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Automated insulin delivery keeps moving toward systems that ask less of the people using them. In this episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, look at two recent developments and talk through what they mean for clinical practice. In this episode: First-in-human results for the MiniMed Vivera algorithm, and how it performed when participants skipped meal announcements What the trial population can and can’t tell us about real-world patients The FDA clearance of the twiist AID system for adults with insulin-treated type 2 diabetes How the twiist algorithm differs from other systems, and tips for setting it up Where reduced-burden AID could go next

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!Automated insulin delivery (AID) is becoming the standard approach for insulin-requiring type 2 diabetes (T2D), and new pivotal data suggest a fourth system may soon join the 3 already cleared for this population.On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed 2 updates in T2D care. The discussion covered the Twiist AID trial and the new joint management algorithm from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD).The single-arm, multicenter trial, published in Diabetes Care, enrolled 307 adults aged 19 to 85 years with insulin-treated T2D who used the system for 13 weeks. Mean HbA1c fell 0.7%, from 8.1% to 7.4%, while continuous glucose monitoring time in range rose from 57% to 73%. Because every 5% gain in time in range carries clinical weight, a 16-point increase represents a substantial shift.Similar benefits appeared in adults older than 65 years, those using >100 units of insulin daily, and those taking glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants kept background therapy, and few counted carbohydrates at baseline. Fixed meal announcements, such as 45 g per meal with carbohydrate ratios adjusted behind them, and an extended-absorption bolus for gastroparesis or grazing patterns may simplify use.The ADA/EASD algorithm now integrates comorbidity assessment with glycemic and weight goals rather than splitting them into parallel pathways. Medical nutrition therapy, 24-hour physical activity behaviors, self-management education, and social determinants of health sit at the top. Directly below, the algorithm calls for early SGLT2 inhibitor and/or GLP-1-based therapy to modify disease and complication risk, a position metformin once held.A footnote extends the atherosclerotic cardiovascular disease recommendation to dual glucose-dependent insulinotropic polypeptide/GLP-1 receptor agonists such as tirzepatide (Mounjaro), reflecting SURPASS-CVOT. Metabolic dysfunction-associated steatotic liver disease and steatohepatitis now sit beside chronic kidney disease and heart failure, with GLP-1-based therapy, low-dose pioglitazone, or SGLT2 inhibitors as options. An evidence graphic also links each additional 500 to 1,000 daily steps with lower all-cause and cardiovascular mortality.Collectively, the updates mark a move away from stepwise treat-to-fail escalation toward earlier organ-protective therapy and, once insulin is needed, automated delivery as the default.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.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! Population-level screening for type 1 diabetes (T1D) is moving into clinical practice, raising questions about who to screen, how to stage results, and how to deliver disease-modifying therapy at scale. On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, recapped the inaugural Breakthrough T1D Clinical and Research Congress in Philadelphia. First-degree relatives carry up to a 15-fold increased risk, and screening children at ages two, six, and 10 years identifies roughly 80% of those who will develop the disease. Evidence guiding adult screening and staging remains limited. One health system estimated up to 45,000 candidates after counting relatives and people with autoimmune thyroid disease, celiac disease, or vitiligo. Placebo-controlled designs, such as the 14-day intravenous infusion regimen in the teplizumab (Tzield) TN10 trial, burden participants. An ongoing comparison of antithymocyte globulin with teplizumab gives every participant active therapy, and involving people with T1D in protocol development may improve enrollment. Eli Lilly is also investigating the Janus kinase inhibitor baricitinib (Olumiant) to delay progression from stage two to stage three disease. Stem cell-derived islet programs from Vertex aim to overcome donor scarcity, with gene editing intended to reduce immunosuppression requirements. Reports of insulin independence with tegoprubart, an anti-CD40 ligand antibody from Eledon, involve few patients receiving infusions every three weeks, and long-term toxicity of agents such as tacrolimus remains a concern. Long-term Edmonton protocol data show many recipients sustain time in range above 90% despite resuming insulin. Adjunctive agents layered on automated insulin delivery address residual cardiorenal risk. Dipeptidyl peptidase-4 inhibitors improve time in range without added hypoglycemia, while generic dapagliflozin lowers mean glucose but requires ketone monitoring given euglycemic diabetic ketoacidosis risk. Glucagon-like peptide-1 (GLP-1) and dual GIP/GLP-1 receptor agonists improve time in range, often at low doses such as tirzepatide (Mounjaro) 2.5 mg weekly. Finerenone (Kerendia) recently gained approval for chronic kidney disease associated with T1D. The 2026 American Diabetes Association Standards of Care also recognize coexisting type 1 and type 2 diabetes, supporting coverage for patients with insulin resistance. Supply policy compounds the clinical burden. Continuous glucose monitoring sensors frequently fail before their labeled wear time, leaving patients on standard monthly allotments without a sensor for meaningful stretches. Collectively, these developments point toward individualized T1D care matched to disease stage and residual beta-cell function, with screening infrastructure, trial access, and supply policy shaping how quickly patients benefit.

