AURORA | An “artificial pancreas” made in Aurora is one of a handful of medical devices touted as successes of the Food and Drug Administration working to “fast-track” approval for certain medical devices.
Alongside FDA Commissioner Dr. Robert Califf, U.S. Sen. Michael Bennet visited the Barbara Davis Center for Diabetes on the Anschutz Campus Friday and met with several children and young adults who have Type I diabetes. Bennet spoke with several local patients who have been participating in a clinical trial to test a new insulin pump researchers have deemed an “artificial pancreas.”
The device, manufactured by the medical device firm Medtronic, continuously and autonomously monitors a user’s blood sugar levels — which can dramatically spike and drop in people with diabetes — without requiring the user to constantly program the machine.
“We’re making great progress and I think these are going to continue to help people,” said David Maahs, a doctor and principal researcher in several ongoing studies involving the “artificial pancreas.” “They’re gradually going to get better and better. Like with cell phones, you went from having a brick phone, to a flip phone, to an iPhone one. I wish it were quicker, but that’s how technology works.”
Bennet has been lobbying the FDA since 2011 to approve the “artificial pancreas” and in 2012 he met with researchers and patients at Anschutz to bolster those efforts. The FDA released guidance on how such devices could be approved in 2012, according to Laurie Cipriano, spokeswoman for Sen. Bennet.
“We went to the FDA and we said, ‘Listen, you’ve got to put guidance out because people need it,’” Bennet said. “And they’ve done that and the result of that is we now have kids in Aurora, Colorado, who are testing these devices that are going to make a difference in the lives of children all across the United States of America. It’s pretty exciting.”
The progressive insulin pumps could be fully FDA-approved and on the market as soon as next spring, according to Medtronic.
In the meantime, clinical trials on the devices are slated to begin at 10 university medical clinics across the country, increasing the sample size from about 100 users at the Barbara Davis Center to more than 1,000 patients with Type I diabetes, according to Jason Gensler, a research assistant at the local health hub.
Gensler, who has Type I diabetes and was a patient at the Davis Center before becoming an employee, has been using the Medtronic device since local trials began last summer. He said that the new pump has changed the way he views and treats the disease.
“It’s pretty well removed most of the burden that diabetes causes in your life,” he said. “You can’t stop thinking about it when you have to plan everything in your life around your diabetes, but once you get on something like (the “artificial pancreas”) … it just relieves so much burden and stress. You can be a heck of a lot happier and you are a lot more passionate about whatever it is you’re doing because you’re not bogged down by diabetes so much.”