FDA approves three-month at-home trial of artificial pancreas
By Adam Brown
Twitter Summary: FDA approves three-month at home #artificialpancreas trial of DiAs system
On June 6, the FDA approved a three-month, at-home artificial pancreas study testing the University of Virginia (UVA)’s DiAs system. Participants will wear the system (a Dexcom CGM, Roche Accu-Chek insulin pump, and a cell phone with the DiAs algorithm) unsupervised over an 11-14 week period for 24 hours per day at home – this represents the longest such US trial of this type of automated insulin delivery device. The device monitors blood glucose (via CGM) and adjusts insulin automatically at all hours, though participants must still handle mealtime bolusing themselves (what some call a “hybrid closed-loop”). Editor-in-chief Kelly Close wrote a test drive earlier this year on her experience in the UVA overnight closed-loop trial with the DiAs system. This study is not yet recruiting participants, and we plan on following this research closely - please stay tuned for more information in trial watch.
Artificial pancreas systems have progressed enormously in the past two years – studies outside the hospital are the norm rather than the exception now, and it’s only been two years since the first such study was reported at the Advanced Technologies and Treatments for Diabetes conference (ATTD) in 2012. Though there are still many questions related to automating insulin delivery (cost, number of devices to carry, whether an academic group will commercialize the devices, etc.), it’s clear that they have enormous potential to improve the management of type 1 diabetes. –AJW/AB
