(HealthDay News) — On Monday, the U.S. Food and Drug Administration approved the Insulet Omnipod 5 insulin delivery system for patients with type 2 diabetes. It is the first such system for use by people with the more prevalent form of the disease.
The FDA first signed off on the system, which automatically adjusts insulin delivery as needed, for type 1 diabetes in 2022. In approving Insulet’s Omnipod 5 insulin delivery system for type 2 diabetes patients, the FDA said the clearance “provides a new option that can automate many of these manual tasks [of tracking and managing blood glucose levels], potentially reducing the burden of living with this chronic disease.”
“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” Michelle Tarver, M.D., acting director of the FDA Center for Devices and Radiological Health, said in a news release announcing the expanded use. “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.”
Insulet applauded the expanded approval.
“Today’s announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes,” Insulet CEO Jim Hollingshead said in a company news release.
With the new system, the wearable product provides up to three days of nonstop insulin delivery without the need to handle a needle. The Omnipod 5 works in concert with a continuous glucose monitor to manage blood glucose with no daily injections and no finger pricks.
In approving the expanded use, the FDA reviewed data from a clinical study of 289 individuals 18 years and older with type 2 diabetes for 13 weeks. Volunteers’ blood glucose control improved, and these improvements were seen across all demographic groups. Adverse events were generally mild to moderate and included hyperglycemia, hypoglycemia, and skin irritation.
What is type 2 diabetes?
Type 2 diabetes is a chronic condition characterized by the body’s inability to produce enough insulin or use it effectively. Insulin is a hormone produced by the pancreas that helps regulate blood sugar levels. In type 2 diabetes, the body becomes resistant to insulin, leading to high blood sugar levels.
While type 2 diabetes can affect anyone, it disproportionately impacts certain communities, including Black individuals. This disparity is largely due to a complex interplay of genetic, environmental, and socioeconomic factors.
How does type 2 diabetes affect the Black community?
One significant factor contributing to the higher prevalence of type 2 diabetes among Black individuals is genetic predisposition. Certain genes have been identified that increase the risk of developing the condition in this population. Additionally, environmental factors play a crucial role. Black individuals are more likely to live in neighborhoods with limited access to healthy foods and safe spaces for physical activity. These factors can contribute to unhealthy dietary habits and sedentary lifestyles, both of which are risk factors for type 2 diabetes.
Socioeconomic disparities also exacerbate the burden of type 2 diabetes in the Black community. Black individuals are more likely to face poverty, unemployment, and discrimination, which can limit access to health care and healthy resources. These disparities can lead to delayed diagnosis and inadequate management of the condition.
The impact of type 2 diabetes on Black individuals is far-reaching. The condition can lead to a range of serious health complications, including heart disease, stroke, kidney disease, and blindness. These complications can have devastating consequences for individuals and their families.
Addressing the disproportionate burden of type 2 diabetes in the Black community requires a multifaceted approach. This includes increasing access to healthy foods and safe spaces for physical activity, improving health are access and affordability, and addressing systemic inequities that contribute to health disparities. By taking these steps, we can help to reduce the prevalence of type 2 diabetes among Black individuals and improve their overall health and well-being.