Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

Tubeless insulin delivery is entering a new phase of competition, as Beta Bionics announced 

 clearance of Mint, its first patch pump, alongside a forthcoming algorithm update designed to individualize glycemic targets without carb counting.



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.


Diabetes Dialogue: Beta Bionics' Mint Patch Pump Gains FDA Clearance


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 

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.

Beta Bionics. Beta Bionics Announces FDA Clearance of Mint, the Company’s Transformative Patch Pump, and Unveils 3D Intelligence as its Next-Generation Insulin Dosing Algorithm. September 14, 2026. Accessed September 15, 2026. 

https://investors.betabionics.com/news-releases/news-release-details/beta-bionics-announces-fda-clearance-minttm-companys

Livingston R. FDA Clears Beta Bionics’ Mint Insulin Patch Pump for Diabetes. 

September 14, 2026. Accessed September 15, 2026. 

https://www.hcplive.com/view/fda-clears-beta-bionics-mint-insulin-patch-pump-for-diabetes

Podcasts

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Beta Bionics' new insulin patch pump, expected to be commercialized in Q1 2027.

Insulin resistance and cardiovascular risk sit at the center of nearly every conversation in modern diabetes care, and 2 recent developments push this conversation forward. Co-hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, open this episode with the newly approved cardiovascular indication for tirzepatide, then turn to fresh data on statin therapy in adults over 70. Both topics carry immediate implications for how clinicians counsel patients on risk reduction across the lifespan.

Diabetes Dialogue: Tirzepatide's New CV Indication and the STAREE Statin Trial 

Tirzepatide Gains FDA Approval for Cardiovascular Risk Reduction

On August 28, 2026, the US Food and Drug Administration approved tirzepatide, marketed as Mounjaro, to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these events.¹ The approval covers cardiovascular death, nonfatal heart attack, and nonfatal stroke.

Isaacs notes some clinicians expected this approval to be uncertain because the pivotal SURPASS-CVOT trial compared tirzepatide with dulaglutide rather than placebo and found noninferiority rather than superiority. Bellini points out dulaglutide already carries its own cardiovascular indication, so a noninferior result still places tirzepatide on equal footing with an agent already proven to reduce cardiovascular risk. The trial enrolled > 13,000 participants across 30 countries, giving the finding a broad and diverse evidence base.

Isaacs walks through a pair of additional analyses strengthening the case for approval. An imputed placebo comparison, built through statistical modeling rather than a true placebo arm, suggested tirzepatide would have shown superiority had an ethical placebo-controlled design been possible given the established benefit of comparator agents. A separate 5-point MACE analysis presented by cardiologist Steve Nissen, MD, of Cleveland Clinic, also favored tirzepatide once additional cardiovascular outcomes were incorporated beyond the original 3-point composite.

Isaacs highlights the approval covers patients at high risk for cardiovascular events rather than requiring established cardiovascular disease, a distinction she expects will broaden access. Bellini adds this framing captures a wide swath of everyday patients, since diabetes, hypertension, elevated cholesterol, and obesity all confer elevated risk on their own.

The hosts also raise an open mechanistic question: whether the cardiovascular benefit stems from tirzepatide's GLP-1 activity, its GIP activity, or both. Isaacs notes dulaglutide achieves cardiovascular benefit with considerably less glucose-lowering and weight-loss potency, raising questions about how much of tirzepatide's effect traces to the GIP component as dual and triple agonists enter development.

Bellini emphasizes patient selection remains individualized regardless of the new indication, since tolerability and prior response still guide the choice between agents. The discussion closes by noting semaglutide and tirzepatide carry distinct indications beyond cardiovascular risk, including kidney disease and MASH for semaglutide and sleep apnea for tirzepatide, keeping regimen selection a multifactorial decision.

STAREE Trial Supports Statin Use for Primary Prevention After Age 70

Statin therapy in older adults has long lacked robust trial evidence, since patients older than 70 have historically been excluded or underrepresented in pivotal statin studies. The STAREE trial, published in the

, randomly assigned nearly 10,000 adults with a mean age of 74.7 years to atorvastatin 40 mg or placebo.²

Bellini highlights the balanced enrollment of 52% women, addressing a long-standing gap in sex representation within statin research. Over a median follow-up of 5.9 years, atorvastatin reduced major cardiovascular events by 30% compared with placebo, a finding both hosts describe as clinically meaningful for a low-cost, generic medication.

Isaacs points out disability-free survival did not differ significantly between groups, suggesting age alone should not automatically dictate statin initiation. She reinforces the value of individualized, shared decision-making for patients with limited life expectancy or significant comorbidity burden.

