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!

Diabetes Dialogue: Oral Ozempic and the Risks of Compounding Formulas

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore major updates in the evolving GLP-1 receptor agonist landscape, with a particular focus on oral semaglutide formulations, branding changes, and regulatory concerns surrounding compounded alternatives.

00:05:33 The importance of administration

00:06:56 Compounding drugs - the Hims and Hers drama

00:07:56 The danger of unregulated compound drugs

The discussion begins with the FDA approval of a higher-dose oral semaglutide formulation now branded as Ozempic for type 2 diabetes. Previously marketed as Rybelsus, the formulation itself remains bioequivalent, with no changes in efficacy, safety, or pharmacokinetics. The rebranding aligns oral and injectable Ozempic, simplifying clinical conversations and reducing prior authorization and coverage confusion. Similarly, oral Wegovy is now available for obesity management, reinforcing a unified naming convention: Ozempic for type 2 diabetes and Wegovy for obesity, regardless of route of administration.

The hosts note that while oral semaglutide has been available for several years, uptake of Rybelsus lagged behind expectations, in part due to limited brand recognition and confusion about its equivalence to injectable semaglutide. Early anecdotal experience suggests greater patient interest in “oral Ozempic,” highlighting the impact of naming clarity on real-world adoption. The simplified dosing structure of the newer formulations may further facilitate transitions during the upcoming rollout period.

Importantly, Isaacs and Bellini review key pharmacologic considerations. Oral semaglutide depends on the absorption enhancer SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) to protect the peptide from gastric degradation and promote systemic uptake. Administration remains strict: taken on an empty stomach with no more than 4 ounces of water, followed by a 30-minute interval before food, beverages, or other medications. Despite daily dosing, the drug retains a long half-life of approximately one week, meaning that temporary discontinuation—for example, prior to planned pregnancy—requires appropriate lead time. They emphasize that daily administration reflects absorption variability rather than a shorter pharmacologic duration.

The episode then pivots to safety concerns surrounding compounded oral semaglutide products. With GLP-1 shortages largely resolved, some telehealth companies—including Hims & Hers—have begun marketing lower-cost compounded oral versions. This has prompted legal action from Novo Nordisk, given that the proprietary SNAC technology is patented and critical to the drug’s validated bioavailability. The hosts caution that compounded oral formulations may lack regulatory oversight, standardized absorption data, and robust phase 1–4 clinical trial evidence. Without validated pharmacokinetics, patients risk receiving ineffective therapy—or potentially unsafe products—despite appealing lower price points.

The episode concludes with cautious optimism. While branding simplification and cost reductions represent meaningful progress in access and patient engagement, the hosts underscore the necessity of evidence-based prescribing and clinician-led patient education. As the GLP-1 therapeutic landscape continues to expand, maintaining safety, regulatory integrity, and pharmacologic rigor remains paramount.

Editor’s 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.

Podcasts

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss Ozempic’s approval in a higher-dose oral form and lingering concerns over compounded drugs.

Integrating Every Facet of Insulin Delivery With Medtronic’s MiniMed Go

 announced its clearance of the Minimed Go, Medtronic’s new mobile application and multiple daily injection (MDI) system for the treatment of insulin-requiring 

. The program coordinates between the InPen smart insulin pen with Abbott’s Instinct sensor and the MiniMed Go Smart MDI system, providing missed dose alerts, a dose calculator, guidance for missed or miscalculated doses, and easier provider collaboration through software reporting.

Diabetes Dialogue hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, sat down to spotlight the device and its promising future in insulin delivery.

Check out the full episode on the MiniMed Go and other tech updates 

The discussion frames MiniMed Go as a significant update to the existing InPen ecosystem, which Medtronic acquired several years ago. It emphasizes its potential to meaningfully improve care for people using multiple daily injections (MDI).

Isaacs and Bellini highlight that MiniMed Go introduces more advanced, intelligence-driven features compared with prior iterations. In contrast to retrospective reporting alone, the new app is intended to provide real-time, actionable guidance, such as identifying likely missed boluses or meals and prompting users with strategies to respond, including correction dosing. These features are designed to reduce common challenges in MDI therapy, such as insulin stacking or delayed treatment decisions, and to help improve overall time in range.

A central focus of the discussion is MiniMed Go’s integration with Medtronic’s new Instinct continuous glucose monitoring sensor, which is based on Libre 3 Plus technology and offers real-time glucose data with up to 15 days of wear. The panel contrasts this with prior InPen integrations, particularly with Dexcom, which involved a multi-hour data delay that limited usefulness for real-time decision-making. Real-time CGM integration is described as a major step forward, enabling users to quickly assess glucose trends, insulin-on-board, and dosing needs directly from their phones.

