FDA Clears Wearable Insulin Delivery Device Omnipod GO for Type-2 Diabetes


Insulet plans to commercialize the new product in the United States starting in 2024.

Insulet has received clearance from the FDA for its new insulin delivery device Omnipod GO, according to a press release from the company.1 The product, designed to treat type 2 diabetes in individuals aged 18 or older, was created for those who would typically take daily injections of long-acting insulin.

The wearable device features a tubeless, waterproof pod that’s offered in 7 pre-programmed daily rates ranging from 10 to 40 units per day. It provides a fixed rate of continuous rapid-acting insulin for 72 hours and operates without the need for a handheld device to control the pod.

Omnipod GO was developed as an alternative to daily injections for people with type 2 diabetes who are early in their treatment journey, according to the press release.

Starting insulin therapy is an important decision that people with diabetes must make, but its initiation is often delayed due to several different factors. One of the most common is insulin distress, which is an emotional response from the patient to the suggested use of insulin.2 Reasons for this response include injection phobia, permanence of therapy, restricted lifestyle and fear of hypoglycemia.

Although insulin therapy has proven to be efficacious, less than 50% of patients for whom it is recommended end up initiating treatment.3 Failing to begin insulin in a timely manner can have many negative health consequences, such as poor glycemic control, reduced life expectancy and compromised quality of life.4

“Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to insulin therapy to treat their type 2 diabetes,” said Jim Hollingshead, president and chief executive officer at Insulet. “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.”

Clinician-related challenges also present barriers to insulin therapy in diabetes treatment. Those who treat patients with the disease have cited a lack of experience initiating insulin and time to educate patients as reasons for clinical inertia, which involves recognition of a problem but failure to act.5

The convenience of Omnipod GO aims to help primary care physicians prescribe, train and get a patient started with insulin therapy. Clinicians will be able to initiate Omnipod Go in their office and patients can access further supplies through a pharmacy.

Omnipod GO has been cleared for use with the following U-100 insulins: insulin aspart (NovoLog, Fiasp), insulin lispro injection (Humalog, Admelog) and insulin lispro-aabc (Lyumjev). Insulet says it plans to commercialize the new product in the United States starting in 2024.

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

1. Insulet Announces FDA Clearance of Omnipod GO, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes. News Release. Insulet. April 25, 2023. Accessed April 25, 2023. https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-Clearance-of-Omnipod-GO-a-First-of-its-Kind-Basal-Only-Insulin-Pod-Further-Simplifying-Life-for-People-with-Type-2-Diabetes/default.aspx
2. Yen FS, Hwu CM. Challenges of optimizing insulin therapy for patients with type 2 diabetes mellitus. Journal of Diabetes Investigation. 2021;12(9):1523-1525. doi:10.1111/jdi.13609
3. Sorli C, Heile MK. Identifying and meeting the challenges of insulin therapy in type 2 diabetes. Journal of Multidisciplinary Healthcare. 2014;7:267-282. doi:10.2147/JMDH.S64084
4. Kim SG, Kim NH, Ku BJ, et al. Delay of insulin initiation in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycemic agents (analysis of patient- and physician-related factors): A prospective observational DIPP-FACTOR study in Korea. Journal of Diabetes Investigation. 2017;8(3):346-353. doi:10.1111/jdi.12581
5. Cuddihy RM, Philis-Tsimikas A, Nazeri A. Type 2 diabetes care and insulin intensification: is a more multidisciplinary approach needed? Results from the MODIFY survey. The Diabetes Educator. 2011;37(1):111-123. doi:10.1177/0145721710388426
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