The Food and Drug Administration (FDA) has cleared the Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for patients 2 years of age and older with type 1 diabetes. Previously, Omnipod 5 was approved for use in individuals 6 years of age and older.

The Omnipod 5 System consists of a tubeless, waterproof, wearable Pod, the Dexcom G6 Continuous Glucose Monitoring (CGM) system (sold separately), and the Omnipod 5 mobile app.

The Pod delivers insulin using built-in SmartAdjust technology, which receives a Dexcom CGM value and trend every 5 minutes and predicts where glucose will be in the next 60 minutes. The system then automatically adjusts or pauses insulin delivery using the user’s customized glucose target. Individuals can place the Pod on the arm, leg, back, abdomen, or buttocks. 

The clearance was based on data from a single-arm multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04476472) that evaluated the Omnipod 5 system in 80 children aged 2 to 5.9 years with type 1 diabetes. Participants used Omnipod 5 for 13 weeks following 14 days of baseline data collection using their standard therapy.

Findings showed Omnipod 5 significantly increased time in range (70–180mg/dL) by 10.9%, or 2.6 hours/day (P <.0001) and reduced time in hypoglycemia (<70mg/dL) by a median of 0.27% (P =.0204). A decrease in HbA1c of 0.55% (6.0mmol/mol) (P <.0001) was observed at the end of the study. Parents and caregivers of study participants also reported improved sleep quality as assessed by the Pittsburgh Sleep Quality Index. 

Omnipod 5 is available via prescription through the pharmacy. The Omnipod 5 mobile app is currently compatible with the Samsung Galaxy S10 (4G); the Company is working on iOS compatibility. The system can also be controlled with the wireless Omnipod 5 Controller, which is provided at no additional cost with the first prescription.

“We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements as well,” said Dr Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.”

References

  1. Insulet announces FDA clearance of Omnipod® 5 for children aged two years and older with type 1 diabetes. News release. Insulet Corporation. Accessed August 22, 2022. https://www.businesswire.com/news/home/20220822005158/en/Insulet-Announces-FDA-Clearance-of-Omnipod%C2%AE-5-for-Children-Aged-Two-Years-and-Older-with-Type-1-Diabetes
  2. Sherr JL, Bode BQ, Forlenza GP, et al. Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm multicenter clinical trial. Diabetes Care. Published online July 26, 2022. doi:10.2337/dc21-2359