The Food and Drug Administration on Monday approved Insulet’s Omnipod 5 automated insulin delivery system for people with Type 2 diabetes. Photo by Insulet
The Food and Drug Administration on Monday approved Insulet’s Omnipod 5 automated insulin delivery system for people with Type 2 diabetes.
In 2022, the FDA signed off on the system for Type 1 diabetes for those 2 years and older. Advertisement
The expanded use is for those 18 and older with Type 2 diabetes.
The interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” Dr. Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes.” Advertisement
Insulet, a public company, applauded the approval.
“Today’s announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of Type 2 diabetes,” Insulet Chief Executive Jim Hollingshead said in a news release.
In 2000, Intuit founder John Brooks III, a father whose son, Rob, was diagnosed with Type 1 diabetes at age 3, developed a small pump device worn directly on the body rather than using tubing.
FDA first cleared an Omnipod Insulin Management System in 2003, which didn’t include a continuous monitoring system.
With the new system, a wearable, tubeless product provides up to three days of nonstop insulin delivery without the need to handle a needle. The Omnipod 5 integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks and can be controlled by a compatible smartphone or by a controller.
Insulin options for people with Type 2 diabetes were limited to methods such as injection with a syringe, an insulin pen or an insulin pump. These require patients to self-administer insulin one or more times a day and check blood glucose frequently to achieve the best results.
“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 in the news release. Advertisement
The FDA reviewed data from a clinical study of 289 individuals 18 years and older with Type 2 diabetes for 13 weeks. The study include a range of racial and ethnic backgrounds, ages, education and income levels.
The study showed that volunteers’ blood sugar control improved compared with before the study, and these improvements were seen across all demographic groups. In addition, there were no complications or serious adverse events related to the use of the SmartAdjust technology.
Adverse events were generally mild to moderate, and included hyperglycemia, or high blood sugar; hypoglycemia, or low blood sugar, and skin irritation.
In the United States, 11.6% of Americans, about 38.4 million people, are diagnosed with diabetes, according to the Centers for Disease Control and Prevention. It is a condition in which the body does not make enough or properly use the blood glucose-regulating hormone insulin.
An estimated 97.6 million adults aged 18 years or older had prediabetes in 2021. About 90% top 95% are Type 2, according to the CDC.
In Type 1, the pancreas does not make insulin, because the body’s immune system attacks the islet cells in the pancreas. In Type 2, the pancreas makes less insulin than used to, and your body becomes resistant to insulin. Advertisement
People with Type 2 diabetes may take medications orally or through injection that can help increase insulin secretion or improve insulin sensitivity. A healthy eating plan and physical activity are also needed.
Keeping the numbers in check reduce the need for insulin.
In March, the FDA approved the first over-the-counter continuous glucose monitor. The Dexcom Stelo Glucose Biosensor System is intended for anyone 18 years and older who does not use insulin or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.
The sensor, which is not on the market yet, is paired with a smartphone or smart device for up to 15 days.
