The Bionic Pancreas Begins an 11-Day Home Study – Plus, an Opportunity for Patients to “Go Bionic”
On July 3, Dr. Ed Damiano addressed the Friends for Life Conference in Orlando with the latest update on his team’s bionic pancreas, which involves automated insulin+glucagon delivery using CGM readings from a Dexcom G4 Platinum, a control algorithm running on an iPhone, and two Tandem t:slim pumps. After opening with a compelling video from the Helmsley Charitable Trust on the “bionic kids” summer camp study (we had the privilege of visiting this camp last summer), Dr. Damiano discussed his team’s current 11-day study, which will test the bionic pancreas in 40 adults with type 1 diabetes. Patients will have the freedom to live at home and go about their normal lives with limited remote monitoring, all while their blood sugar is managed 24/7 by the bionic pancreas. Dr. Damiano put it best: “We give them the bionic pancreas and then wave goodbye.” The current trial won’t be completed until early May 2015, though Dr. Damiano gave a sneak preview of the preliminary results from two participants who have already completed their 11-day tests; both patients had a mean blood glucose around 133 mg/dl and spent less than 1% of time below 60 mg/dl. While these numbers are consistent with previous results, they are particularly encouraging given that this trial is a true home study and the bionic pancreas was worn for more than twice as long as it was during the Beacon Hill and 2013 summer camp studies.
Dr. Damiano’s team will conduct another camp study this summer as well, this time focusing on younger children 6-11 years old. Once the ongoing 11-day study and the camp study are complete, the team plans to conduct a final pivotal study in 2016, which will have hundreds of participants use the final version of the bionic pancreas device (a single device with two chambers, one for insulin and one for glucagon, along with an embedded control algorithm and integrated CGM) for several months. The team has an ambitious timeline indeed, but a necessary one for Dr. Damiano to fulfill his dream of having the bionic pancreas on the market by the time his son with type 1 diabetes enters college in 2017.
Funding is one of the biggest obstacles to meeting that deadline, as the team needs ~$5 million to build the integrated bionic pancreas device in the next two months. At Friends for Life, Dr. Damiano urged each family in attendance to take the “Go Bionic” challenge and raise $5,000 by September 1. This is an important and unique opportunity, as it will provide people with diabetes the chance to bring an innovative product to market. If you would like to support the Go Bionic Campaign, please visit their donation page. For more information on this topic, please read our resource page on all things related to the artificial pancreas. We will be back soon with specific advice on the Bionic Challenge. –AJW