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.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!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 The Lancet. 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.

Insulin-resistant patients with type 2 diabetes who require high-dose therapy have long lacked a rapid-acting option concentrated enough for compact insulin pumps. New pharmacokinetic data on an ultra-rapid U-500 insulin aspart, alongside additional phase 3 results for a combined once-weekly insulin icodec-semaglutide regimen, both aim to close persistent gaps in insulin delivery for this population. In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed two studies addressing unmet needs in insulin therapy for type 2 diabetes. The investigational agent AT278 is a highly concentrated insulin aspart formulated at 500 units/mL, distinct from existing U-500 regular human insulin, which behaves more like an intermediate-acting product. In a single-center, randomized, double-blind, crossover euglycemic clamp study spanning body mass index from 25 to 38 kg/m², AT278 produced significantly faster absorption and a greater glucose-lowering effect within the first hour versus both standard U-100 insulin aspart and U-500 regular human insulin. The ultra-rapid pharmacokinetic and pharmacodynamic profile held consistent across the BMI range studied. Current U-500 regular insulin requires dosing 30 minutes before meals while simultaneously serving as basal and prandial coverage, complicating use in automated insulin delivery systems and limiting compatibility with smaller-volume pumps. A concentrated, rapid-onset formulation could allow patients with high insulin requirements to use compact pumps and extended-wear infusion sets without the absorption problems tied to large-volume subcutaneous depots. Drawn from an early-phase study, the findings position AT278 as a potential first ultra-rapid option for prandial dosing in this population, though regulatory approval for pump use remains undefined. Separately, the phase 3 COMBINE 4 trial evaluated a fixed combination of once-weekly insulin icodec (Awiqli) and semaglutide, known as IcoSema, against once-daily insulin glargine U-100 in 485 adults with type 2 diabetes and baseline A1C above 8%. Over 40 weeks, IcoSema reduced A1C by 3.32 percentage points versus 2.44 points with glargine, a between-group difference of 0.88 percentage points, while producing a 0.79 kg weight reduction compared with a 3.81 kg gain with glargine. Time in range reached 79.8% with IcoSema versus 64.5% with glargine, consistent with the mechanistic rationale of pairing glucagon-like peptide-1 receptor agonism with basal insulin to limit postprandial excursions. These results build on earlier COMBINE 1 through 3 data, which showed IcoSema achieving noninferior or superior A1C reduction, superior weight outcomes, and lower hypoglycemia rates versus comparators. A single weekly injection combining basal insulin with a GLP-1 receptor agonist could reduce treatment burden and consolidate pharmacy copays, though semaglutide exposure remains capped by concurrent insulin titration, averaging 0.66 mg in COMBINE 4. Whether either agent reaches United States practice, including reported uncertainty around a domestic IcoSema launch, will determine their eventual role in managing insulin-resistant type 2 diabetes.

