Sen. Collins Asks FDA Director about Status of Allowing Younger Children to Access ‘Life-Altering’ Artificial Pancreas

Dr. Shuren thanked Senator Collins for her enduring support of the diabetes community, said he hoped the technology “will move forward quickly”

Click HERE to watch Senator Collins’ Q&A with Dr. Shuren

Washington, D.C. - At a Health, Education, Labor and Pensions Committee hearing today, U.S. Senator Susan Collins, a member of the Committee, questioned Dr. Jeffrey Shuren, director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, about the status of the artificial pancreas for children under the age of 14. 

In September 2016, the FDA approved an artificial pancreas system to improve the management of Type 1 diabetes by automatically controlling blood glucose levels. While this major step forward will help revolutionize diabetes care, it is currently only approved for use by individuals age 14 and older.

“Dr. Shuren, I was delighted to hear you talk about the artificial pancreas. I chaired and founded the Diabetes Caucus in the Senate back in 1998. We have tripled funding for research, which has helped,” said Senator Collins. “But the collaboration that you talked about that has allowed the artificial pancreas to come to market three years earlier, I believe you said, then otherwise would be the case, is going to make such a tremendous difference in the lives of so many children who have Type 1 diabetes.”

“I remember holding a hearing on the promise of an artificial pancreas ten years ago, and it was really wonderful to learn of this development last year and to see it coming to market,” Senator Collins continued. “I understand, however, that the initial access is going to be limited to older children and adults with Type 1 diabetes. Can you update me on what’s going on as far as clinical trials to allow younger children access to this potentially life-altering technology?

“I appreciate by the way all your support in the diabetes community for all these many years,” Dr. Shuren replied. “Yes, the device will be available for patients 14 and older, but additional data is being collected in terms of younger children. The reason is because they are more active, their lifestyle is different, and we just have to make sure that technology—that they’re able to use it given how they eat, how they play. It is our hope that that will move forward quickly as well.”