NIH taps a trio of devicemakers for ‘artificial pancreas’ trial

t:slim X2 insulin pump--Courtesy of Tandem Diabetes Care

Diabetes players Dexcom and Tandem Diabetes Care are joining forces with digital health company TypeZero Technologies on a closed-loop system for blood glucose control.

The system will include Dexcom’s G5 glucose sensor, a Tandem insulin pump and a smartphone that will run TypeZero’s inControl closed-loop algorithm. The combined platform will continuously predict blood sugar levels and adjust insulin delivery automatically, according to a statement. While the system is intended to regulate basal, or background, insulin, it also automates correction boluses and still lets the user manually deliver bolus insulin ahead of meals.

It will be tested in the NIH-funded International Diabetes Closed Loop Trial, which will kick off later this year. The partners are looking to enroll 240 adults with Type 1 diabetes in the trial.

“The IDCL Trial is designed as a pivotal trial of a closed-loop control-to-range system, and includes seven institutions in the U.S. and three in Europe led by the University of Virginia,” said Boris Kovatchev, director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the IDCL Trial, in the statement. “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.”

While the current iteration of the closed-loop system runs the inControl algorithm on a smartphone, the partners hope to integrate Dexcom's G6 sensor into Tandem's t:slim X2 insulin pump and incorporate TypeZero's algorithm directly into the pump's touchscreen, according to the statement. They expect to introduce this new design to the trial in 2017 and anticipate that it, along with data from the trial, will be the foundation of a future regulatory submission.

There is currently one approved “artificial pancreas,” Medtronic’s hybrid closed-loop system, which earned the FDA nod in September. It is indicated for people aged 14 and older with Type 1 diabetes and regulates background insulin levels with “little to no input” from the patient. The system comprises Medtronic’s MiniMed 670G insulin pump, an infusion patch and catheter for insulin delivery, and a sensor that continuously measures glucose levels under the skin.