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Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the Portal implanted insulin pump, which has received Breakthrough Device designation from the FDA.
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore advances in implantable diabetes technologies, focusing on a novel implantable insulin pump from Portal Diabetes that has received FDA Breakthrough Device designation.
00:00:01 Intro
00:00:14 Implantable insulin pumps
00:01:06 What is breakthrough status?
00:03:00 How the pump works
00:03:41 What makes it different from MiniMed?
00:07:36 How does it administer insulin?
00:09:47 The Twiist pump with EverSense
00:13:30 Outro
The hosts begin by clarifying that breakthrough status is granted to technologies with the potential to substantially improve care, allowing for more streamlined clinical development and regulatory interaction. They contextualize the innovation historically, referencing earlier implantable pump systems developed by MiniMed, now part of Medtronic. Although those systems were used in the United States and remain available in limited European markets, they were ultimately eclipsed by the convenience and lower cost of subcutaneous pump platforms.
The Portal system differs fundamentally from traditional subcutaneous insulin pumps. Surgically implanted in the abdomen, the device delivers insulin intraperitoneally, allowing rapid absorption into the portal circulation. The hosts emphasize the physiologic implications of this route: markedly faster onset and offset of insulin action, elimination of pre-meal bolusing, and potentially improved safety around exercise due to shorter insulin tail effects. Such pharmacokinetic advantages may better approximate endogenous insulin secretion compared with subcutaneous delivery.
A distinguishing feature of the new platform is its aim to achieve fully automated, closed-loop insulin delivery through integration with continuous glucose monitoring (CGM). Unlike current hybrid closed-loop systems, which still require meal announcements and manual bolusing, the envisioned system would respond dynamically to rising glucose levels without user input, significantly reducing cognitive and behavioral burden for people with diabetes.
The discussion also addresses critical technical and practical considerations. The company is reportedly developing a proprietary temperature-stable concentrated insulin formulation, potentially exceeding U-500 strength, to maximize reservoir longevity. Refill intervals are projected at six to twelve weeks via a minimally invasive in-office percutaneous procedure, avoiding explantation. However, questions remain regarding device miniaturization, durability, infection risk, insulin stability, precision micro-dosing with highly concentrated formulations, and long-term cost-effectiveness. As the hosts note, payer acceptance will be essential for market viability, particularly given historical cost barriers associated with implantable systems.
In addition, the episode highlights the first commercial interoperability between the implantable Eversense 365 CGM and the Twiist insulin pump. The year-long implantable sensor reduces insertion frequency, mitigates compression artifacts, and may benefit individuals with dermatologic sensitivity to transcutaneous sensors. Although initial weekly calibrations are required, these decrease over time. With pump connectivity now available, the hosts anticipate expanded adoption among patients seeking lower-maintenance CGM options.
Overall, the conversation conveys measured optimism. While both technologies remain early in adoption and face clinical, regulatory, and economic hurdles, they represent meaningful progress toward physiologic insulin replacement, reduced therapeutic burden, and expanded personalization in advanced diabetes care.
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.
