The U.S. Food and Drug Administration (FDA) approved the world’s first artificial pancreas — the MiniMed 670G hybrid closed looped system. The medical device is designed to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people with type 1 diabetes (14 years of age and older).
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.
In clinical trials, the 670G system kept people with T1D within their desired blood sugar range 72 percent of the time, vs. 67 percent without the system. At night, the most dangerous time for blood sugar highs and lows, the difference was even more pronounced, 75 percent in range vs. 67 percent without the technology. Overall glucose control, as measured by HbA1c levels, improved from 7.4% at baseline to 6.9% at study end.
“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.”
In the past decade, JDRF has invested more than $116 million in diverse artificial pancreas research projects, with the goal of aiding the development of multiple, reliable treatment choices for people living with T1D, as well as helping people have broad access to the resulting products.
“This announcement is a historic achievement for JDRF. After years of laying the ground work, this breakthrough is a testament to the reason JDRF exists – to help people with T1D lead better, safer, healthier lives while we continue on the path to cure and prevent the disease altogether,” said JDRF CEO Derek Rapp. “It marks a major accomplishment in one of our highest priority research areas.”
“As part of our commitment to improving diabetes care, the FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with type 1 diabetes as quickly as possible,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA’s evaluation and subsequent approval of novel devices that can make a difference for patients.”
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.
The device is manufactured by Medtronic MiniMed (NYSE: MDT).
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November 12, 2012
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