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Savvy Updates, 3/16/25

Mar 16, 2026 | Advocacy, Diabetes Business, Featured, Research News, Technology Updates | 0 comments

In this week’s issue of The Savvy Diabetic: 

    • ATTD 2026 Highlights
    • First-ever real-world evidence of Eversense 365 at ATTD 2026
    • MiniMed Unveils Next-Gen Vivera Fully Closed-Loop Algorithm
    • Intraperitoneal Insulin an Option for Select T1D Patients
    • Reclassification From Type 2 to Type 1 Diabetes Not Uncommon
    • Insulet issues warning on certain Omnipod 5 pumps 
    • Upcoming Free Virtual Events: All about cellular transplantation and Immunology
      • “Meet Our DRI Scientists” with Dr. Camillo Ricordi and Dr. Norma Kenyon
      • A Conversation with Dr. Leonardo Ferreira: New Paths Toward a T1D Cure
    • Sana Biotechnology Positive Clinical Results: T1D/ Islet Cell Transplantation Without Immunosuppression
    • FDA Launches New Adverse Event Look-Up Tool


ATTD 2026 Highlights… more news next week …

ATTD 2026 (19th International Conference on Advanced Technologies & Treatments for Diabetes) is a major scientific conference held from March 11–14, 2026, in Barcelona, Spain, focusing on cutting-edge technologies, AI, glucose sensors, insulin pumps, and therapeutic innovations to improve diabetes management.

Key themes include insulin pumps/delivery systems, glucose sensors (invasive/non-invasive), closed-loop systems (artificial pancreas), and prevention of Type 1 diabetes.  The event is intended for clinicians, researchers, tech developers, investors, and regulatory bodies, and it features scientific sessions, the “International Fair of New Technologies in Diabetes,” and presentations.

Dexcom Technology & Outcomes
        • Non-Insulin Type 2 Success: New registry data shows that long-term use of the Dexcom G7 supports significant weight management and A1C reduction for people with Type 2 diabetes who are not on insulin.
        • Reduction in Hospitalizations: Real-world data indicate that starting Dexcom CGM is associated with a significant decrease in diabetic ketoacidosis (DKA)-related hospitalizations and ER visits for both children and adults with Type 1 diabetes.
        • Product Roadmap: Dexcom provided updates on its next-generation G8 sensor and the safety of Smart Basal, a new optimizer for basal insulin dosing in Type 2 patients.
MannKind Inhaled Insulin (Afrezza): Pediatric Potential: Clinical data from the INHALE-1 study was presented, supporting the use of  Afrezza, (inhaled insulin) in youth.
        • FDA Status: The FDA is currently reviewing a supplemental Biologics License Application (sBLA) for pediatric use (ages 4–17), with a target action date of May 29, 2026. 
Other Major Highlights
        • Insulet Omnipod 6: Plans were discussed for the 2026 launch of the Omnipod 6 automated insulin delivery system, which will feature an adaptive learning algorithm.
        • Abbott Clinical Data: New study data from Abbott highlights rising trends in diabetic ketoacidosis and explores patient barriers to ketone self-monitoring.
        • AI & Digital Health: A major theme of the conference has been the transition from simple glucose data to AI-driven insights to improve personalized diabetes management.
        • T1D Screening: Joint sessions by Sanofi and Medtronic explored real-world settings for early-stage Type 1 diabetes screening.

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First ever real-world evidence of Eversense 365 presented at ATTD demonstrates sustained performance and positive impact throughout one-year of wear posted by GlobeNewsWire.com, 14 March 2026.

