for people that take insulin (both Type 1 and Type 2 diabetics).Michael provides tons of useful information about what Afrezza is, how dosing works, who Afrezza is appropriate for, how to get a prescription, how to pay for it, etc. We go in-depth on some really important topics and I think you will find this episode to be extremely useful.If you are interested in Afrezza, please reach out to Afrezza Assist to get the process started. They are extremely helpful and will let you know what to expect as you speak to your doctor, insurance company, and pharmacy. https://afrezzaassist.comEpisode Links:Episode 25 - my initial thoughts on Afrezza https://stream.redcircle.com/episodes/a48ce257-6477-4472-a7b2-3ecebeab6c00/stream.mp3Afrezza FAQs: https://afrezza.com/faqs/Prescribing doctors: https://afrezza.com/find-a-doctor/Afrezza Assist: https://afrezzaassist.com

Mike Castagna, PharmD, MBA, discusses his journey to becoming CEO of MannKind (NASDAQ: MNKD) https://mannkindcorp.com/

It's in the news! Got a few minutes? Get caught up! Top stories this week: new research that keeps beta cells safer after transplant, a new drug for type 2 also shows weight loss success, the makers of Afrezza buy a simple patch pump, Beyond Type 1 tackles mental health and diabetes and lots more! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Episode Transcription Below (or coming soon!) Please visit our Sponsors & Partners - they help make the show possible! *Click here to learn more about OMNIPOD* *Click here to learn more about AFREZZA* *Click here to learn more about DEXCOM* 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. we go live on social media first and then All sources linked up at diabetes dash connections dot com when this airs as a podcast. XX In the news is brought to you by T1D Exchange! T1D Exchange is a nonprofit organization dedicated to improving outcomes for the entire T1D population. https://t1dexchange.org/stacey/ XX Our top story, another approach to beta cell encapsulation. There are a few methods being tested to protect the transplanted cells from the body's immune system. A new and promising one seems to be a new biomaterial in the form of microgel beads. This study was in mice only but after three months the beta cells survived and maintained blood sugar levels with no rejection drugs. Interestingly, this study put the cells into the omentum, not the liver as is apparently the usual spot. I never heard of the omentum.. in case you haven't, it's a layer of tissue connecting the stomach with the other abdominal organs. It's non-vital so it's safer if any complications take place. No word on when human trials might begin here. https://newatlas.com/medical/microgel-beads-safer-path-cell-transplants-treat-diabetes/ XX FDA approval for a new injection for type 2 diabetes called Mounjaro. It's made by Eli Illy and is shown to lower blood sugar and can help patients lose weight. Existing medicines target a hormone called the glucagon-like peptide-1 that is involved in the control of blood sugar. But Mounjaro targets a second hormone, the glucose-dependent insulinotropic polypeptide, as well. It is the first medicine to target both. While not yet approved as an obesity treatment, it's performed very well in clinical trials for weight loss. One study showed it helped patients lose an average of 16 to 22 percent of their weight: That's on par with bariatric surgery https://www.statnews.com/2022/05/13/fda-approves-lilly-diabetes-drug-that-analysts-expect-to-be-a-big-seller/ XX Big deal for MannKind, the makers of Afrezza inhalable insulin. They're acquiring Zealand Pharma's wearable V-Go Insulin Delivery Device. The V-Go is a patch pump that's meant for people with type 2 – it delivers basal insulin at a set rate all day long and can give boluses only in increments of 2 units of insulin at a time, up to 36 units in 24 hours. The deal is expected to close by the end of the month. https://www.mddionline.com/diabetes/mannkind-acquires-wearable-insulin-device-zealand-pharma XX Young adults who were at risk of food insecurity had an increased incidence of diabetes 10 years later, according to the results of a study from Washington State University. Although previous research has associated food insecurity with a range of health issues, this study showed a connection over time, which could indicate a causal relationship. The investigators could not identify the exact reason for this connection, previous research has shown that food-insecure households often have diets with lower nutritional values. The study results did not indicate differences among ethnicities or races, but they also said that a limitation of the study was the number of minorities in the sample, which could be too low to show a pattern, according to investigators. The investigators plan to evaluate food insecurity risk and health issues within American Indian and Alaska Native and American Indian populations, which they said are often left out of annual reports on food insecurity. XX Beyond Type 1 has a new mental health portal.. announced as part of this Mental Health Awareness Month. The global nonprofit is partnering with BetterHelp to provide affordable mental health resources and services to its online community with two weeks of free, professional online therapy. Beyond Type 1 will continue to expand the resources available on the site.. it's not just for this month. https://beyondtype1.org/mental-health/. XX Another entry into the quest to find a non-invasive way to monitor glucose. Movano Inc reports they have – quote - successfully validated the functionality of its proprietary and patented system-on-a-chip. They say this is designed specifically for blood pressure or glucose monitoring systems. It's very early here.. they are also creating a prototype for clinical studies. But this tech got them a new patent. We're keeping an eye on these non-invasive devices – it remains to be seen if any will be accurate enough to use to dose insulin. https://www.prnewswire.com/news-releases/movano-successfully-completes-functional-testing-of-smallest-ever-custom-mmwave-sensor-designed-for-non-invasive-glucose-and-cuffless-blood-pressure-monitoring-301545710.html XX Right back to the news in a moment but first we've got a new sponsor. As I mentioned, The T1D Exchange Registry is an online research study, designed to harness the power of individuals with type 1 diabetes. It's a research study conducted online over time, designed to foster innovation and improve the lives of people with T1D. 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. By sharing opinions, experiences and data, patients can help advance meaningful T1D treatment, care and policy Sign up at T1DExchange.org slash Stacey (that's S-T-A-C-E-Y). XX Back to the news.. Big candy recall, so heads up if you use any of these for lows. It includes specific varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies due to the potential presence of a very thin metal strand embedded in the gummies or loose in the bag. No illness or injuries have been reported. I'll link up the specific lot and manufacturer information. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mars-wrigley-confectionery-us-llc-issues-voluntary-recall-specific-varieties-skittlesr-gummies XX A college fashion design major has a unique senior project. Naomi Kinnamon spent her senior year working on a collection titled “Type 1 Of A Kind.” This series draws on her experiences as a woman with type 1 diabetes who struggles to find clothing that fits comfortably with her insulin pump. She's lived with type 1 since 6th grade and says the most difficult clothing to find were dresses and jumpsuits. So she designed her own. Kinnamon showed off her designs at SCAD – the Savannah College of Art and Design and I'll link that up in the show notes. https://www.wsav.com/now/scad-senior-designs-clothing-for-women-with-type-1-diabetes/ XX On this week's long format episode, you'll hear about the latest on the iLet Bionic Pancreas. Next week.. Mike Joyce is set to complete an incredible long-distance hiking trail. It's actually three trails – the longest in the US – he'll talk about how he does this with type 1. Listen wherever you get your podcasts That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.

How MannKind CEO Michael Castagna (MNKD) is managing disappointing news from the FDA and staying focused on its goal of making hyper-personalized therapies. Ultra Clean Holdings (UCTT) sees an end to the global chip shortage. LendingClub (LC) focus on loan originations sees a big payoff. Why Proto Labs (PRLB) may be failing to course correct despite months of effort. The Drill Down with Cory Johnson offers a regular look at the business stories behind stocks on the move. Learn more about your ad choices. Visit megaphone.fm/adchoices

