01/28/2022
YASSS!!! 👏👏👏
After much anticipation, we couldn’t be happier to share that the Omnipod® 5 Automated Insulin Delivery (AID) System has officially been cleared by the Food and Drug Administration (FDA) for individuals ages 6 years and older with type 1 diabetes. 🎉
➡️ Omnipod 5 is the first tubeless AID system managed through a compatible smartphone* in the U.S.
➡️ Omnipod 5 is also the only tubeless AID system that integrates with the Dexcom G6® Continuous Glucose Monitor (CGM) System** to automatically adjust insulin delivery and manage glucose levels both day and night, helping to protect against highs and lows***.
Like Omnipod DASH® it continues to be wearable and waterproof†.
We’ll now start a Limited Market Release (LMR), where the system will be used by an already predetermined number of people living with diabetes so that we can incorporate user learnings to deliver a best-in-class product experience for Podders® like you. The great news is, Omnipod 5 is expected to be broadly available shortly after the LMR. We’ll be sure to keep you posted.
Read more about Omnipod 5 and AID here: https://bddy.me/3rhyoul
Don’t wait to experience Pod therapy. Get started on Omnipod DASH® today with a free 30-day trial††: https://bddy.me/3Hb4c9C
Safety info: https://www.omnipod.com/safety
*For a list of compatible smartphone devices visit Omnipod.com/compatibility
**Dexcom G6 is not included.
***Brown S. et al. Diabetes Care. 2021;44:1630-1640. Prospective pivotal trial in 240 participants with T1D aged 6 - 70 yrs [adults/adolescents (n= 128; aged 14-70 yrs) children (n=112; aged 6-13.9 yrs)]. Study included a 14-day standard therapy (ST) phase followed by a 3-month Omnipod 5 hybrid closed-loop phase. Mean overnight time 70-180 mg/dL (6AM-12AM) in adults/adolescents and children, ST vs. 3-mo Omnipod 5: 64.8% vs. 72.5%; 51.5% vs. 64.6%, P