Diabetes: FDA provides guidance on artificial pancreas

On Thursday the Food and Drug Administration issued draft guidelines for researchers and manufacturers working to develop and build an artificial pancreas to help patients with Type 1 diabetes control their blood sugar.

About 3 million Americans have Type 1 diabetes, which develops when cells in the pancreas stop producing enough insulin to control blood sugar. Patients with the disease must monitor their blood glucose aggressively. If it goes too high, they have to carefully calculate how much insulin they need to bring it in line -- and then get an injection. If a person with Type 1 diabetes’ blood sugar drops too low, he or she could require a dose of another hormone, glucagon, to raise it back up.

The unrelenting and error-prone process can be exhausting, so patient advocacy groups such as the Juvenile Diabetes Research Foundation have been pushing the development of an artificial pancreas that would tightly control blood sugar levels much as the actual organ: monitoring glucose levels continually and automatically delivering the right dose of insulin, through a pump, into the body. The system would work by connecting the monitoring system to a computer, which in turn would calculate the correct insulin dose and send a signal to the insulin pump to deliver the needed hormones.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the agency’s guidance would “provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients” while also assuring that the machines would be safe and effective.


In a separate statement, officials at the Juvenile Diabetes Research Foundation said they were encouraged by the FDA draft, noting that “artificial pancreas technologies have the potential to be the most revolutionary advance in treating Type 1 diabetes since the discovery of insulin.”

When devices are likely to be available to patients in the U.S. remains unclear.

The FDA’s website shows what an artificial pancreas might look like (scroll down for illustration.)

Visit this FDA webpage for more information on the artifical pancreas, including links to the new guidance.

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