The hosts emphasize the importance of these advances for patients who prefer MDI over insulin pump or automated insulin delivery systems. While clinical guidelines encourage offering advanced insulin delivery technologies—especially for people with type 1 diabetes or insulin-deficient type 2 diabetes—many patients decline pumps due to lifestyle preferences, meal patterns, or treatment burden. MiniMed Go is positioned as a practical, lower-complexity option that still delivers meaningful clinical support for this population.

The conversation also situates MiniMed Go within the broader market landscape, noting that InPen is currently the only connected insulin pen available in the U.S., following the withdrawal or uncertainty surrounding other competitors. The panel expresses reassurance that Medtronic continues to invest in and support InPen, viewing this as critical for maintaining innovation and choice in MDI care. Isaacs and Bellini conclude with cautious optimism about future sensor integrations and a call for improved pharmacy-based access and reimbursement pathways to simplify prescribing and expand patient access to connected pen technology.

Medtronic. Medtronic Diabetes announces FDA clearance for MiniMed Go Smart MDI system featuring Instinct sensor made by Abbott. January 12, 2026. Accessed January 21, 2026. 

https://news.medtronic.com/2026-01-12-Medtronic-Diabetes-announces-FDA-clearance-for-MiniMed-Go-TM-Smart-MDI-system-featuring-Instinct-sensor-made-by-Abbott

Videos

This segment of Diabetes Dialogue spotlights the FDA clearance of the MiniMed Go and its collaborative capacity with various other devices.

Diabeloop’s DBLG2 and a Closed Loop With the Twiist Delivery System for T1D

On December 18, 2025, Diabeloop received 510(k) clearance from the 

 for its DBLG2 algorithm, which is designed to automate and personalize insulin delivery for patients with 

. The app analyzes glucose data in real-time, altering insulin dosage delivery to maintain blood sugar levels within a target range.

Following this announcement, Diabeloop partnered with Sequel Med Tech to pair the algorithm with Sequel’s automated insulin delivery system Twiist. This collaboration moved Twiist closer to a closed-loop solution, delivering personalized and proven clinical outcomes while maintaining ease of use. Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, sat down to discuss this recent advancement and its indications for insulin monitoring moving forward.

Check out the full episode on the 2025-2030 Dietary Guidelines for Americans 

Isaacs opens the discussion of Diabeloop’s newly FDA-cleared insulin delivery algorithm and its implications for the evolving landscape of automated insulin delivery. Although initially hesitant to cover the clearance, given the frequent disconnect between regulatory approval and real-world availability, she and Bellini revisit the topic after the announcement of a confirmed partnership with the Twiist pump. With anticipated readiness by late 2026 and a projected commercial launch in 2027, the discussion shifts from speculation to a more concrete assessment of how this system may enter clinical practice.

A central focus of the conversation is what differentiates Diabeloop from existing hybrid closed-loop systems. The hosts emphasize that Diabeloop is designed to be a truly fully closed-loop algorithm, requiring no meal announcements or manual boluses, though optional meal inputs may further increase time in range. This positions Diabeloop as a step beyond current systems such as Tidepool Loop and even Beta Bionics’ iLet, which, while highly automated, still rely on some degree of user input. The panel frames this as a meaningful advance toward reducing the daily cognitive burden of diabetes management, particularly for individuals who struggle with consistent bolusing or pre-meal timing.

The hosts discuss the potential clinical and behavioral impact of such a hands-off approach, noting how frequently clinicians counsel patients on bolus timing and meal announcements to optimize glycemic outcomes. They suggest that Diabeloop’s design may help more patients reach glycemic targets with fewer interactions, potentially improving adherence and quality of life. At the same time, they consider whether patients’ needs may evolve over time, with some initially preferring minimal interaction and later seeking greater control and customization.

This leads to a broader discussion of interoperability and choice. The group explores whether future pump platforms might allow patients to switch between algorithms as easily as they currently change continuous glucose monitors, while acknowledging the added safety and regulatory complexities inherent to insulin delivery. They highlight that Twiist’s willingness to support multiple algorithms represents a notable departure from the industry norm, where most pump manufacturers remain tightly coupled to proprietary software.

Finally, the hosts reflect on the absence of CamAPS from Twiist’s current lineup, noting that it remains the only FDA-cleared algorithm approved for pregnancy in the United States. While expressing disappointment, they recognize that Diabeloop offers a distinctly different use case compared with more customizable algorithms and may attract a broader audience. The episode concludes with cautious optimism, positioning Diabeloop as a bold and potentially transformative step toward more accessible, low-burden automation, while underscoring the importance of safety, flexibility, and patient-centered choice as closed-loop technologies continue to advance.

