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For the estimated one million Americans who take multiple daily insulin injections to manage type 2 diabetes, daily care is a manual process of constant calculation, finger pricks, and injections. On August 26, 2024, the United States Food and Drug Administration cleared Insulet Corporation's Omnipod 5 Automated Insulin Delivery System for adults with type 2 diabetes. This clearance makes the system the first tubeless automated insulin delivery technology available to this patient group, who previously relied on manual injections or traditional insulin pumps.
The clearance expands the label of a system that was previously restricted to patients with type 1 diabetes. The wearable, tubeless pod holds up to 200 units of fast-acting insulin and integrates with a continuous glucose monitor to adjust insulin delivery every five minutes. By automating basal insulin delivery, the system reduces the daily calculation burden on patients, helping stabilize blood glucose levels throughout the day and night.
For clinicians and payers, this regulatory decision addresses a long-standing disparity in diabetes technology access. While automated insulin delivery has become the standard of care for type 1 diabetes, type 2 patients requiring intensive insulin therapy have historically faced strict insurance barriers. Payers have typically required documentation of frequent, severe hypoglycemia or a type 1 diagnosis before authorizing automated systems. The FDA clearance provides the clinical and regulatory foundation required to change these coverage policies.
Clinical evidence from the SECURE-T2D trial
The regulatory clearance was based on data from the SECURE-T2D clinical study, a prospective, multicenter clinical trial that evaluated the system in 305 adults. Participants had type 2 diabetes, had used insulin therapy for at least three months, and had an average baseline HbA1c of 8.2 percent. The trial cohort included individuals from various racial, ethnic, and socioeconomic backgrounds to reflect the demographic distribution of type 2 diabetes in the United States.
The trial results showed measurable improvements in glycemic control. Participants experienced a mean decrease in HbA1c of 0.8 percentage points, lowering the cohort average to 7.4 percent. Patients who entered the trial with a baseline HbA1c of 9.0 percent or higher experienced a mean decrease of 1.5 percentage points.
The study also measured time in range, defined as the percentage of time glucose levels remained between 70 and 180 milligrams per deciliter. Participants experienced an average increase in time in range of 20 percentage points, equivalent to an additional 4.8 hours per day. This improvement occurred alongside a decrease in hyperglycemic exposure, without an increase in hypoglycemic episodes. Only one severe hypoglycemic event was reported during the trial, and it occurred while the system was operating in manual mode. The trial data indicate that the automated algorithm safely adjusted insulin delivery across a patient population with varying degrees of insulin sensitivity.
Market expansion and clinical integration
The market for this technology is distinct from the type 1 diabetes market. Of the approximately 30 million people in the United States diagnosed with type 2 diabetes, about 2.5 million require insulin therapy. Within this group, approximately 1 million people use intensive insulin therapy, meaning they require multiple daily injections or an insulin pump. This latter group represents the primary target market for the newly cleared indication.
Insulet plans to distribute the system for type 2 diabetes through its established retail and specialty pharmacy channels rather than the durable medical equipment channel. The pharmacy-benefit model is designed to simplify the prescribing process for primary care physicians, who manage the majority of type 2 diabetes patients in the United States. Historically, primary care clinics have faced administrative barriers when prescribing advanced diabetes technology through the durable medical equipment channel, which often requires extensive documentation and prior authorization processes.
The integration of automated systems into primary care clinics requires a shift in clinical workflows. While endocrinologists are accustomed to managing automated insulin systems, primary care providers often have less experience with these platforms. To encourage adoption, the technology must be straightforward to initiate and manage. The system integrates with existing continuous glucose monitors, including the Dexcom G6 and G7, as well as the Abbott FreeStyle Libre 2 Plus, allowing patients to use familiar sensing technologies.
Future outlook for automated systems
The introduction of automated insulin delivery for type 2 diabetes arrives at a time when the broader metabolic health market is changing. The use of glucagon-like peptide-1 (GLP-1) receptor agonists has altered early-stage treatment for type 2 diabetes, often delaying the transition to insulin therapy. However, for patients with advanced disease and progressive beta-cell dysfunction, insulin remains a biological necessity.
The SECURE-T2D trial included patients who were concurrently taking GLP-1 medications, demonstrating that the automated system can be used safely alongside these therapies. As combination therapies become more common, clinical protocols will need to guide physicians on how to balance automated insulin delivery with GLP-1 regimens.
The rate of adoption among primary care providers will serve as a key metric for the commercial success of the technology. If Insulet can successfully leverage its pharmacy distribution model and secure favorable coverage decisions from Medicare and major commercial insurers, automated insulin delivery could transition from a specialized tool for type 1 diabetes to a standard management option for intensive type 2 diabetes care.
Source: Insulet Corporation
