UVA Receives $3.4 million NIH Grant for Artificial Pancreas Trial with 250 Participants in Network Closed-Loop System
By Adam Brown
On November 18, the University of Virginia (UVA) announced that it received a $3.4 million NIH grant for three artificial pancreas studies to be conducted at UVA and Stanford. Notably, the three studies will occur in patients’ homes, and a very large population of 250 adults and children in total will participate in the three trials combined. The first study will be one month long, aiming to reverse hypoglycemia unawareness. As currently planned, a follow-up study will be even longer, lasting an impressive three months and aiming for long-term improvement in glucose control (A1c). The goal is to begin the trials in April/May 2014 depending on FDA approval, with the first results expected in mid-2015. The large size, long-term, and more real-world nature of these trials is very notable, especially considering that results from the first artificial pancreas studies to occur outside of the hospital were first reported not so very long ago in February 2012. See this issue for Kelly’s recent experience on this system – she had an incredible time testing it and sees it as a landmark product.
The University of Virginia’s artificial pancreas system, called the Diabetes Assistant, runs a control algorithm on an Android smartphone that communicates with an insulin pump (Roche or Tandem) and a Dexcom CGM. The insulin-only system uses “treat-to-range” control during the day, meaning patients will still bolus for meals, but the system will aim to keep glucose in a designated range by increasing/decreasing insulin infusion as needed. Overnight, the system will “treat-to-target,” with the goal of stabilizing glucose and giving patients a fresh start at 110-120 mg/dl every morning – yes! These trials will also use a new network approach to artificial pancreas design, which is intended to make the system safer by distributing the system’s computing between local services and the cloud.–TW/AB