A wearable, pocket-sized, automated insulin delivery device has been approved by the US Food and Drug Administration (FDA). The company calls is the iLet Bionic Pancreas but it's obviously not bionic any more than String Theory is a scientific theory. However, it is now available in this universe for the almost two million Americans with type 1 diabetes.

The bionic pancreas combines an insulin infusion pump with algorithm-controlled dosing decision software. Work on it began in the lab of Boston University Professor Ed Damiano when his son was diagnosed with type 1 diabetes at age 11 months. In people with type 1 diabetes, the pancreas doesn’t produce enough insulin—an essential hormone for converting and storing sugars. The chronic condition carries a host of complications.

It uses a Bluetooth glucose monitor so the iLet can deliver tailored insulin doses every five minutes, based on calculations of current and past glucose levels and the body’s reaction to past insulin deliveries. It can be clipped on a bra strap or thrown in a pocket and the ability to constantly measure glucose levels and calculate, with help from their doctor, their correct insulin dose means it is convenient.

Photo courtesy of Beta Bionics.

Users of the iLet just need to enter their weight to get started—the system will then use continuous learning to do the rest, regulating blood glucose levels with minimal input. A paper the inventors wrote showed the iLet helped adults and children maintain healthier blood glucose levels, outperforming existing standard-of-care methods—a significant step on its path to FDA clearance.

It has been cleared for people aged six years and older with type 1 diabetes.