United States federal health authorities have finally given the green light for the first automated insulin delivery system for patients with type 1 diabetes.
On Wednesday, the U.S. Food and Drug Administration (FDA) announced its approval of the so-called artificial pancreas that could automatically regulate the blood sugar levels of patients with type 1 diabetes, an autoimmune disease characterized by the body's immune system destroying the insulin-producing cells in the pancreas.
The device MiniMed 670G monitors blood sugar levels and then delivers background, or basal, insulin doses. It will also shut down insulin delivery once glucose levels drop too low.
MiniMed 670G is manufactured by Medtronic, the world's largest medical technology development company with operational headquarters in Minnesota.
The surprise approval, which was not expected until sometime next year, means that type 1 diabetes patients will soon be able to hook up to the device and skip regular finger pricks to monitor their blood sugar.
"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, director of FDA's Office of In Vitro Diagnostics and Radiological Health.
Individuals who have type 1 diabetes need to replace the insulin that their body does not produce through daily injections or by using a small catheter connected to an insulin pump. Knowing the right amount of insulin needed though is crucial. Too much or too little insulin can have potentially deadly consequences.
This is how MiniMed 670G offers convenience. The device constantly measures the person's blood sugar levels. It uses a computer algorithm that determines if the person's blood sugar level is too high or too low. If it is too high, it will give the correct insulin though a small catheter hooked into the skin and connected to an insulin pump.
The device, however, is not a fully automated artificial pancreas so diabetes patients who will use it still need to figure out the amount of carbohydrates in their food and input this into the system. The insulin delivery site also has to be changed every three days.
The device, which is approved for use by type 1 diabetes patients who are at least 14 years old will be available by Spring next year, Medtronic said. The company is already conducting clinical trials in younger patients.