Once-weekly basal insulin therapy has moved from clinical trial data to pharmacy shelves, offering clinicians a new option for patients who struggle with the daily burden of insulin injections. The shift addresses a persistent adherence problem in basal insulin therapy, where missed or inconsistent daily dosing undermines glycemic control. In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the pharmacy launch of insulin icodec (Awiqli), the first once-weekly basal insulin now available in the United States. The approval rests on data from approximately 4200 participants across the phase 2 and phase 3 ONWARDS program. In insulin-naive participants enrolled in ONWARDS 1, 3, and 5, insulin icodec produced superior reductions in hemoglobin A1c compared with once-daily basal insulin. Among participants switching from daily basal therapy in ONWARDS 2, icodec showed noninferior glycemic control alongside improved treatment satisfaction scores. Insulin icodec has also been studied in type 1 diabetes but did not receive approval in this population after trials showed higher rates of hypoglycemia relative to daily basal insulin. Additional studies in type 1 diabetes are ongoing, leaving open the possibility of future expansion beyond the current type 2 indication. Dosing requires new clinical habits, since insulin icodec is formulated as U-700, a concentration allowing a full week's dose to be delivered in a comfortable injection volume. Adjustments occur in 10-unit increments rather than the single-unit changes used with daily basal insulins, though the weekly total still translates into modest day-to-day changes of roughly one to two units. Patients switching from daily basal insulin require a loading dose, calculated by multiplying the total daily dose by 10.5, to reach steady state faster than a standard weekly conversion would allow. Titration follows fasting glucose. Clinicians add 20 units when readings exceed 130 mg/dL, maintain the dose between 80 and 130 mg/dL, and subtract 20 units below 80 mg/dL. Because increases and decreases are dosed in 20-unit blocks, most cycles are reassessed over two to four weeks rather than week to week. The reduced injection frequency carries particular relevance for older adults, caregivers, and patients whose adherence to daily regimens has proven inconsistent. As pharmacy access expands, coverage and prior authorization requirements will shape how quickly insulin icodec moves into routine practice, but early trial and satisfaction data point toward a meaningful shift in basal insulin management.

Advances in diabetes care rarely arrive through a single channel, and the 2026 annual meeting of the Association of Diabetes Care and Education Specialists (ADCES) reflected this breadth, with new insulin delivery hardware, cardiometabolic risk management, and endocrine screening criteria all drawing attention from clinicians in Columbus, Ohio. On a recent episode of Diabetes Dialogue, recorded on-site at ADCES26, co-hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed sessions and exhibits spanning insulin delivery technology, cardio-kidney-metabolic (CKM) risk reduction, beta-cell preservation, ketone monitoring, and hypercortisolism screening. On the exhibit floor, 2 simplified insulin delivery devices signaled a push toward patients still managing diabetes on multiple daily injections. Pivot, a tubeless patch pump from Modular Medical, holds up to 300 units of insulin, delivers preset 2-unit boluses, and supports 2 distinct basal rates, though it is not yet an automated insulin delivery (AID) system. CeQur's Simplicity bolus-only patch has moved toward 7-day wear with up to 240 units of capacity and a one-unit dosing option, positioning it alongside once-weekly basal and incretin therapies on a shared weekly schedule. A case-based session on CKM syndrome, built around a patient newly diagnosed with type 2 diabetes and discharged on insulin without pen needles, illustrated how risk calculators such as PREVENT can guide therapy beyond glycemic control. The case incorporated glucose-lowering therapy alongside GLP-1 and SGLT2 inhibitor use for cardiorenal protection, discontinuation of an unindicated beta blocker masking hypoglycemia symptoms, and a plan to taper insulin as other agents took effect. A separate discussion focused on C-peptide, a marker of residual endogenous insulin production, as an emerging clinical trial endpoint in type 1 diabetes. Patients who retain measurable C-peptide despite long-standing autoimmune beta cell loss appear to experience fewer cardiovascular events, less diabetic ketoacidosis, and less severe hypoglycemia, reinforcing interest in beta-cell-preserving therapies during early-stage disease. Continuous ketone monitoring, an emerging sensor category, was covered through patient cases including pregnancy-related nutritional ketosis and a case of latent autoimmune diabetes in adults treated with an SGLT2 inhibitor without insulin, a combination carrying risk for euglycemic diabetic ketoacidosis. The hosts noted real-time ketone data could eventually clarify when SGLT2 inhibitor use is appropriate in insulin-requiring patients despite this risk. A well-attended early-morning session addressed hypercortisolism as an underrecognized driver of treatment-resistant hypertension and hyperglycemia. Updated American College of Endocrinology guidance now recommends screening when hemoglobin A1c remains >7.5% or blood pressure remains uncontrolled despite maximal glucagon-like peptide-1, SGLT2 inhibitor, and multidrug antihypertensive therapy, with diabetes care and education specialists playing a growing role in identifying candidates and coordinating referral. The hosts also highlighted Blue Circle Health, a nonprofit offering ≤6 months of virtual bridge care, including dietitian visits, social work support, and insurance navigation, for people with type 1 diabetes across 20 states. Collectively, the sessions underscored a field advancing simultaneously on device design, risk stratification, biomarker science, and access to supportive care.