Enrollment begins for predictive low glucose trial

Tandem Diabetes Care has announced the enrollment of the first participant in an at-home trial assessing predictive low glucose suspend technology, according to a press release.

The trial will assess the safety and efficacy of Tandem’s t:slim X2 insulin pump with predictive low glucose suspend, which suspends insulin delivery when glucose gets to low and resumes delivery when glucose rises. The trial will also use Dexcom’s G5 mobile continuous glucose monitor as part of the delivery system.

“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 the release. “We remain on track to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA in early 2018.”

The trial is a randomized crossover study comparing the t:slim X2 pump with predictive low glucose suspend for 3 weeks and a standard CGM-integrated t:slim X2 pump without the suspension for 3 weeks.

The trial plans to enroll 90 participants with type 1 diabetes aged at least 6 years.

“This new PLGS algorithm will allow for the automatic suspension of insulin delivery when glucose is predicted to be low,” Bruce Buckingham, MD, professor of pediatric endocrinology at The Lucille Salter Packard Children’s Hospital, Stanford University, said in the release. “This is beneficial throughout the day but can be lifesaving at night when a person is otherwise unable to react.”