TypeZero Technologies' Artificial Pancreas Solution, inControl AP, Will Be Tested in a Large Scale, NIH Funded ($12.7 Million) Clinical Study Run by the University of Virginia and 8 Other Locations in 2016
TypeZero's inControl AP platform will revolutionize diabetes management for many Type 1 patients around the world.
Jan 04, 2016, 17:44 ET from TypeZero
CHARLOTTESVILLE, Va., Jan. 4, 2016 /PRNewswire/ -- TypeZero Technologies is pleased to announce that we will provide our 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 ("IDCL"). This trial is scheduled to begin in early 2016 and is managed by Dr. Boris Kovatchev and the Center for Diabetes Technology at the University of Virginia ("UVA").
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. "inControlAP 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.
TypeZero Technologies, which is headquartered in Charlottesville, VA is a digital health and technology company that specializes in software and analytics that revolutionize the way the world treats and manages Type 1 and Type 2 diabetes. The Company applies mathematical analysis and modern engineering practices to the problem of diabetes. At TypeZero we build personalized analytics and control solutions based upon proven metabolic models to help people with diabetes improve health outcomes and reduce stress while dramatically reducing cost of treatment. Our products range from mobile minute-by-minute closed-loop control of blood glucose (Artificial Pancreas) to cloud-based predictive analytics, to smart bolus calculators to clinician tools for therapy optimization. TypeZero is a private company currently backed by angel investors and early stage venture capital and is growing rapidly. To learn more visit www.TypeZero.com
For more information, contact:
Molly McElwee-Malloy, RN, CDE
212 East Main Street, Suite 202
Charlottesville, VA 22902