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!Triple hormone receptor agonism is emerging as a frontier in metabolic disease treatment, and topline phase 3 results for retatrutide suggest the strategy can push weight loss and glycemic control beyond current incretin therapies, even as a separate JAMA analysis raises questions about oversight in online GLP-1 prescribing.1,2 On the latest episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed topline results from the TRIUMPH-2 and TRIUMPH-3 trials of retatrutide, a glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon receptor triple agonist. TRIUMPH-2 enrolled 1000 participants with type 2 diabetes across 98 centers and tested 4 mg, 9 mg, and 12 mg doses against placebo over 80 weeks. The 12 mg dose produced weight loss up to 21% from a baseline of 106 kg, or roughly 23 kg. Hemoglobin A1C fell between 1.4 and 1.6 percentage points from a baseline of 7.7%, versus 0.2 points with placebo, a large glycemic effect given the near-normal starting A1C and discontinuation of 14% at the highest dose. TRIUMPH-3 enrolled over 1900 participants with class II or III obesity (body mass index of 35 or higher) and established cardiovascular disease, randomized to 9 mg, 12 mg, or placebo over 80 weeks. The 12 mg dose delivered 23% weight loss versus 3% with placebo, alongside a 37% reduction in triglycerides, 17% reduction in non-high-density lipoprotein cholesterol, and 9.3 mmHg reduction in systolic blood pressure. Major adverse cardiovascular event outcomes trended favorably but did not reach significance, an expected limitation of an 80-week trial. Gastrointestinal effects were common across both trials, including diarrhea in up to 34% of participants and nausea in up to 28%, consistent with the broader incretin class. Isaacs and Bellini also discussed a JAMA secret-shopper study, led by Ashwin Chetty, MD, examining online GLP-1 prescribing across 49 telehealth websites. Of these, 92% prescribed the requested medication and 70% mailed it, often without required photo verification, blood work, or clinician video visits, in some cases within five minutes. Compounded formulations, including unproven sublingual drops, were frequently offered alongside add-on supplements marketed as personalization, a workaround linked to compounding rules requiring documented medical need. Together, the findings illustrate a widening gap between the therapeutic ceiling GLP-1-based agents are reaching in controlled trials and the variable oversight surrounding real-world access to these drugs, underscoring the need for clinicians to proactively screen patients for unsupervised use. 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.

To begin the episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the rapidly evolving landscape of wearable insulin delivery, focusing on recent developments in patch pump technology and the growing number of tubeless insulin delivery systems entering the market. The conversation centers on the recent FDA clearance of the Pivot patch pump from Modular Medical, which the hosts describe as an important addition to a field that has historically been dominated by a single tubeless option. Isaacs reviews the design of the Pivot system, explaining that while it is a tubeless insulin pump, it differs from current automated insulin delivery (AID) systems because it does not communicate with a continuous glucose monitor (CGM) or use an insulin-dosing algorithm. Instead, the device delivers programmable basal insulin with ≤2 selectable basal rates and allows users to administer manual bolus doses. The hosts note its 300-unit insulin reservoir, highlighting the larger capacity as a potential advantage for individuals with higher daily insulin requirements. Bellini discusses where Pivot may fit into current clinical practice, suggesting it could provide an option for people who are unwilling or unable to use CGM technology but would still benefit from wearable insulin delivery. She also points to the possibility of future partnerships with commercially available AID algorithms, which could allow the platform to evolve into a more automated system. The hosts acknowledge that current diabetes guidelines generally favor AID for individuals with type 1 diabetes but recognize that simplified technologies continue to have an important role for select patient populations. The discussion expands to the broader pipeline of tubeless insulin pumps currently under development. Isaacs and Bellini review anticipated products from Tandem, Beta Bionics, and Medtronic, noting that virtually every major insulin pump manufacturer is now investing in patch pump technology. They compare reservoir capacities, expected timelines, and device designs while emphasizing the increasing demand for tubeless systems that improve convenience and reduce many of the practical challenges associated with traditional tubing. The hosts also examine several practical design considerations. They discuss Pivot's reusable and disposable components, explaining that many newer patch pumps incorporate reusable elements because of existing intellectual property surrounding fully disposable tubeless systems. While reusable components may lower manufacturing costs, they also introduce considerations such as the potential for patients to misplace components or inadvertently lose them during hospitalizations. Isaacs adds that the simplified design and absence of an onboard algorithm may ultimately make the device more affordable, although real-world pricing remains