Bellini adds serious adverse events occurred at similar rates in both arms, at 2.7%, countering the common perception statins routinely cause significant side effects in older patients. She encourages clinicians to try alternative statins before concluding a patient cannot tolerate the drug class. The hosts close by addressing dementia risk directly: daily statin therapy did not significantly change dementia rates over nearly 6 years, a neutral finding they frame as reassuring given ongoing patient concerns.

Editors’ Note: Disclosures for Isaacs include Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

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. 

. Published online August 28, 2026. doi:10.1056/NEJMoa2607314

Diana Isaacs, PharmD, and Natalie Bellini, DNP, unpack tirzepatide's new CV indication and the STAREE statin trial in older adults.

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.

Diabetes Dialogue: Non-Invasive EEG Sensor Aims to Track Glucose in Real Time

Halpern's group originally identified the underlying signal while using deep brain stimulation electrodes to study 

, 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.

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. Halpern reports being a consultant for Insightec and employment with SynchNeuro.

Kinsey N. SynchNeuro Has a Working Prototype, a New Study Launching, and a Forecast for Your Blood Sugar | Health Moonshot Update. 

. May 27, 2026. Accessed August 26, 2026. 

https://media.startuphealth.com/p/synchneuro-has-a-working-prototype-a-new-study-launching-and-a-forecast-for-your-blood-sugar-health-

In this episode of Diabetes Dialogue, co-hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Casey Halpern, MD, to discuss SynchNeuro's investigational, non-invasive EEG-based glucose monitor.

Diabetic ketoacidosis remains a leading cause of preventable hospitalization in diabetes care, yet ketone testing has lagged far behind glucose monitoring in both accuracy and adoption. Continuous ketone monitoring aims to close this gap, giving clinicians and patients a real-time window into a metabolic state that urine strips and intermittent blood testing have rarely captured well.

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, spoke with Eden Miller, DO, founder of Diabetes and Obesity Care, and Davida Kruger, NP, of Henry Ford Health, about the FDA clearance of the FreeStyle Libre Duo (Abbott), a combined glucose and ketone sensor. Both guests served on the international advisory board contributing to the sensor's development and co-authored related work in 

Diabetes Dialogue: FreeStyle Libre Duo Cleared for Ketone Monitoring

The sensor pairs a 10-day wear with a 1-hour warm-up and reports glucose and beta-hydroxybutyrate readings every minute through the existing Libre app. Direct beta-hydroxybutyrate tracking offers an earlier signal than urine ketone testing, which measures acetoacetate and lags physiologic change. Ketone values <0.6 mmol/L default to a glucose-focused display, values between 0.6 and 3.0 mmol/L trigger a trend view with directional arrows, and a fixed threshold of 3.0 mmol/L generates an urgent high alert.

Guests emphasized glucose and ketone levels do not always move together. Pump-suspension research led by Jennifer Sherr, MD, PhD, at Yale, showed considerable variability in time to ketosis, with some patients developing ketosis within 4 hours of an interruption and others remaining ketone-free well beyond it. This variability carries particular relevance for patients using sodium-glucose cotransporter-2 (SGLT2) inhibitors off-label in type 1 diabetes, since euglycemic ketosis can develop without corresponding hyperglycemia.

At launch, the sensor is expected to pair with select automated insulin delivery systems, including Beta Bionics' iLet, with expanded compatibility anticipated for Omnipod 5 and Medtronic's Instinct sensor into 2027, though no pump algorithm will adjust dosing based on ketone data yet. Coverage will begin through commercial insurance only, without Medicare or Medicaid reimbursement established at this time. Clinicians will need updated protocols to interpret ketone trend arrows manually, distinguishing benign nutritional ketosis from evolving decompensation before automated support becomes available.

Continuous ketone monitoring marks a shift comparable to the early adoption of continuous glucose monitoring, when clinicians needed guidance interpreting new, high-frequency physiologic data. As real-world experience accumulates over the coming year, the technology is positioned to inform individualized ketone thresholds, refine detection of infusion-set failure, and potentially reduce emergency care tied to diabetic ketoacidosis.

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. Kruger reports disclosures with Abbott, CeQur Corporation, Embecta, Eli Lilly, MannKind, Medtronic, and others. Miller reports disclosures with Abbott, Bayer, Corcept, Eli Lilly, Insulet, Novo Nordisk, and others.

U.S. Food and Drug Administration. FDA authorizes first wearable device that continuously monitors both ketone levels and blood sugar. Published August 25, 2026. Accessed August 25, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-wearable-device-continuously-monitors-both-ketone-levels-and-blood-sugar

In this episode, co-hosts Isaacs and Bellini are joined by Eden Miller, DO, and Davida Kruger, NP, to discuss the FDA's recent clearance of the FreeStyle Libre Duo ketone monitor.

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES

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