This week "In the News...." Did wearing a CGM in the water disqualify a high school swimmer? What his family says happened and why they're suing. The ADA wants to start using the word "remission" instead of "reversed" for type 2 diabetes - we'll talk about why. Dexcom says they are no long smoothing data, new migraine and diabetes research and T1Interntioanl is out with their latest survey results about the price and use of insulin. Join us Live on Facebook each Wednesday at 4:30pm EDT! Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode transcript below   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.  As always, I'm going to link up my sources in the Facebook comments – where we are live – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more if you want, whenever you want. XX In the News is brought to you by Real Good Foods! Find them in your local grocery store, Target or Costco. Real Food You Feel Good About Eating. XX Top story this week.. A discrimination complaint against the Colorado High School Activities Association has been filed with the U.S. Department of Justice. At issue? A student was disqualified for wearing his continuous glucose monitor.  Ethan Orr is a 16-year-old swimmer whose team qualified for the state championships. According to his attorney Orr wore a blood glucose monitor taped to his arm during seven prior matches, including the one in which his team qualified for the state championships, with no issue. But at this meet, the ref said Orr would not be allowed to swim in his last race because of his glucose monitor and tape. They didn't have a sub so the whole team was disqualified. The attorney says, “This is simply blatant discrimination against a kid with a disability, and it led to unnecessary and unfair consequences to him, his teammates, and the school,” According to the lawsuit, Orr is protected under two federal laws – the Americans with Disabilities Act and Section 504 of the Rehabilitation Act of 1973. I've reached out to the local reporter on this story and hope to talk to the family soon XX People with type 2 diabetes should be considered in remission after sustaining normal blood glucose levels for three months or more without medication. That's a new consensus statement from the American Diabetes Association® and several other international groups. They recommend testing every year to determine long term maintenance. The real news here – as I see it – is trying to get people to stop saying “Reversal” or “cure” when it comes to diabetes. The statement here doesn't seem to be about the science, but says the word remission “strikes an appropriate balance” between the diabetes not being active and progressive, but also recognizing improvement may not be permanent. https://www.diabetes.org/newsroom/press-releases/2021/international-experts-outline-diabetes-remission-diagnosis-criteria XX Got lots of comments and questions about some changes noticed on the Dexcom G6 app recently. Turns out, Dexcom has removed what's called data smoothing from its most recent update. As of August 9th they say “The Dexcom G6 app used to smooth all but your current reading on your trend graph. With data smoothing, there can be some differences between the G6 reading you see in real time (the white circle) and the G6 readings you see in the past on your graph (black dots). I'm showing a photo here – I'll post this with the podcast episode for those listening.   To avoid these differences, we removed data smoothing from the Dexcom G6 app in the 1.9 release, but the Follow app and Receiver continue to smooth past CGM data. We will remove smoothing in an upcoming Follow app release to match the G6 app, but we don't plan to remove data smoothing from the Receiver.”   These differences don't affect the real-time glucose data, alarm, or alerts. Honestly, I'm not sure why they're doing this or why they smoothed in the first place.. but we'll follow up and try to find out more XX Not a lot of answers here, but this is interesting.. apparently, people with type 2 diabetes are unlikely to develop migraines and people who get regular migraines are less likely to develop diabetes. To find out why.. scientists are looking at two small proteins that are linked to migraine and drive production of insulin. This team from the University of Tennessee says some of the newer treatments for migraines could increase the risk of diabetes because of the use of these proteins. They want to figure out how to prevent that.   https://www.fiercebiotech.com/research/mouse-study-shows-how-causes-behind-migraine-pain-can-improve-diabetes-treatment XX T1International is out with results of their 2020 global out of pocket cost survey for people with type 1 diabetes. Worldwide, one out of every four respondents reported having under-used their insulin at least once within the last year due to high cost. 63.2% of participants reported disruption of insulin supplies and 25.3% reported an increase of insulin prices related to the COVID-19 pandemic. They've conducted this survey every two years since 2016, adding additional questions each year. This time, the Results were published as a research paper in the Journal of Diabetes Research and Clinical Practice, linked in the show notes. https://www.t1international.com/access-survey/ XX More to come, including news about a rare form of diabetes, but first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Real Good Foods. Where the mission is Be Real Good They make nutritious foods— grain free, high in protein, never added sugar and from real ingredients— I was in Target this week and I saw the new Entrée bowls, I bought the Lemon Chicken and the Lasagna. The Lemon chicken was great! It uses hearts of palm pasta instead of regular noodles which I thought sounded odd but really tasted good. They keep adding to the menu line! You can buy online or find a store near you with their locator right on the website. I'll put a link in the FB comments and as always at d-c dot com. Back to the news… XX This is from the UK but I think it's an important reminder that there are more than 2 types of diabetes. It's new plan to discover and treat mono-genetic diabetes. That's caused by a single gene mutation – although the specific gene affected can differ. The condition occurs in two types, neonatal – which can occur within the first six months of life – and MODY that develops later, often before the age of 25. About 2% of all diabetes cases are thought to be monogenetic… the National Health System in England is forming a new training and treatment program to make sure these patients received the correct treatment sooner. https://www.theguardian.com/society/2021/aug/30/nhs-england-to-train-staff-in-all-trusts-to-spot-rare-type-of-diabetes XX And finally, thousands of people in the path of Hurricane Ida are still without power and possibly need help getting their medication. I want to make you aware of the Diabetes Disaster Response Coalition (DDRC). This is a coalition of lots of diabetes groups – if you need immediate help or want to plan for an emergency, they have the resources. Physicians and health care providers can call 1-314-INSULIN to report diabetes supply shortages and request support.  People with diabetes and their loved ones can call 1-800-DIABETES (800.342.2383) is available to support people with diabetes and their loved ones for more information. https://diabetesdisasterresponse.org XX Please join me wherever you get podcasts for our next episode -Tuesday –  we're talking to the folks from Walmart about their deal with Novo to sell their own brand of Novolog Insulin.. The episode out right now is with MannKind, makers of Afrezza inhalable insulin. That's In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.      