Senseonics, a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces new data from a real-world evidence study which demonstrates the sustained performance and positive impact of Eversense 365 across the full one-year period. These findings were presented during an oral presentation entitled ‘Real-World Evaluation Of The Implantable One Year Eversense 365 CGM System’ at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place on March 11-14 in Barcelona, Spain.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Francine Kaufman, M.D., Chief Medical Office at Senseonics. “Since Eversense 365 was launched in the US, we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

        • Analysis revealed strong patient adherence, glucometrics and hypoglycemic outcomes, demonstrating how Eversense 365 can support effective management of diabetes over a full one-year period with just one implantable CGM sensor.
        • 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets, reinforcing that Eversense 365 is the most accurate CGM in low glucose ranges1,2,3, where errors can have the greatest impact on patient safety and treatment decisions.
        • Analysis by age revealed that Eversense 365 supported positive glucometrics and outcomes across all age groups. However, glycemic outcomes were seen to improve with increasing age, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70%, with over 85% achieving hypoglycemic targets. The trend was also observed with adherence, with over 95% average wear time in those 65 years and older. This suggests that, whilst all age groups can benefit from Eversense 365, there may be particular benefits and positive outcomes in older populations.

Read more: First Ever Real-World Evidence of Eversense 365 Presented at ATTD

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MiniMed Unveils Next-Gen Vivera Fully Closed-Loop Algorithm by Diabetech Justin for Diabetech.com, 12 March 2026.

MiniMed, formerly known as Medtronic Diabetes, showcased feasibility study results for its next-generation algorithm, Vivera at this years Advanced Technologies & Treatment for Diabetes (ATTD) in Barcelona. The new algorithm is a fully closed-loop insulin delivery system that represents a significant step beyond today’s MiniMed 780G algorithm. Current FDA-cleared systems are considered “hybrid closed-loop,” meaning users still need to bolus for meals to achieve optimal glucose control. Vivera could change that, by delivering optimal results while giving users the freedom to announce meals on their own terms.

Vivera is built entirely from the ground up, not an incremental update but a completely new algorithm. It’s designed to improve the experience for both pump users and their healthcare providers. For patients, meal announcements become fully optional, and MiniMed is eliminating SmartGuard exits, meaning fewer interruptions and less day-to-day user intervention. The algorithm will introduce an expanded range of glucose targets, starting as low as 90 mg/dL, and then options at 100, 110, and 120, plus two new higher targets at 130 and 140. MiniMed says its redesigned temp target sits at 150 mg/dl.

Getting started on MiniMed pumps will be easier thanks to the 48 hours SmartGuard warmup period going away and the algorithm automatically adjusting. These new enhancements could also make prescribing the supported pumps easier on healthcare providers.  Joining today’s unannounced Meal Detection is machine learning to each individuals physiology. The algorithm learns from patterns of its user. If a user has hypos at night, it adapts to those trends to prevent hypos in the evening.

Next up is a pivotal trial, which would require each participant to use the system for three months. There’s no word yet on when it will begin or how long clearance might take after that. Plus, MiniMed has more in the pipeline with two next-generation insulin pumps in the works, and has already submitted the MiniMed Flex to the FDA for clearance.

Read more: MiniMed Unveils Next-Gen Vivera Fully Closed-Loop Algorithm

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Intraperitoneal Insulin an Option for Select T1D Patients, by Miriam E. Tucker for Medscape.com,13 March 2026.  

A second-generation intraperitoneal insulin pump — the next-generation MiniMed Implantable Insulin Pump System (MIIPS 2020),  which is not yet commercially licensed but can be obtained in some cases on compassionate-use grounds — may be an option for select patients with type 1 diabetes (T1D) for whom subcutaneous insulin delivery isn’t possible. 

“It’s important for clinicians to understand how intraperitoneal insulin fits into the clinical pathway for people with T1D and know how to refer to specialist centers for review,” said Nick Oliver, MD, the Wynn Professor of Metabolism, Imperial College London, who presented background about the device at the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2026. “Greater awareness of intraperitoneal insulin has the potential to greatly help people with challenging skin conditions, and people experiencing recurrent, severe hypoglycemia despite optimized subcutaneous insulin with multidisciplinary education and support,” he explained.An international position statement, due to be published later in 2026, will guide use of the MIIPS 2020. The implanted device delivers insulin into the peritoneum, enabling direct absorption by the liver and bypassing systemic challenges experienced by a small population with T1D. It lasts about 7 years, similar to a pacemaker, and holds 20 mL of U100 insulin (2000 units) or 8000 units of Insuman U400 insulin. Reservoir refills are required about every 3-4 months, through a port on the skin’s surface.

