2011 Children’s Congress: The Artificial Pancreas and the FDA

After having worked the past three Children’s Congresses, I love the fact that each class of our delegates is key in making sure that we continue to push forward towards a cure and ensure that federal funding continues to support this effort. 

However, the CC11 delegates not only helped in making sure that Congress understood the need to keep funding diabetes research towards a cure but they also made a step towards making the management of diabetes easier. While at the Senate hearing on Transforming Lives Through Diabetes Research, I heard the FDA representative, at least three times, mention that the agency was aiming to release draft guidelines for outpatient trials for the artificial pancreas… and this, on the heals of the FDA releasing draft guidelines for the Low Glucose Suspend (LGS) system. The FDA press release notes LGS as a ‘system [which] can help reduce or lessen the severity of a dangerous drop in glucose levels (hypoglycemia) by temporarily reducing or stopping the delivery of insulin. However, patients must still manage their glucose levels with a glucose meter and give themselves insulin, if necessary.’ Although not a closed-loop system that can turn insulin off and on like an artificial pancreas system, still a step in the right direction, even if we have to wait until the end of the year to get going on closed-loop system. 

What you can do:
The work for the Children’s Congress delegates doesn’t stop here but they’ll need your help! We need to make sure that Congress continues help us get the artificial pancreas to those that need it. Congress has been instrumental in encouraging the FDA to expedite the outpatient research guidelines for the artificial pancreas but it can’t stop there. We’ll also need Congress’ help to make sure we are able to determine the cost and coverage of the device once approved by the FDA. We’ll need you to participate in the 2011-2012 Promise to Remember Me Campaign and remind your Members of Congress to keep the artificial pancreas top of mind by attending meetings for the Promise Campaign, sharing your story of living with type 1 diabetes, and how devices like the artificial pancreas can make the management of diabetes easier for millions! Please sign up today!

Hasan