Home Diabetes Care Omnipod GO Receives FDA Approval for Adults with Type 2 Diabetes

Omnipod GO Receives FDA Approval for Adults with Type 2 Diabetes

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 US. This monumental approval is the primary of its kind as the only real 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 individuals with type 1 diabetes (T1D) for over 20 years. 

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

Moreover, the Omnipod is the one insulin pump that might be worn while swimming and showering, without the necessity to suspend insulin delivery for users. 

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

If users with T2D start insulin therapy on the Omnipod GO but then go on to want more intensive insulin therapy through mealtime bolusing, this could 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 usage of the next insulins within the system:

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

Individuals with insulin-dependent T2D have often found themselves lacking insulin pump options, especially for tubeless pumps, which is the Omnipod’s signature feature. Historically, individuals with T2D either needed to follow multiple each day injections, or use Tandem or Medtronic’s tubed insulin pumps as their only options. This approval will expand what brand and variety of insulin pumps individuals with T2D can use. This seminal approval will finally give individuals with T2D more selections and suppleness in relation to their insulin therapy decision-making.

Jim Hollingshead, Ph.D., president and ceo of Insulet, said in a press release, “Omnipod GO was designed to serve greater than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes. Our goal is to assist individuals 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 recent solution to market and deliver on our mission to simplify life for individuals with diabetes.” 

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

Omnipod GO is anticipated to launch in 2024. Adults with T2D can ask their doctor about getting a prescription for the Omnipod GO and may begin therapy right of 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 medical health insurance provider to seek out out eligibility requirements  and what insulin pump supplies they cover. 

If Omnipod GO just isn’t covered by your insurance, you’ll be able to all the time file an appeal, use a durable medical equipment coupon, or utilize Insulet’s patient assistance program to assist with costs.  

This content mentions Insulet, an energetic partner of Beyond Type 1.

News coverage by the Beyond Type 1 team is operated independently from any content partnerships. Beyond Type 1 maintains full editorial control of all content published on our platforms.


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