How much do you really know about the only inhalable insulin? This week, Stacey interviews the CEO of MannKind, makers of Afrezza. Mike Castagna talks about how Afrezza works, misconceptions about the product, the worldwide market, pediatric studies and lots more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. More about Afrezza Tim Street's blog Diabettech  Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode transcription below: Stacey Simms  0:00 Diabetes Connections is brought to you by Dario health manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom This is Diabetes Connections with Stacey Simms. This week all about Afrezza How much do you really know about the inhalable Insulet. I had a great conversation with the people who make it   Mike Castagna  0:34 For me, it's about using the right product to meet your needs to get you in control. And if you're doing well, great, we're going to avoid the long term complications. But if you're not doing your health, and you gotta really try to find the best set of tools, they're gonna make you successful and fit your lifestyle.   Stacey Simms  0:47 That's mankind CEO Mike Castagna. We talked about how Afrezza works misconceptions the worldwide market pediatric studies and lots more. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Welcome to another week of the show. We so glad to have you here we aim to educate and inspire about diabetes with a focus on people who use insulin. And this week, we're talking about the use of the only inhalable insulin, my son was diagnosed with type one right before he turned two, he is 16. My husband has type two diabetes, I don't have diabetes at all. But I have a background in broadcasting. And that is how you get the podcast, I have to say that personally, my family is very interested in Afrezza Benny really would like to try this seat. Of course, as I mentioned in that tease up there, they're looking at pediatrics, he is still under 18. So it's not proof for his age group. But we're watching it really closely. And I have a lot of friends. A lot of bloggers and people in the diabetes community have talked about this for years. And some things have changed. So I wanted to have them on the show and find out more. So a little bit of background for you. If you are brand new to all this, Afrezza was approved in the United States in 2014. And the company that makes it is mankind. For a while it was sold by Santa Fe, but then mankind took it back. It's one of those things where sometimes the business side seems to have gotten more attention than the product itself. So what is Afrezza it is a powder, it comes in cartridges, and you suck it in you inhale it with a special inhaler device. To me, it looks more like a whistle than a traditional inhaler like an asthma inhaler. It's not like a big tube. I'll link up some photos in the show notes. I'll also link up the Afrezza website so you can learn more and see their information. And my guest this week is Dr. Mike Castagna, the CEO of mankind now he has a Doctorate of pharmacy, he worked as a pharmacist behind the counter for CVS at the start of his career. But then he went back to school and he got an MBA from the Wharton School of Business. He's fun to talk to he doesn't mince words, and he truly believes in this product, I do have to tell you that Mike mentions monomeric insulin a couple of times, I'm going to come back after the interview and explain more about that give you a better definition. All you really need to know is that it's faster than how liquid insulin is made. And all of that in just a moment. But first Diabetes Connections is brought to you by Daario. And over the years I find we manage diabetes better when we're thinking less about all the stuff of diabetes tasks. That's why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed, get the diabetes management plan that works with you and for you, Daria is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections. Mike, thanks for joining me, I'm really excited to catch up. And look, I'm stuttering because I can't believe this is the first time we're talking to you. But thanks for coming on. Oh, thank you, Rodney. I'm super excited before we jump in and start talking about Afrezza Can you give us some perspective kind of dial back because mankind is not. It's not a name that came out of nowhere? There's really important history. Can you kind of talk about that a little bit first?   Mike Castagna  4:14 Sure. Mankind comes from our founder named after Al Mann and Al Mann was a true innovator. He started I think 17 companies and everything from the cochlear implant to the pacemaker to insulin pumps that many of us know today as Medtronic used to be called mini med. And Al Mann built the insulin pumps over the 80s and 90s and was very successful and sold that company to Medtronic. And then he took literally $1 billion of his own money and invested in mankind. And he had put this company together through three companies he owned the technology to make Afrezza was really a combination of companies and the reason he was so dedicated as he saw in the pump market, which we now see today on CGM was that the variability in mealtime control was so high and the fluctuations you see that the influence takes about an hour and a half to kick in. And it's hard to get real time control if you can't get a faster acting insulin. And so he set out to make a real time acting insulin, so phrases and hailed as monomeric. And that was really what the magic was in our technology making a dry powder was was free dryness, if you heard of dippin dots ice cream, we have basically large dipping machines in our factory, but we free dry the particles to make a freezer and under stabilize the monomeric form. So when you're inhaling, you're inhaling influenza, as soon as it's in your blood is active, or when you inject it has to hold hexamer and has to break down there were about 45 minutes. And that's how you can make it stabilize an injectable form. But it has to break down and then it starts working. And that's why there's always this lag effect between we see injectable and foam in and help us is very different products were categorized with real time rapid acting, but the name mankind comes from elmen and the guy who probably 60% of people on pumps have their own pumps that he created. So amazing gentlemen, huge contributions to diabetes and millions of people were alive today because of his work and his generosity and roven to take that forward here and kids and frozen inhaled insulin.   Stacey Simms  6:06 I mean, never look at dippin dots the same again.   Mike Castagna  6:10 I see a large factory of they don't like it, you know, we can always make different types of things don't go well.   Stacey Simms  6:15 I love it. Let me ask you to go into a little bit more detail about how someone who uses Afrezza would actually use it. Can you talk a little bit about like a daily routine?   Mike Castagna  6:25 Yeah, I mean, I know, you know, well, you're in this disease. I mean, people sometimes graze all day, and they just kind of ride their sugars and take a little bit some along the way or many boluses. And some people you know, eat once or twice a day, or some people, you know, carb restricted and everyone has a different way. And I think that you know, the big thing difference was for the patients that I see is, it's in the moment, meaning you don't have to time your meal and your insulin, when you're going to take it and where you're going to be. As soon as your food arrives. You take your first dose.   Stacey Simms  6:50 Most people I know who use Afrezza take a long acting insulin with it. Is that pretty standard for people with type one?   Mike Castagna  6:57 Yeah, I'll take one year, right? Yeah, you need a basal insulin of some sort, you know, and, and a meal time was held, we do have some patients on pumps where they will use their punches for their basil, for example, and use a phrase for real time corrections. So you know, the average patient is very different. We have some patients that are type twos, you know not not on any basil, you'll need to be on basil for if you're type two. But if you're type one, you need to basil, long acting insulin, and you need your meal time. And we know the biggest problem in this country is still mealtime control is the number one thing people with diabetes struggle with. And it's a big reason why, you know, six, or seven or eight, you know, eight out of 10 people basically are not a goal on insulin because of the mealtime control. So it's a daily challenge for everybody.   Stacey Simms  7:39 Can you talk a little bit about how Afrezza is kind of measured out? Because when we think of mealtime, insulin, everything's a carb ratios. And especially as I mentioned, if you're on an insulin pump, you're you're putting in the carbs that you eat. So how does that work?   Mike Castagna  7:51 Yeah, it's funny, I get into many debates with people because, you know, I'm a pharmacist by training, but I'm not the smartest guy. But I couldn't do all the work people do every day to influence sensitivity ratios and carb counting and timing. And all I can tell you is everyone's masks off by 50%, one direction or another. And so we have this false pretense that we're that accurate. And dosing are influenced by down to the half a unit or one unit. And the reality is your angle of injection can decrease, you know, change your absorption by 25%, your site of injection can change absorption, your your stress level can change your impact with your insulin, there's so many things that go into your daily dosing of insulin, that, you know, being that precise, down to the unit is not as accurate as we all think. And I think that's that's one of the misnomers of, you know, the timing is what you really struggle with when you're using injectable insulin, and you just don't know what's going to happen. You know, when people I guess doctors often you know, you don't have to carb count with Afrezza . And they give me funny looks. And the reality is, you know, we've never done a study where you're carb counting to get your dose of insulin, that's, you know, so becomes a four 812 dose linear all the way up to 48 units, it's additive, and you just got to be close enough. And so it's about a two to one ratio, you know, there's no direct pulmonary equivalent to injectable insulin, unfortunately, but, you know, people are taking five units of injectable insulin per meal, they're gonna need about eight units of Afrezza and maybe even 12. And you're gonna figure that out, it's your first meal or two what what the right dose is for you. But you just got to be close enough. And that's a big misunderstanding for people of how accurate the dose has to be. This is the sixth dose cartridge is a big problem. I know plenty of type one patients who take for a 1224 meal, especially they haven't Chinese food or sushi, they just they dose a lot. So I think that's something people have been comfortable, so dramatically different than anything they've ever been trained or taught in their history of living with diabetes.   Stacey Simms  9:36 I would assume that a prescription for Afrezza comes with a doctor's visit where someone whether it's someone who works for Afrezza, or the endocrinologist talks to you about how to do this dosing. You said you figure it out, but I've got to assume that you're not just sending people home with this inhalable and say, just test it, I mean, right somebody, you're at a ratio   Mike Castagna  9:59 and I think That's the key thing is, you know, having patients understand because it's odorless and tasteless. So you inhale, and you're like, what did I get it? And I'm like, yeah, if you inhaled, and I have the second, it's in your blood, it's in your lungs, it's breath activated. So you can't really, of course, you can try to mess up something. But we have something called Blue Hill, where we can show proper inhalation technique in the office on an iPhone app or an Android. And so you know, we hope that patients are being trained either by our trainers or the doctors offices, and will propagation technique looks like that's number one. And then number two is the right dosing. And as you know, individualized dosing is important and fun. And, again, that's why I say we take a lot of the math out because it's either gonna be a four or an eight, and all of a sudden, you're like, Oh my god, I'm gonna take an eight units, it's a lot it's really not when you're taking inhalation units versus injectable units and that's what people got to get comfortable with if their first or second dose so they really do figure out this meal did this or pizza is going to take longer so pick another dose and now our people do figure it out pretty much within the first week. And then there's one thing actually I want to mention because I often forget this is because injectable insulin is such a long tail it's in your body for four to six hours before it's out and that feeds into your basal rate your long acting and so when people switch over presence pretty much out of your body in a net roughly an hour and a half. Sometimes people need to adjust their basil and that's something to watch out for if you do switch to Afrezza enter you're struggling with with some of the basil rates. Some patients you know I hear people anecdotally you know, we don't want to study their the bump up their basil 10 15% on Lantus. And I've heard patients on to see that because it does have that long tail of down there in front sometimes on the basil. So there are the other metrics patients have to watch out for when they are switching to the product. It's not just the uptime, it's also something that basil where you look at   Stacey Simms  11:38 I have a question and I i apologize because it's a it's a bit ridiculous. I'm gonna ask it anyway. Right back to the interview in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing we're usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be very frightening. Which is why I'm so glad there's a different option for emergency glucagon, it's Gvoke Hypopen. Gvoke Hypopen is pre mixed and ready to go with no visible needle, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com slash risk. Now back to my interview with Mike, where I will ask that ridiculous question.   You had mentioned it's tasteless, odorless, I recall hearing and I'll have to fact check this. But I recall hearing that years ago dandruff shampoo, they had to add like that tingly feeling because people didn't think it was working like it's totally fake. But people just didn't believe it was a medicated shampoo because it didn't have an unpleasant sensation. Have you thought or talked at all about adding like a flavor or a feeling to so people really know that they got it? Or is that just really bananas?   Mike Castagna  13:12 If somebody might company come and talk to you ahead of time? There's somebody internally who wants us to look at like cherry flavor Afrezza especially as they go into pediatrics? And the answer is, look, there's blueberry Metformin because the metformin smells awful and tastes awful, probably. So you know, those things are possible. We've never done them. And to my knowledge in this industry with dry powders, it is a question that came up recently. Is that should we be thinking about the cherry flavor Afrezza or some other flavor? And I think the answer is TBD. We I don't know what the date is on inhaling the food coloring dye or whatever. Yeah. But that's some of the stuff we have to justify that it's safe and effective. And along with FDA would want us to test but they come up recently and another internal discussion. And since you're asking, I think we'll look at it, even if maybe there's a way to even show a placebo, that's a cherry flavor or something right a one time dose to see what it's like. So I don't know. But now, but people like I said, it's sometimes you get a call, like you know, when you take a phrase of one out of four people will get a cough initially. And generally there were the first four weeks that cough goes away 97% of the people. So I always tell people, you're having a cough, like as long as not interrupting your life, it should slowly get to your first refill. And it should be mostly resolved by that your body's getting used to putting a powder in your lungs. But that's uh, you know, when people ask, what's the difference between injectable and inhaled in terms of safety, you know, you're putting a drug powder in for the first time in your body and your body could choose that. And the number one thing that's different, were injectable insulin. You know, you have other other things. You're dealing with injection sites and pump sites and scar tissue and things like that.   Stacey Simms  14:48 Does the body actually acclimate to the powder or is it just a question of someone gets better and used to the inhalation sensation?   Mike Castagna  14:55 You know, it's it's a good question. I don't know if I have a black and white answer here. bodies give. Yeah, my guess is the body's getting used to putting a dry powder in and just exit and you get used to like weed. You can drink a glass of water before and after and help you minimize it. But it's generally like that's what it feels like it's not a productive call frightening, there's not a call to happens 10 minutes later, it usually happens. We have to inhale.   Stacey Simms  15:17 You mentioned BlueHale , can you tell us a little bit more about what that is?   Mike Castagna  15:21 Yeah, so BlueHale  is to two different things. The first one that we're looking at is with the patient training device. So we can show you whether you had a good emulation or not a good emulation and show you that technique. The second version, actually, you can detect with those you put in the cartridge and hilar. So it has a proprietary software there that we can see what cartridge you put in for the adapter. And it'll tell you on your app, if you took a for a 12 or 16, how much you took in that session. And then we hooked integrate that with the CGM data. So now you can show those response curves on CGM one day and eventually I want to get into AI and predictive analytics. But we're not there yet. But we think that's the magic of what people really want, which is one that I use the thing when you live with diabetes, you just must remember and be that perfect to know exactly what those you did with them. You took it, what meal you were and then I simulated being a patient for a week. And I realized I could remember if I took a four and eight, I take a six or 620 is that 30 minutes or one hour like it was it was amazing. When you just think about life and people are human. They're there. They're human. So they're not keeping track. And they're not that accurate. They're just estimating. And that's when I talked about the dosing of insulin, like we're always estimating everything, we're estimating the time our food is going to come and how long it's going to work. You know, what the carbs are? How much am I gonna eat or drink? Like, it's all accurate? It's all off. None of it's that accurate. That to me is the thing I realized when I was thinking of doing one of those a disease, you don't you think they're perfect. They're not. They're human beings. And that's when I see one out of five doses of injectable insulin are intentionally missed. And the predominant one that's missed is actually lunchtime, which makes sense to wear out in a social environment. They don't want to inject. And by the time they get back, they forget it's probably too late. Or you're already high.   Stacey Simms  17:00 What do you mean by intentionally Miss? You mean? Like they people just forget?   Mike Castagna  17:03 No, no, they intentionally knew they should take a dose of insulin, but they're in a lunch conversation, or they forgot their insulin in the office. Or they'll have their CGM receiver on the bike, or they essentially don't they miss one of the five doses. So if you're missing 20% of your doses, it's really hard to get in control. And there's all kinds of reasons, but that's intentional omission versus unintentional. Which is I forgotten.   Stacey Simms  17:23 I'm curious what the sources on that that's, I mean, I don't doubt it. I'm just curious.   Mike Castagna  17:27 Yeah, I couldn't find it. follow up on that. I have your email, I'll look for it. Yeah, no, because I didn't believe it. And then there was a study done with one of the pens coming out that has digital connectivity. And I looked at it and I looked at the data and like, wait, if a person needs three times a day, seven days a week, that's at least 1721 doses, right? And I think the average person is taking like 1212 shots a week. And I'm like, Well, that doesn't make sense. But you realize, you know, again, we're human, people aren't always as compliant as we want, or they don't eat three times a day perfectly are the two big meals, you know, everyone does something different. So having insulin that meets your needs, and your lifestyle, I think is really important in the world. And you know, look, we like our products, obviously, we're here, we love the Afrezza. But But I also just for me, it's about using the right product that meets your needs to get you in control. And if you're doing well, great, you're gonna avoid the long term complications. But if you're not, you own your health, and you got to really try to find the best set of tools that are going to make you successful and fit your lifestyle. And, you know, obviously, we're not doing well when 80% of people on insulin on a boat. I mean, that's that, to me is the number one thing, I look at this country and say, well, despite all the adoption of pumps, and technology and CGM, we still have not made a meaningful difference in percent of people to go. And that's frustrating.   Stacey Simms  18:35 Way back in the beginning of this interview, we talked about Chinese food and pizza. And I'm just curious, you know, these are things that are hard to dos for, because they they kind of they come later, you know, what most people listening are very familiar with, and I think probably have their own system for dosing, whether it's an extended bolus or injecting more than once. How would you do something like that on a Friday? Is it a question of you would take what you think when you're eating, and then again, in a bit later, like, how do you account for those high fat foods?   