Tandem Diabetes Care (NSDQ:TNDM) said today that it enrolled the first patient in an at-home pivotal trial of its t:slim X2 insulin pump combined with the company’s predictive low glucose suspend algorithm.
Using DexCom’s G5 mobile continuous glucose monitor and Tandem’s predictive technology, the insulin pump is designed to halt insulin delivery when it predicts low blood glucose and resume insulin delivery when glucose levels begin to rise.
The 90-patient Prolog study is slated to compare two, 3-week periods of at-home insulin pump use – one period using the t:slim X2 pump with Tandem’s predictive technology and the second period using a standard CGM-integrated t:slim X2 pump without automated insulin suspension.
The study’s primary endpoint is to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s predictive algorithm, according to the San Diego-based company.
“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,” president & CEO Kim Blickenstaff said in prepared remarks. “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 I 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 I diabetes, and especially parents of children with Type I,” principal investigator Dr. Bruce Buckingham added. “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.”