Touchscreen insulin pump maker Tandem Diabetes announced a new clinical trial for an insulin pump with a predictive low glucose suspend (PLGS) algorithm. Another step on the road to an artificial pancreas, PLGS allows Tandem to automatically suspend insulin delivery when it predicts low glucose and resume it when glucose starts to rise again.
“The start of this pivotal trial is another important step forward in our automated insulin delivery programs, and comes on the heels of very encouraging feasibility study data,” Kim Blickenstaff, president and CEO of Tandem Diabetes Care, said in a statement. “We remain on track to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA in early 2018. Subject to FDA approval, we are preparing to launch in summer of 2018, and plan to make this new feature accessible for existing t:slim X2 customers via a remote software update using our Tandem Device Updater.”
The pivotal trial, which is part of the data Tandem needs to collect for its FDA submission, will include 90 participants at 6 research centers around the country. Participants will be randomized into two groups that will each be monitored for three weeks as they manage their insulin at home. Both groups will use a t:slim X2 Pump from Tandem and a Dexcom G5 continuous glucose monitor, but one will have PLGS enabled while the other will not.
The primary outcome measure of the study will be glucose sensor values, and the secondary outcome measures include glucose control and instances of hypo- and hyperglycemia.
"Mild to moderate hypoglycemia occurs frequently during the day for people with Type 1 diabetes, but of more concern is the severe hypoglycemia which can occur at night causing seizures or even death," principal investigator Dr. Bruce Buckingham said in a statement. "This is a real concern to all people living with Type 1 diabetes, and especially parents of children with Type 1. This new PLGS algorithm will allow for the automatic suspension of insulin delivery when glucose is predicted to be low. This is beneficial throughout the day, but can be lifesaving at night when a person is otherwise unable to react.”