Artificial pancreas large-scale clinical study

Charlottesville, Virginia – TypeZero Technologies officials announce that the company will provide the inControl AP (artificial pancreas) diabetes management platform as the core analytic and control technology for the NIH sponsored, $12.7 million clinical study called the International Diabetes Closed Loop Trial. This trial is scheduled to begin early this year and is managed by Dr. Boris Kovatchev and the Center for Diabetes Technology at the University of Virginia.

inControl AP, TypeZero’s first “artificial pancreas” product, was developed from prototype technology licensed from the University of Virginia in 2013. Over the past four years the core technology has been tested in numerous FDA clinical studies and has evolved into a stable and secure suite of applications running on a mobile device linked to an insulin pump and continuous blood glucose monitor, which automatically monitors and controls blood-glucose levels for patients with Type 1 diabetes. “inControl AP represents the next generation of diabetes management products which will dramatically change the way people with Type 1 diabetes treat and manage their disease. Our participation in this unprecedented NIH sponsored multicenter trial is transformational and will help accelerate TypeZero’s path to delivering a product to the Type 1 community,” said Chad Rogers, CEO of TypeZero Technologies.

Over the past two years, TypeZero Technologies has worked to translate the core technologies licensed from UVA into FDA approvable solutions to support patients with Type 1 and Type 2 diabetes. This represents the first step in the translation of those technologies into revolutionary products. The results achieved in this large-scale study will set the stage for TypeZero’s algorithms to support various medical device manufacturers in the development of next generation, “smart” insulin delivery devices. The data in this trial will confirm the power of inControl to dramatically reduce a patients’ average blood sugar level while simultaneously reducing a patient’s risk of hypoglycemic events.

“This study represents the culmination of more than ten years of work and numerous FDA approved studies and will allow us to test this groundbreaking technology and solidify the safety and efficacy of this artificial pancreas system on a large number of patients on an international platform,” said Dr. Boris Kovatchev director of the Center for Diabetes Technology at UVA.

The NIH grant was awarded to the IDCL Consortium led by Dr. Boris Kovatchev and Dr. Stacey Anderson, from UVA, Dr. Frank Doyle (Harvard), Dr. Yogish Kudva (Mayo Clinic) and Dr. Carol Levy (Mt. Sinai) which will run this study at 9 institutions across the globe. The U.S. sites include the University of Virginia, Harvard, Mount Sinai, the Mayo Clinic, Stanford, Barbara Davis Center at the University of Colorado. The European sites include the University of Padua (Italy), the University of Montpellier (France), Academic Medical Center Amsterdam (Holland). The study will be coordinated by the Jaeb Center for Health Research.

In a separate release, co-principal investigator and engineering lead on the project Francis J. Doyle III, dean and John A. & Elizabeth S. Armstrong Professor of Engineering & Applied Sciences at Harvard SEAS said, "The idea is that this can lead to an improved quality of life for individuals with this disease – not a solution to diabetes, but a means to really extend the quality of their healthful living.

Watch Prof. Doyle discussing the artificial pancreas and the significance of the clinical trials.

For Doyle, the launch of the clinical trials is the latest milestone in a research pursuit now in its twentieth year. Early in his career, he co-authored one of the first papers on the systems control aspects of a hypothetical artificial pancreas. From theoretical mathematical modeling to clinical testing, his research group has been building on that work ever since, as the technology has evolved from open-loop studies with humans in the loop to closed-loop systems embedded on a chip.

Doyle and SEAS senior researcher Eyal Dassau, collaborators at the University of California, Santa Barbara before joining Harvard in the fall of 2015, are also part of a team working on a pediatric version of the artificial pancreas system as well as an implantable version of the device.

Source: TypeZero Technologies