Asked to comment, ATTD meeting co-chair Tadej Battelino, MD, head of the Department of Endocrinology at UCH-UMC Ljubljana, and chair and professor of pediatrics at the University of Ljubljana, Slovenia, said, “I think this is really for extreme cases where they can’t use external pumps. It’s obviously very good to have it, and I’m sure there is a group of people that can benefit, but it’s a niche product.”

Read more: Intraperitoneal Insulin an Option for Select T1D Patients

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Reclassification From Type 2 to Type 1 Diabetes Not Uncommon by Miriam E. Tucker for Medscape.com, 13 March 2026.  

Nearly 4% of people in the US initially diagnosed with type 2 diabetes (T2D) between July 2016 and October 2024 were later reclassified as having type 1 diabetes (T1D), a new analysis of data from the TriNetX database showed.  “We still have this problem of identifying people with type 1 diabetes,” said endocrinologist Jeremy H. Pettus, MD, associate professor of medicine at the University of California, San Diego (UCSD), who presented the study findings at the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2026. “We really have to think about this and move towards using autoantibodies more often, he added. Individuals who had been initially misdiagnosed tended to be younger than those who retained the T2D diagnosis, but there was no difference when stratified by BMI, Pettus reported. The reclassified group also had higher healthcare utilization.

In RECLASS-T1D, Pettus and colleagues retrospectively analyzed data from TriNetX electronic health records for a total of 6,759,145 people diagnosed with either prediabetes or T2D between July 1, 2016, and October 30, 2024. Overall, 2.2% (147,419 individuals) were later reclassified as having T1D. Among 3,400,462 initially diagnosed with T2D, 3.9% (129,866) were reclassified as T1D. “And keep in mind, we’re only identifying the people who were reclassified, so there [were] lots of people, I imagine, who were still floating around with type 1 diabetes [who] never got the right diagnosis,” Pettus noted. 

Read more: Reclassification From Type 2 to Type 1 Diabetes Not Uncommon


Insulet issues warning on certain Omnipod 5 pumps due to manufacturing issue by Sean Whooley for DrugdeliveryBusiness.com, 12 March 2026.  Insulet initiated a voluntary medical device correction for specific lots of Omnipod 5 insulin pump pods.

Acton, Massachusetts-based Insulet said it identified a manufacturing issue with certain Omnipod 5 lots through its ongoing product monitoring. Its correction applies to specific identified lots distributed in the U.S. All other Omnipod 5 pods and Omnipod products remain safe to use.

Insulet said that certain pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the pod rather than infuse into the body as intended. When the pod fails to deliver insulin properly, users may experience high blood glucose levels due to under-delivery.  In severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA).

According to a news release, Insulet received 18 reports of serious adverse events associated with high blood glucose levels. Those events included hospitalization and DKA. The company reports no deaths related to the issue. It noted that the issue does not affect the continuous glucose monitor (CGM) systems that integrate with Omnipod 5.

Read more: Insulet issues warning on certain Omnipod 5 pumps due to manufacturing issue


Upcoming Free Virtual Events: All about cellular transplantation and Immunology
“Meet Our DRI Scientists” will feature Dr. Camillo Ricordi and Dr. Norma Kenyon from the University of Miami. Both are internationally recognized researchers in cellular transplantation and immunology.
        • When: Wednesday, March 18, 2026
        • Time:   4:00 – 5:30 PM PT // 7:00–8:30 PM ET
        • Virtual event (Zoom link provided after registration)
        • To register: DRI: Meet the Scientists
The panel will discuss four decades of progress in islet transplantation and cell therapy, including the impact of the Ricordi Chamber and the future of immune-targeting strategies designed to protect transplanted insulin-producing cells. The conversation will also explore efforts aimed at reducing or potentially eliminating the need for long-term anti-rejection drugs. For anyone following developments in cell therapies and transplantation research in type 1 diabetes, this should be an informative discussion.

