August 27, 2024 – People with Type 2 diabetes can now wear a tool that robotically delivers insulin doses after advanced surgery permit from the FDA on Monday.
Called Omnipod 5It is the primary approved for adults with type 2 diabetes and might be worn repeatedly for as much as 3 days and works at the side of a continuous glucose monitor.
Taking insulin to regulate blood sugar levels is among the many treatment options for nearly one in 10 U.S. adults who've type 2 diabetes, although many individuals manage the condition through lifestyle changes corresponding to weight-reduction plan and exercise or by taking other medications get the grip.
Undertreated type 2 diabetes can result in serious complications corresponding to heart attacks, vision and kidney problems, or hyperosmolar hyperglycemic state (HHS), by which very high blood sugar levels cause mental changes corresponding to confusion or hallucinations and possibly lack of consciousness.
People with type 2 diabetes can currently get insulin using a syringe, pen or pump, with frequent blood sugar checks required.
Automated insulin delivery (AID) systems have previously only been approved for individuals with type 1 diabetes, although some doctors have prescribed them off-label to type 2 diabetes patients. Type 1 diabetes is taken into account an autoimmune disease and occurs much less continuously than type 2 diabetes. In type 1, the body stops producing insulin. In type 2, the body cannot use insulin well.
“I have seen firsthand how difficult it is for patients to achieve their goals with injections,” Anne L. Peters, MD, director of the University of Southern California’s Westside Center for Diabetes, said in an announcement Press release. “Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay within insulin range, resulting in remarkable improvements in clinical outcomes and overall quality of life. I believe this innovative technology has the potential to transform the lives of people with type 2 diabetes who require insulin.”
While the newly approved automated system represents an easier alternative to self-administered options, it still requires necessary setup steps and patient education.
“I have seen patients whose primary care physicians sent the Omnipod prescription to the pharmacy without any real knowledge of the system or the next step plan. … They really need guidance, especially patients who have never done pre-meal insulin dosing,” said Marie E. McDonnell, MD, director of the diabetes program at Brigham and Women's Hospital in Boston.
In its regulatory announcement, the FDA cited data from a study of 289 adults with type 2 diabetes who used Omnipod 5 for 13 weeks and had improved blood glucose control without complications or serious hostile events, although some people within the study had hyperglycemia (high Blood sugar levels) suffered from blood sugar), hypoglycemia (low blood sugar) and skin irritation.
The device's manufacturer, Insulet, said in a news release that the device is already widely covered by many insurance policy, including Medicare Part D.
Miriam E. Tucker of Medscape Medical News contributed to this text.