216 episodios
- On this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, FNP-BC, talk through the latest addition to the weekly basal insulin landscape and what it means for clinicians starting or switching patients. Their conversation centers on real-world considerations for bringing a new insulin option into practice.
Watch the video and get the full description: https://www.hcplive.com/view/diabetes-dialogue-weekly-insulin-efsitora-alfa-gets-fda-approval-for-type-2-diabetes
#Diabetes #Endocrinology #DiabetesDialogue - Chronic kidney disease remains a persistent risk for people with type 1 diabetes, with roughly 30% of this population in the US developing the complication despite optimized glucose, blood pressure, and lipid management. Until now, no therapy directly targeted the mineralocorticoid receptor pathway implicated in this progression for this group.
On a recent episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the US FDA approval of finerenone (Kerendia) for chronic kidney disease associated with type 1 diabetes.
The approval marks the first new therapy in 30 years for this population and represents the third indication for finerenone, following its approvals for chronic kidney disease with type 2 diabetes in 2025 and for heart failure with left ventricular ejection fraction above 40%. Regulators granted priority review, and the decision draws on a broader evidence base spanning roughly 20,000 patients across five pivotal phase 3 trials of the nonsteroidal mineralocorticoid receptor antagonist class.
The phase 3 FINE-ONE trial, a randomized, placebo-controlled, double-blind study, enrolled 242 adults with type 1 diabetes across nine countries and 80 sites and supported the approval. Finerenone added to standard of care reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline over six months compared with placebo. Overall, 68.1% of participants receiving finerenone achieved a UACR reduction of at least 30%, versus 46.6% with placebo, a threshold the American Diabetes Association associates with slowed CKD progression.
Finerenone carries a risk of hyperkalemia, requiring potassium monitoring, and should not be combined with steroidal mineralocorticoid receptor antagonists such as spironolactone or with concurrent ACE inhibitor and angiotensin receptor blocker therapy. Unlike SGLT2 inhibitors, which remain unapproved in type 1 diabetes due to concerns about euglycemic diabetic ketoacidosis, finerenone offers clinicians a mechanistically distinct option with a defined safety profile in this population.
The approval also renews attention on UACR screening, which remains underused in primary care despite annual screening recommendations for all patients with diabetes. Broader adoption of routine screening, paired with earlier mineralocorticoid receptor antagonist initiation, may extend the renoprotective gains demonstrated in FINE-ONE to more patients with type 1 diabetes. - Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
Tubeless insulin delivery is entering a new phase of competition, as Beta Bionics announced FDA clearance of Mint, its first patch pump, alongside a forthcoming algorithm update designed to individualize glycemic targets without carb counting.1,2
On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the clearance and its implications for practice. The conversation centered on device specifications, insurance pathways, and an upcoming three-mode dosing algorithm called 3D Intelligence.
Mint is a tubeless, three-day-wear pump holding 200 units of insulin, built around a nonrechargeable two-year battery and IPX8 water resistance rated to five feet for 60 minutes. It pairs with iOS and Android at launch and requires no phone for priming, addressing adherence barriers seen with existing automated insulin delivery systems. Sensor compatibility includes the Dexcom G7 and Abbott's Libre 3 Plus, with Libre Dual and Senseonics' Eversense integration planned to follow.
Beta Bionics expects to begin shipments in the first quarter of 2027, targeting production of approximately 1.5 million units for the year, with at least 40% of payers anticipated to offer pharmacy-benefit coverage at launch. This model would allow patients on any current pump, including those previously limited to durable medical equipment acquisition, to access Mint through pharmacy channels once coverage is in place.
The forthcoming 3D Intelligence update introduces three insulin-dosing profiles built on real-world data from more than 40,000 current iLet users, expanding on the meal-announcement-only interface which has defined the iLet since launch. The original mode preserves the existing algorithm, the optimized mode aims to reduce hypoglycemia while maintaining time above range, and the conservative mode delivers a more measured correction response for patients at higher hypoglycemia risk, such as older adults. The update remains pending FDA clearance but is expected to reach existing iLet users via software update around the Mint launch.