Mike Castagna  19:02 Yeah, you know, I'm going to pick on Anthony Hightower, who I know you interviewed before. So I actually met Anthony on a bed over social media. And he had showed me your servers where he ate pizza. So I'll pick on him because I want the public discussion here, sir. He pizza and his sugars are basically flat over the two, three hours post meal. And I said, I'm like, shocked. He's like, this is something people cannot do naturally on the history of injectable insulin, they they always struggle. And when you eat pizza, you're going to struggle not just for hours, but potentially for the next day because just throws everything off. I think in his case, right? I've watched him he took a big dose up front, you know, let's say he's gonna take 12 units of injectable he took 24 units of Afrezza. And then he washed her wasn't an hour, and then an hour she was above where he started. He took another dose, maybe took a four and he has to tap it off. And then an hour later, just thought was too high or not right. But you can always keep your sugars in that kind of control. That's one of the studies we did back in 2018, called this test study was showing that you could do as soon as one hour with no more hyper risk. And that was a big concern of people, how can I do that one hour, well, pretty much hit its peak effect in one hour. So if your servers are still moving in the wrong direction, you can correct them at that point. And so that's where someone on pizza or Chinese food, like, yeah, it's a high dose up front and may manage it through the whole system. Or they may see an hour or two later, they're still high and to take another dose, that they can bring it down at some point.   Stacey Simms  20:20 Alright, let's talk about the big questions that people generally have. And that the one I hear the most is, Is it safe? Right? Is it? Is it okay to inhale this stuff into my lungs? Can you talk about the studies that you've done?   Mike Castagna  20:32 Yeah, I think if we were able to make inhaled insulin 100 years ago, we'd be scratching our heads those who would inject themselves three times a day. So I think it's just an unfortunate matter of 100 years of difference. But we studied a phrase that probably over 3000 patients 70, some trials $3 billion over 20 years, like, that's how much money time and energy is going into prove the safety and effectiveness of this product. And you know, and I tell people like you know, there is no data to say that it's not safe. We have all the rodent studies, all the CT scans that along looking for fibrosis looking for pulmonary issues, we found nothing. So it doesn't sit in the lung. There's an old product called exubera on the market years ago. And exubera was a sugar based manatal formulation which got absorbed over time into your lungs in a friend this case, the it's got water and human influence. So when we ask about what ingredients are you worried about the human influence, human influence, it's the whole AI base, but it's human influence characteristic, and water is purified. So we know that safe and the other only other carrier in our products SDK p which is a excluded product that is not metabolized in the body, it's just 100% extruded. So you know, there's three ingredients in our product. One is human insulin, one is water, and one is tkp. And SDK p comes out of the system. So I don't I don't think the body is afraid of human insulin. And what are so I think, you know, I always struggle with this topic. Because, you know, what happened is there was some lung cancer cases and Newser, were they there was a couple of our data. But you know, in the seven years since FDA approval, we've seen no safety signals come up in the postmarketing. We have almost 10,000 patients on the presidency. I know people in the drug for 1012 years. And so, you know, we don't see anything that gives us concern. And we're going into kids now, who would have to take the drug for 40 5060 years. So I think it's hard to prove something that you've never seen. But safety comes with time. And I think the good news is product has been approved by the FDA for seven years now. And we've not seeing any safety signals in our database, which we look every year, our rems program ended early by the FDA and and we've continued to show good data and all the studies we've done, we've not seen anything new come up in our anywhere safety issues. So if you're, you know, the populations, I would say if you have COPD, and asthma, this is not the right drug for you.   Stacey Simms  22:41 So a dumb question, though. If you have diabetes, and you smoke, can you get an Afrezza? prescription?   Mike Castagna  22:48 We would say you should not? Yes, we have a warning for that.   Stacey Simms  22:52 Well, I just wanted to be clear that there was an actual warning, it wasn't just a please don't because it's bad for   Mike Castagna  22:57 warning. Don't   Stacey Simms  23:00 tell me about the study with kids. Because I've got one, I've got a 16 year old who was quite interested in this product.   Mike Castagna  23:06 Yeah, no, I just found out Unfortunately, the dagga three year old cousin in the family have just come down with type one. And she will, she'll be four and our studies gonna go down to four years old to 17 years old, when we launch it. So I'm excited, we had to do a study to show that the pharmacokinetics and dynamics of inhaled insulin are similar in kids as it as adults. And so once that study was complete, we we wrote a protocol down to the FDA and said, We'd like to go into the next phase, and now run a larger study head to head against the standard of care. And the FDA has pretty much signed off on that protocol at this point. And we have contracted with a third party to now run that trial. And we'll be having our investigator meeting here in next month. And so hopefully, we'll see our first patient in the four to 17 year old range, probably here in September, October time frame. So super excited, long time to get here took too long from my perspective, but can't wait to help kids. But our founder Outman invested, he became very wealthy when he sold the insulin pump company. And he took $1 billion of his own money and made Afrezza inhaled insulin because he felt the problem with the injectable subcutaneous delivered insulin was it just took too long to work. And you know, somebody has an hour lag effects from food. That's real timing, it's always hard to catch those two even. And so he really wanted to make an inhaled insulin that really mimic a physiologic insulin that you see in the body. And he felt the only way you could get there was through a dry powder, lung delivered instantaneous insulin, you can also get there through an implantable pump. But that didn't work out when they tried that back in the 90s. I recall. So people got infections and things like that. So that would that didn't work. So they really were going to get a in my mind that physiologic inform that's gonna be monomeric stabilized is probably going to happen only through the inhaled route. So we have we have to get comfortable with this from overall efficacy and safety. Otherwise, you're not going to really ever get this control that people are looking for real time.   Stacey Simms  24:55 No man, he lived long enough to see Afrezza approved, didn't he?   Mike Castagna  24:59 He's All approved. And unfortunately, I'm here because he died on my daughter's birthday. So I was debating whether to come to mankind or not. And I'm very superstitious, the Al Mann pick the day he died. And he died February 25 2016. And then they made decision to join and help save the company and save a frozen kick on the market. Because I think, you know, I saw all these wonderful patients stories online. And I said, these patients like Anthony Hightower is one of them, what they did something that no one else did, they did something we never did in our clinical trials. And so I got to talk to them. And I realized we just didn't dose it properly. So you go back to the development of the product, a lot of the challenges were under dosing because everybody's trying to compare one to one to injectable insulin, and therefore one of underdosing patients, and therefore, they got equal outcomes didn't do any worse than injectable insulin per se. But could they have gotten better outcomes if we dosed improperly? Right? And I think that's, that's the state of we're now trying to generate to show that the kids buddy now be head to head, or if he knows him properly, what happens? Right, and that's we're really focused on right now.   Stacey Simms  26:01 Is there anything that you wanted to talk about that I haven't answered?   Mike Castagna  26:04 No. I mean, we're only available in the US, we're in the process of going to Europe. So I don't know if you have any. Yeah, we do. Though, so I know, we have patients on a name patient basis in Germany, and UK and Italy. So you know, their governments are actually important a president and pay for it. We're in the middle of filing for Australia. We were approved in Brazil, and we're going to India so so you'll see this more and more around the world. You have listeners in those markets. There's not gonna happen this year. And hopefully, the next year or the following year in some of these markets, we'll be looking at bringing it to more patients in those markets.   Stacey Simms  26:37 Well, and just got a big approval here in the United States for Medicare patients. Right.   Mike Castagna  26:42 Yeah. So that one, I, you know, we get a lot of questions on that one. And so you know, this market CGM patients were told you need to be injecting yourself, I think four times a day, we couldn't get your CGM. So then doctors were not getting patients Afrezza. And so we were able to ask CMS to change that, and they did to the year but rather haven't done they're not done. And so here we are a year later that that policy is now being updated. I want to thank CMS and all that you're helped make that happen. And I think it helps in people in CGN, because I understand that removes some of the other requirements to get CGM, even an injectable these patients so little mankind was the one who started that process. And then we're able to help a lot more people. So it's great. And we're trying to get Medicare $30 a month insulin. So we have Medicare listeners. And you know, we're trying to make sure we help get patients access that are on Medicare. I think that's important.   Stacey Simms  27:33 That doesn't stack up in terms of cost in the United States.   Mike Castagna  27:36 Yeah, I mean, you know, fortunately, the billion dollar debacle in this country is drug pricing, as we all know, and as a pharmacist, I know firsthand when people go through an LMS they're on how many co pays are on. And so we really have tried hard to make sure that no patients pay no more than $15. So we have copay card programs, we actually have a free drug programs, they really can't afford it, we'll give it to you for free. If you're going through the prior authorization process, we give it to you for free while you're going through that. So we all want payers and reimbursement to be the excuse of why a patient can't get access to our product, we think that people will do well on our product, we're willing to take that bet that they'll see good results. And if they see good results, the payers will usually pay for it. And it says you may or may not know that there's a monopoly in diabetes between two insulin players, and three payers, who are all working together to make sure there's no competition. You know, that's unfortunate, but they pay to make sure that patients have a difficult time getting Afrezza . And that's always one of my frustrations of competition or diseases. You know, 400 years, we've seen the precise the dispensing from 20 hours a while 95 and let's say miles, hundreds of dollars. You know, for me on the payer side, we want to make sure patients we try to bring it down to about $15 on commercial and Medicare, you know, they generally pay comparable to what they would and some Medicare plans a little bit higher I can you know, that's a hit or miss when you when you go to submit for reimbursement, but we try to do everything we can to make sure people will have access to our product   Stacey Simms  28:57 $15 for $15 for commercial patients, no, no, but what is it? What is it for? What do you get for $15? Is it a month? Is it a   Mike Castagna  29:05 my week? Yeah, whatever, whatever. You gave two boxes, three boxes, whatever is on that prescription for that month,   Stacey Simms  29:10 for the month. Okay, I didn't mean to interrupt you.   Mike Castagna  29:12 I don't think I know, I was gonna say I forgot we actually have a cash pay program. And people are paying cash for their insulin. And we do see several 1000 people a month paying cash for injectable insulin, we have influenced savings comm where it's $99 a month for frezza. And you know, can you a bigger box or more doses, you might pay 199 but we tried to make the cash price, you know, roughly $100 a month. If we if you had no insurance, for example.   Stacey Simms  29:37 I'm not sure you can answer this question. But I will ask it anyway, is the biggest challenge for you all the failure of exubera? Is it just people not knowing what this is? You know, as you move forward, you know, what is the big challenge to get more people to adopt us?   Mike Castagna  29:51 I mean, for me, the biggest challenge are the doctors. We created a program we basically gave it for free to patients for two years for 15 bucks. Like no no priority. Nothing, we just charge you $15. And that didn't change a lot of doctors from jumping on board. And doctors just don't know our data. And so they think this product doesn't have a lot of data behind it. And they don't know our data, they don't know. Like when I would ask a doctor, how fast from the time you inject your bolus, your pump to the time you look on a CGM, that your institute sugars are coming down, and I get in these endocrinologist, I'll get five minutes and mediate and 20 minutes an hour, the answers, I need 90 minutes, 220 minutes, that's the answer. And so they don't even know the pharmacokinetics and pharmacodynamics differences between injectable insulin inhaled, and then you have doctors, right, you know, calling some of these ultra acting drugs faster, we'll look at the package inserts, they're no faster than their old products. And there's a lot of misperceptions out there some of these newer launches of old tracking insulin, and to me they're, they're really not that much different than the predecessor and look at the data, you know, there's not a faster, there's not dramatically faster onset or offset or, you know, a one c lowering or weight gains on very much the same. So, no, I think it's just a matter of doctors trying to really understand the data.   Stacey Simms  31:02 Before I let you go, are there any plans in the future to change anything about the way it looks? or different colors? I mean, I know it sounds kind of silly, when you're just trying to get people to adopt the new technology, but from a user standpoint, and look, I know, you've heard all the jokes of my friends who use this will make you can't comment on designers. They don't say anything, they'll make comments like, you know, taking a hit or whatever, right? I mean, it's it's inhaling, it's this little thing that you're, you're inhaling, it looks a certain way. I'm curious if the cosmetics of it are anything that are on your radar, or needs to be improved even?   Mike Castagna  31:36 No, I mean, I think when you spend, you know, $3,000,000,000.20 years doing a new drug development or taking 100 year old product and reinventing it, you had to get that right in terms of device design and airflow dynamics and consistency. And those. And I think all that's really important because, you know, misperception that oh, my God, it's going to be less can be more variable than injectable insulin. And the data just doesn't support that statement. And so for us, we have one of the world's most unique installation platforms across the entire pharmaceutical industry, we deliver more power to the lung, the most technologies out there. So that's why you can get consistency, those two those, and you don't have a lot of variabilities, because our technology and our device is called a low velocity inhaler. And what that means is there's a resistor that helps slow the powders as they're coming out of the inhaler. So they get deep into the lungs. And that's why you get that nice absorption curves that we see. And we're most inhalers or high gloss inhalers. So it's just enough sucking air as hard as you can, and hoping you get you know, 20 30% of lung drug into your lungs, and mostly stuck in your teeth to device in the back of your throat. That's most dry powder inhaler technologies out there today. And so that's something unique to us and our technology and our device, they all work really well together, you couldn't just take our powder and put into another inhaler, and or just as well would not work. So yeah, we're pretty happy with the device I we are going to other diseases. So you know, we're we're going down to the FDA with our partner for an approval in October for pulmonary hypertension patients. And we have several other orphan lung areas we're going into to help more patients with lung disorders. So you know, I think that's important, like our, our technology, our inhaler, our platform is gonna be used in more and more patients over the next decade than just diabetes.   Stacey Simms  33:13 Well, that's what I was gonna ask is, if it works, so well, you know, will you partner with other medications? That's great to hear.   Mike Castagna  33:18 Yeah, you know, we're really busy, we probably have about 10 to 12 formulations of products working on this year and five marone products in the pipeline. And so it's it's a really good time of mankind, we're super excited to be here. And it was a turnaround, the company struggled for many, many years. And we're on our way to success. And I think, firstly, you'll be you'll be hearing more about it. So I know it's been a long time. And maybe you didn't talk to us yet. But hopefully you'll talk to us more and more as we continue to generate new data and more more patients start using it.   Stacey Simms  33:45 I'd love to, I'd love to, especially with the kids programs. And like I said, I've got a 16 year old who is very curious about this. And, you know, once once safe and effective. Once we get all that safety stuff in here. It's mom says, you know, I'll definitely I know, I would like to check it out. So I really appreciate you coming on and spending so much time with me and my listeners and explaining all this and we'll definitely talk again. Thanks, Mike.   You're listening to Diabetes Connections with Stacey Simms. More information at Diabetes connections.com. Always on the episode homepage. I also have a transcription as well, sometimes those podcast players don't display the show notes and the links. So if you have any trouble, just go back to Diabetes connections.com. And I just want to say that I did reach out to have Mike or somebody from Afrezza on the show. And you heard him say, you know, it's been a while, um, you know, it just took a while to connect to the right person. Let's just say that, and I will have them back on because lots of good stuff is happening. As you heard. I want to take a second and kind of explain Monomeric insulin and, you know, I'll be honest with you. The scientific points here are really not my strong suit. I'm a communications major, right. So I did what I always do, and I am People who know a lot more than I do to help me explain it. I went to the Facebook group Diabetes Connections as a group. And you know, I said, How do you explain monomeric insulin I know it's faster. And Tim Street, who is just wonderful and runs the diabettech.com page that's like diabetes tech diabetic, and I'll link that up as well. He provided this explanation, which really brought it home for me, and boy, I hope I'm pronouncing everything correctly. So Tim wrote, insulin naturally links its chains together to form stable molecules. Typically it connects two together and then links three of those two chains together. Additionally, to create six This is highly stable and described as hexameric. In order to use these chains, you have to break the molecules apart to single chains, which are monomers. Typically fast acting insulins are stored as dimers, two monomers connected, which are easier to split, then hexamers. by storing the insulin as a single chain, a monomer, the body doesn't have to break the chains to instantly use the insulin molecule it receives. And that is why Afreeza wraps the monomeric form in the capsules, to make it ultra fast. Thank you, Tim, that actually made a lot of sense. I gotta tell you, we have the smartest people and the kindest people in this Facebook group. If you're not there yet, and you want to join, come on in, I highly recommend it. You don't have to be a Tim Street. You don't have to be able to explain these concepts. You do have to be nice. And you do have to not post a lot of drama. I'm very tough on my diabetes groups. I run two of them. They're very nice and friendly places for a reason. But Tim, seriously, thank you so much. That was a great explanation. And I really appreciate it. Diabetes Connections is brought to you by Dexcom. If you're a veteran, the Dexcom g six continuous glucose monitoring system is now available at VA pharmacies in the United States. Qualified veterans with type one and type two diabetes may be covered. Picking up your Dexcom supplies at the pharmacy may save you a lot of time to connect with your doctor for more info Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. It's all@dexcom.com backslash veterans, and all the information is always at Diabetes connections.com. Before I let you go, just a quick note about back to school, I have never done less. I packed up a bag for Benny to bring to the nurse. He brings his daily supplies with him every day in his backpack. But of course, like most people, our nurse has backup supplies for him. So I put those together. He brought them in along with our plan or orders, you know from our endo. And that was it. I haven't set foot in the building. I'm not sure when I will go in or if I will go in probably when you forget something or they run out there. But I've never done less work. You know, I did a lot of work over the years to go to school and meet with people and he's got it. So not much to report. It feels very strange. All right. Please join me this Wednesday when we have our in the news live on Facebook every Wednesday at 430 and then we turn that into a podcast episode. I love doing that. It's been a lot of fun. I hope you're enjoying it. Give me your news tips. If you've got any from this week, just email me Stacey at Diabetes connections.com thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days until then be kind to yourself.   Benny  38:27 Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

