The U.S. Food and Drug Administration has approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.  The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired.  “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.”  The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.  According to the U. S. Centers for Disease Control and Prevention, approximately 5 percent of people with diabetes have type 1 diabetes. Also known as juvenile diabetes, type 1 diabetes is typically diagnosed in children and young adults. Because the pancreas does not make insulin in people with type 1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels). In addition, management of type 1 diabetes includes following a healthy eating plan and physical activity.

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