Tandem Diabetes Care, a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced enrollment of the first patients in an at-home pivotal trial for its t:slim X2 Insulin Pump using Tandem’s predictive low glucose suspend (PLGS) technology. The insulin pump system, which uses an integrated Dexcom G5® Mobile Continuous Glucose Monitor (CGM), is designed to suspend insulin delivery when low blood glucose is predicted and subsequently resume insulin delivery when glucose levels begin to rise.
The PROLOG (PLGS for Reduction Of LOw Glucose) study is a multi-center, randomized crossover study comparing two 3-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The clinical trial will include 90 participants with type 1 diabetes ages 6 and above at five research centers across the United States and is being coordinated by the Jaeb Center for Health Research in Tampa, Florida. The primary endpoint of the study is to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s PLGS algorithm.
“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,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “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.”
“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. This is a real concern to all people living with type 1 diabetes, and especially parents of children with type 1,” said Dr. Bruce Buckingham, Professor of Pediatric Endocrinology at The Lucille Salter Packard Children’s Hospital, Stanford University, and principal investigator of the PROLOG trial. “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.”