It's "In the News..." the only LIVE diabetes newscast! -- Top stories this week: T2D screening guidelines to change New Gvoke Kit approved Gestational Diabetes cases up in younger women Are magnets & radio waves coming to T1D care? Update on #DiversityInDiabetes -- Links and sources in the transcript Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcript below:   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.  As always, I'm going to link up my sources in the Facebook comments – where we are live on Wednesday August 25th 2021 – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more if you want, whenever you want. XX In the News is brought to you by Real Good Foods! Find them in your local grocery store, Target or Costco. Real Food You Feel Good About Eating. XX Top story this week.. the number of young people with type 2 nearly doubled in the United States from 2001 to 2017. These researchers found significant increases in all types of diabetes among both sexes and across racial and ethnic groups. Type 1 diabetes remains more common among white youth. The highest rates of type 2 diabetes were seen in youth who are Black or Native American. It's interesting that these CDC and NIH researchers say they don't know the cause of the huge increase in type 2. They talk about rising obesity, but wonder what's behind that? They also wonder if it's because of increased screenings, environment or something else. https://www.reuters.com/business/healthcare-pharmaceuticals/diabetes-surges-among-american-youth-study-shows-2021-08-24/ XX Big change recommended in screening for adults with type 2. The U.S. Preventive Services Task Force now recommends screening for people who are overweight starting at age 35… five years earlier than recommended right now. That would include 40% of the US adult population. This task force recommends screenings that insurance companies must completely cover, without out of pocket costs to the insured, under the Affordable Care Act. XX FDA approval for Gvoke Kit to treat severe hypoglycemia. Xeris pharmaceuticals already provides Gvoke glucagon as an autoinjector and a prefilled syringe.. this Kit is for patients who prefer to draw up their own doses of glucagon using a vial and syringe. You don't have to mix anything, it's still a ready-to-use liquid glucagon. Could be helpful to those who prefer mini-glucagon doses – which are NOT FDA approved – but are sometimes used during illness. Note that's my comment, Xeris and the FDA is not talking about mini glucagon dosing at all.   https://www.fiercepharma.com/drug-delivery/xeris-a-rival-to-lilly-and-novo-gets-fda-nod-for-glucagon-kit   XX Growing numbers of pregnant women are developing gestational diabetes. Between 2011 and 2019, rates of gestational diabetes in the United States jumped 30%, according to a large nationwide study of first-time mothers. The cause? Not clear. Every age group saw an increase – from 15 to 44 – so it's not just moms getting older, which is happening. These researchers want to look at non -traditional risk factors like stress. This was a huge study – 13 million moms in the US. https://www.upi.com/Health_News/2021/08/18/diabetes-pregnancy/7401629306285/ XX In the – no thank you – department – researchers say they've got an implanted pump you'd refill just by swallowing a capsule. The catch? First, they have to implant the pump – which is described as the size of flip phone - along the abdominal wall, interfaced with the small intestine.   That refill capsule is magnetic, so the implant draws the capsule toward it. It then punches the capsule with a retractable needle and pumps the insulin into its reservoir. The needle must also punch through a thin layer of intestinal tissue to reach the capsule. These Italian developers testing it all out in pigs – they say it controlled blood glucose successfully… for several hours. https://spectrum.ieee.org/implantable-medical-devices https://www.newscientist.com/article/2287225-diabetes-implant-is-restocked-by-swallowing-magnetic-insulin-capsules/ XX Another maybe it'll work item… Israeli startup Hagar has something called G-Wave technology that measures blood sugar levels using noninvasive radio waves. The prototype puts the tech into a ceramic bracelet. Uses Bluetooth to transmit readings to an a mobile app with display and alert functions. A proof-of-concept study found the company's radio frequency technology was able to continuously measure glucose levels with at least 90% accuracy, compared to the estimated 70% rate for traditional continuous glucose monitors. They claim that's because it measures glucose in real time. Hagar now plans to launch clinical trials to pursue FDA approval https://www.fiercebiotech.com/medtech/hagar-brews-up-11m-after-a-serendipitous-spill-led-to-creation-new-cgm-tech XX More to come, but first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Real Good Foods. Where the mission is Be Real Good They make nutritious foods— grain free, high in protein, never added sugar and from real ingredients— I was in Target this week and I saw the new Entrée bowls, I bought the Lemon Chicken and the Lasagna. The Lemon chicken was great! It uses hearts of palm pasta instead of regular noodles which I thought sounded odd but really tasted good. They keep adding to the menu line! You can buy online or find a store near you with their locator right on the website. I'll put a link in the FB comments and as always at d-c dot com. Back to the news… XX Big grant goes to Scripps Whittier Diabetes Institute to study the use of CGMs in hospitalized patients with type 2. This is a $3.1 million dollar grant from The National Institutes of Health. It's to build on research going on now – during the COVID-19 pandemic. CGM devices have been approved for outpatient use since 1999, but their use in the hospital setting remains limited to research efforts and the special conditions allowed during the pandemic. https://timesofsandiego.com/tech/2021/08/10/scripps-whittier-diabetes-institute-gets-3-1m-for-glucose-device-study/-- XX Congrats to Diversity in Diabetes for their newly minted 501c3 status. The group was founded last summer and is dedicated to creating awareness and providing solutions to end health disparities and the lack of representation in the diabetes space. Their big event – People of Color Living with Diabetes Virtual Summit kicks off Sept 16 – more info and how to register in the show notes. XX Please join me wherever you get podcasts for our next episode -Tuesday –  we're talking to the folks from MannKind, makers of Afrezza inhalable insulin. You had a lot of questions for them.. looking forward to that episode! The episode out right now is with Kyle Banks – a Broadway performer diagnosed with type 1 while acting in the Lion King. That's In the News for this week.. if you like it, please share it! If you're watching this replay on YouTube please subscribe, if you're listening via the audio podcast please follow. Whatever it's called – I appreciate you being here. Thanks for joining me!  

