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Implantable Portal Insulin Pump Receives FDA Breakthrough Designation
Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the Portal Pump's recent Breakthrough Designation from the FDA.
On February 17, 2026, Portal Diabetes’s Portal Pump, an investigational implantable insulin pump system, received Breakthrough Device Designation from the US Food and Drug Administration (FDA). Clinical trials are expected to begin in Q4 2027.1
Diabetes Dialogue cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the implications of this device, already being referred to as the first real “artificial pancreas.”
Check out the full episode on implantable insulin pumps and interoperability here.
In this segment, Isaacs and Bellini turn to a novel and largely re-emergent concept in diabetes technology: implantable insulin delivery. The discussion is prompted by Portal Diabetes receiving FDA Breakthrough Device designation for its implantable “Portal Pump,” a status intended to accelerate early-phase clinical development for technologies that may significantly improve care. Although implantable pumps are not entirely new—earlier systems developed by MiniMed, now part of Medtronic, were previously available in the United States and remain in limited use in Europe—the hosts emphasize that Portal’s platform represents a modern, potentially transformative iteration.
The segment reviews the physiologic rationale for intraperitoneal insulin delivery. Unlike subcutaneous pumps, which require infusion site changes every few days and depend on pre-meal bolusing to mitigate delayed absorption, the implantable system would deliver insulin directly into the peritoneal space, allowing rapid entry into the bloodstream. The hosts underscore that insulin delivered via this route has a markedly faster onset and offset—on the order of minutes—more closely approximating endogenous pancreatic insulin secretion. Clinically, this could reduce or eliminate the need for pre-bolusing, decrease postprandial excursions, and substantially lower the cognitive burden associated with carbohydrate estimation and dose timing. The rapid pharmacokinetics may also improve safety during exercise by limiting prolonged insulin activity and reducing hypoglycemia risk.
A central point of differentiation from prior implantable systems is Portal’s plan to pursue a fully closed-loop model integrated with continuous glucose monitoring. Earlier devices required meal announcements and user input, whereas this next-generation approach aims to automate insulin delivery entirely. The hosts note that while current “artificial pancreas” systems reduce workload, they remain hybrid systems; a fully automated implantable platform could meaningfully shift the paradigm toward true physiologic replacement and burden reduction.
The conversation also addresses practical and technical considerations. The device would be surgically implanted in the abdomen, with insulin refilled in-office via a transcutaneous port approximately every 6–12 weeks. Portal is reportedly developing a proprietary, temperature-stable, concentrated insulin formulation to maximize the longevity of the reservoir. However, questions remain regarding optimal insulin concentration (e.g., U-500 or higher), micro-dosing precision, device size, infection risk, leakage prevention, long-term safety, and cost-effectiveness.
Isaacs and Bellini conclude with measured optimism, recognizing both the substantial engineering and economic hurdles ahead and the potential for this technology to represent a meaningful advance in automated, physiologic insulin delivery.
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.
