A new clinical trial to investigate the use of artificial pancreas system is set to begin, bringing in touchscreen insulin pump maker Tandem Diabetes Care; Dexcom, which makes continuous glucose monitor; and digital, personalized medicine company TypeZero Technologies.
The International Diabetes Closed Loop trial, funded by a grant from the National Institutes of Health to the University of Virginia, aims to enroll 240 adults with type 1 diabetes. The participants will come from 10 different clinical sites throughout the world – including Mount Sinai Hospital in New York, Stanford University Hospital and the Mayo Clinic in the United States, as well as medical centers in France, Italy and the Netherlands.
A Tandem insulin pump and Dexcom G5 sensor will be included as part of a blood glucose control system that combines the devices with a smartphone running TypeZero’s closed loop algorithm app inControl. Working together, the system can predict high and low blood sugar levels and adjust insulin delivery throughout the day, and the user is still able to manually inject insulin for meals.
Dr. Boris Kovatchev, who is the director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the trial, said the study is designed as a pivotal trial of a closed-loop control-to-range system.
“The integration of technology provided by Tandem, Dexcom and TypeZero in this trial represents a new level of sophistication in artificial pancreas research and development,” Kovatchev said in a statement.
Researchers expect to later add a Dexcom G6 sensor-integrated pump to the trial but integrating with the Tandem t:slim X2 pump. The t:slim X2 Pump, which was just made available last month, integrates with inControl’s algorithms directly into the touchscreen interface, and the entire system will be added to the trial in 2017.
“The addition of Tandem’s innovative touchscreen pumps to the IDCL Trial is tremendous, and a great first step in the integration of our inControl algorithm into a future software update for the t:slim X2 pump,” TypeZero CEO Chad Rogers said in a statement. “We look forward to bringing these solutions to patients in the upcoming trial and ultimately delivering a best-in-class automated insulin delivery solution to patients across the globe.”
TypeZero has an existing connection with the University of Virginia – its technology includes a series of algorithms developed from initial research conducted there, and the technology has been used in more than 28 clinical studies comprising over 475 participants.
Together, the companies anticipate that the integrated system and data collected from the trial will be the basis for Tandem’s future regulatory submission.
“A world-class automated insulin delivery system needs to be simple to use, rely on the most accurate CGM data available, and use a proven and trusted algorithm,” Tandem’s CEO Kim Blickenstaff said in a statement. “We believe the combination of Tandem, Dexcom, and TypeZero technologies will deliver all three, and we are honored to be working together with them for this trial.”