It's time to give patients a chance to do something different to gain control of their disease. Michael Castagna is the CEO of MannKind, the company on the - “cutting edge of helping transform the care of diabetes where people can really get real-time control.” Michael is an entrepreneurial executive with more than 20 years of experience in the strategic development in Fortune 500 companies as well as privately held biotech start-ups. His innovation is driven by a mission to develop the products and therapies that can help people take control of their health and experience the best of what life has to offer. Let's dive right into this episode where you'll learn how Afrezza hit the market, how it's changing the speed of the ‘in and out' of insulin, how it all works, and how it may just be the future of insulin. [00:01 - 05:36] Opening Segment I introduce Michael Castagna Michael shares his background and story Journey and success in the pharmaceutical world  The approval of Afrezza  [05:37 - 13:53] The Fastest Acting Insulin on the Market Michael shares the touch and go process of Afrezza  Mistake made along the way Investing his own money  Getting back on track Explaining the inner workings of Afrezza  Human insulin  Fast acting  How it gets out of the body Following the pediatrics  Green light to phase 3 [13:54 - 25:16] Impacting Mankind with MannKind Partnerships with doctors The ones who understand take it on board  Michael talks about the transition process of MannKind Royalties  Pipeline  Technology  Current numbers Michael looks out to the next 5 years of MannKind and Afrezza Thoughts on acquisitions  Organic growth and shareholder value  Afrezza as a global product  Launching the next drugs [25:17 - 29:02] Closing Segment The future of Insulin Michaels final message to listeners  You have nothing to lose  Try a new tool and get to know it Think about your patients  Final Words  Tweetable Quotes: “I liked running into the fires and fixing things…” - Michael Castagna “It works fast, it works completely different from injectable insulin… It's in and out of the body quickly.” - Michael Castagna “Why not try a whole new tool…? We're going to be here for the next 20 years. Your patients want to try this. Give them a chance to do something different to gain control of their disease.” - Michael Castagna Resources Mentioned:  https://afrezza.com/ (Afrezza) Connect with Michael on https://twitter.com/mannkindcorp/status/983794225039880192?lang=en (Twitter), https://www.linkedin.com/in/michael-castagna-a15770/ (LinkedIn), and https://www.facebook.com/MannKindCorp/posts/michael-castagna-ceo-of-mannkind-believes-were-on-the-cutting-edge-of-helping-tr/10156426077168629/ (Facebook). Go check out https://mannkindcorp.com/ (https://mannkindcorp.com/) a learn more about how they are making life more human! To know more, you can connect with me, David Kliff onhttps://www.linkedin.com/in/ephraim-glick-8403a465/ ( )https://www.facebook.com/DiabeticInvestor/ (Facebook), https://twitter.com/diabetic_invstr?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor (Twitter), and https://www.linkedin.com/in/david-kliff-78b669b/ (LinkedIn), or email me at dkliff@diabeticinvestor.com. Be sure to visit https://diabeticinvestor.com (https://diabeticinvestor.com) for more insights and real-time analyses on the evolving business of diabetes. Don't be shy, I'd love to hear from you! You can also reach me at 224-715-3761. NOTE*: We are in no way a replacement for real medical professionals. All information in this podcast is obtained through reliable sources. Please be aware of our https://diabeticinvestor.com/investment-newsletter-disclaimer/ (Disclaimer). LEAVE, SUBSCRIBE, REVIEW + help someone who wants to learn more about the wacky world of...

