Insulet’s Omnipod 5 Outperforms Standard Insulin Pump Therapy

Insulet presented results from its first randomized controlled trial of the Omnipod 5 automated insulin delivery (AID) system. It’s also the first time Omnipod 5 has been evaluated by international participants.
 
The trial results from 194 patients were shared at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). Omnipod 5 was compared to insulin pump therapy with continuous glucose monitoring (CGM) in adults with Type 1 diabetes in the U.S. and France.
 
The control group used their usual insulin pump with a Dexcom G6 CGM, and the intervention group used Omnipod 5 with Dexcom G6. Data showed that using Omnipod 5 led to 17.5% improvement in time in range (TIR), lowered HbA1c, decreased percentage of time in hypoglycemia, and lessened mean glucose in those with elevated HbA1c levels.
 
All primary and secondary trial endpoints were met, and there were no events of severe hypoglycemia or DKA with Omnipod 5.
 
Insulet also presented patient-reported results for psychosocial measures: diabetes distress, hypoglycemia confidence, and diabetes-related quality of life. Using Omnipod 5, according to the company, showed meaningful improvements in these three measures.
 
The company said this trial data shows superiority of Omnipod 5 compared to standard pump therapy with CGM and indicates it should be offered as first-line therapy for adults with type 1 diabetes.
 
“Since Omnipod 5’s first commercial launch in the United States, we have been working diligently to expand into new markets and improve access to this life-changing technology,” said Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet’s senior VP and medical director. “By gathering evidence from international participants through a randomized controlled trial, we have demonstrated the true benefit of using our tubeless, disposable automated insulin delivery (AID) system to manage type 1 diabetes over alternative forms of therapy and illustrated the superiority of Omnipod 5 compared to standard pump therapy with CGM for people with type 1 diabetes.”
 
Last month, the Omnipod 5 AID gained CE mark clearance to add compatibility of Abbott’s FreeStyle Libre 2 Plus CGM sensor for type 1 diabetes patients aged two years and older.