Tandem Diabetes Care enrolled the first patients in a pivotal trial of a system, based on its touchscreen insulin pump, that automatically stops insulin delivery when a patient’s blood glucose levels are predicted to fall.
The system comprises Dexcom’s G5 continuous glucose monitor and Tandem’s t:slim X2 insulin pump and its predictive low-glucose suspend (PLGS) algorithm. It is designed to suspend insulin delivery when low blood glucose levels are predicted and resume delivery when glucose levels begin to rise, the company said in a statement.
The multicenter, randomized crossover study will compare the use of the t:slim X2 pump with PLGS and the t:slim X2 pump alone. It will involve 90 participants aged 6 and older who have Type 1 diabetes and will compare two three-week periods of at-home pump use. 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 company said.
“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 Tandem CEO Kim Blickenstaff in the 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.”
Several companies are working on systems that automatically adjust insulin delivery based on data from a continuous glucose monitor. Tandem and Dexcom teamed up with TypeZero Technologies in November to develop a closed-loop system for blood glucose control, which will be tested in the NIH-funded International Diabetes Closed Loop Trial. Roche, Senseonics and TypeZero are working on a long-term system that will be tested in the same trial.
Medtronic has led the pack so far, snagging FDA approval for its hybrid closed-loop system last fall. Based on its MiniMed 670G insulin pump, the system regulates background, or basal, insulin via a sensor that can be used for seven days at a time.