NIH’s National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) www.niddk.nih.gov awarded a $12.7 million grant to the Center for Diabetes Technology at the University of Virginia (UVA) http://med.virginia.edu/diabetes-technology to conduct clinical trials for an Artificial Pancreas (AP) device.
The device which automatically monitors and regulates blood sugar levels in people with type 1 diabetes will undergo final testing in two clinical trials beginning in early 2016. The first trial referred to as the International Diabetes Closed-Loop Trial will test technology developed at UVA and refine the device for clinical use by TypeZero Technologies http://typezero.com, the startup company that licensed the UVA system.
The first study will include 240 patients with type 1 diabetes to test the safety and effectiveness of the AP for six months while going about their regular daily routines. The AP will be compared to a standard insulin pump on two key measures to report on how well blood sugar levels are controlled and whether the risk of hypoglycemia or low blood sugar is reduced.
The second trial will examine a new control algorithm developed by a Harvard co-investigator to test whether it further improves control of blood glucose in patients with type 1 diabetes. The second trial will follow 180 patients who have completed the first study for an additional six months to test the Harvard developed algorithm and to determine whether it further enhances blood sugar control.
According to Stacey Anderson MD and Boris Kovatchev PhD., Directors at the UVA Center for Diabetes Technology, “The trials are some of the largest long term clinical trials of the artificial pancreas in the patient’s natural environment. The AP is not a single function device since it is an adaptable wearable network surrounding the patient in a digital treatment ecosystem.”
At the center of the AP platform is a reconfigured smartphone that runs advanced algorithms and links wirelessly to a blood sugar monitor and an insulin pump, as well as to a remote monitoring site. People with the artificial pancreas can also access assistance via telemedicine.
The AP will be tested at UVA plus eight other sites, to include Harvard www.harvard.edu, Icahn Mount Sinai School of Medicine http://icahn.mssm.edu, Mayo Clinic www.mayoclinic.org, University of Colorado www.colorado.edu , Stanford www.stanford.edu, Montpellier University in France www.umontpellier.fr/en, University of Padova in Italy www.unipd.it/en, and the Academic Medical Center at the University of Amsterdam www.uva.nl/en/home.