Diabeloop. Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery Algorithm in an App: a Strategic Turning Point. January 8, 2026. Accessed January 20, 2026. 

https://www.diabeloop.com/media-press/press-releases/diabeloop-fda-510k-clearance

Diabeloop. Diabeloop and Sequel Med Tech Enter Partnership to Integrate FDA-Cleared DBLG2 Into the Twiist Automated Insulin Delivery System. Presswire. January 14, 2026. Accessed January 20, 2026. 

https://presswire.com/release/diabeloop-and-sequel-med-tech-enter-partnership-to-integrate-fda-cleared-dblg2-into-the-twiist-automated-insulin-delivery-system-2/

This segment of Diabetes Dialogue spotlights the recent announcement of a partnership between Diabeloop and Sequel Med Tech.

US 2025-2030 Dietary Guidelines: Addressing Alcohol Intake Recommendations

The US Department of Health and Human Services and the US Department of Agriculture released the 2025-2030 Dietary Guidelines for Americans on January 7, 2026. Along with establishing the first-ever limit on processed foods, firmly encouraging a focus on whole foods, and recommending a higher proportion of protein, the guidelines come with several uncertainties and limitations.

Prominent among these uncertainties is a significantly broader suggestion of how people should manage their alcohol intake. Rather than explicitly stating a recommended number of drinks, the guidelines now advise patients to limit their alcohol intake. To address and attempt to explain this vague suggestion, Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, met with Susan Weiner, MS, a nationally recognized dietitian and diabetes care and education specialist.

Check out the full episode on the 2025-2030 Dietary Guidelines for Americans 

Weiner opens by raising substantive concerns about revisions to alcohol-related recommendations in the newly released US dietary guidelines, emphasizing the clinical and policy implications of shifting from quantitative to more ambiguous language. She notes that previous guidelines clearly defined alcohol limits—less than two drinks per day for men and one drink per day for women—while also specifying standard drink sizes and citing evidence linking alcohol consumption to adverse outcomes such as cancer, liver disease, metabolic dysfunction, and other chronic conditions. In contrast, the updated guidance broadly advises individuals to “drink less,” without numerical thresholds, detailed definitions, or accompanying references to alcohol-related harms. Weiner argues that this lack of specificity reduces the guidance’s practical value for clinicians and increases the risk of misinterpretation by patients, who may rationalize unsafe drinking behaviors under vague recommendations.

The discussion highlights how this ambiguity is particularly concerning in populations with diabetes or alcohol-induced dysglycemia, where alcohol can acutely and chronically disrupt glucose regulation, exacerbate liver disease, and affect multiple organ systems. Bellini reflects on the importance of having firm, evidence-based language that clinicians can reference directly in counseling and documentation, noting that tighter guidance previously served as a useful clinical tool. Bellini expresses worry that the revised wording may be perceived as a loosening of standards, potentially undermining public health messaging at a time when alcohol consumption increased during and after the COVID-19 pandemic.

Beyond individual patient care, the conversation emphasizes that dietary guidelines function as policy instruments. Weiner notes that these recommendations shape nutrition education curricula taught to children, influence school lunch programs, and may affect federal food and nutrition programs such as WIC, SNAP, and even military food services. From this vantage point, changes to alcohol guidance could have broad societal consequences, reinforcing the need for clarity and scientific rigor.

The segment also explores how professional organizations interpret and adopt federal dietary guidelines. Isaacs observes that groups such as the American Heart Association appear to be maintaining more conservative, established recommendations (such as the plate method, emphasis on lean meats, and limiting saturated fats) despite broader inclusions in the new guidelines, including butter and beef tallow. Weiner anticipates that organizations focused on cardiovascular disease, cancer, and metabolic health will publicly scrutinize and potentially challenge the revised alcohol language, given its established links to disease, mental health outcomes, and excess caloric intake. The discussion concludes with the expectation that further debate and guidance from professional societies will emerge, underscoring that alcohol cannot be excluded from clear, evidence-based dietary recommendations.

Editor’s 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. Weiner reports no relevant disclosures.

Mozaffarian D. The 2025-2030 Dietary Guidelines for Americans. JAMA. Published online January 14, 2026. 

This segment of Diabetes Dialogue spotlights the new guidelines’ broad suggestion regarding alcohol, as well as how organizations may interpret it.

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

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