The US Food and Drug Administration yesterday issued new guidelines that may speed the development and approval of an artificial pancreas to treat type 1 diabetes in the United States, according to a news report by Reuters.
The new guidelines give researchers and medical device makers clear instructions for obtaining approval on clinical trials that meet the FDA’s strict guidelines for proving safety and effectiveness in the real world. This guidance reflects months of negotiations among the FDA, patient groups, device manufacturers and researchers.
According to the Reuters report, the guidance provides maximum flexibility for manufacturers to innovate in the development of the artificial pancreas, also known as a low glucose suspend device.
The artificial pancreas could help automate blood glucose testing and treatment for the 3 million Americans living with type 1 diabetes, a disorder of the body’s immune system in which it attacks and destroys cells in the pancreas that make insulin.
The device is worn outside the body and would regularly monitor glucose and track blood sugar with a sensor. It would automatically pump the correct dose of insulin when if there’s too much glucose in the blood and automatically shut off the pump when blood glucose levels get dangerously low.
High blood sugar causes complications like kidney failure, blindness and heart disease. Low blood sugar can cause hypoglycemia, a potentially deadly condition if not treated properly.
Currently, people with type 1 diabetes must monitor their blood sugar levels and take insulin multiple times a day. To do this, they collect blood with a finger prick and check the droplet on a test strip in their blood glucose meter.
Despite doing all these things, some people with type 1 diabetes cannot always maintain their blood sugar levels within their target zone, according to the Juvenile Diabetes Research Foundation. Changes in a person’s activity level, eating habits, and growing body may make it difficult to maintain safe glucose levels.
Source: Reuters, Juvenile Diabetes Research Foundation
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