乌鸦传媒

The FDA cleared the for adults with type 2 diabetes, the agency announced on Monday.

An interoperable automated glycemic controller, Insulet's SmartAdjust technology is software that automatically adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.

Used in Insulet's tubeless Omnipod 5 Automated Insulin Delivery (AID) System, the technology eliminates the need for multiple daily injections by automatically adjusting insulin delivery every 5 minutes.

"The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management," said Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, in a statement. "Automated insulin dosing technology has previously been available only for people with type 1 diabetes. Today's action helps expand access to this important diabetes management tool to millions of adults living in the U.S. with type 2 diabetes."

The Omnipod 5 is now the only AID system that can be prescribed for both type 1 and type 2 diabetes management.

"Today's clearance provides a new option that can automate many of these manual tasks, potentially reducing the burden of living with this chronic disease," the FDA said.

This could impact the estimated 6 million people in the U.S. living with insulin-dependent type 2 diabetes and the 2.5 million of whom use multiple daily injections, . Only around a quarter of those with type 2 diabetes on insulin achieve an HbA1c level of 7% or less and half have a level over 8%.

Insulin therapy options before this for type 2 diabetes were limited to self-administration with an injection with a syringe, an insulin pen, or an insulin pump, all of which require patients to check blood glucose frequently to achieve the best results.

Supporting the clearance were findings from the 289-participant SECURE-T2D study. Omnipod 5 users had a 0.8-percentage point lower HbA1c compared with baseline (7.4% vs 8.2%, P<0.001). This reduction was 2.1% for those with a prior HbA1c of 9% or higher.

Prior to study entry, all were on a stable insulin regimen without prior AID use. During the 13-week trial, participants used the Omnipod 5 system in conjunction with a Dexcom G6 continuous glucose monitor.

Reductions in hyperglycemia, total daily insulin dose, and improvements in diabetes distress were also reported. Users had a 20% improvement in time in range -- increasing by 4.8 hours per day -- without increasing time in hypoglycemia.

Adverse events during the study were generally mild to moderate and included hyperglycemia, hypoglycemia, and skin irritation. There were no complications or serious adverse events related to the technology.

"I've seen first-hand how difficult it is for patients to reach their targets with injections," trial investigator Anne Peters, MD, of the University of Southern California Westside Center for Diabetes in Beverly Hills, said in a company release. "Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life."

"I believe this innovative technology has the potential to transform the lives of insulin-requiring people with type 2 diabetes," added Peters.

Insulet said the Omnipod 5 AID System is widely covered by many insurance plans including Medicare Part D.

Comment