The FDA just authorized the Insulet Omnipod 5 tubeless insulin delivery system for pediatrics with type 1 diabetes starting as young as age 2. This remarkable moment marks the availability of the world’s first tubeless, wearable insulin delivery system for toddlers.

The Omnipod 5 received FDA approval earlier this year for integration with the Dexcom G6 continuous glucose monitor for adults and kids with type 1, but Insulet also petitioned the FDA to approve this technology for toddlers.

First Tubeless Hybrid Closed Loop System

This first tubeless hybrid closed loop system to receive FDA authorization includes the Omnipod 5, Dexcom G6 CGM and a phone app or controller to manage insulin delivery and monitor glucose levels. The Omnipod holds three days worth of insulin in a pod delivery device without the need for tubing, which can be helpful for active toddlers. No calibration or fingersticks are required.

As a hybrid loop system, the Omnipod and Dexcom are continuously data sharing, so most of the insulin delivery is automated. However, users can make needed adjustments, deliver bolus insulin and easily share data with the smartphone app or Ominpod 5 Controller.

Promising Outcome Data

Based on a study presented at the annual ADA Scientific Session, children with type 1 diabetes experienced a drop in A1C levels from a baseline of 7.4% to 6.9% and they remained at this improved A1C level for one year into the study. Time in range also increased from 57% at baseline to 68% after using the Omnipod 5 for three months. In addition, there were no reported cases of DKA or severe hypoglycemia. For more information on the latest in insulin pumps and CGMs, please join our Virtual Conference with technology expert Diana Issacs. In addition to explaining the technology, she provides an awesome “show and tell”.

Lila Grace Moss wears Omnipod on Runway

On a related note, I would like to give recognition to the courageous Lila Grace Moss, who lives with type 1 diabetes. On a recent runway show, she did not shy away from wearing her Omnipod as she modeled the latest fashion styles with camera’s clicking and hundreds of audience members.

Social media took note and many instagram followers thanked Lila for her bold and brave statement.

Thanks Lila!

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