This Is What We’ve Been Waiting For!L.D.
Last month, in Nashville, the American Association of Clinical Endocrinologists hosted the 24th Annual Clinical Congress. The AACE is an association of physicians aimed at improving the quality of patient care, with one of their focal points being individuals with diabetes. This year, Edward Damiano opened the event, and had some exciting news to share about the future of diabetes management.
Damiano, whose son was diagnosed with type 1 diabetes when he was 11 months old, is the developer of the bionic pancreas. Having recently gathered results from the initial stages of a small, short term trial, the bioengineer was pleased to share that trial participants who used the device showed less instance of hypoglycemia and displayed greater glycemic control, generally.
The goal of the artificial pancreas is to take some of the management out of having diabetes. Instead, people can rely upon the device to use an algorithm to appropriately dispense glucagon to regulate insulin levels.
The early stages of testing took place in 2014. Trial participants were a group of 19 pre-teens at summer camp. The goal was to glean information about the efficacy of the device as well as its durability. The bionic pancreas, in its current iteration, consists of four parts: a Dexcom monitor, two tandem infusion pumps, and an iPhone accessible algorithm. Future plans include consolidating the four parts into a singular device.
In addition to design modifications, Damiano and his team are planning a yearlong study with nearly 500 participants. At this time, they will evaluate participants’ HbA1c levels and CGM results. Additionally, there are some safety issues that need to be addressed before it can be considered for FDA approval. Ensuring accurate dosing, preventing crashing and glitches, and cybersecurity are all issues that currently stand in the way of the bionic pancreas making it on the market, but Damiano feels confident with the FDA’s continued cooperation and the help of outside technical security experts, the device could be three years away from release.
Watch the video below to hear Edward Damiamo talk about the exciting developments he and his team have made!
Want to be part of the push to get the FDA to make the review of the bionic pancreas a priority?