FDA Clears the Omnipod 5 System for Type 2 Diabetes

The US Food and Drug Administration (FDA) cleared the Omnipod 5 for use by people aged 18 and older with type 2 diabetes, a first for any automated insulin delivery (AID) system. 

The Omnipod 5 system comprises a tubeless plastic “pod” worn on the body that automatically delivers insulin based on data communicated to it wirelessly from a compatible continuous glucose monitor (CGM), also worn on the body. Users still need to interact with the system for mealtime insulin dosing and in some cases to adjust for exercise. Previously, the Omnipod 5 was approved only for people with type 1 diabetes aged 2 years and up. Other AIDs are still only approved for people with type 1 diabetes. 

The new indication was based on data from the real-world multicenter SECURE-T2D trial of a racially diverse group of 305 adults with type 2 diabetes who were using insulin. About half were also using a glucagon-like peptide-1 receptor agonist (GLP-1RA). Use of the Omnipod 5 resulted in a significant A1c reduction from 8.2% at baseline to 7.4% at 13 weeks (P<0.001), with no differences in outcome by GLP-1RA use. 

Study investigator Viral Shah, MD, told Medscape Medical News that use of AIDs in people with type 2 diabetes who require insulin treatment makes sense, especially for those who require premeal as well as basal insulin. “Type 2 diabetes is a progressive disease, and many with longstanding disease don’t have enough beta cells…So I don’t see a difference between people with type 1 diabetes and those with type 2 diabetes who are on multiple daily injections because they both do not have enough insulin production.”

Indeed, Marie E. McDonnell, MD, director of the diabetes program at Brigham Health, Boston, Massachusetts, noted that “there are patients with advanced type 2 diabetes who don’t tolerate GLP-1 receptor agonists. That’s not an uncommon scenario, and insulin does really become the drug of choice for many of them.” 

McDonnell, who has no financial ties to Insulet, also pointed out that there are people misdiagnosed with type 2 who actually have autoimmune (type 1) diabetes, as well as other types that often are lumped under the heading of type 2 diabetes, including those with monogenic diabetes, pancreatic disease, or post-transplant diabetes. “It’s actually quite complex. This new indication makes a lot of sense just in terms of not having to go through hoops to justify insulin technology that is safer and easier for people with insulin-deficient type 2, or without type 1 but with other forms of insulin deficiency.” 

Both Shah and McDonnell have prescribed the Omnipod 5 off-label to some of their patients with type 2 and other types of diabetes. Private insurance will typically cover it, although prior authorization is often required. Medicare Part B requires certification of C-peptide deficiency for coverage of insulin pumps. 

Shah, who is professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at Indiana University, Indianapolis, said: “We haven’t encountered any big issues with the insurance companies approving pumps and AID systems in type 2 but at the same time, having that official label helps.”

McConnell said that the Omnipod 5 is the most common AID she prescribes for her patients with type 2 diabetes, since it’s the only one covered under pharmacy rather than as durable medical equipment (as are other pumps with tubing). “Because it goes through as a pharmacy benefit it is an easier transition for most people with type 2 diabetes who have been traditionally less engaged with technology and equipment suppliers,” she told Medscape Medical News. 

This new indication is likely to increase uptake of the Omnipod 5 into primary care, where the vast majority of people with type 2 diabetes are managed, Shah noted. “This opens up an avenue for primary care to manage more diabetes, so that people don’t have to wait in line a long time to see an endocrinologist…I’m very optimistic in the way that the diabetes technology field is moving is helping our primary care practitioners to really optimize diabetes care by themselves.”

But McConnell worries about the capacity in primary care for both the technical and administrative aspects of the system’s use. The diabetes program she runs at Brigham and Women’s has a team that works full-time dealing with the paperwork involved in diabetes device insurance coverage, an advantage that most nonspecialist practices don’t have. 

And, she notes, use of Omnipod 5 requires proper adjustment of the settings and patient education, particularly around meal dosing. “I’ve seen patients whose primary care physicians have sent the Omnipod prescription to the pharmacy without any real knowledge of the system or next step plan. It was a problem. You really need guidance, especially patients who have never done premeal insulin dosing. I hope that the company will do the right thing by ensuring that the patients and their providers have sufficient product support.”

An Insulet spokesperson told Medscape Medical News: “We are continuing to expand our education, training, and support for [healthcare professionals], including primary care practices. Our team will continue to assist with prior authorizations when needed, as we do today.”

Shah has received honoraria from Dexcom, Insulet, Tandem Diabetes Care, Embecta, Sanofi, Novo Nordisk, Genomelink, and LumosFit for consulting, speaking, or advising. McDonnell has conducted research for Dexcom but did not take salary from it. 

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker.