In recent weeks the US Food and Drugs Administration (FDA) has approved Beta Bionics iLet Bionic Pancreas for use by people over 6 years of age living with type 1 diabetes in the US.

When paired with the Dexcom G6 continuous glucose monitor, the pocket-sized device can deliver tailored insulin doses every five minutes, based on calculations of current and past glucose levels and the body’s reaction to previous insulin deliveries. Where a standard insulin pump must be adjusted manually based on what the user estimates the carbohydrate count of their meal to be, the bionic pancreas adjusts insulin levels internally through communication with the Dexcom G6. This allows blood glucose levels to be regulated with minimal input from the user. At set up, all that is needed is for the wearer to enter their weight and following that the only interaction needed is to input an estimation of whether a meal is low, medium, or high in carbohydrates.

In trials the iLET Bionic Pancreas was found to be effective in keeping blood glucose levels in target range for 11% longer than when participants were using their usual diabetes technology. The device was also found to reduce HbA1c levels across all the participant groups, regardless of their ethnic background, education, or income level. 

Beta Bionics says the device provides more flexibility in type 1 diabetes management and takes away the constant measuring of blood glucose levels and calculations for insulin doses that so many living with type 1 diabetes have to do each day. 

The approval by the FDA in the US is a huge milestone in a two-decade journey for Ed Damiano who was inspired to develop the system after his son was diagnosed with diabetes when he was just 11 months old.

“This milestone is particularly poignant to me as the news of FDA clearance coincided with the 24th birthday of my son, David, who developed type 1 diabetes as an infant, just over 23 years ago,” Damiano, founder and executive chairman at Beta Bionics, told Boston University’s The Brink.

The iLET Bionic Pancreas is currently only available in the US.