Maureen Kingsley

November 14, 2016

3 Min Read
Artificial Pancreas Race Intensifies

Sponsored by the University of Virginia and funded by NIH, a new clinical trial combines advanced technologies from three medtech companies.

Maureen Kingsley

Tandem tslim G4Expected to start late this year, the International Diabetes Closed-Loop Trial (IDCLT) will combine technologies from three companies that are looking to make major strides in type 1 diabetes therapy via commercialization of a true artificial pancreas: Tandem Diabetes Care, Dexcom, and TypeZero Technologies.

The trial--sponsored by the University of Virginia and funded by NIH--will include 240 people between the ages of 14 and 75 who have type 1 diabetes.

IDCLT is set up as "a pivotal trial of a closed-loop control-to-range system and includes seven institutions in the United States and three in Europe led by the University of Virginia," Boris Kovatchev, PhD, director of the Center for Diabetes Technology at the University of Virginia and principal investigator of IDCLT, said in a statement.

The technologies involved include the t:slim G4 model of insulin pump by Tandem Diabetes Care, a Dexcom G5 sensor for continuous blood glucose monitoring, and inControl closed-loop-algorithm software developed by TypeZero Technologies.

With its glucose-monitoring function, insulin pump, and software all working together, the system predicts high and low blood-sugar levels and adjusts insulin delivery accordingly throughout each day. In addition to making basal insulin adjustments, TypeZero's inControl software automates correction boluses. The user manually boluses insulin for meals--a situation similar to Medtronic's new FDA-approved MiniMed 670G insulin pump.

Tandem and Dexcom anticipate adding to the trial in 2017 a Dexcom G6-sensor-integrated t:slim X2 pump that incorporates inControl's algorithms directly into the pump's touchscreen interface. (Tandem Diabetes Care manufactures the only touchscreen insulin pumps sold in the United States.) The three companies expect the integrated design, along with data from the IDCLT, to serve as a future regulatory submission from Tandem.

"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," said Kovatchev a the University of Virginia.

Kim Blickenstaff, president and CEO of Tandem Diabetes Care, added that "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."

The race toward creating a true closed-loop and fully automated artificial pancreas includes many competitors. Last week, for instance, Qmed reported on BD's collaboration with JDRF to develop an extended-wear insulin-infusion set that would remain effective beyond the three days of use that currently available infusion sets offer. In September of this year, Medtronic's MiniMed 670G artificial-pancreas-type device earned FDA approval, as did Abbott's Freestyle Libre Pro continuous glucose monitoring system. Two years ago, Animas Corp., a subsidiary of J&J, won FDA approval for its Animas Vibe insulin pump and continuous glucose monitoring system.

Additionally, startup company Beta Bionics, led by a Boston University professor with financial backing from Eli Lilly and Co., developed a bionic pancreas called iLet that is scheduled to begin its final round of human clinical trials early next year.

Maureen Kingsley is a contributor to Qmed. 

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[Image of t:slim G4 model of insulin pump courtesy of Tandem Diabetes Care]

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