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New Paths Toward a Cure for Type 1 Diabetes

        • A conversation with Dr. Leonardo Ferreira
        • Tuesday, 31 March 2026
        • 5pm PT/8pm ET
        • Zoom: New Paths Toward a Cure for T1D
        • This event will be recorded and available on the T1Dto100 YouTube channel: YouTube.com/@T1Dto100

Researchers around the world are exploring new ways to treat — and possibly cure — Type 1 diabetes. One promising approach focuses on replacing insulin-producing beta cells and helping the immune system stop attacking them.

In this webinar, Dr. Leonardo Ferreira will share the work his research team is doing to develop new cell-based therapies that may one day help restore natural insulin production.  He will also discuss Sana Technologies research advances, as noted below.

Don’t worry — this discussion will focus on the big ideas and what they might mean for people living with T1D, rather than complicated scientific details.  Most importantly, this will be a conversation.  Participants will have the opportunity to ask questions and engage directly with Dr. Ferreira about his research and what it may mean for the future of Type 1 diabetes treatment.

This session is part of the T1D to 100 research discussion series, helping our community stay informed about emerging science and potential future therapies.

Leonardo M. R. Ferreira, PhD is a scientist studying new ways to treat diseases caused by problems in the immune system, including Type 1 diabetes.  He is an Assistant Professor of Pharmacology and Immunology at the Medical University of South Carolina. His research focuses on developing advanced cell therapies that may one day help protect or replace the insulin-producing cells destroyed in Type 1 diabetes. Dr. Ferreira completed his undergraduate studies in biochemistry at the University of Coimbra in Portugal and earned his PhD at Harvard University. He later continued his research at University of California, San Francisco, where he worked on ways to train the immune system to accept transplanted cells.

Today, his laboratory studies how specially designed immune cells might help prevent immune attacks, protect transplanted cells, and support future treatments for autoimmune diseases like Type 1 diabetes.


Sana Biotechnology Announces Continued Positive Clinical Results from T1D Study of Islet Cell Transplantation Without Immunosuppression by BioSpace.com, 13 March 2026.

Sana Biotechnology, Inc., a company focused on changing the possible for patients through engineered cells, today announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. The study is being conducted in partnership with Uppsala University Hospital.

“We are pleased to share the results through 14 months from this first-in-human study transplanting hypoimmune-modified primary islet cells into a patient with type 1 diabetes,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “These findings build upon previously presented data and continue to show no safety issues, along with continued immune evasion, survival, and function of the transplanted cells. Importantly, the results demonstrate the positive impact of improved glucose control on beta cell function and the dynamic functional capacity of beta cells transplanted in a single low dose without immunosuppression. This work suggests that the hypoimmune technology has the potential to enable a functional cure for type 1 diabetes without immunosuppression, and we look forward to working with Sana as it brings forward SC451, a more scalable approach, at higher doses.”

“These data continue to highlight the potential for HIP-modified cells to survive, function, and evade immune detection long-term in people post-transplant, a finding that we believe could have broad impact in type 1 diabetes and beyond,” said Steve Harr, MD, Sana’s President and CEO. “The data presented today also demonstrate how improvement in glycemic control – which is anticipated with higher doses of hypoimmune islets – can further enhance the function of these cells. We remain focused on advancing SC451, a HIP-modified stem cell-derived islet cell therapy, into the clinic and expect to file an investigational new drug application (IND) and initiate a Phase 1 trial as early as this year. Our goal is to offer patients a single treatment that delivers durable, normal blood glucose without the need for exogenous insulin or immunosuppression, and we look forward to continuing our collaboration with Dr. Carlsson and his colleagues at Uppsala University to advance this vision.”

Read more: Sana Biotechnology Announces Continued Positive Clinical Results


FDA Launches New Adverse Event Look-Up Tool was reported by the US FDA on FDA.gov/news-events, 11 March 2026.

The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.  

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. In the months ahead, all remaining product centers will begin processing adverse event reports in AEMS. The agency will also migrate historical adverse event data to AEMS, decommission certain legacy systems, and roll out enhanced application program interfaces (APIs) and data analytics tools. By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information.

Legacy systems to be replaced by AEMS in May include MAUDE (Manufacturer and User Facility Device Experience) — containing reports for medical devices.

Read more: FDA Launches New Adverse Event Look-Up Tool
 
 
 

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