to be determined. Attention then shifts to recent updates from CeQur Simplicity, which recently announced a 7-day bolus-only patch featuring an expanded 240-unit insulin reservoir and a new one-unit dosing option for individuals requiring smaller mealtime insulin doses. The hosts discuss how these enhancements could broaden the device's applicability while maintaining its emphasis on simplicity, requiring neither smartphone connectivity nor a dedicated mobile application. Bellini highlights the potential synergy between the 7-day patch and emerging once-weekly basal insulin formulations, suggesting that synchronizing weekly basal insulin administration with weekly patch replacement could simplify treatment routines and improve adherence. She emphasizes that insulin therapy should continue to complement guideline-directed pharmacologic management, including GLP-1 receptor agonists, SGLT2 inhibitors, and other glucose-lowering therapies when appropriate. The episode concludes with an optimistic assessment of the future of insulin delivery technology. Isaacs and Bellini emphasize that increasing competition among manufacturers is likely to expand patient choice, improve affordability, and accelerate innovation. They express particular enthusiasm for the continued growth of tubeless insulin delivery, broader pharmacy benefit coverage, and the next generation of AID systems, all of which they believe will further individualize diabetes management and improve outcomes for people requiring insulin therapy. 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.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!To begin the episode, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss recent advances in type 1 diabetes (T1D) research following presentations at the American Diabetes Association (ADA) Scientific Sessions and the American Association of Clinical Endocrinology (AACE) Annual Meeting. They focus on promising data from an islet cell transplantation study in which all 12 participants achieved insulin independence, with some maintaining normal glycemia for up to 2 years after transplantation. Isaacs explains that the transplanted islet cells restore endogenous insulin production and emphasizes that the study’s most notable innovation is its immunosuppression strategy. Rather than relying on calcineurin inhibitors such as tacrolimus, which are associated with significant toxicities, particularly nephrotoxicity, the investigators used the investigational anti-CD40 ligand therapy tegoprubart. The hosts discuss how this approach may improve the long-term safety and feasibility of islet transplantation and note ongoing efforts to develop more convenient formulations beyond the current intravenous infusion administered every 3 weeks. The conversation then turns to the clinical significance of the findings. Bellini highlights that all 12 enrolled participants achieved insulin independence, distinguishing these results from earlier transplantation efforts such as the Edmonton protocol. The hosts also describe the substantial improvements in quality of life reported by participants, including sustained HbA1c values in the normal range without restrictive dietary practices and complete resolution of severe hypoglycemia. Because the trial enrolled individuals with recurrent, life-threatening hypoglycemia, they emphasize that the observed benefits are particularly meaningful for this high-risk population. The hosts also examine several unanswered questions that remain before this approach can become widely available. They discuss the durability of insulin independence, the long-term need for immunosuppressive therapy, treatment costs, and the challenges associated with scaling islet transplantation beyond specialized research centers. Additional findings are reviewed, including the need for repeat transplantation in 2 participants and observations suggesting that individuals with higher body mass index may require greater islet mass to achieve insulin independence. They also discuss the use of tirzepatide in 2 participants, raising questions about the role of insulin resistance and adjunctive therapies following transplantation. Broadening the discussion, Isaacs and Bellini review several emerging strategies aimed at expanding access to curative therapies. These include stem cell-derived islets, large-scale beta cell manufacturing, gene-editing approaches, and encapsulation technologies intended to protect transplanted cells while reducing or eliminating the need for chronic immunosuppression. Drawing on presentations from Aaron Kowalski, PhD, and Laura Jacobsen, MD, they emphasize that despite major advances in continuous glucose monitoring, automated insulin delivery systems, and adjunctive pharmacotherapy, subcutaneous insulin administration remains fundamentally nonphysiologic and cannot fully eliminate long-term complications or disease burden. The episode concludes with a broader discussion of the future of type 1 diabetes research. The hosts highlight efforts to expand eligibility for islet transplantation trials, including studies involving individuals with chronic kidney disease who were previously excluded because of concerns surrounding traditional immunosuppressive therapies. They also underscore the importance of continuing to pursue disease-modifying therapies despite improvements in diabetes technology, emphasizing that glycemic targets alone do not eliminate complications or address disparities in access to care. While acknowledging that a universally applicable cure remains years away, Isaacs and Bellini conclude that the field is making meaningful progress toward safe, durable, and scalable therapies capable of fundamentally changing the treatment of type 1 diabetes. 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.