Good News for Diabetics: FDA Approves First-Ever 'Artificial Pancreas'
People suffering from type-1 diabetes will no longer need to experience daily pricking just to monitor their blood glucose level. The Food and Drug Administration finally gave its approval to the so-called "artificial pancreas" developed by Medtronic.
"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," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a press release.
The device, dubbed as MiniMed 670G hybrid closed looped system, functions just like a human pancreas. With the help from the Medtonic's most advanced algorithm SmartGuard(TM) HCL, MiniMed 670G could automatically monitor glucose and provide appropriate basal insulin doses when needed.
"With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes - particularly for minimizing glucose variability and maximizing time in the target range," explained Richard M. Bergenstal, M.D., principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, in a statement.
The MiniMed 670G could measure glucose levels every five minutes and automatically administer or withhold insulin based on its readings.
For the system to work, a sensor will be attached to the body to measure glucose levels under the skin. Additionally, an insulin pump will be strapped in the body. The pump will be connected to an infusion patch using catheter, which will deliver the insulin.
The process of monitoring and administration of insulin needs little or no input from the user. However, user may need to request insulin doses to counter carbohydrate consumption.
The device was approved for the treatment of people 14 years of age and older who are suffering from type-1 diabetes.
At present, more than 29 million people in the U.S. are living with diabetes, with about 5 percent of those suffering from type-1 diabetes.