Omnipod GO Receives FDA Approval for Adults with Type 2 Diabetes

On April 25, 2023, the Food and Drug Administration (FDA) approved the Omnipod GO in the United States. This monumental approval is the first of its kind as the sole basal-only insulin pod pump available for adults 18 years and older with type 2 diabetes (T2D). 

The Omnipod GO is an insulin pump system manufactured by Massachusetts-based Insulet, which has been developing state-of-the-art insulin pumps for people with type 1 diabetes (T1D) for over 20 years. 

This insulin delivery system provides a prefixed rate of continuously dispensed rapid-acting insulin for 72 hours. The pod is tubeless and waterproof and offers up to seven preprogrammed delivery rates of insulin, between 10-40 units per day. 

Additionally, the Omnipod is the only insulin pump that can be worn while swimming and showering, without the need to suspend insulin delivery for users. 

The Omnipod GO is approved for basal insulin only, and its functionality does not allow for bolusing mealtime insulin. It also does not connect with any continuous glucose monitoring systems (CGMs). It is not approved for therapeutic use in those with T1D. 

If users with T2D start insulin therapy on the Omnipod GO but then go on to need more intensive insulin therapy through mealtime bolusing, this can offer a smoother transition to other insulin pump therapies, including the Omnipod DASH or Omnipod 5 system. 

The FDA approval for the Omnipod GO includes the use of the following insulins in the system:

• Insulin aspart (Novolog, Fiasp) 
• Insulin lispro (Humalog, Admelog) 
• Insulin lispro-aabc (Lyumjev) 

People with insulin-dependent T2D have often found themselves lacking insulin pump options, especially for tubeless pumps, which is the Omnipod’s signature feature. Historically, people with T2D either had to stick with multiple daily injections, or use Tandem or Medtronic’s tubed insulin pumps as their only options. This approval will expand what brand and type of insulin pumps people with T2D can use. This seminal approval will finally give people with T2D more choices and flexibility when it comes to their insulin therapy decision-making.

Jim Hollingshead, Ph.D., president and ceo of Insulet, said in a statement, “Omnipod GO was designed to serve more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes. Our goal is to help people with type 2 diabetes successfully shift to insulin therapy with a product that fundamentally changes how they feel about diabetes management.”

He continued, “We’re excited to bring this new solution to market and deliver on our mission to simplify life for people with diabetes.” 

This is a huge step in the advancement of insulin therapy for people living with T2D—people will now have more flexibility in choice and how they manage their diabetes. Hopefully this approval will spur more innovation in the T2D space. 

Omnipod GO is expected to launch in 2024. Adults with T2D can ask their doctor about getting a prescription for the Omnipod GO and can begin therapy right in their doctor’s office, with ongoing supplies of the product available through their pharmacy. 

Insurances may not cover the Omnipod GO, so check your insurance coverage at Insulet’s webpage, or call your health insurance provider to find out eligibility requirements  and what insulin pump supplies they cover. 

If Omnipod GO is not covered by your insurance, you can always file an appeal, use a durable medical equipment coupon, or utilize Insulet’s patient assistance program to help with costs.