It's "In the News..." the only LIVE diabetes newscast! Top stories this week: Maine passes insulin safety net program MS Attorney General vs Insulin Companies Afrezza covered by Medicare D-Data Exchange news Looking ahead to ADA2021 Join Stacey live each Wednesday at 4:30pm EDT at www.facebook.com/diabetesconnections Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcription below:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and each week I'll share the top diabetes stories and headlines of the past seven days.  We do this live on Facebook so whether you're joining me right now or watching or listening after, I'm here to get you up to speed quickly on what's happening with diabetes technology, research, and our community. As always, I'm going to link up my sources in the Facebook comments and in the show notes at d-c dot com so you can read more when you have the time. XX In the News is brought to you by Inside the Breakthrough. A new history of science podcast full of “Did You Know Stuff” XX first off.. want to give you a heads up that ADA Scientific Sessions is kicking off this weekend, so expect to hear studies from just about everyone in the space. I've got interviews lined up for the main show. There are usually some breakthroughs and – while you can't really count on it – some FDA approvals seem to come out this time of year as well. Stay tuned and follow the hashtag #2021ADA . XX Legislation news.. the Governor of Maine last night signed a new law creating an insulin safety net program in that state. It allows eligible Mainers to go to a pharmacy to get a 30 day emergency supply of insulin caped at $35. It's modeled after a Minnesota law that was passed last year, the “Alec Smith Insulin Affordability Act.” Exactly what eligible means in this case it tough to find.. although it looks like everyone with type 1 who has less than a seven day supply – and - with some exceptions, can be used once every 12 months. https://www.wmtw.com/article/democrats-propose-bill-that-would-create-insulin-safety-net-program-cap-price-for-one-monthly-supply-at-dollar35/36512006 XX Mississippi's Attorney General Lynn Fitch has filed a lawsuit against drug manufacturers and pharmacy benefit managers she says are working together to manipulate and inflate insulin prices. She says, quote, “ As the mother of a diabetic, I know the emotional, physical, and financial toll the unconscionable price of insulin has on families,” These companies are exploiting the vulnerable. I'm fighting back because you should never have to decide between paying the ever-increasing price of insulin or compromising your care.” The complaint alleges violations of the Mississippi Consumer Protection Act for unfair and deceptive practices as well as unjust enrichment and civil conspiracy. https://khn.org/morning-breakout/mississippi-attorney-general-alleges-insulin-price-fixing-sues-makers/ XX Starting next year, Afrezza inhaled insulin will be covered by Medicare.  It will offer all doses under the 2022 Medicare Part D Senior Savings Model.. capping the co-pay per 30-day supply at 35-dollars. Afrezza is the only inhaled ultra rapid acting mealtime insulin in the US. MannKind – the company that makes it – has other assistance programs. But this is the first time it's covered by Medicare https://www.globenewswire.com/en/news-release/2021/03/15/2192789/29517/en/MannKind-to-Participate-in-2022-Medicare-Part-D-Senior-Savings-Model-to-Make-Insulin-More-Affordable-for-Seniors.html XX Some updates on the The American Diabetes Association's Standards of Medical Care in Diabetes. These include more information on heart and kidney disease in type 2 and the studies we've been talking about for a while about teplizumab. Those show THAT medication can delay onset of type 1 in high risk relatives of people with T1D. https://www.medscape.com/viewarticle/953438 XX DiabetesMine hosted it's D-Data ExChange – a biannual gathering of leaders in diabetes technology and innovation. Organizers say the focus was on increasing access, expanding the market for tools like CGM to non-insulin users and consumers which has been a hot topic lately, and  building out education and support. Couple of interesting presentations.. including Waveform – a new 14-day-wear CGM with a rechargeable transmitter and reusable sensor insertion tool. Levels – which is a consumer CGM product not just for people with diabetes and from Nudge BG – Diabetes inventor Lane Desborough's new algorithm designed to slightly move or “nudge” basal insulin in response to CGM data. https://www.healthline.com/diabetesmine/summer-2021-diabetesmine-d-data-exchange-tackles-acces-education-and-support#Whats-on-the-June-#DData2021-program?   XX quick break – want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Inside the Breakthrough is a podcast that mixes historical wisdom with modern insight – it's a science show that's also entertaining. I love it. They cover everything from snake oil to the actual Eureka moment. There's even an episode about the guy who discovered the importance of hand washing in hospitals and how no one believed him. And this actually relates to diabetes! Listen to Inside the Breakthrough wherever you listen to podcasts.. Back to the news… Canada has passed an act to establish a national framework for diabetes. The idea is to improve prevention, management and research. Diabetes Canada developed Diabetes 360° in collaboration with more than 100 groups and individuals from across the country. The World Health Organization recommends every country implement a national diabetes strategy-and since 2013, Canada has been without one https://www.diabetes.ca/media-room/press-releases/legislation-for-national-diabetes-framework-in-canada-becomes-law XX That's Diabetes Connections – In the News.  If you like it, share it. And feel free to send me your news tips. Stacey @ diabetes dash connections dot com. Please join me wherever you get podcasts for our next episode -Tuesday – it's a bit up on the air right now.. but I am scheduled to take part in a news conference with Nick Jonas, who famously lives with type 1. I hope to bring that to you – and we're sitting down with Dexcom's CEO next week so if you have a question you want to ask, post it for me in Diabetes Connections – The Group. Our current episode out right now is all about the PROTECT trial –hoping to slow down or even stop diabetes in the newly diagnosed. Thanks and I'll see you soon  

MannKind Corporation, Q1 2021 Earnings Call, May 12, 2021

The first appointment following a diabetes diagnosis is an important opportunity to begin an optimal management plan. Through a patient-centred approach, this should include discussion of the patient’s personal goals and circumstances, and education on the importance of glycaemic control. To help us put this into practice we are joined by Dr John Buse, Professor of Medicine at the University of North Carolina School of Medicine, and author of the ADA and EASD consensus report on the management of hyperglycaemia in type 2 diabetes. For more free education, visit the DKIP website, follow us on Twitter (@dkipractice) or connect on LinkedIn. References - Khunti, et al. Prim Care Diabetes. 2017;11(1):3-12 - Paul, et al. Cardiovasc Diabetol. 2015;14:100 - Davies, at al. Diabetologia. 2018;61(12):2461-2498 - Buse, et al. Diabetes Care. 2020;43(2):487-493 - Matthews, et al. Lancet. 2019;394(10208):1519-1529 Disclosures: Dr John Buse declares consulting fees and travel support (paid to the University of North Carolina) from Adocia, AstraZeneca, Dance Biopharm, Eli Lilly, Fortress Biotech, MannKind, NovaTarg, Novo Nordisk, Sanofi, Senseonics, vTv Therapeutics, and Zafgen; consulting fees from Cirius Therapeutics Inc, CSL Behring, Fortress Biotech, Mellitus Health, Moderna, Neurimmune AG, Pendulum Therapeutics, Stability Health and Zealand Pharma; stock options in Mellitus Health, Pendulum Therapeutics, PhaseBio, and Stability Health; grant support from NovaTarg, Novo Nordisk, Sanofi, Tolerion and vTv Therapeutics. Funding statement: This independent educational activity is supported by an educational grant from Eli Lilly, Merck Sharp & Dohme Corp and Novo Nordisk A/S. The educational content has been developed by Liberum IME in conjunction with an independent steering committee; the financial supporters have had no influence on the content of this education.

With Nate Pile, Editor of "Nate's Notes"

Michael Castagna is our Chief Executive Officer and serves on the Board of Directors for MannKind Corporation. Dr. Castagna has over 20 years of experience in healthcare, pharmaceutical, biotech, and specialty pharmacy industries. He joins MannKind from Amgen, Inc., where he spent over three years as Vice President, Global Commercial Lead for a portfolio of nine biosimilar drugs, and Vice President, Global Lifecycle Management. Prior to Amgen, Dr. Castagna, was Executive Director of Bristol-Myers Squibb’s Immunology franchise, where he served as co-lead to relaunch Orencia IV and launch Orencia SC, both rheumatoid arthritis drugs. Before BMS, Dr. Castagna was with Sandoz (Novartis) as Vice President and Division Head for Biopharmaceuticals, North America, where he established the US Biologics Business Unit and relaunched its lead product, Omnitrope, a human growth hormone. Prior to Sandoz, he held a variety of positions with EMD (Merck), Serono, Pharmasset and DuPont Pharmaceuticals. He received his Bachelors of Science – Pharmacy degree from Philadelphia College of Pharmacy, his Doctor of Pharmacy from Massachusetts College of Pharmacy, and his MBA from the Wharton School of Business at the University of Pennsylvania.

With Nate Pile, Editor of "Nate's Notes"

With Nate Pile, Editor of "Nate's Notes"

I have received many questions about insulin costs. The most common concern? The price of insulin and long-term affordability. In this episode, I interviewed Michael Castagna, Chief Executive Officer of MannKind, the makers of the inhaled insulin about their 4 dollar a day insulin program. What do you think about purchasing rapid-acting insulin for 4 dollars a day? It can be done assuming you use The post Afrezza’s Inhaled Insulin – One Solution to High Insulin Prices? appeared first on Diabetes Health.

With Nate Pile, Editor of "Nate's Notes"

With Nate Pile, Editor of "Nate's Notes"

Think less but see it grow. Also, why you shouldn't be too hard on Mannkind and eat more cheese.

MannKind stock has a passionate following, but being passionate does not always mean that an investment will win.  A look at the fundamentals of MannKind, what needs to happen, and when.

- Nate Pile, Editor of "Nate's Notes" - Please call 1-800-388-9700 for a free review of your financial portfolio

In this episode, Michael Castagna, MBA, PharmD, CEO of biopharmaceutical company Mannkind Corporation, shares his perspective on innovation and how pharmaceutical manufacturers are navigating the changing landscape with Suzette DiMascio, CHE, CMCE, CPC, host of the Specialty Pharmacy Podcast.

Anthony Hightower has used Afrezza for the past two years. He credits it (along with a Toujeo, a newer basal insuin) with completely changing his T1D management. In addition to excellent numbers, Anthony shares what else Afrezza has to offer. He explains, he liked it so much, he went to work for Mannkind, the company that makes Afrezza. He and Stacey also talk about the challenges Anthony faced since his diagnosis as a teenager. He admits he spent 20 years trying to avoid thinking about diabetes and credits the online community & the Diabetes Unconference with saving his life. Stacey also shares what those little "clips" are that come with some pump insets. Her family learned the hard way at the beach a while back! She shares how her husband McGyver'd a solution when they'd left the clips at home. And, find out how to contribute to our 100th episode coming up soon!

Mannkind Corporation is the first and currently only maker of inhalable insulin. Their CCO Michael Castagna, a PharmD, answers a bunch of questions about Afrezza, including how it works, why users like it, and what the concerns are around long-term side effects. 

The Motley Fool's Kristine Harjes and Todd Campbell discuss what trial failure, commercial failure, and patent expiration at Celldex, MannKind, and PDL BioPharma, respectively, teaches investors about managing risk in the industry.

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Motley Fool's Michael Douglass and Todd Campbell dig into MannKind Corp.'s first quarter earnings to see if MannKind is a bargain, or a bust.

MannKind and Orexigen: two companies with big promise, but can they deliver on profit? Healthcare analyst Michael Douglass and healthcare contributor Todd Campbell discuss the risks facing these biotech stocks.

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