My son Sam, who is 14, faces the day like every other kid his age — waking up, getting dressed, eating breakfast, brushing teeth, finding shoes and rushing out the door to start the day. But there’s one big difference — most kids Sam’s age don’t have to test their blood and take insulin before they walk out the door.
And most moms haven’t been up around the clock checking on their child just to make sure he will be alive in the morning. But that is what you do when somebody has type 1 diabetes, an autoimmune disease that prevents your body from making insulin, a hormone necessary to live.
When you have a child with an incurable disease, everyday life is very different. Each day, Sam tests his blood sugar levels four or five times with a small finger prick. He needs insulin and gets his through an insulin pump that is constantly attached to him. He needs to tell the insulin pump what to do when his glucose is too high or when he is about to eat.
Next to a cure, the most promising technology for type 1 diabetes is an artificial pancreas, an external device about the size of a cellphone, which could help control both high and low blood sugar around the clock. This system combines a continuous glucose monitor and an insulin pump with sophisticated computer software to provide the right amount of insulin at the right time, similar to what a real pancreas does for a person without the disease. It could help nearly 3 million Americans with type 1 diabetes, but they do not have access to it.
Making technology like this available to regular people like my son requires a deep commitment across private, public and government sectors. Over the past six years, the Juvenile Diabetes Research Foundation (JDRF) has made significant investments in research funding towards advancing artificial pancreas technology, and created the Artificial Pancreas Project in 2005. The National Institutes of Health has funded multiple grants to help accelerate the process.
But despite successful studies which show that artificial pancreas technologies improve blood sugar control, to date, the devices have only been tested in inpatient or hospital settings. It’s now time to test the artificial pancreas in more real-world conditions, outside of the hospital and ultimately in a home setting.
JDRF and a team of the world’s leading diabetes experts have submitted recommendations to the FDA of how the artificial pancreas process could move safely and effectively forward so that outpatient studies could begin. If the FDA adopts this guidance document, it would serve as a pathway for researchers and companies to develop safe and effective artificial pancreas devices.
This past June, 150 children with type 1 diabetes descended on Capitol Hill for JDRF Children’s Congress to remind lawmakers why finding a cure for type 1 diabetes is important. In a hearing before the Senate Committee on Homeland Security and Government Affairs, they urged lawmakers to do all they can to help speed the delivery of new technologies, like the artificial pancreas, to people whose lives would dramatically improve.
Their plea will not fall on deaf ears. More than 300 members of Congress, leading clinician organizations representing 6,000 clinical endocrinologists, and 26,000 leading medical professionals and researchers have signed onto letters urging the FDA to adopt the guidelines. I hope they listen.
Debra Garelick is a volunteer for the Juvenile Diabetes Research Foundation. She lives in Boulder.