Expanded sensor compatibility, dual-platform smartphone support, and pharmacy-benefit access position Mint to broaden automated insulin delivery uptake beyond populations previously constrained to durable medical equipment coverage. Combined with the 3D Intelligence update, the changes reflect a shift toward individualized dosing within a system historically defined by simplicity, without reintroducing manual basal rates or carb-ratio calculations. As competing patch pump programs advance through the FDA pipeline, the addition reinforces momentum toward algorithm-driven, low-burden insulin delivery across the type 1 diabetes population.
Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others. - In this episode of Diabetes Dialogue, co-hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, take on 2 recent developments that are reshaping how clinicians think about cardiovascular risk in people with diabetes. They start with a newly expanded indication for a dual incretin therapy, discussing what the supporting evidence means in practice and which patients may now be eligible. The hosts then turn to long-awaited trial evidence on statin therapy in older adults, a population historically underrepresented in this research. Along the way, they weigh open questions about mechanism, tolerability, and how to balance benefit against life expectancy and comorbidity. Throughout, Isaacs and Bellini emphasize individualized, shared decision-making when counseling patients on risk reduction at every age.
References
Eli Lilly and Company. FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. Press release. August 28, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjaro-tirzepatide-reduce-cardiovascular
Zoungas S, Wolfe R, Moran C, et al. Atorvastatin, cardiovascular events, and disability-free survival in older adults. N Engl J Med. Published online August 28, 2026. doi:10.1056/NEJMoa2607314 - Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
Non-invasive glucose monitoring is entering a new phase, with an EEG-based wearable positioned to sense blood sugar through brain rhythms rather than interstitial fluid. Early data from the developer suggest the approach may anticipate glucose changes ahead of standard continuous glucose monitors (CGMs), a claim rooted in the physiology of glucose transit from bloodstream to tissue.
On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Casey Halpern, MD, professor of neurosurgery and chief of stereotactic and functional neurosurgery at the University of Pennsylvania, about SynchNeuro, the company he cofounded to develop the device.
Halpern's group originally identified the underlying signal while using deep brain stimulation electrodes to study obesity and type 2 diabetes, finding that certain brain rhythms tracked blood glucose in real time regardless of electrode location. Because the signal is diffuse rather than localized, the team determined it could be captured non-invasively via scalp EEG, most reliably over the temporal lobe, an area accessible with a small sensor worn behind the ear. Device positioning has proven forgiving, with built-in signal-quality feedback guiding users to adjust placement as needed.
Accuracy data remain preliminary, drawn from EEG recordings paired with CGM readings in several dozen users over up to two weeks of continuous wear. Comparing readings synchronized to standard CGM timing, the sensor's mean absolute relative difference runs around 10% to 11%, approaching the accuracy range typically reported for interstitial fluid-based devices. Notably, Halpern reported that accuracy improves when comparing the sensor's output from 20 minutes earlier against subsequent CGM readings, suggesting the EEG signal reflects blood glucose upstream of the diffusion delay inherent to interstitial fluid sensing.
The company is enrolling additional users toward an algorithm-training cohort in the hundreds, which Halpern said internal power calculations suggest should be sufficient before pursuing regulatory clearance. Plans include an initial focus on type 2 diabetes and prediabetes, with a potential wellness-category launch preceding a full US Food and Drug Administration clinical-claims pathway. Beyond glucose, the platform is being explored for ketone monitoring, sleep apnea, and stroke risk prediction, applications that would each require separate regulatory work.
Collectively, the findings position EEG-based glucose sensing as a potential complement or alternative to interstitial fluid CGMs, particularly for patients seeking a non-invasive, intermittently wearable option, though larger validation cohorts and regulatory review will determine whether the anticipatory accuracy signal holds up at scale.
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Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a podcast hosted by Drs. Diana Isaacs and Natalie Bellini aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care. A video version of each episode is available at HCPLive.com/Clinical/Endocrinology.
Please direct podcast-related inquiries to PCampbell@MJHLifesciences.com.
Editor's note: Episodes predating January 2023 were hosted by Endocrinology Network. Episodes predating March 2022 were titled The Endocrine Outlook.
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